An interventional study of Audit and Feedback in Pulmonary Disease, COPD and Chronic Bronchitis, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
The purpose of this study is to evaluate a multifaceted intervention to improve the quality of end-of-life communication between patients with COPD and their primary care providers using information about patients preferences for end of life care and how to communicate and use this information to activate patients, family members, and healthcare providers.
This project builds on previous work that described preferences important to patients at end-of-life and desire for life-sustaining therapy by incorporating these attributes into a multifaceted intervention designed to improve the quality of end-of-life communication.
Our specific aim was to evaluate a multifaceted intervention to improve the quality of end-of-life communication between patients with moderate or severe COPD and their primary care providers. The intervention is based on self-efficacy theory and includes provider education, local champions and role models, determination of patients individual barriers and facilitators regarding communication about end-of-life care, preferences for communication about end-of-life care and preferences for end-of-life care and using this information to activate patients, family members, and healthcare providers.
For both control and intervention patients we collected the following information which was incorporated into a one-page summary report:
The intervention was incorporated into a usual clinic visit. For the upcoming clinic visit, we generated an individualized one-page patient specific feedback form for intervention group patients and providers. Patients and providers in the control group did not receive the form.
The generated one-page feedback form was:
The methods used for this study could be translated into clinic practice and possibly generalized to other chronic life-threatening conditions.
268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.
This study's enrollment of 376 is above the median of 120 across 184 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
One or more of the following:
1 Have 3 or more outpatient clinics visits for COPD (ICD-9) in the two years prior to enrollment.
Plus
Exclusion Criteria:
Audit and Feedback
Behavioral: Audit and Feedback
Usual care
Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.
Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale
The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.
Time frame: Measured at enrollment and 2 weeks after targeted clinic visit
Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.
We measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.
Time frame: Assessed 2 weeks after targeted clinic visit
| Milestone | Intervention (Audit and Feedback) | Control (Usual Care) |
|---|---|---|
| Started | 194 | 182 |
| Completed | 151 | 155 |
| Not completed | 43 | 27 |
| Withdrew: Withdrew/loss to follow-up | 43 | 27 |
The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.
| units on a scale | Intervention | Control |
|---|---|---|
| Pre-visit | 23.3 (19.9 to 26.8) | 19.2 (15.9 to 22.4) |
| Post-visit | 34.0 (28.5 to 39.4) | 25.5 (20.4 to 30.5) |
We measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.
| Proportion of participants reporting | Intervention | Control |
|---|---|---|
| Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit. | 0.30 (0.19 to 0.41) | 0.11 (0.06 to 0.16) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | 0/194 (0%) | 0/194 (0%) |
| Control | — | 0/182 (0%) | 0/182 (0%) |
42 clinicians were randomized to the intervention group. 50 clinicians were randomized to the control group. 376 patients were enrolled and assigned to their clinician's treatment group.
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 69.4 ± 10.0 | 69.4 ± 10.0 | 69.4 ± 10.0 |
| Sex/Gender, Customized(percent) | Intervention | Control | Total |
|---|---|---|---|
| Male | 97.9 | 96.2 | 97.1 |
| Race/Ethnicity, Customized(percent) | Intervention | Control | Total |
|---|---|---|---|
| White | 85.3 | 87.0 | 86.1 |
| Smoking Status(percent) | Intervention | Control | Total |
|---|---|---|---|
| Never smoked | 3.9 | 3.1 | 3.5 |
| Past smoker | 73.2 | 65.0 | 69.2 |
| Current smoker | 22.9 | 31.9 | 27.3 |
| Male Clinicians(percent) | Intervention | Control | Total |
|---|---|---|---|
| Number | 50.0 | 44.0 | 47.1 |
| Clinician clinic(percent) | Intervention | Control | Total |
|---|---|---|---|
| Geriatric | 7.1 | 8.0 | 7.6 |
| Primary care/internal medicine | 64.3 | 68.0 | 66.1 |
| Pulmonary | 28.6 | 24.0 | 26.4 |
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