N/A
N=417
Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?
Health Risk Appraisal · Heart Disease · Prevention
Bottom Line
View on ClinicalTrials.gov: NCT01828567 ↗Enrolled (actual)
417
Serious AEs
28.3%
Results posted
Sep 2018
Primary outcome: Primary: Enrollment in Prevention Services — 91; 56 participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shared decision making with a Prevention Coach (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment in Prevention Services |
91; 56 | <.0001 sig |
| SECONDARY Patient Activation Measures (PAM) |
62.4; 60.6 | — |
| SECONDARY Patient Activation Measures |
67.0; 63.2 | 0.030 sig |
| SECONDARY Patient Activation Measures |
67.0; 63.2 | 0.030 sig |
| SECONDARY Framingham Risk Score |
22.4; 22.5 | 0.330 |
| SECONDARY Framingham Risk Score |
22.4; 22.5 | 0.330 |
Summary
The VA has committed to disseminate a web-based Healthy Living Assessment(HLA) tool and use it as the cornerstone of a personalized prevention plan to engage patients to improve their health behaviors that lead to high health risk. Health risk assessments done in isolation, however, do not generally lead to behavior change. Our study will test the effectiveness of a Shared Decision Making intervention designed to activate Veterans to enroll in effective prevention programs. The intervention will be conducted over the telephone, by a prevention coach, and will be linked to the patients' primary care team. The co-primary outcomes will be patient activation and patient enrollment in prevention programs; 10-year risk of major cardiac events will also be measured.
Eligibility Criteria
Inclusion Criteria
To be included in the study, patients must meet the following:
- enrolled in primary care at the Durham or Ann Arbor Health Care Systems
- have one modifiable risk factor identified by a healthy living assessment (physical inactivity, overweight or obese by BMI, or tobacco user)
Exclusion Criteria
Individuals will be excluded if they have any of the following:
- have been hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past three months
- have an active diagnosis of psychosis
- have any other health condition they feel would impede participation in the study
- reside in a nursing home
- are severely impaired in hearing or speech, so that they cannot respond to telephone calls
- have significant cognitive or memory impairment
- do not have access to a telephone
- are participating in another prevention intervention study
- are already enrolled in a formal prevention service
Data sourced from ClinicalTrials.gov (NCT01828567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.