Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?

Not Applicable

Completed

• Conditions: Health Risk Appraisal; Heart Disease; Prevention
• Interventions: Behavioral: Shared decision making with a Prevention Coach

• Registration Number: NCT01828567
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed 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 Veterans Health Administration (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 Veterans Administration (VA) usual care. The study will be performed at the Durham and Ann Arbor Veterans Administration Medical Centers (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 (HLA) 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 (FRS). Process evaluations of the intervention and its implementation will also be conducted to inform future dissemination and implementation should it prove effective.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-10
• Study Start: 2014-10-01
• Primary Completion: 2016-12-30
• Results First Submitted: 2017-12-19
• Study Completion: 2017-12-30
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Results First Posted: 2018-09-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Shared decision making with a Prevention Coach	Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Primary Outcome Measures

Name	Time	Method
Enrollment in Prevention Services	1 and 6 months (cumulative)	Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.

Secondary Outcome Measures

Name	Time	Method
Patient Activation Measures (PAM)	Baseline assessment	Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
Framingham Risk Score	6 months	The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.
Patient Activation Measures	6 months assessments	Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant

Trial Locations

Locations (2)

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States