Pulmonary Disease, COPD, Chronic Bronchitis, Emphysema
Conditions
Keywords
Communication, Palliative Care
Brief summary
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.
Detailed description
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: 1. Preferences about cardiopulmonary resuscitation (CPR) and mechanical ventilation 2. Preferences for communication with provider 3. Measure of severity of airflow obstruction 4. Barriers and facilitators to communication 5. Preferences for end-of-life care 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: 1. Mailed to the patient to share with their surrogate 2. Sent to their provider prior to the clinic visit 3. Provided to the patient prior to their clinic visit The methods used for this study could be translated into clinic practice and possibly generalized to other chronic life-threatening conditions.
Interventions
BEHAVIORALAudit and Feedback
Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 2\. Have been hospitalized with a primary discharge diagnosis (ICD-9) for COPD in the two years prior to enrollment. 3\. Active use of inhaled beta-agonist and ipratropium bromide (or equivalent in combination inhalers like Combivent) in the 12 months prior to enrollment. Plus 1. Have a future visit scheduled in one of the eligible primary care or chest clinics; and 2. Have airflow limitation
Exclusion criteria
1. If they have cognitive dysfunction, language barriers or severe psychiatric disorder that would preclude them from completing the questionnaires. This was assessed initially by the patients provider and by the research assistant during in-person interviews. 2. The provider taking care of their COPD does not participate. 3. Have a new diagnosis of COPD within the last month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale | Measured at enrollment and 2 weeks after targeted clinic visit | The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit. | Assessed 2 weeks after targeted 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. |
Countries
United States
Participant flow
Pre-assignment details
Patients gave written informed consent before enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Audit and feedback | 194 |
| Control Usual care | 182 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrew/Loss to follow-up | 43 | 27 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 10 | 69.4 years STANDARD_DEVIATION 10 | 69.4 years STANDARD_DEVIATION 10 |
| Clinician clinic Geriatric | 7.1 percent | 8.0 percent | 7.6 percent |
| Clinician clinic Primary care/internal medicine | 64.3 percent | 68.0 percent | 66.1 percent |
| Clinician clinic Pulmonary | 28.6 percent | 24.0 percent | 26.4 percent |
| Male Clinicians | 50.0 percent | 44.0 percent | 47.1 percent |
| Race/Ethnicity, Customized White | 85.3 percent | 87.0 percent | 86.1 percent |
| Sex/Gender, Customized Male | 97.9 percent | 96.2 percent | 97.1 percent |
| Smoking Status Current smoker | 22.9 percent | 31.9 percent | 27.3 percent |
| Smoking Status Never smoked | 3.9 percent | 3.1 percent | 3.5 percent |
| Smoking Status Past smoker | 73.2 percent | 65.0 percent | 69.2 percent |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 194 | 0 / 182 |
| serious Total, serious adverse events | 0 / 194 | 0 / 182 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale | Pre-visit | 23.3 units on a scale |
| Intervention | Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale | Post-visit | 34.0 units on a scale |
| Control | Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale | Pre-visit | 19.2 units on a scale |
| Control | Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale | Post-visit | 25.5 units on a scale |
Comparison: Power calculation: With 60 providers in each group, maintaining the probability of a type I error of 0.05, power of 0.90, provider level mean QOC score of 54.5 and provider level standard deviation in QOC score of 12.0, the minimal detectable difference in QOC score would be 7.5.p-value: 0.03GEE regression
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit. | 0.30 Proportion of participants reporting |
| Control | Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit. | 0.11 Proportion of participants reporting |