Quality and Evidence-Based Respiratory Care

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Chapter 2

Quality and Evidence-Based Respiratory Care

Lucy Kester and James K. Stoller

Chapter Objectives

After reading this chapter you will be able to:

Describe the elements that constitute quality respiratory care.

Explain methods used for monitoring the quality of respiratory care that is provided.

Explain how respiratory care protocols enhance the quality of respiratory care services.

Define disease management.

Describe evidence-based medicine.

Quality is defined as a characteristic reflecting a high degree of excellence, fineness, or grade. Ruskin, a nineteenth-century British author, stated, “Quality is never an accident. It is always the result of intelligent effort.” Conclusions drawn from the assessment of quality are only temporary because the components of quality are constantly changing. Specifically, quality, as applied to the practice of respiratory care, is multidimensional. It encompasses the personnel who perform respiratory care, the equipment used, and the method or manner in which care is provided. Determining the quality of services provided by a respiratory care department requires intelligent efforts to establish guidelines for delivering quality care and a method for monitoring this care. The conclusions derived from monitoring the respiratory care provided change as clinical practice and expectations change. In the current cost-attentive era of health care, quality can be challenged by pressures to minimize cost, making the measurement and monitoring of quality even more important.

This chapter reviews issues related to the quality of respiratory care. First, we review the elements of a hospital-based respiratory care program, focusing on medical direction, practitioners, and technical direction. With the objective of quality being the competent delivery of indicated care, we discuss respiratory care protocols as one strategy to ensure quality. Methods for monitoring quality are discussed next, with attention to the role of The Joint Commission (TJC) and peer review organizations (PROs). We then discuss the effect of several health care delivery strategies on respiratory care quality. Finally, we review the concept of evidence-based medicine as it applies to the practice of respiratory care.

Elements of A Hospital-Based Respiratory Care Program: Roles Supporting Quality Care

Medical Direction

The medical director of respiratory care is professionally responsible for the clinical function of the department and provides oversight of the clinical care that is delivered (Box 2-1). Medical direction for respiratory care is usually provided by a pulmonary/critical care physician or an anesthesiologist. Whether the role of a respiratory care service medical director is designated as a full-time or part-time position, it is a full-time responsibility; the medical director must be available on a 24-hour basis for consultation with and to give advice to other physicians and the respiratory care staff. The current philosophy of cost containment and cost-effectiveness, dictated by medical care market forces, poses a challenge to the medical and technical leadership of respiratory care services to provide increasingly high-quality patient care at low cost. A medical director must possess administrative and medical skills.¹

Perhaps the most essential aspect of providing quality respiratory care is to ensure that the care being provided is indicated and that it is delivered competently and appropriately. Traditionally, the physician has evaluated patients for respiratory care and has written the specific respiratory therapy orders for the respiratory therapist (RT) to follow. However, such traditional practices have often been shown to be associated with misallocation of respiratory care.2–4 This misallocation may consist of ordering therapy that is not indicated, ordering therapy to be delivered by an inappropriate method, or failing to provide therapy that is indicated.⁵ Table 2-1 reviews studies evaluating the allocation of respiratory care services and the frequency of misallocated care.^3,6–12 These studies provide ample evidence that misallocation of respiratory care occurs frequently. Such misallocation has led to the use of respiratory care protocols that are implemented by RTs (as described under Methods for Enhancing the Quality of Respiratory Care).

TABLE 2-1

Frequency of Misallocation of Respiratory Care Services in Selected Series

Type of Service	Author	Date	Patient Type	No. Patients	Frequency of Overordering	Frequency of Underordering
Supplemental oxygen	Zibrak et al⁶	1986	Adults	NS	55% reduction in incentive spirometry after therapist supervision began	NA
	Brougher et al⁷	1986	Adult, non-ICU inpatients	77	38% ordered to receive oxygen despite adequate oxygenation	NA
	Small et al⁸	1992	Adult, non-ICU inpatients	47	72% of patients checked had PaO₂ > 60 mm Hg or SaO₂ > 90% but were prescribed oxygen	NA
	Kester and Stoller³	1992	Adult, non-ICU inpatients	230	28% for supplemental oxygen	8% for supplemental oxygen
	Albin et al⁹	1992	Adult, non-ICU inpatients	274	61% ordered to receive supplemental oxygen despite SaO₂ ≥ 92%	21% underordered, including 19% prescribed to receive inadequate O₂ flow rates
	Shelledy et al¹²	2004	Adults	75	0	5.3% indicated but not ordered
Bronchial hygiene techniques	Zibrak et al⁶	1986	Adults	NS	55% reduction in incentive spirometry after therapist supervision began	NA
	Shapiro et al¹⁰	1988	Adult, non-ICU inpatients	3400 evaluations	61% reduction of bronchial hygiene after system implemented	NA
	Kester and Stoller³	1992	Adult, non-ICU inpatients	230	32%	8%
	Shelledy et al¹²	2004	Adults	75	37.5%	8%
Bronchodilator therapy	Zibrak et al⁶	1986	Adults	NS	50% reduction in incentive aerosolized medication after therapist supervision began	NA
	Kester and Stoller³	1992	Adult, non-ICU inpatients	230	12%	12%
	Shelledy et al¹²	2004	Adults	75	34.4%	5.3%

	Kester and Stoller³	1992	Adult, non-ICU inpatient	230	40%	6.7%
ABGs	Browning et al¹¹	1989	Surgical ICU inpatients	724 ABGs	42.7% inappropriately ordered before guidelines implemented	NA

NS, Not stated; NA, not assessed.

Modified from Stoller JK: The rationale for therapist-driven protocols. Respir Care Clin N Am 2:1–14, 1996.

Respiratory Therapists

In addition to capable medical direction and the application of well-constructed respiratory care protocols (see p. 26), capable RTs are an indispensable element of a quality respiratory care program. The quality of RTs depends primarily on their training, education, experience, and professionalism. Training teaches students to perform tasks at a competent level, whereas clinical education provides students with a knowledge base they can use in evaluating a situation and making appropriate decisions.¹³ Both adequate training and clinical education are required to produce qualified RTs for assessment of patients and implementation of respiratory care protocols.¹⁴

Designations and Credentials of Respiratory Therapists

There are two levels of general practice credentialing in respiratory care: (1) certified respiratory therapists (CRTs) and (2) registered respiratory therapists (RRTs). Students eligible to become CRTs and RRTs are trained and educated in colleges and universities. After completion of an approved respiratory care educational program, a graduate may become credentialed by taking the entry-level examination to become a CRT. A CRT may be eligible to sit for the registry examinations to become a credentialed RRT. Students who complete a 2-year program graduate with an associate degree, and students who complete a 4-year program receive a baccalaureate degree. Some RTs go on to complete a graduate degree (e.g., master or doctorate) with additional study in the areas of respiratory care, education, management, or health sciences. The further development of graduate education in respiratory care has been encouraged by the American Association for Respiratory Care (AARC), and programs are both currently available and under development.¹⁵

Respiratory care education programs are reviewed by the Committee on Accreditation for Respiratory Care (CoARC). This committee is sponsored by four organizations: the AARC, the American College of Chest Physicians (ACCP), the American Society of Anesthesiologists (ASA), and the American Thoracic Society (ATS). The CoARC is responsible for ensuring that respiratory therapy educational programs follow accrediting standards or essentials as endorsed by the American Medical Association (AMA). Members of the CoARC visit respiratory therapy educational programs to judge applications for accreditation and make periodic reviews. The mission of the CoARC, in collaboration with the Association of Specialized and Professional Accreditors, is to promote quality respiratory therapy education through accreditation services. An annual listing of accredited respiratory therapy programs is published. As of November 2010, there were approximately 415 CoARC-approved respiratory care programs.

Credentialing is a general term that refers to the recognition of individuals in particular occupations or professions. Generally, the two major forms of credentialing in the health fields are state licensure and voluntary certification. Licensure is the process in which a government agency gives an individual permission to practice an occupation. Typically, a license is granted only after verifying that the applicant has demonstrated the minimum competency necessary to protect the public health, safety, or welfare. Licensure laws are normally made by state legislatures and enforced by specific state agencies, such as medical, nursing, and respiratory care boards. In states where licensure laws govern an occupation, practicing in the field without a license is considered a crime punishable by fines or imprisonment or both. Licensure regulations are based on a practice act that defines (and limits) what activities the professional can perform. Two other forms of state credentialing are less restrictive. States that use title protection simply safeguard the use of a particular occupational or professional title. Alternatively, states may request or require practitioners to register with a government agency (registration). Neither title protection nor state registration constitutes a true practice act, and because both title protection and registration are voluntary, neither provides strong protection against unqualified or incompetent practice.

Certification is a voluntary, nongovernment process whereby a private agency grants recognition to an individual who has met certain qualifications. Examples of qualifications are graduation from an approved educational program, completion of a specific amount of work experience, and acceptable performance on a qualifying examination. The term registration is often used interchangeably with the term certification, but it may also refer to a type of government credentialing. As a voluntary process, certification involves standards that are often higher than the minimum standards specified for entry-level competency. A major difference between certification and licensure is that certification generally does not prevent others from working in that occupation, as do most forms of licensure. Both types of credentialing apply in respiratory care.

The primary method of ensuring quality in respiratory care is voluntary certification or registration conducted by the National Board for Respiratory Care (NBRC). The NBRC is an independent national credentialing agency for individuals who work in respiratory care and related services. The NBRC is cooperatively sponsored by the AARC, the ACCP, the ASA, the ATS, and the National Society for Pulmonary Technology. Representatives of these organizations make up the governing board of the NBRC, which assumes the responsibility for all examination standards and policies through a standing committee. The NBRC provides the credentialing process for both the entry-level CRT and the advanced-practitioner RRT. As established in January 2006, to be eligible for either the CRT or the RRT examination, all candidates must have an associate degree or higher. An additional advanced-practitioner credential, the neonatal/pediatric specialist (NPS), has been established for the field of pediatrics. The NBRC also encourages professionals in the field to maintain and upgrade their skills through voluntary recredentialing. Both CRTs and RRTs may demonstrate ongoing professional competence by retaking examinations. Individuals who pass these examinations are issued a certificate recognizing them as “recredentialed” practitioners. In addition to the certification and registration of RTs, the NBRC provides credentialing in the area of pulmonary function testing for certified pulmonary function technologists (CPFTs) and registered pulmonary function technologists (RPFTs). Since its inception, the NBRC has issued more than 350,000 professional credentials to more than 209,000 individuals. As of 2010, there were approximately 206,150 active RTs, many of whom hold more than one credential. Table 2-2 shows the distribution of these credentialed individuals.

TABLE 2-2

Distribution of Credentialed Practitioners

Credential Type	No. Credentialed Practitioners
CRT	206,150
RRT	117,215
CPFT	12,393
RPFT	4192
NPS	10,060

As of October 14, 2010.

Note: Practitioners may hold more than one credential (i.e., RRTs are also CRTs and NPS are also CRTs and RRTs).

At the time of publication, 49 states, the District of Columbia, and Puerto Rico have some form of state licensure. Many states use the NBRC entry-level respiratory care examination for state licensing, whereas others simply verify NBRC credentials. Most licensure acts require the RT to attain a specified number of continuing education credits to maintain his or her license. Continuing education helps practitioners keep abreast of the changes and advances that occur in their health care field.

Licensure and certification help ensure that only qualified RTs participate in the practice of respiratory care. Many institutions conduct annual skills checks or competency evaluations in compliance with TJC requirements. Beyond TJC–required skills checks, experience with respiratory care protocols suggests the need to develop and monitor additional skills among RTs (Box 2-2). Assurance and maintenance of these skills require ongoing training and quality review programs, which are discussed in the section on Monitoring Quality Respiratory Care.

Box 2-2 Additional Respiratory Therapist Skills Required for Implementing Protocols

• Assess and evaluate patients regarding indications for therapy and for the most appropriate delivery method

• Be cognizant of age-related issues and how they affect the patient’s ability to understand and use various treatment modalities

• Adapt hospital policies and procedures to alternative care sites

• Conduct and participate in research activities to ensure a scientific basis for advances in respiratory care technology

• Communicate effectively with all members of the health care team, and contribute to the body of literature concerning the field of respiratory care

Professionalism

By definition, professionalism is a key attribute to which all RTs should aspire and that must guide respiratory care practice. Webster’s New Collegiate Dictionary defines a profession as “a calling that requires specialized knowledge and often long and intensive academic preparation.” A professional is characterized as an individual conforming to the technical and ethical standards of a profession. RTs demonstrate their professionalism by maintaining the highest practice standards, by engaging in ongoing learning, by conducting research to advance the quality of respiratory care, and by participating in organized activities through professional societies such as the AARC and associated state societies. Box 2-3 lists the professional attributes of the RT. We emphasize the importance of these attributes because the continued value and progress of the field depend critically on the professionalism of each practitioner.¹⁶

Box 2-3 Professional Characteristics of a Respiratory Therapist

• Completes an accredited respiratory therapy program

• Obtains professional credentials

• Participates in continuing education activities

• Adheres to the code of ethics put forth by the institution or state licensing board or both

• Joins professional organizations

In the highly regulated careers of health care, professionalism also requires compliance with external standards, such as the standards set by TJC and by the government. One such standard is defined by the Health Insurance Portability and Accountability Act (HIPAA) of 1996. HIPAA sets standards regarding the way sensitive health care information is communicated and revealed in the transmission of medical records and in the written and verbal communication of information in the hospital. Some specific provisions of HIPAA are presented in Box 2-4. As with all hospital and health care personnel, standards of respiratory therapy professionalism require knowledge of HIPAA and compliance with its terms.

Box 2-4 Health Insurance Portability and Accountability Act of 1996 (HIPAA)

The use and disclosure of protected health information (PHI) by a covered entity are prohibited unless it is a permitted use or disclosure for purposes of treatment, payment, or health care operations or is authorized by the patient. When disclosure or use of PHI is permitted, ensure that only the minimum necessary information is disclosed.

Definition of Terms

Use: Release of PHI within the institution

Disclosure: Release of PHI outside the institution

PHI: Individually identifiable health information

Covered entity: Health care provider, health plan, health care clearinghouse

Permitted: As long as there are reasonable safeguards in place regarding the Privacy Rule and the information given is the “minimum necessary”

Treatment: Necessary information can be disclosed to all involved in treatment (physicians, nurses, allied health personnel)

Payment: To allow for billing, for insurance purposes and third-party payers

Authorized: Patient’s written agreement for permitted use

Minimum necessary: Reasonably necessary to accomplish intended purpose

Technical Direction

Another important element for delivering quality respiratory care is technical direction. Technical direction is often the responsibility of the manager of a respiratory care department, who must ensure the equipment and the associated protocols and procedures have sufficient quality to ensure the safety, health, and welfare of the patient using the equipment. Medical devices are regulated under the Medical Device Amendment Act of 1976, which comes under the authority of the U.S. Food and Drug Administration (FDA). The FDA also regulates the drugs delivered by RTs. The purpose of the FDA is to establish safety and effectiveness standards and to ensure that these standards are met by equipment and pharmaceutical manufacturers.

Procedures and protocols related to the use of equipment and medications must be written to provide a guide for the respiratory care staff. In addition, equipment must be safety checked, and specific maintenance procedures must be performed on a regular basis. Because of rapidly changing respiratory care technology, the job of the technical director poses significant challenges. Circuit boards and computers have replaced simpler mechanical devices. New medications and delivery devices for the treatment of asthma and new strategies for treating other respiratory diseases (e.g., low-stretch ventilatory approaches for acute respiratory distress syndrome [ARDS]) continue to evolve. Individuals responsible for technical direction must ensure that these new devices, methods, and strategies not only are effective but also deliver a benefit commensurate with the cost.

Methods for Enhancing Quality Respiratory Care

Respiratory Care Protocols

In an effort to improve the allocation of respiratory care services, respiratory care protocols (also known as therapist-driven protocols) have been developed and are in use in many hospitals in the United States, Canada, and other countries. Respiratory care protocols are guidelines for delivering appropriate respiratory care treatments and services (i.e., treatments and services that are indicated, delivered by the correct method, and discontinued when no longer needed). Protocols may be written in outline form or may use algorithms (an example of which is a branching logic flow diagram [Figures 2-1 and 2-2]).

FIGURE 2-1 Respiratory care protocol. Aerosolized bronchodilator therapy algorithm for current or history of bronchospasm.

FIGURE 2-2 Respiratory care protocol to determine when oxygen concentration should be increased or decreased or when the therapy should be discontinued. *(1)* Shortness of breath, tachycardia, diaphoresis, confusion. *(2)* Oxygen saturation measured by pulse oximeter (SpO₂) criteria may be modified with documented evidence of preexisting chronic hypoxemia. *(3)* Appropriate time lapse for recheck: 10 minutes for patients without pulmonary history; 20 minutes for patients with pulmonary history. *Note:* Oxygen concentration should not be decreased more than once per shift.

Gaylin and colleagues ¹⁷ conducted a telephone survey in 1999 of 371 RT members of the AARC, of whom 51% were practitioners, 26% were clinical supervisors, and 23% were administrators. When asked if their organizations used guidelines or protocols, 98% of the respondents indicated that they did. Of the 2% who did not, 53% were planning their use.¹⁷ A survey conducted by the AARC in 2005 indicated that of 681 responding hospitals, 73% were providing care by means of at least one protocol.¹⁸ More recently, the 2009 AARC Human Resources Survey showed that of 2764 responders, about two-thirds (65.7%) indicated that they have delivered respiratory care by protocol.¹⁹ The use of respiratory care protocols by qualified RTs is a logical practice based on the premise that well-trained RTs possess extensive knowledge of respiratory care modalities and have the assessment and communication skills required to execute the protocols effectively.²⁰

Mini Clini

A Specific Treatment Protocol: Aerosolized Bronchodilator Therapy

Problem

A 54-year-old woman is admitted to the hospital with an exacerbation of COPD. She has a history of smoking one and one-half packs of cigarettes a day for 32 years. She is alert and oriented, and her respiratory rate is 32 breaths/min. On auscultation, she has bilateral wheezes on inspiration and exhalation. Her vital capacity (1.3 L) is greater than the predicted minimal volume for effective incentive spirometry, but she is unable to take in a slow, deep breath and hold it for longer than 5 seconds, which is the criterion sometimes used for appropriate MDI use. What should the RT do now?

Solutions

Following the aerosol therapy protocol algorithm, this patient would receive an aerosolized bronchodilator treatment from a small volume nebulizer with a mouthpiece. An algorithm for aerosolized bronchodilator therapy is shown in Figure 2-1.

Mini Clini

A Specific Purpose Protocol: Oxygen Therapy Titration

Problem

A 42-year-old man has returned to a medical-surgical nursing unit from the recovery room after a cholecystectomy. He has no history of lung disease and is wearing a nasal cannula at 2 L/min. He is alert and oriented, and his respiratory rate is 18 breaths/min and heart rate is 82 beats/min. When the RT arrives to check his oxygen setup and pulse oximeter reading, his SpO₂ (pulse oximeter reading) is 97% on the 2 L/min nasal cannula. What should the RT do next?

Solutions

Following the oxygen therapy titration protocol algorithm, the RT removes the nasal cannula and returns in 15 minutes to recheck the patient’s SpO₂ reading, which is now 93% on room air. The RT discontinues the oxygen therapy. An oxygen therapy titration algorithm is shown in Figure 2-2.

The success of a respiratory care protocol program requires several key elements, including active and committed medical direction, capable RTs, collaboration with physicians and nurses, careful monitoring, and a responsive hospital environment (Box 2-5). As further evidence of the widespread acceptance of protocols, the ACCP has identified the elements of an acceptable respiratory care protocol (Box 2-6). This document may serve as a guide for developing protocols. Protocols may be constructed for individual therapies, such as aerosol therapy, bronchopulmonary hygiene, oxygen therapy, hyperinflation techniques, suctioning, and pulse oximetry. Protocols also can be written for a specific purpose, such as arterial blood gas (ABG) sampling, weaning from mechanical ventilation, decannulating a tracheostomy, and titrating oxygen therapy.

Box 2-5 Key Elements of a Respiratory Care Protocol Program

• Strong and committed medical direction

• Capable RTs

• Active quality monitoring

• Collaborative environment among RTs, physicians, and nurses

• Responsiveness of all participants to address and correct problems

Box 2-6 Elements of an Acceptable Respiratory Care Protocol as Described by the American College of Chest Physicians

• Clearly stated objectives

• Outline that includes an algorithm

• Description of alternative choices at decision and action points

• Description of potential complications and corrections

• Description of end points and decision points at which the physician must be contacted

• Protocol program

Successful implementation of protocols requires acceptance by various stakeholder communities in the hospital, including the hospital administrators, physicians, nurses, and RTs themselves. Hospital administrators are likely to be accepting to the extent that they are convinced that protocols enhance patient care, improve allocation of respiratory care services, and reduce costs. Physicians are likely to accept RT protocols if they are convinced that protocols will enhance their patients’ care, preserve the physician’s ability to specify orders if desired, and maintain the physician’s awareness of changes in a patient’s condition and changes in the respiratory care plan. Physicians’ acceptance also requires their having trust in the quality, professionalism, and competence of the respiratory therapy staff. Nurses are likely to accept protocols if they are persuaded that protocols will enhance the efficiency of care, help relieve sometimes excessive nursing workloads, and preserve communication with the bedside nurse regarding the patient’s plan of treatment. Finally, successful implementation and acceptance of protocols by RTs requires a desire to be progressive, confidence in their own assessment and communication skills, “ownership” of the protocol process (e.g., by participating in drafting the protocol policies and strategies by which protocols are put in place), and willingness to change and to abandon antiquated task-driven practices in respiratory care.

Features of RT departments that are ready for and that embrace change have been studied ²¹ and are presented in Box 2-7. Steps and tactics to ensure successful implementation of respiratory care protocols are described in Box 2-8. Selecting a planning team with broad membership that includes physicians, nurses, and administrators is a key element in developing a protocol implementation process that avoids potential barriers and satisfies the institution’s specific and unique requirements. Once protocols have been designed, it is often advisable to pilot them either individually or on a single hospital floor or unit. This staged rollout with an initial pilot trial allows an opportunity to work out unanticipated problems and obtain helpful feedback from the individuals involved before using the protocols on a hospital-wide basis.

Box 2-7

“Highly Desired” Features of a Change-Avid Respiratory Therapy Department

1. Having a close and collegial working relationship between the medical director and the RTs

2. Having a strong and supportive champion for change in the hospital administrative structure (e.g., hospital leaders, medical director)

3. Using data and other evidence to define problems and to measure the effectiveness of proposed solutions

4. Using multiple and redundant types of communication to cascade information throughout the respiratory therapy department

5. Being attentive to the forces of resistance and obstacles to change and being able to navigate within institutional systems and people to achieve change

6. Being willing to confront, engage, and gain closure on tough issues

7. Having and maintaining a culture of internal, self-imposed, systematic, ongoing education and knowledge acquisition

8. Consistently rewarding and recognizing change-avid behavior among respiratory therapy department members

9. Fostering ownership for change rather than just complying with external policies and demands and, as part of this ownership, taking the time to identify and involve stakeholders in change (e.g., physicians, nurses, hospital thought leaders and decision makers)

10. Paying attention to leadership development and succession planning in the RTs

11. Having and communicating a vision in the department

From Stoller JK, Kester L, Roberts VT, et al: An analysis of features of respiratory therapy departments that are avid for change. Respir Care 53:871–884, 2008.

Box 2-8 Tactics for Implementing Respiratory Care Protocols

1. Select a planning team with diverse membership

2. Conduct an audit to assess the occurrence of misallocation of therapy to justify departure from usual care

3. Identify sources of resistance (e.g., physicians, nurses, administrators, RTs)

4. Design a protocol program that fits the individual hospital

5. Develop a training program for RTs

6. Develop an evaluation and quality monitoring system

A comprehensive approach for using protocols is to combine specific protocols to form a respiratory therapy consult service or an evaluate-and-treat program, which is used in institutions such as the University of California at San Diego and the Cleveland Clinic. With the use of a respiratory therapy consult service, the sequence of events for a respiratory therapy consult may occur as shown in Box 2-9.

Box 2-9 Sequence of Events for a Respiratory Care Consult

1. A physician writes an order for a respiratory care protocol or consult

2. A physician order entry system or the nursing unit secretary notifies an RT evaluator

3. The evaluator assesses the patient using specific guidelines

4. The evaluator writes a care plan using designated indications and algorithms and documents the care plan in the patient’s chart for review by the physician

5. The RT covering the nursing unit delivers the care

6. The patient is assessed on a shift-by-shift basis for changes in status and indicated modifications for the care plan, which are also documented

7. The physician is notified of any deterioration in the patient’s status

8. When indications for respiratory care no longer exist, respiratory care treatment is discontinued, and notification is placed in the patient’s chart

A carefully structured assessment tool and care plan form (Figures 2-3 and 2-4) are essential elements for a comprehensive protocol program. These tools help ensure consistency among therapist evaluators. The following Mini Clini on Writing a Respiratory Care Plan shows how an assessment tool and care plan document, used in conjunction with corresponding algorithms, can guide therapists in formulating an appropriate respiratory care plan.

FIGURE 2-3 Evaluation form for guiding a standardized patient assessment and assigning a severity of respiratory illness score. The score for the greatest degree of dysfunction for each assessment category is written in the right-hand column and tallied to determine the severity of respiratory illness (triage) score. (Courtesy Cleveland Clinic Respiratory Institute, Cleveland, Ohio.)

FIGURE 2-4 Care plan form for recording a patient’s indications for therapy and the therapeutic modalities for treating the indications. (Courtesy Cleveland Clinic Respiratory Institute, Cleveland, Ohio.)

Mini Clini

Writing a Respiratory Care Plan

Problem

A 40-year-old woman with a history of asthma was admitted to the hospital for gastrointestinal dysmotility with abdominal distention. Her chest radiograph showed an elevated diaphragm with accompanying atelectasis in the bases of the lung fields. Her laboratory test results were as follows: white blood cell count 10,200 cells/mcl, hemoglobin 11.6 g/dl, and platelet count 260,000/mm³. Her pulse oximetry reading was 96% on room air; no ABGs were drawn. Her heart rate was 84 beats/min, blood pressure was 110/78 mm Hg, respiratory rate was 20 breaths/min, and temperature was 36.8° C. She was alert and oriented, and her vital capacity was 1.35 L. She is 5 feet 7 inches tall and has a predicted minimal vital capacity of 0.927 L (15 ml/kg of ideal body weight). On auscultation, her breath sounds were decreased bilaterally, and she had slight inspiratory wheezes in the apices of her lung fields. She had a weak, nonproductive cough and was able to ambulate on her own. Perform a respiratory care evaluation for this patient.

Solutions

The patient’s assessment score sheet and her respiratory therapy care plan, using the respiratory therapy consult protocol and treatment algorithms currently in use at the Cleveland Clinic, are shown (see Figures 2-3 and 2-4).

Demonstrated advantages of respiratory care protocols include better allocation of respiratory care services without an increased frequency of respiratory care treatments and cost savings. Other advantages include more dynamic respiratory care with more adjustment of respiratory care services to keep pace with patients’ changing clinical status and more versatile use of respiratory care services.12,22–25

Monitoring Quality Respiratory Care

Beyond ensuring that all elements of a high-quality respiratory care program are in place, quality must be monitored to ensure that it is being maintained. Strategies to monitor quality include intrainstitutional monitoring practices, centralized government monitoring bodies, such as the Centers for Medicare and Medicaid Services (CMS), and voluntary agencies such as TJC.

Intrainstitutional quality assurance often uses skills checks or competencies. Competence, or the quality of being competent, can be defined as having suitable or sufficient skill, knowledge, and experience for the purposes of a specific task.²⁶ Competence for a specific skill is frequently determined by observation of the practitioner’s performance of the skill according to a prescribed checklist. Annual competency checks are documented for skills and procedures that carry some degree of patient risk (e.g., arterial puncture, aerosol therapy, bilevel positive airway pressure setup). An example of a skills checklist is shown in Figure 2-5.

FIGURE 2-5 Example of a skills checklist for suctioning.

Although skills checks have traditionally been done in person or with direct supervision of patient care activities, a new dimension of skills training and certification that is being widely implemented is the use of clinical simulation, using either low-fidelity or high-fidelity simulation trainers. Such simulation training (see Chapter 7), in which RTs use technology that attempts to reproduce reliably a true patient or true patient scenario, is similar to the flight simulator training that commercial airline pilots undergo to achieve certification to fly various airplanes. Uses of simulation training in respiratory therapy involve intubation, ventilator management, arterial line placement, and optimizing teamwork in acute resuscitation scenarios.²⁷

Many health care organizations, including hospitals, subacute facilities, and outpatient clinics, seek voluntary accreditation as a way to improve their service and assure the public that they maintain high standards. In health care, TJC is a very important organization. TJC was formed in 1951 by the American College of Surgeons, the American Hospital Association, and the AMA. Accreditation by TJC is based on satisfying specific standards established by professional and technical advisory committees.

TJC requires a hospital service to have a quality assurance plan to provide a system for controlling quality. Nine generally recognized steps for a quality assurance plan are used as the basis for quality assurance programs (Box 2-10).

Current standards of TJC for accreditation emphasize organization-wide efforts for performance improvement. Despite increased emphasis on cost containment, quality care remains the first goal of hospitals and respiratory care services. Performance improvement, also commonly called continuous quality improvement, is an ongoing process designed to detect and correct factors hindering the provision of quality and cost-effective health care. This process crosses department boundaries and follows the continuum of the patient’s care. In 2009, TJC set forth three standards for monitoring performance improvement along with associated elements of performance detailing how the monitoring is to be conducted. These standards are listed in Box 2-11. Meeting quality goals is increasingly being tied to reimbursement rates by the CMS and insurers to hospitals; this phenomenon has been called “pay for performance.”²⁸ Beyond general monitoring goals for respiratory care, use of respiratory care protocols creates the need for additional quality monitoring benchmarks regarding correctness, consistency, efficacy, and effectiveness (Box 2-12).

Box 2-11

TJC Standards for Performance Improvement

• The hospital collects data to monitor its performance

• The hospital compiles and analyzes data

• The hospital improves performance on an ongoing basis

Compiled from The Joint Commission, Oakbrook Terrace, IL.

Box 2-12 Quality Monitoring Benchmarks

• Monitoring the correctness of respiratory care plans

• Monitoring the consistency of formulating respiratory care plans among therapist evaluators

• Evaluating the efficacy of algorithms or protocols

• Evaluating the overall effectiveness of the protocol program

At the present time, specific methods to monitor the quality of respiratory care protocol programs include conducting care plan audits in real time and ensuring practitioner training by using case study exercises. Evolving innovations include using simulation exercises to enhance and to measure the performance of RTs.

Monitoring correctness of respiratory care plans can be accomplished by using a care plan audit system. Care plan auditors must be therapists who are experienced in providing respiratory care and patient assessment. The auditors must also be practiced in using the institution’s protocol system and in writing care plans. With an auditing system, the auditor writes a care plan for a patient and compares it with the care plan written by the therapist evaluator to determine correctness. A specified number of audits should be performed monthly, with results tabulated and reported monthly or quarterly, depending on the size of the hospital. Feedback must be provided to the evaluators whose care plans are being audited to show their proficiency or to indicate areas that require improvement. Figure 2-6 shows a form used at the Cleveland Clinic to provide feedback to evaluators.

FIGURE 2-6 Form for providing feedback to therapist evaluators on their patient assessment and care plan writing performance. Agreement is indicated by an A (auditor) and a T (therapist) in the same triage scoring box or therapeutic category. (Courtesy Cleveland Clinic Respiratory Institute, Cleveland, Ohio.)

Another monitoring method found useful for respiratory therapy consult services is the case study exercise (or simulated patient scenario exercise). Simulated patient exercises can help determine the consistency of respiratory care plans among therapist evaluators. The scores of individual therapists may be tracked over time to identify problems and to assess improvement.

Simulated patient exercises may consist of a set of three or four patient scenarios. All RTs working under the protocol system, whether or not they are evaluators, complete an assessment sheet and, following the associated algorithms, write a care plan for each scenario. The assessment sheets and the care plans are compared with the “gold standard,” or correct assessments and care plans as determined by the consensus of the education coordinator and the supervisors. Scores are tabulated for the individual therapists, and the number of errors for each therapy is examined. If a particular therapy consistently has a large number of associated errors, the algorithm is reviewed for errors or vagueness. To facilitate administering and grading patient simulation exercise results, a computer-based system that scores the assessments and care plans and provides feedback to the RT has been used. Performance data of individual RTs are maintained in a database to calculate and track aggregate performance statistics.

Peer Review Organizations

In addition to the voluntary accreditation process that health care organizations use to help ensure that patients are receiving quality care, the federal government has established an elaborate system of PROs to evaluate the quality and appropriateness of care given to Medicare beneficiaries. PROs evaluate care provided to individual patients in real time to assess and ensure compliance with federal guidelines.

In recent years, health care organizations have attempted to improve the quality of patient care while reducing costs by implementing several innovative health care models. Historically, models that were commonly implemented were hospital restructuring and redesign and patient-focused care. Protocols and disease management represent continuing solutions. Accountable care organizations (ACOs)²⁹ have also been proposed as a solution to enhance quality and lessen cost. An ACO can be broadly thought of as an emerging model in which a group of health care providers aligns and agrees together to try to meet quality and care targets and to receive payments as a collective entity, from which individual payments can then be disbursed. The ACO can benefit as a group from its success and can absorb losses as a group related to its failure to meet the targets.

Restructuring and redesign involved changing the basic organization of health care services in an attempt to do more with less while increasing value. Approaches for restructuring commonly included cross-training employees, using unlicensed assistive staff, and decentralizing services.³⁰ When respiratory care departments are decentralized and respiratory care management is eliminated, RTs are deployed to individual nursing units and report to nursing supervisors. When complete decentralization occurs, the responsibilities of equipment purchase and maintenance, continuing education, and quality improvement may be assigned to nursing personnel, who often are uncomfortable with these additional burdens.³⁰

Although less commonly practiced, another aspect of restructuring and redesign is cross-training personnel and using assistive staff. Cross-training among professional health care workers can be attempted by teaching activities normally performed by a specific discipline but not restricted by licensing to personnel of another discipline. Nurses might cross-train RTs to perform phlebotomy, whereas RTs might cross-train nurses to perform meter dose inhaler (MDI) therapy. Although theoretically appealing, this strategy has fallen into disfavor because of the substantial associated challenges in implementation.

Cross-training assistive personnel involves on-the-job training of unlicensed personnel, who may not have an educational background in health care, to perform basic technical functions. These assistive personnel may learn to perform some nursing functions, such as taking vital signs, measuring intake and output, and inserting urinary catheters; laboratory technician activities, such as phlebotomy and simple urinalysis; and respiratory therapy activities, such as incentive spirometry follow-up and oxygen checks. The intent of using cross-trained assistive personnel, whose compensation is lower than licensed health care workers, is to enable an institution to reduce the number of nurses, laboratory technicians, and RTs that they employ, reducing costs. Although some aspects of hospital restructuring and redesign have been implemented and persist, others (e.g., cross-training and decentralization) have been abandoned.

Protocols

As described previously, protocols are guided pathways to help direct specific aspects of a patient’s treatment regimen. The primary purpose of respiratory care protocols is to provide therapy to patients needing and likely to benefit from therapy but to avoid delivering services to patients not likely to benefit. A comprehensive protocol program using clinical practice guidelines can provide a dynamic system for modifying the respiratory care regimen in response to a patient’s changing clinical status.

The widespread use and acceptance of respiratory care protocols have been encouraged by studies reporting reduced misallocation of respiratory care and the cost savings associated with protocols. In addition to observational studies,²² the benefits of RT protocols have been shown in randomized, controlled trials for weaning patients from mechanical ventilation^31–34 and for allocating respiratory therapy to adult inpatients not in intensive care units (ICUs).^24,25 Table 2-3 presents selected studies showing the effect of respiratory care protocols on the misallocation of respiratory therapy. Most studies show a significant decrease in overordering respiratory care services, whereas only a few address underordering services, which is a phenomenon more difficult to assess. Table 2-4 reviews studies addressing the cost savings associated with using protocols, which suggest that respiratory care protocols can effect savings by enhancing appropriate allocation of respiratory care services.^{12,24,25,35–41} Table 2-5 summarizes the results of five randomized, controlled trials on the effectiveness of respiratory care protocols. These studies establish the efficacy of respiratory care protocols in weaning patients from mechanical ventilation^30–32 and in enhancing the allocation of services to adult patients not in ICUs.^23,24

TABLE 2-3

Changes in Modalities After Protocol Implementation

Author and Year Published	Observed Reductions in Misallocated Therapy After Implementation of Protocols	Change from Preprotocol to Current Status
Hart et al,³⁵ 1989	37% (aerosol, hyperinflation)	48%-11%
Walton et al,³⁶ 1990	49.1% (aerosol, chest physiotherapy)
Beasley et al,³⁷ 1992	11.9% (blood gas use)	42.7%-30.8%
Ford,³⁸ 1994	57% (aerosol, chest physiotherapy)	7000-4000 treatments
Orens,³⁹ 1993	35% (aerosol, bronchopulmonary, hygiene, hyperinflation oxygen, oximetry)

From Haney DJ: Therapist-driven protocols for adult non-intensive care unit patients: availability and efficacy. Respir Care Clin N Am 2:93–104, 1996.

TABLE 2-4

Cost Savings Associated With Respiratory Care Protocols

Author	Date	Duration of Study	Cost Savings
Hart et al³⁵	1989	3 mo	$4316 (decrease in actual costs)
Walton et al³⁶	1990	6 yr	9.7% (decrease in charges)
Orens³⁹	1993	1 yr	$81,826 (decrease in costs for one nursing unit)
Ford³⁸	1994	1 yr	$150,000 (decrease in costs)
Komara and Stoller⁴¹	1995	40 patients	53.3% (decrease in costs)
Shrake et al⁴⁰	1996	2 yr, 4420 patients; cost comparisons:3 mo postprotocol	$15,337 for 3 study mo, annualized to $61,348/yr
Stoller et al²⁴	1998	1 yr, 145 patients	$20 (decrease in true costs/patient)
Kollef et al²⁵	2000	9 mo, 694 patients	$186 (decrease in charges/patient)
Shelledy et al¹²	2004	3 mo, 75 patients	$75,395 (estimated annual decrease)

Modified from Haney DJ: Therapist-driven protocols for adult non-intensive care unit patients: availability and efficacy. Respir Care Clin N Am 2:93–104, 1996.

TABLE 2-5

Summary of Available Randomized Trials on the Effectiveness of Respiratory Care Protocols

Clinical Activity	Author	Date	No. Patients	Findings
Weaning from mechanical ventilation	Kollef et al³¹	1997	357	Use of protocols was associated with shorter duration of mechanical ventilation
	Ely et al³²	1996	300	Routine daily trials of spontaneous breathing trials were associated with shorter duration of mechanical ventilation
	Marelich et al³³	2000	253	Use of protocols shortened duration of mechanical ventilation
Respiratory care protocol service	Stoller et al²⁴	1998	145	Use of respiratory therapy consult service was associated with improved allocation of respiratory care service with lower costs and no adverse events
	Kollef et al²⁵	2000	694	Use of respiratory protocol service was associated with fewer orders discordant with guidelines and lower charges

From Stoller JK: Are respiratory therapists effective? Assessing the evidence. Respir Care 46:56, 2001.

Disease Management

Disease management refers to an organized strategy of delivering care to a large group of individuals with chronic disease to improve outcomes and reduce cost. Disease management has been defined as a systematic population-based approach to identify persons at risk, intervene with specific programs of care, and measure clinical and other outcomes.42,43 Disease management programs comprise four essential components: (1) an integrated health care system that can provide coordinated care across the full range of patients’ needs; (2) a comprehensive knowledge base regarding the prevention, diagnosis, and treatment of disease that guides the plan of care; (3) sophisticated clinical and administrative information systems that can help assess patterns of clinical practice; and (4) a commitment to continuous quality improvement. Disease management programs may be developed for chronic conditions such as asthma, diabetes, chronic obstructive pulmonary disease (COPD), and congestive heart failure.

A disease management program for COPD might be adopted by a health care provider, insurance company, or health maintenance organization in defining its practice approach to individuals with COPD. The disease management program might contain algorithms addressing when to suspect COPD, tests to perform (e.g., spirometry, alpha₁-antitrypsin level, diffusing capacity), medications to prescribe based on disease severity, management of exacerbations, and indications for rehabilitation. Disease management programs are often outlined in documents containing branched logic algorithms that specify care, similar to respiratory care protocols; however, disease management protocols often address large groups and are based on an underlying diagnosis rather than on individual signs and symptoms. Other dimensions of the COPD disease management program include a data collection activity regarding the number of patients served, the outcomes of care, and, perhaps, the associated costs. In addition, ongoing review and periodic updating and revision of the care algorithms are important dimensions of the program.

Evidence-Based Medicine

Another important concept regarding quality care is evidence-based medicine. Evidence-based medicine refers to an approach to determining optimal clinical management based on several practices, as follows:43–47 (1) a rigorous and systematic review of available evidence, (2) a critical analysis of available evidence to determine what management conclusions are most sound and applicable, and (3) a disciplined approach to incorporating the literature with personal practice and experience. In a broader context, evidence-based medicine can be thought of as understanding and using the best quality evidence available (i.e., the best-designed, most rigorous clinical trials) to support the most appropriate and correct possible clinical decisions.

In rating the quality of scientific evidence, it is important to recognize the various designs and types of study designs from which scientific evidence comes.⁴⁸ The simplest and least rigorous design is a single case report, in which a new clinical issue or problem is described in a single patient. A description of the favorable outcome of using a new mode of mechanical ventilation in one patient with refractory hypoxemia would be a single case report. Although single case reports have value in pointing out new insights and new possibilities for treatment, disease associations, or disease causation, they cannot prove the effectiveness of a treatment or the causality of a risk factor because they, by nature, lack a control or comparison group (i.e., a group that is similar to the patient or patients described, differing only in whether the risk factor of interest was present or the treatment of interest was applied). Collecting a group of patients with similar clinical features is called a case series and may have greater impact in that it suggests that the issue is more general than in a single patient alone. However, similar to a single case report, a case series cannot prove the efficacy of a treatment or the causality of a risk factor because no comparison or control group is included.

Cohort studies, which compare the clinical outcomes in two compared groups (or cohorts), generally have greater scientific rigor than case studies or case series and consist of two broad types of study designs: observational cohort studies and randomized controlled trials. In trying to establish whether a treatment works (i.e., has efficacy), an observational cohort study would compare the outcomes between two groups of patients when the treatment was allocated to one group but not the other by either physician or patient choice. More specifically, an observational cohort study of a new mode of mechanical ventilation would compare the outcomes between two groups of similar patients (i.e., especially similar with regard to their risk of developing the outcome measure that is being studied) when the mode of mechanical ventilation was determined either by physician choice (i.e., the physician decided to use this treatment in this patient) or by patient choice. In contrast, a randomized controlled trial, sometimes regarded as the most methodologically rigorous study design (when well conducted), would compare the outcomes of two similar groups of patients when the use of the new mode of mechanical ventilation was determined by chance alone (randomization) rather than by patient or physician choice. In the ideal situation, a randomized controlled treatment trial eliminates all sources of bias that would prevent attributing differences in outcomes between the compared groups to anything other than the treatment itself, “isolating” the effect of the treatment. Said differently, at its best, a randomized controlled treatment trial provides rigorous evidence regarding the efficacy of the treatment when all other potentially confounding variables (e.g., features of the compared patient groups, other medications or treatments used) are eliminated from consideration, allowing the investigators and the readers of the clinical trial results to ascribe confidently outcome differences between the compared groups to the treatment itself.

Variants of the randomized controlled trial include the parallel-control study and the crossover study (Figure 2-7). Parallel-control treatment studies compare two groups: one receives the treatment being studied, and the other receives the control treatment. Sometime after the end of the treatment, outcomes of the two groups are assessed and compared regarding the main outcomes of interest in the study. A parallel-control randomized trial of low-stretch ventilation for ARDS would compare one group of patients receiving low-stretch ventilation with another (otherwise similar) group receiving conventional, higher stretch ventilator settings, and the two groups would be compared after a prespecified time period with regard to key outcomes, such as survival, discharge from the ICU, and organ system failures. This design was used in the ARDS Net clinical trial showing the superiority of using a tidal volume of 6 ml/kg (ideal body weight) in managing patients with acute lung injury or ARDS.⁴⁹

FIGURE 2-7 Study design of the two types of randomized controlled trial: parallel-control and crossover. In a parallel-control trial, after randomization (R), one group receives the study treatment, while the control group receives the comparison treatment (possibly a placebo). At the end of the subsequent observation period, study outcomes are measured, and the trial is over. In a crossover trial, one group initially receives the study treatment, and the other group receives the comparison treatment; outcomes are measured; and after a washout period (see text), each group receives the alternative treatment for another interval of time, after which outcomes are measured again.

In the other type of randomized controlled trial—the crossover trial—the study treatment is first administered to one group of study subjects while the other group receives the control or comparison treatment, and then, after measuring outcomes and a subsequent “washout period” (in which the effects of the initial treatment decay and wear off fully), the group initially given the study treatment receives the control treatment and vice versa. The crossover study design offers a statistical advantage of greater power to detect a difference between the compared groups if a difference exists, but crossover studies can be performed only when the effects of the initial treatment administered to the first study group can be assured to wear off completely, allowing the study group to return to its baseline state before the alternative treatment is administered.

Evidence-based medicine requires knowledge of how to analyze carefully the results of clinical trials (e.g., randomized controlled trials and observational cohort studies) and how to incorporate the results of such research into high-quality clinical practice. Other tools of evidence-based medicine include systematically reviewing the available literature, or what is called meta-analysis of the literature.²⁸ A meta-analysis of a clinical issue (e.g., does a low-stretch mechanical ventilation strategy improve survival in ARDS?⁴⁹) identifies, analyzes, and summarizes the body of literature about this topic by assessing the quality of the available evidence and giving greater weight to better designed, more rigorous studies. Sometimes, meta-analyses pool the actual data from different trials together when pooling is scientifically and statistically permissible. In other instances (called narrative analyses), the meta-analysis simply evaluates the quality of the data from each available trial (based on explicit methodologic criteria) to offer a conclusion about the clinical issue.

A meta-analysis performed as part of an evidence-based approach to determining the optimal ventilatory approach for ARDS might weigh the results of large randomized clinical trials of low-stretch versus conventional tidal volume approach mechanical ventilation more heavily than the results of small observational studies. A 2003 evidence-based review of the management of individuals with alpha₁-antitrypsin deficiency (see Chapter 23) issued graded recommendations for testing for this genetic cause of COPD.⁵⁰ A level A recommendation (i.e., that testing should be performed) was issued to test all symptomatic adults with airflow obstruction on pulmonary function tests (whether carrying the diagnosis of emphysema, COPD, or asthma in which airflow obstruction fails to reverse completely with bronchodilators), asymptomatic individuals with persistent airflow obstruction on pulmonary function tests with identifiable risk factors (e.g., cigarette smoking, occupational exposure), individuals with unexplained liver disease, and adults with a skin condition called necrotizing panniculitis.⁵⁰ Although the hope is that issuing such evidence-based guidelines will improve the care that such individuals receive by allowing clinicians to access efficiently the best available information, experience suggests that clinicians may be slow to adopt the best available evidence in caring for their patients.⁵¹

Although some authors point out that evidence-based medicine does not differ from prior practice in which clinicians were always called on to analyze carefully available data and make clinical judgments based on the best-quality information available, evidence-based medicine does specify precise methods for analyzing available information and allowing the clinician to judge best the available evidence. As a measure of the importance of evidence-based medicine in respiratory care, several articles in Respiratory Care considered the effectiveness of RTs and of various respiratory care treatment modalities using an evidence-based approach.45–47 The Clinical Practice Guidelines of the American Association for Respiratory Care are being systematically reviewed to reflect the rigorous techniques of evidence-based medicine and to ensure that guidelines for respiratory care management reflect the best available evidence.⁴⁷ The proof that low-stretch ventilation is associated with improved survival in patients with ARDS and the methods used to enhance awareness of this best practice are further examples of evidence-based medical practice.

Summary Checklist

• Quality respiratory care can be defined as the competent delivery of indicated respiratory care services.

• Crucial elements for quality respiratory care include:

Energetic and competent medical direction