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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01828567
Acronym
ACTIVATE
Enrollment
417
Registered
2013-04-10
Start date
2014-10-01
Completion date
2017-12-30
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Risk Appraisal, Heart Disease, Prevention

Keywords

veterans, health risk assessment, primary prevention, shared decision making, Healthy Living Assessment

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.

Interventions

BEHAVIORALShared 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 Patient Aligned Care Team (PACT), and a follow-up call one month later to assess the progress of the prevention plan.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Enrollment in Prevention Services1 and 6 months (cumulative)Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.

Secondary

MeasureTime frameDescription
Patient Activation Measures (PAM)Baseline assessmentPatient 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
Patient Activation Measures1 month assessmentPatient 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 ScoreBaselineThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
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.
208
Control
Usual care
209
Total417

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyExcluded - did not meet criteria41
Overall StudyLost to Follow-up279

Baseline characteristics

CharacteristicInterventionControlTotal
Age, Continuous55.3 years
STANDARD_DEVIATION 12.7
56.3 years
STANDARD_DEVIATION 11.7
55.8 years
STANDARD_DEVIATION 12.2
Race/Ethnicity, Customized
Black or African American
90 Participants79 Participants169 Participants
Race/Ethnicity, Customized
Other
19 Participants20 Participants39 Participants
Race/Ethnicity, Customized
White
99 Participants110 Participants209 Participants
Region of Enrollment
United States
208 Participants209 Participants417 Participants
Sex: Female, Male
Female
36 Participants25 Participants61 Participants
Sex: Female, Male
Male
172 Participants184 Participants356 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 2080 / 209
serious
Total, serious adverse events
65 / 20853 / 209

Outcome results

Primary

Enrollment in Prevention Services

Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.

Time frame: 1 and 6 months (cumulative)

Population: Unknowns were removed from the denominator: Intervention n=29; control n=15.

ArmMeasureValue (NUMBER)
InterventionEnrollment in Prevention Services91 participants
ControlEnrollment in Prevention Services56 participants
Comparison: The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.p-value: <0.000195% CI: [1.66, 3.89]Regression, Logistic
Secondary

Framingham Risk Score

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.

Time frame: Baseline

Population: Unknowns were removed from the denominator: Intervention n=7; control n=2.

ArmMeasureValue (MEAN)Dispersion
InterventionFramingham Risk Score21.8 average scoreStandard Deviation 16.8
ControlFramingham Risk Score22.7 average scoreStandard Deviation 16.8
Secondary

Framingham Risk Score

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.

Time frame: 6 months

Population: Unknowns were removed from the denominator: Intervention n=22; control n=18.

ArmMeasureValue (MEAN)Dispersion
InterventionFramingham Risk Score22.4 average scoreStandard Deviation 17.5
ControlFramingham Risk Score22.5 average scoreStandard Deviation 16.3
Comparison: Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.p-value: 0.3395% CI: [-0.7, 2.2]Repeated Measures
Secondary

Patient Activation Measures

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

Time frame: 1 month assessment

ArmMeasureValue (MEAN)Dispersion
InterventionPatient Activation Measures63.7 average scoreStandard Deviation 13.8
ControlPatient Activation Measures61.4 average scoreStandard Deviation 11.1
Comparison: For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.p-value: 0.20495% CI: [-0.8, 3.7]Repeated Measures
Secondary

Patient Activation Measures

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

Time frame: 6 months assessments

ArmMeasureValue (MEAN)Dispersion
InterventionPatient Activation Measures67.0 average scoreStandard Deviation 13
ControlPatient Activation Measures63.2 average scoreStandard Deviation 13.3
p-value: 0.0395% CI: [0.2, 4.7]Repeated Measures
Secondary

Patient Activation Measures (PAM)

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

Time frame: Baseline assessment

ArmMeasureValue (MEAN)Dispersion
InterventionPatient Activation Measures (PAM)62.4 average scoreStandard Deviation 12.7
ControlPatient Activation Measures (PAM)60.6 average scoreStandard Deviation 12.3

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026