Pro-Change Population Health Solution

Risk Behavior Clinical Trial

— PCPHS  

Official title:

Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02755636
• Other study ID #: HHSN261201500015C
• Status: Recruiting
• Phase: Phase 2
• First received: March 30, 2016
• Last updated: May 31, 2016
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2016
• Source: Pro-Change Behavior Systems
• Contact: Deborah A Levesque, Ph.D
• Phone: 401-360-2975
• Email: dlevesque[@]prochange.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Risk Behavior

Intervention

Behavioral:
• PCPHC
Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard

Other:
• Usual care
Primary care as usual

Locations

Country	Name	City	State
United States	Connecticut Health Center, Inc.	Middletown	Connecticut
United States	Pro-Change Behavior Systems, Inc.	South Kingstown	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Pro-Change Behavior Systems	Community Health Center, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

Agency for Healthcare Policy and Research. CAHPS 2.0 survey and reporting kit. Rockville, MD: Agency for Healthcare Policy and Research; 1999.

Cantril H. The pattern of human concerns. New Brunswick, NJ: Rutgers University Press; 1965.

Centers for Disease Control and Prevention. Measuring Healthy Days: Population Assessment of Health-Related Quality of Life. Atlanta, GA; 2000.

Duke CC, Lynch WD, Smith B, Winstanley J. Validity of a New Patient Engagement Measure: The Altarum Consumer Engagement (ACE) Measure. Patient. 2015 Dec;8(6):559-68. doi: 10.1007/s40271-015-0131-2. Erratum in: Patient. 2015 Dec;8(6):569. — View Citation

Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. — View Citation

Graham JW, Flay BR, Johnson CA, Hansen WB, Collins LM. Group comparability: A multiattribute utility measurement approach to the use of random assignment with small numbers of aggregated units. Evaluation Review 1984;8(2):247-60.

Hargraves JL, Hays RD, Cleary PD. Psychometric properties of the Consumer Assessment of Health Plans Study (CAHPS) 2.0 adult core survey. Health Serv Res. 2003 Dec;38(6 Pt 1):1509-27. — View Citation

Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27. — View Citation

Prochaska J, Prochaska J, Prochaska J. Building a science for multiple-risk behavior change. In: Riekert KA, Ockene JK, Pbert L, editors. The handbook of health behavior change. 4 ed. New York: Springer; 2014. p. 245-67.

Prochaska JO, Redding C, Evers K. The Transtheoretical model and stages of change. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behavior and Health Education: Theory, Research and Practice. 4 ed. San Francisco, CA: Jossey-Bass; 2008. p. 97-122.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in number of cigarettes smoked per day	Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance)	Baseline, 12 months	No
Other	Progress to the Action stage for smoking cessation	Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance)	12 months	No
Other	Change in number of alcoholic drinks per week	Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance)	Baseline, 12 months	No
Other	Progress to the Action stage for drinking within recommended limits	Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance)	12 months	No
Other	Change in level of leisure-time exercise	Will be assessed using Godin's Leisure-Time Exercise Questionnaire (Godin & Shephard, 1985) only among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance)	Baseline, 12 months	No
Other	Progress to the Action stage for meeting national guidelines for physical activity	Will only be assessed among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance)	6 months, 12 months	No
Other	Change in body mass index (BMI)	Will be calculated using height and weight only among patients who are overweight (BMI of 25 kg/m2 or higher) at baseline (exploratory analysis; study is not powered to find significance)	Baseline, 12 months	No
Other	Progress to the Action stage for engaging in four key behaviors for healthy weight management	Progress to the Action stage for 1) reducing daily calorie intake by 500 calories/day, 2) limiting saturated and trans fat intake, 3) managing emotional distress, and 4) meeting national guidelines for physical activity will only be assessed among patients who are overweight (BMI of 25 kg/m2 or higher) at baseline (exploratory analysis; study is not powered to find significance)	6 months, 12 months	No
Other	Change in level of depression	Will be assessed using the Patient Health Questionnaire (PHQ-8) (Kroenke, Strine, Spritzer, Williams, Berry, & Mokdad, 2009) only among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance)	Baseline, 12 months	No
Other	Progress to the Action stage for managing depression	Will only be assessed among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance)	6 months, 12 months	No
Primary	Change in number of cancer risk behaviors	Change in number of cancer risk behaviors will be computed by taking the difference in the count of the four cancer risk behaviors (cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity) from baseline to 12 months follow-up. At each time point, the index will range from 0 to 4, with each risk behavior scored a "1" if present, and "0" if not present (Prochaska, Prochaska, & Prochaska, 2014).	Baseline, 12 months	No
Secondary	Change in consumer engagement	Change in consumer engagement will be computed by taking the difference in scores on the Altarum Consumer Engagement Measure (Duke, Lynch, Smith, & Winstanley, 2015) from baseline to 12 months follow-up. The measure assesses four dimensions of engagement in healthcare: 1) commitment, 2) informed choice, 3) navigation, and 4) ownership.	Baseline, 12 months	No
Secondary	Adherence with cancer screenings	Adherence with cancer screenings be the percentage of age- and gender-based U.S. Preventive Services Task Force-recommended screenings received during follow-up.	12 months	No
Secondary	Change in satisfaction with medical care	Change in patient satisfaction will be computed by taking the difference in participant scores on a 1-item global rating of satisfaction with care scale from baseline to 12 months follow-up. The scale is taken from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey (Agency for Healthcare Policy and Research, 1999; Hargraves, Hays, & Cleary, 2003).	Baseline, 12 months	No
Secondary	Change in well-being	Change in well-being will be computed by taking the difference in the Cantril Self-Anchoring Scale (Cantril, 1965) from baseline to 12 months follow-up. The measure asks participants to imagine a ladder with steps numbered from zero to ten, with the top representing the best possible life and the bottom representing the worst possible life, and to indicate where they feel their life falls currently and where it will be in five years.	Baseline, 12 months	No
Secondary	Change in health-related quality of life	Change in well-being will be computed by taking the difference in the Centers for Disease Control and Prevention Healthy Days (2000) Core Measures from baseline to 12 months follow-up. The measures assess overall self-rated health, recent physical symptoms, recent mental and emotional distress, and recent activity limitations.	Baseline, 12 months	No