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The Effect of Respiratory Therapist-Initiated Treatment Protocols on Patient Outcomes and Resource Utilization^*

^* From the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Washington University School of Medicine (Drs. Kollef and Shapiro), and Department of Respiratory Care Services, Barnes-Jewish Hospital (Mss. Clinkscale, Cracchiolo, Clayton, and Hossin, and Mr. Wilner), St. Louis, MO. This investigation was supported by a grant provided by the American Association of Respiratory Care.

Correspondence to: Marin H. Kollef, MD, FCCP, Pulmonary and Critical Care Medicine, Washington University School of Medicine, Campus Box 8052, 660 South Euclid, St. Louis, MO 63110; e-mail: mkollef{at}pulmonary.wustl.edu

	Abstract

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Context: Physicians frequently prescribe respiratory treatments to hospitalized patients, but the influence of such treatments on clinical outcomes is difficult to assess.

Objective: To compare the clinical outcomes of patients receiving respiratory treatments managed by respiratory care practitioner (RCP)–directed treatment protocols or physician-directed orders.

Design: A single center, quasi-randomized, clinical study.

Setting: Three internal medicine firms from an urban teaching hospital.

Patients: Six hundred ninety-four consecutive hospitalized non-ICU patients ordered to receive respiratory treatments.

Main outcome measures: Discordant respiratory care orders, respiratory care charges, hospital length of stay, and patient-specific complications. Discordant orders were defined as written orders for respiratory treatments that were not clinically indicated as well as orders omitting treatments that were clinically indicated according to protocol-based treatment algorithms.

Results: Firm A patients (n = 239) received RCP-directed treatments and had a statistically lower rate of discordant respiratory care orders (24.3%) as compared with patients receiving physician-directed treatments in firms B (n = 205; 58.5%) and C (n = 250; 56.8%; p < 0.001). No statistically significant differences in patient complications were observed. The average number of respiratory treatments and respiratory care charges were statistically less for firm A patients (10.7 ± 13.7 treatments; $868 ± 1,519) as compared with patients in firms B (12.4 ± 12.7 treatments, $1,124 ± 1,339) and C (12.3 ± 13.4 treatments, $1,054 ± 1,346; p = 0.009 [treatments] and p < 0.001 [respiratory care charges]).

Conclusions: Respiratory care managed by RCP-directed treatment protocols for non-ICU patients is safe and showed greater agreement with institutional treatment algorithms as compared with physician-directed respiratory care. Additionally, the overall utilization of respiratory treatments was significantly less among patients receiving RCP-directed respiratory care.

Key Words: asthma • chronic obstructive pulmonary disease • outcomes • protocols • respiratory care

	Introduction

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The administration of respiratory treatments is a necessary component of the care of hospitalized patients, especially those individuals with thoracoabdominal disease processes. However, a number of clinical studies suggest that respiratory treatments are often needlessly prescribed to patients who do not derive benefit from their administration.^{1 2 3 4 5 6 7 8 9 10} To date, few investigations have attempted to define the optimal method for the utilization of respiratory treatments or to determine the impact of various respiratory care utilization strategies on patient outcomes.^{11 12 13} This represents an important area of investigation because of the potential complications associated with inappropriate use of respiratory treatments and the need to conserve valuable medical resources for treatments that are more likely to provide patient benefits.^{14 15}

To better determine the optimal use of respiratory treatments for hospitalized patients not requiring ICU admission (ie, non-ICU patients), we performed a clinical trial that had two main objectives. The first goal of our study was to determine the occurrence of administered respiratory treatments that were discordant with the respiratory care guidelines of the hospital. Our second goal was to test the hypothesis that the use of respiratory care practi-tioner (RCP)-directed treatment protocols would decrease the occurrence of discordant respiratory treatments.

	Materials and Methods

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Study Location and Population
The study was conducted at a university-affiliated urban teaching hospital: Barnes-Jewish Hospital (BJH; 1,400 beds). During a 9-month period (February 1998 to October 1998), all patients ordered to receive respiratory treatments from the three internal medicine firms of the hospital (firms A, B, C) were potentially eligible for this investigation. The internal medicine firms are closed groups of internal medicine house officers, teaching physicians, and private attending physicians caring for patients on the medicine floors of BJH. Physicians are assigned to the firms so as to achieve a similar distribution of teaching and private attending physicians as well as a similar distribution of general internists and subspecialty-trained physicians, including pulmonary subspecialists. The patient populations served by the three firms are also similar in terms of their physicians’ practices (eg, general internal medicine vs subspecialty practices). There is no crossover of physicians between the internal medicine firms, which also have their own administrative structures (eg, chief residents, chiefs of service). Patients admitted to the internal medicine firms received their care on one of four hospital floors according to bed availability. Each of the medical floors involved in this study had a mixture of patients from the different medical firms. Patients were entered into the investigation if they were > 16 years old and excluded if they had a diagnosis of cystic fibrosis. The study was approved by the Washington University School of Medicine Human Studies Committee.

Study Design
Patients were assigned, at the time of hospital admission, to have their respiratory care managed by RCP-directed treatment protocols or by physician-directed orders. All patients assigned to firm A received RCP-directed treatments, whereas patients assigned to firms B and C received physician-directed respiratory care. Patient assignment to a medicine firm was based on their attending or clinic physician’s firm assignment. All patients without an attending or clinic physician were randomly assigned by the hospital admissions office to one of the medicine firms. The primary outcome measure was the occurrence of discordant respiratory care orders. Discordant respiratory care orders were defined as written orders that omitted clinically indicated treatments (eg, absence of an order for bronchopulmonary hygiene in a patient with lobar atelectasis), as well as orders for treatments that were not clinically indicated according to protocol-based treatment algorithms (eg, an order for bronchopulmonary hygiene in a patient without an appropriate indication; Fig 1 ). Secondary outcome measures included the total number of respiratory care treatments per patient, charges for respiratory care treatments, hospital length of stay, patient-specific complications, and hospital mortality. All data were collected on a standardized data collection form by registered respiratory therapists who were blinded to patients’ firm assignments as well as to whether patients’ respiratory care orders were protocol guided.

View larger version (37K): [in this window] [in a new window] [Download PPT slide]   Figure 1.. Treatment guideline for bronchial hygiene. IPPB = intermittent positive-pressure breathing; IS = incentive spirometry; DBC = deep breathe and cough.

Two RCPs (L.C. and L.H.) prospectively evaluated all respiratory care orders to determine the presence of discordant orders. These two RCPs were blinded to patients’ firm assignments as well as to whether patients’ respiratory care orders were protocol guided, had no other clinical or administrative duties during their participation in the study, and contributed to the initial development and updating of the respiratory care treatment protocols used at BJH. Respiratory care orders were obtained daily by the two reviewers using an automated medical order communication system without having to directly review the medical record order sheets. This was done to minimize observer bias in regards to who wrote the original respiratory care orders (physician vs respiratory therapist). All respiratory care orders, discordant order assessments, and patient outcomes were subsequently reviewed by the medical directors of the respiratory care department (M.H.K. and S.D.S.). This was done to ensure that the discordant classification of respiratory care orders adhered to the explicit definitions described above.

RCP-Directed Respiratory Care
Each firm A patient ordered to receive RCP-directed treatments underwent formal assessment by a registered respiratory therapist who had > 5 years of experience as a respiratory care supervisor. The respiratory therapist performing the patient assessment determined the patient’s respiratory care needs based on the institutional treatment protocols. A respiratory care plan was developed and orders were written. The patient’s treating physician requesting respiratory care was informed of the patient assessment. Treating physicians who disagreed with the assessment and orders of the RCP performing the evaluation were allowed to change the orders. However, all disagreements were subsequently reviewed by the medical directors of the respiratory care department for final discussion with the treating physicians.

Physician-Directed Respiratory Care
All aspects of respiratory care were ordered by the treating physicians for patients assigned to firms B and C. Respiratory therapists could not make changes in the treatment orders without a physician’s order. However, respiratory therapists could communicate their opinions and observations about patients’ needs for respiratory care to the treating physicians.

Definitions
All definitions were selected prospectively as part of the original study design. We calculated acute physiology and chronic health evaluation (APACHE) II scores on the basis of clinical data available from the first 24-h period of hospitalization.¹⁹ Lifestyle scores were previously defined as follows²⁰ : 0 indicates employed; 1, independent, fully ambulatory; 2, restricted activities, able to live on own and get out of home to do basic necessities, severe limitation in exercise ability; 3, housebound, cannot get out of house unassisted, cannot live alone or perform heavy chores; and 4, bed- or chair-bound. The diagnostic criteria for nosocomial pneumonia were modified from those established by the American College of Chest Physicians.²¹ Nosocomial pneumonia was defined as the development of a new or progressive radiographic infiltrate in conjunction with two of the following: fever (temperature > 38.3°C), leukocytosis (leukocyte count > 10 x 10⁹/L), and purulent tracheal aspirate. Lobar atelectasis was defined as displacement of a fissure along with opacification of a lobe demonstrated radiographically. Immunosuppression was defined as patients receiving corticosteroids, having a positive serum HIV antibody, having received chemotherapy in the past 45 days, or having neutropenia (absolute neutrophil count < 0.5 x 10⁹/L) resulting from the administration of chemotherapy, or as recipients of an organ transplant (kidney, liver, heart, lung, bone marrow) requiring immunosuppressive agents.

Statistical Analysis
We estimated the sample size needed to provide 90% power to detect a difference in the rate of discordant orders of 20%. We used an error of 0.05 (two-tailed) and assumed a baseline rate of discordant orders of 50% on the basis of preliminary surveys conducted before performing the investigation. According to these assumptions, 269 patients were needed in each study group to provide the desired power. All comparisons were unpaired, and all tests of significance were two-tailed. Continuous variables were compared using the Student’s t test for normally distributed variables and the Wilcoxon rank sum test for non-normally distributed variables. The ² or Fisher’s Exact Test were used to compare categorical variables. The primary data analysis was an intention-to-treat analysis, comparing the rate of discordant orders among patients assigned to receive RCP-directed treatments in firm A and the patients receiving physician-directed respiratory care in firms B and C.

Multiple logistic regression analysis, using a commercial statistical package, was used to identify predictor variables that were significantly related to the likelihood of having a discordant order for respiratory care (eg, presence of a discordant order as the dependent outcome variable).²² Baseline covariants were included in models that were judged a priori to be clinically sound. This was prospectively determined to be necessary to avoid producing spuriously significant results with multiple comparisons.²³ Potential predictor variables for model entry were identified using univariate analysis, where a p value of 0.15 was used to determine entry into the logistic regression model. A stepwise approach was used to enter new terms into the logistic regression model, and 0.05 was set as the limit for the acceptance or removal of these terms. Results of the logistic regression analysis are reported as adjusted odds ratios with 95% confidence intervals (CIs).

	Results

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Patients
Six hundred ninety-four consecutive patients ordered to receive respiratory treatments from firms A, B, and C were enrolled into the study. At the time of randomization, no statistically significant differences were found among the three firms for age, sex, ethnicity, lifestyle scores, APACHE II scores, smoking status, presence of a do-not-resuscitate order, tracheostomy at the time of hospital admission, and the presence of COPD, congestive heart failure, underlying malignancy, seropositivity for HIV, or an immunocompromised state (Table 1 ). Patients in firm B were statistically more likely to have an admission diagnosis of COPD or asthma and statistically less likely to have an admission diagnosis of cancer compared with patients in firms A and C. Firm C patients were statistically more likely to have an admission diagnosis of pneumonia compared with patients in firms A and B.

View larger version (19K): [in this window] [in a new window] [Download PPT slide]   Figure 2.. Box plots for respiratory treatments administered to patients assigned to the three internal medicine firms. Boxes represent 25th to 75th percentiles with 50th percentile (solid line) and mean (broken line) values shown within the boxes. The 10th and 90th percentiles are shown as capped bars, and closed circles mark the 5th and 95th percentiles.

View larger version (34K): [in this window] [in a new window] [Download PPT slide]   Figure 3.. The percentage of study patients receiving small-volume nebulizer treatments and metered-dose inhaler treatments according to their internal medicine firm assignments, with upper 95% CIs, are shown.

View larger version (20K): [in this window] [in a new window] [Download PPT slide]   Figure 4.. Box plots for respiratory care charges in patients with and without discordant respiratory care orders. Boxes represent 25th to 75th percentiles, with 50th percentile (solid line) and mean (broken line) values shown within the boxes. The 10th and 90th percentiles are shown as capped bars, and closed circles mark the 5th and 95th percentiles.

	Discussion

TOP Abstract Introduction Materials and Methods Results Discussion References

The main importance of our findings is that they offer an additional strategy for more effectively using respiratory care in hospitalized patients. Protocols have previously been used to guide specific aspects of respiratory care for hospitalized patients including the weaning of mechanical ventilation,^{24 25} infection control practices for the prevention of ventilator-associated pneumonia,^{26 27} chest physiotherapy,⁶ the clinical use of arterial blood gases,¹⁰ and inhaled bronchodilator administration.^{28 29} Many of those protocols were specifically designed for implementation by RCPs to achieve improvements in patient outcomes, reduce unnecessary medical care costs, and to unburden physicians from tasks that could be performed by RCPs.¹ The use of such protocols represents an effective strategy for standardizing medical practices within medical institutions. The potential benefits associated with such standardization of medical practices include improvements in patient outcomes, reducing medical care costs, enabling the identification of clinical practices requiring change or improvement, improving the quality of nonblinded clinical research, and establishing a foundation for the performance of quality improvement efforts.^{30 31} Standardized medical practices and protocols achieve such benefits primarily by helping to create less variable or "chaotic" medical environments. This occurs by decreasing errors in clinical management, improving the effectiveness of available treatments, increasing the accountability of medical providers, and providing a reference of measure to assess practices that deviate from the accepted standard.³²

The findings of this investigation are consistent with the results of previous studies demonstrating the ability of RCPs to prescribe and perform respiratory treatments for hospitalized non-ICU patients. Stoller and colleagues¹³ conducted a randomized controlled trial comparing RCP-directed respiratory care with physician-directed respiratory care. These investigators found that RCP-directed respiratory care demonstrated better agreement with the "standard care plan" of their institution and was associated with lower costs as compared with physician-directed respiratory care. These outcomes were achieved without any increase in adverse events, hospital mortality, or hospital length of stay. Similar studies have been performed focusing on specific aspects of respiratory care. Several clinical investigations have demonstrated the ability of RCPs to successfully wean patients from mechanical ventilation as compared with traditional physician-directed weaning.^{24 25 33} Similarly, Alexander and coworkers⁶ have shown that simple respiratory care guidelines, based on clinical practices supported by peer-reviewed investigations, could be used to reduce the performance of unnecessary respiratory treatments without compromising patient care. Such reductions were associated with significant cost savings and also allowed RCPs to concentrate their efforts on treatments that potentially were more likely to result in beneficial patient outcomes. However, it is important to note that most of the institutions involved in the study of protocols and guidelines for respiratory care (eg, Cleveland Clinic Foundation, Cedars-Sinai Medical Center) have extensive experience with protocol development and utilization. Therefore, the results of clinical investigations examining protocol-directed therapy from these institutions may, in part, be related to their medical practice cultures (ie, medical cultures accepting protocol- or guideline-directed treatments). The importance of such an environment for the successful implementation of quality improvement efforts, including protocol-based therapies, has recently been described.³⁴

Our study has several limitations. First, it was performed within a single institution using house officers to write most of the treatment orders for patients admitted to the internal medicine firms. Therefore, these results may not be generalizable to patients receiving respiratory care at other centers, particularly nonteaching hospitals. Second, our economic analysis only allowed us to examine respiratory care charges and not costs. However, these charges are directly related to the number and type of respiratory treatments provided to patients. This is consistent with other study results showing that the number of prescribed respiratory treatments is the most important determinant of respiratory therapy costs and charges.^{6 10} Reductions in administered respiratory treatments may not necessarily reduce the number of respiratory therapists needed at a given institution. Therefore, the economic impact of implemented respiratory therapy protocols should ideally be assessed in terms of resource utilization as well as manpower needs. Another important limitation of our study is the possibility of bias on the part of the RCPs performing the assessments for firm A patients. It is possible that these RCPs altered their normal practices to achieve better compliance with the institutional respiratory care algorithms during the study period. Lack of compliance with protocols and guidelines, after they are initially tested and implemented, is a common limitation of such methods aimed at standardizing medical practices.³⁵ The use of automated protocols using prompts and required inputs from bedside health-care providers represents one strategy for ensuring more uniform levels of protocol compliance over time.^{36 37}

Another important limitation of this study is that we only had experienced RCPs involved in performing patient assessments. This was purposely done to obtain support for the performance of this study from the admitting physicians. Therefore, these results may have differed if we had used less-experienced individuals in this capacity. Additionally, the numbers of treatments other than nebulizers and metered-dose inhalers were small, limiting the power of our results for those interventions. Lastly, RCPs in the control arm of this study were not impeded from communicating their clinical opinions to the treating physicians. We did not track this communication, nor did we monitor how often physicians deviated from the opinions of the RCPs in firms B and C. A recent investigation suggests that this may be an important barrier to the implementation of RCP-directed guidelines.³⁸

In summary, the use of RCP-directed treatment protocols decreased the overall use of respiratory care and decreased respiratory care charges without resulting in any detrimental clinical outcomes. Protocol-guided treatment represents an effective strategy for standardizing medical practices and focusing the efforts of health-care workers on specific tasks needing to be performed in a timely manner. Additionally, protocols can serve as important educational tools providing clinicians information on the appropriateness of various medical practices for specific disease processes.¹³ However, the effective use of protocol-directed therapies requires a dedicated effort on the part of the institution to ensure its success. This implies that such protocols are maintained and updated on a regular basis to optimize their clinical applicability, have adequate support staff in place to perform the necessary treatments, and do not impair or interfere with the ability of clinicians to alter practices based on their own experiences.^{34 39}

	Footnotes

 
Abbreviations: APACHE = acute physiology and chronic health evaluation; BJH = Barnes-Jewish Hospital; CI = confidence interval; RCP = respiratory care practitioner

Received for publication March 5, 1999. Accepted for publication June 28, 1999.

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