Respiratory Disease Management

Study Overview
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Brief Summary
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The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning.

Detailed Description
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The investigators propose to carry out a prospective, randomized, trial at Barnes-Jewish Hospital (1250-bed urban academic hospital). Eligible patients will be identified by a senior study coordinator who will also obtain informed consent for study participation. Adults greater than 18 years of age and less than 65 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following: patients with spirometrically confirmed COPD at high risk for repeat hospitalization or ED visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation, chronic home use of oxygen, or a course of systemic corticosteroid therapy in the preceding 12 months. Exclusion criteria include patients not expected to survive their hospitalization, presence of metastatic cancer, bed-bound individuals, non-English speaking patients, and patients unable to provide informed consent.

Official Title
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Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: RT management
* Other: Ususal care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults greater than 18 years of age and less than 64 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following: patients with spirometrically confirmed COPD at high risk for repeat hospitalization or emergency department (ED) visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation, chronic home use of oxygen, or a course of systemic corticosteroid therapy in the preceding 12 months. Exclusion Criteria: patients not expected to survive their hospitalization, presence of metastatic cancer, bed-bound individuals, non-English speaking patients, and patients unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Ususal care. | Other: Ususal care<br>* Routine respiratory care.<br>|
| Active Comparator: Intervention<br>Patients assigned to the RT management arm will receive a 1-hour educational in-service conducted by a respiratory therapist case manager. The patient education session will include general information about COPD, direct observation of inhaler techniques, a review and adjustment of outpatient COPD medications, smoking cessation counseling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, and instruction in hand hygiene. | Other: RT management<br>* Patients assigned to the RT management arm will receive a 1-hour educational in-service conducted by a respiratory therapist case manager. The patient education session will include general information about COPD, direct observation of inhaler techniques, a review and adjustment of outpatient COPD medications, smoking cessation counseling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, and instruction in hand hygiene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The combined number of hospital admissions and ED visits for a COPD exacerbation | Coordinators will use two strategies, First, they will monitor the automated medical record. All inpatient, outpatient, and ED visits to BJC affiliated institutions. Second coordinators will conduct bi-monthly telephone inquires to patients to determine if they had recent hospital or ED visits. | 6-month follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations and ED visits for other causes | Number of times a subject is hospitalized or visit the ED during the study period. | up to 3 months | 
| Hospital and intensive care unit (ICU) lengths of stay | the number of days a subject is in the intensive care unit | 6 months | 
| Respiratory medication use | prescribed respiratory medications dose and usage | 6 months | 
| All causes of mortality | documentation of all causes of mortality | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD