Integrating Care After Exacerbation of COPD

Study Overview
=================
Brief Summary
-----------------
This clinical trial is designed to determine whether an intervention that provides information to primary care providers about gaps in care for their patients recently discharged from hospital for COPD can reduce hospital re-admissions and mortality and improve their patients' quality-of-life.

Detailed Description
-----------------
Chronic obstructive pulmonary disease (COPD) exacerbations are common among Veterans admitted to hospital, lead to worsening health-related quality of life, and are important drivers of health care expenditures. As many as half of patients discharged for COPD are readmitted within 6 months. An intervention to improve COPD care is needed, not only to treat patients for COPD and their accompanying comorbidities, but also to redesign the care delivery system. The goal of this clinical trial is to test an intervention to improve patient care during the transition from hospital to outpatient setting for patients discharged for COPD. The investigators are targeting the intervention to Patient Aligned Care Team (PACT) providers who are randomized to receive the intervention or not receive the intervention. For the intervention, study clinicians, consisting of experienced primary care providers and pulmonary specialists, reviewed the medical record for each patient discharged from hospital for COPD. The team looked for gaps in care for COPD and key co-morbidities such as obesity, hypertension, diabetes, and cardiovascular disease. They focused on immediate care processes associated with the hospital admission and comorbid disease treatment. For providers in the intervention group, the team placed any patient care recommendations into the medical record using a non-visit consult note and pre-filled order sets. The patient's provider then accepted, modified, or declined any or all of the recommendations based on personal knowledge of the patient's history. The investigators hypothesize that the intervention will: 1) improve patient quality of life; and 2) decrease hospital readmission and mortality after hospital admission for COPD exacerbation.

Official Title
-----------------
Integrating Care After Exacerbation of COPD (InCasE)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Behavioral: guideline treatment recommendations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Providers: Primary care provider (MD, NP, PA) from VA Puget Sound or Boise VA. Willingness to participate in the informed consent process and complete interviews and questionnaires. Patients: Having a provider that is participating in this clinical trial. Discharged alive with either a primary discharge diagnosis of COPD or acute respiratory failure with a secondary diagnosis of COPD. Willing and able to participate in the informed consent process and complete interviews and questionnaires. Exclusion Criteria: Providers: none Patients: Having previously participated in the study. Significant cognitive dysfunction, language barrier, or severe psychiatric disorder that would preclude completing the questionnaires.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual. | |
| Experimental: guideline treatment recommendations<br>Primary care clinicians receive treatment recommendations for their patients discharged from hospital for a COPD exacerbation. | Behavioral: guideline treatment recommendations<br>* Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Hospital Re-admission and Mortality | Composite measure of hospital readmission for any cause at 180 days and all-cause mortality. | 180 days post-discharge | 
| COPD-related Patient Quality-of-life (Clinical COPD Questionnaire) | self-report survey of patients' quality-of-life with scores ranging from 0-6 with lower scores representing better health; not all participants completed surveys. | 6 weeks post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS) | self-report survey of patients' general physical health quality-of-life scored from 0-100 with higher scores indicating better health. | 6 weeks post-discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized controlled trial, quality of life, patient readmission, mortality, patient satisfaction, intervention studies, multicenter study