Chronic Obstructive Pulmonary Disease
Conditions
Keywords
randomized controlled trial, quality of life, patient readmission, mortality, patient satisfaction, intervention studies, multicenter study
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.
Interventions
BEHAVIORALguideline treatment recommendations
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Hospital Re-admission and Mortality | 180 days post-discharge | Composite measure of hospital readmission for any cause at 180 days and all-cause mortality. |
| COPD-related Patient Quality-of-life (Clinical COPD Questionnaire) | 6 weeks post-discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS) | 6 weeks post-discharge | self-report survey of patients' general physical health quality-of-life scored from 0-100 with higher scores indicating better health. |
Countries
United States
Participant flow
Recruitment details
We grouped primary care teams into 30 clusters and randomly assigned each cluster to one of 30 30-day time periods at which time the team would moved from control to intervention. Teams gained and lost providers each month as indicated by addition and attrition below. We also have indicated the number of eligible patient discharges that occurred for each group.
Pre-assignment details
Prior to randomization, 224 providers were invited with 7 refusing, leaving 217 providers included in randomization; 7 additional providers left primary care prior to Step 0, leaving 210 providers who initially participated in the control group in Step 0.
Participants by arm
| Arm | Count |
|---|---|
| Provider Participants all primary care providers: demographic information not collected | 365 |
| Control Patient Participants data for all patients discharged under care of a provider in the control group | 191 |
| Intervention Patient Participants data for all patients discharged under care of a provider in the intervention group | 161 |
| Total | 717 |
Baseline characteristics
| Characteristic | Control Patient Participants | Intervention Patient Participants | Total | Provider Participants |
|---|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 8.6 | 69.7 years STANDARD_DEVIATION 8.1 | 69.7 years STANDARD_DEVIATION 8.35 | — |
| Provider type Attending Physician | — | — | 66 provider participants | 66 provider participants |
| Provider type Nurse Practitioner/Physician Assistant | — | — | 38 provider participants | 38 provider participants |
| Provider type Physician Fellow/Resident Physician | — | — | 35 provider participants | 35 provider participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 4 Participants | — |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants | — |
| Race (NIH/OMB) Black or African American | 8 Participants | 14 Participants | 22 Participants | — |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 5 Participants | 5 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 16 Participants | 30 Participants | — |
| Race (NIH/OMB) White | 166 Participants | 120 Participants | 286 Participants | — |
| Sex: Female, Male Female | 182 Participants | 155 Participants | 337 Participants | — |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 191 | 15 / 161 |
| other Total, other adverse events | 20 / 191 | 38 / 161 |
| serious Total, serious adverse events | 84 / 191 | 68 / 161 |
Outcome results
Primary
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.
Time frame: 6 weeks post-discharge
Population: For 365 enrolled providers, we surveyed 352 patients discharged from hospital for COPD. Not all participants completed surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | COPD-related Patient Quality-of-life (Clinical COPD Questionnaire) | 3.50 CCQ total score | Standard Deviation 1.22 |
| Guideline Treatment Recommendations | COPD-related Patient Quality-of-life (Clinical COPD Questionnaire) | 2.97 CCQ total score | Standard Deviation 1.2 |
Primary
Number of Patients With Hospital Re-admission and Mortality
Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.
Time frame: 180 days post-discharge
Population: For 365 enrolled providers, we analyzed 352 patients discharged from hospital for COPD for readmission or mortality
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Patients With Hospital Re-admission and Mortality | 84 Participants |
| Guideline Treatment Recommendations | Number of Patients With Hospital Re-admission and Mortality | 61 Participants |
Secondary
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.
Time frame: 6 weeks post-discharge
Population: For 365 enrolled providers, we surveyed 352 patients discharged from hospital for COPD. Not all participants completed surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS) | 29.92 units on a scale | Standard Deviation 12.22 |
| Guideline Treatment Recommendations | Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS) | 33.25 units on a scale | Standard Deviation 11.94 |