This trial is active, not recruiting.

Conditions health risk appraisal, heart disease, prevention
Treatment shared decision making with a prevention coach
Sponsor VA Office of Research and Development
Start date October 2014
End date December 2016
Trial size 450 participants
Trial identifier NCT01828567, CRE 12-288


The VA has committed to disseminate a web-based Healthy Living Assessment 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose health services research
Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment
shared decision making with a prevention coach
A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.
(No Intervention)
Usual care

Primary Outcomes

Enrollment in prevention services
time frame: 1 and 6 months (cumulative)

Secondary Outcomes

Patient Activation Measures
time frame: 1 and 6 months (separate assessments)
Framingham Risk Score
time frame: 6 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?
Principal investigator Eugene Z Oddone, MD MHSc
Description Over half of all deaths, and many illnesses, can be attributed to four modifiable risk factors: tobacco use, overweight/obesity, physical inactivity, and alcohol use. There are clear links between these modifiable factors and heart disease, cancer, chronic lung disease, and stroke which continue to be the leading causes of death in the United States. Significant improvements have been made in controlling conditions that lead to heart disease, cancer and stroke (e.g., hypertension and hyperlipidemia). However, the underlying behavioral factors (e.g., obesity, tobacco use, and physical inactivity) have not been addressed as well. Prevention is particularly important for Veterans because of the high prevalence of significant risk factors for poor health. For example, more than 70% of VHA patients are overweight (body mass index [BMI] 25kg/m2) and one-third are obese (BMI 30kg/m2), which is significantly higher than the US population. Smoking also remains a significant problem among Veterans, with VHA enrollment data from 2010 indicating a prevalence of 20%. Younger Veterans are at particularly high risk for developing chronic illnesses because they are more likely to be overweight/obese and smoke more heavily than non-Veterans. The investigators propose a two-site, two-arm randomized trial measuring the effectiveness of a Shared Decision Making (SDM) intervention in activating Veterans to enroll in effective prevention services, and improve cardiovascular risk, compared to VA usual care. The study will be performed at the Durham and Ann Arbor VAMCs. Each arm will have 225 patients; patients will be VA users with at least one modifiable risk factor (obese, inactive, or tobacco user) who are not currently enrolled in a prevention service. The SDM intervention will be conducted by a prevention coach, telephone based, and will use the output from VHA's Healthy Living Assessment to engage Veterans in a conversation where individual preferences are matched to behaviors, and choices for specific prevention services. The resulting prevention action plan will be shared with the Veterans primary care team, and documented in the medical record. Outcomes will be obtained at baseline, 1 month and 6 months after enrollment by blinded research personnel. The primary outcomes will be: 1) proportion enrolled in effective prevention services; and 2) change in the Patient Activation Measure (PAM). The secondary outcome is 10-year risk of coronary events, as measured by Framingham Risk Score. Process evaluations of the intervention and its implementation will also be conducted to inform future dissemination and implementation should it prove effective.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.