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Pro-Change Population Health Solution (PCPHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02755636
Recruitment Status : Unknown
Verified May 2016 by Deborah Levesque, Pro-Change Behavior Systems.
Recruitment status was:  Recruiting
First Posted : April 29, 2016
Last Update Posted : June 2, 2016
Sponsor:
Collaborator:
Community Health Center, Inc.
Information provided by (Responsible Party):
Deborah Levesque, Pro-Change Behavior Systems

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.

Condition or disease Intervention/treatment Phase
Risk Behavior Behavioral: PCPHC Other: Usual care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions
Study Start Date : May 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: PCPHC intervention
PCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months
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

Active Comparator: Usual care
Usual primary care plus study assessments at baseline, 6, and 12 months
Other: Usual care
Primary care as usual




Primary Outcome Measures :
  1. Change in number of cancer risk behaviors [ Time Frame: Baseline, 12 months ]
    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).


Secondary Outcome Measures :
  1. Change in consumer engagement [ Time Frame: Baseline, 12 months ]
    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.

  2. Adherence with cancer screenings [ Time Frame: 12 months ]
    Adherence with cancer screenings be the percentage of age- and gender-based U.S. Preventive Services Task Force-recommended screenings received during follow-up.

  3. Change in satisfaction with medical care [ Time Frame: Baseline, 12 months ]
    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).

  4. Change in well-being [ Time Frame: Baseline, 12 months ]
    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.

  5. Change in health-related quality of life [ Time Frame: Baseline, 12 months ]
    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.


Other Outcome Measures:
  1. Change in number of cigarettes smoked per day [ Time Frame: Baseline, 12 months ]
    Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance)

  2. Progress to the Action stage for smoking cessation [ Time Frame: 12 months ]
    Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance)

  3. Change in number of alcoholic drinks per week [ Time Frame: Baseline, 12 months ]
    Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance)

  4. Progress to the Action stage for drinking within recommended limits [ Time Frame: 12 months ]
    Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance)

  5. Change in level of leisure-time exercise [ Time Frame: Baseline, 12 months ]
    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)

  6. Progress to the Action stage for meeting national guidelines for physical activity [ Time Frame: 6 months, 12 months ]
    Will only be assessed among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance)

  7. Change in body mass index (BMI) [ Time Frame: Baseline, 12 months ]
    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)

  8. Progress to the Action stage for engaging in four key behaviors for healthy weight management [ Time Frame: 6 months, 12 months ]
    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)

  9. Change in level of depression [ Time Frame: Baseline, 12 months ]
    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)

  10. Progress to the Action stage for managing depression [ Time Frame: 6 months, 12 months ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755636


Contacts
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Contact: Deborah A Levesque, Ph.D 401-360-2975 dlevesque@prochange.com
Contact: Deborah Van Marter, M.P.H. 401-360-2981 dvanmarter@prochange.com

Locations
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United States, Connecticut
Connecticut Health Center, Inc. Recruiting
Middletown, Connecticut, United States, 06457
Contact: Daren Anderson, MD    860-347-6971    AndersD@chc1.com   
Contact: Bridget Teevan, MPH    860-416-3088    TeevanB@chc1.com   
United States, Rhode Island
Pro-Change Behavior Systems, Inc. Recruiting
South Kingstown, Rhode Island, United States, 02879
Contact: Deborah A Levesque, Ph.D.    401-360-2975    dlevesque@prochange.com   
Contact: Deborah Van Marter, M.P.H.    401-360-2981    dvanmarter@prochange.com   
Principal Investigator: Deborah A Levesque, Ph.D.         
Sponsors and Collaborators
Pro-Change Behavior Systems
Community Health Center, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Deborah A Levesque, Ph.D. Pro-Change Behavior Systems

Publications:
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.
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.
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.
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.

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Responsible Party: Deborah Levesque, Chief Science Officer, Pro-Change Behavior Systems
ClinicalTrials.gov Identifier: NCT02755636    
Other Study ID Numbers: HHSN261201500015C
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Deborah Levesque, Pro-Change Behavior Systems:
Health Behavior Change
Primary Health Care
Patient Participation
Provider-Patient Communication
Cluster-Randomized Trial
Mobile Health