Clinical trial NCT02755636: Pro-Change Population Health Solution
Official title: Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Risk Behavior
Keywords: Health Behavior Change
Primary Health Care
Patient Participation
Provider-Patient Communication
Cluster-Randomized Trial
Mobile Health
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
Collaborators: name: Community Health Center, Inc.
First posted: 2016-04-29
Enrollment: 780
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools designed to assist patients and primary care providers (PCPs) in applying evidence-based principles of health behavior change to reduce four cancer risk behaviors-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-and depression among at-risk patients. The intervention is based on the Transtheoretical Model of Behavior Change (TTM, the "stage model") and includes computer-tailored interventions and text messages for patients and a clinical dashboard for providers. The efficacy of the intervention will be assessed in a cluster-randomized trial involving 780 patients recruited from 12 federally qualified health centers randomly assigned to intervention or usual care.

Detailed description: A cluster-randomized design will be used to assess the efficacy of the PCPHS intervention for multiple behavior change for cancer prevention by comparing 6- and 12-month outcomes among 780 primary care patients recruited by 12 federally qualified health clinics randomly assigned to intervention or usual care. A Multiattribute Utility Measurement Approach will be used to ensure that clinics assigned to the two conditions are approximately equivalent on clinic size, patient demographics, and cancer risk behaviors (e.g., rates of smoking, overweight, and obesity). The most similar clinics will be paired, and one clinic within each pair will be assigned to intervention, and the other to usual care.

Patients with an upcoming appointment and who meet study inclusion criteria will be invited to participate in the study, which will begin with an online baseline survey. In addition, patients in the intervention group will complete an online health risk intervention (HRI) that assesses and intervenes on the four cancer risk behaviors targeted in the intervention-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-as well depression. It will also assess whether participants have received cancer screenings recommended by age and gender.

After the HRI session, intervention participants will have access to the TTM CTIs targeting their risk factors during the next six months. Patients assigned to the usual care condition will receive care as usual.

Providers at the six clinics assigned to intervention will receive training on the TTM and the clinical dashboard. They will have access to the dashboard via the patient electronic medical record (EMR) during the intervention period, and will be expected to use the dashboard to deliver the one-on-one component of the TTM intervention. The clinical dashboard will:

1. Report whether the participant has received recommended cancer screenings;
2. Summarize data on targeted behavioral risks for cancer;
3. Summarize data on level of depression;
4. For each cancer risk behavior, show stage of change for meeting recommended guidelines; if at least mild depression show stage of change for using healthy strategies to manage depression; and
5. For each cancer risk behavior and depression management, provide stage-matched scripts providers can use to help participants progress to the next stage of change or to prevent relapse to an earlier stage.

Intervention group providers will deliver the dashboard-guided session at the patient's next clinic visit. The dashboard will be updated as the participant completes CTI sessions post-visit. Study participants who return to the clinic for any reason during the intervention period will be flagged, and the provider will use the dashboard to review progress and deliver updated stage-matched guidance.

All study participants will receive an online survey to assess outcomes at 6 and 12 months follow-up. Participants who don't complete the online survey within two weeks will be contacted by a survey research company to complete the survey by phone.

Eligibility criteria: Inclusion Criteria:

Has at least one of the following behavioral risk factors for cancer:

1. Cigarette smoker
2. Exceeds recommended limits for alcohol intake
3. Does not meet national guidelines for physical activity
4. Overweight or obese

Exclusion Criteria:

1. Currently pregnant
2. Currently undergoing cancer treatment
3. Serious medical condition that could prevent participation in the study for a full year
4. History of mania, schizophrenia, or other psychoses
5. Admitted to an inpatient mental health facility within the previous 2 years
6. Currently enrolled in the In It to Quit Study at the Community Health Center, Inc.
7. Unable to read English or Spanish
8. Unable to receive text messages

Note: Risky drinkers who screen positive for alcohol dependence will not be eligible for the intervention's risky drinking program, which focuses on limiting drinking to national guidelines. Treatment and control participants who screen positive for alcohol dependence and who are not engaging in any of the other targeted cancer risk behaviors will screen out of the study.

Primary outcomes:
measure: Change in number of cancer risk behaviors
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in consumer engagement
timeFrame: Baseline, 12 months
measure: Adherence with cancer screenings
timeFrame: 12 months
measure: Change in satisfaction with medical care
timeFrame: Baseline, 12 months
measure: Change in well-being
timeFrame: Baseline, 12 months
measure: Change in health-related quality of life
timeFrame: Baseline, 12 months
Other outcomes:
measure: Change in number of cigarettes smoked per day
timeFrame: Baseline, 12 months
measure: Progress to the Action stage for smoking cessation
timeFrame: 12 months
measure: Change in number of alcoholic drinks per week
timeFrame: Baseline, 12 months
measure: Progress to the Action stage for drinking within recommended limits
timeFrame: 12 months
measure: Change in level of leisure-time exercise
timeFrame: Baseline, 12 months
measure: Progress to the Action stage for meeting national guidelines for physical activity
timeFrame: 6 months, 12 months
measure: Change in body mass index (BMI)
timeFrame: Baseline, 12 months
measure: Progress to the Action stage for engaging in four key behaviors for healthy weight management
timeFrame: 6 months, 12 months
measure: Change in level of depression
timeFrame: Baseline, 12 months
measure: Progress to the Action stage for managing depression
timeFrame: 6 months, 12 months
Locations:
city: Middletown
country: United States
facility: Connecticut Health Center, Inc.
state: Connecticut
city: South Kingstown
country: United States
facility: Pro-Change Behavior Systems, Inc.
state: Rhode Island
Study officials:
affiliation: Pro-Change Behavior Systems
name: Deborah A Levesque, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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