Risk BehaviorPhase 2PCPHSNCT02755636
Pro-Change Population Health Solution
A Phase 2 study testing PCPHC in people with Risk Behavior, run by Pro-Change Behavior Systems at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior
- What is being tested?
- PCPHC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has at least one of the following behavioral risk factors for cancer:
- Cigarette smoker
- Exceeds recommended limits for alcohol intake
- Does not meet national guidelines for physical activity
- Overweight or obese
Who cannot join
- Currently pregnant
- Currently undergoing cancer treatment
- Serious medical condition that could prevent participation in the study for a full year
- History of mania, schizophrenia, or other psychoses
- Admitted to an inpatient mental health facility within the previous 2 years
- Currently enrolled in the In It to Quit Study at the Community Health Center, Inc.
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- Unable to read English or Spanish
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Connecticut Health Center, Inc.
Middletown, Connecticut, 06457
Daren Anderson, MD, 860-347-6971, AndersD@chc1.com
Bridget Teevan, MPH, 860-416-3088, TeevanB@chc1.com
- Recruiting
Pro-Change Behavior Systems, Inc.
South Kingstown, Rhode Island, 02879
Deborah A Levesque, Ph.D., 401-360-2975, dlevesque@prochange.com
Deborah Van Marter, M.P.H., 401-360-2981, dvanmarter@prochange.com
About this study
Official title: Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions
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.
Read the 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:
- Report whether the participant has received recommended cancer screenings;
- Summarize data on targeted behavioral risks for cancer;
- Summarize data on level of depression;
- 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
- 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.
- Conditions
- Risk Behavior
- Being tested
- PCPHC, Usual care
- Keywords
- Health Behavior Change, Primary Health Care, Patient Participation, Provider-Patient Communication, Cluster-Randomized Trial, Mobile Health
- Medical subject headings
- Risk-Taking, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCPHCBehavioural
Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard
Usual careOther
Primary care as usual
| Study group | Role | What they receive |
|---|---|---|
| PCPHC intervention | Experimental | PCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months Receives: Behavioral: PCPHC; Other: Usual care |
| Usual care | Active comparator | Usual primary care plus study assessments at baseline, 6, and 12 months Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 12 months
Secondary outcomes (5)
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.
Measured: Baseline, 12 months
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.
Measured: 12 months
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).
Measured: Baseline, 12 months
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.
Measured: Baseline, 12 months
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.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Community Health Center, Inc.
- Responsible party
- Principal investigator, Deborah Levesque, Pro-Change Behavior Systems
- Investigators
- Deborah A Levesque, Ph.D., Principal investigator, Pro-Change Behavior Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755636
- Sponsor's protocol ID
- HHSN261201500015C
- Acronym
- PCPHS
- Status last verified
- May 2016
- First submitted
- 30 Mar 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
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.
PubMed 26097010Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Graham 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. doi: 10.1111/j.1475-6773.2003.00190.x.
PubMed 14727785Kroenke 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.
PubMed 18752852Prochaska 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Platform for Primary Care Delivery of Evidence-Based Cancer Risk Behavior Interventions
- ClinicalTrials.gov ID
- NCT02755636
- Acronym / sponsor ID
- PCPHS / HHSN261201500015C
- Conditions
- Risk Behavior
- Keywords
- Health Behavior Change, Primary Health Care, Patient Participation, Provider-Patient Communication, Cluster-Randomized Trial, Mobile Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Collaborators
- Community Health Center, Inc.
- Study start
- May 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Report whether the participant has received recommended cancer screenings;
- Summarize data on targeted behavioral risks for cancer;
- Summarize data on level of depression;
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCPHC intervention | Experimental | Behavioral: PCPHC, Other: Usual carePCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months |
| Usual care | Active comparator | Other: Usual careUsual primary care plus study assessments at baseline, 6, and 12 months |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cigarette smoker
- Exceeds recommended limits for alcohol intake
- Does not meet national guidelines for physical activity
- Overweight or obese
Key exclusion criteria (9 listed)
- Currently pregnant
- Currently undergoing cancer treatment
- Serious medical condition that could prevent participation in the study for a full year
- History of mania, schizophrenia, or other psychoses
- Admitted to an inpatient mental health facility within the previous 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCPHCMobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard | Behavioural | PCPHC intervention |
| Usual carePrimary care as usual | Other | PCPHC intervention, Usual care |
Primary outcome
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).
5 secondary outcomes
Change in consumer engagement
Time frame: Baseline, 12 months
Adherence with cancer screenings
Time frame: 12 months
Change in satisfaction with medical care
Time frame: Baseline, 12 months
Change in well-being
Time frame: Baseline, 12 months
Change in health-related quality of life
Time frame: Baseline, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- BackgroundAgency for Healthcare Policy and Research. CAHPS 2.0 survey and reporting kit. Rockville, MD: Agency for Healthcare Policy and Research; 1999.
- BackgroundCantril H. The pattern of human concerns. New Brunswick, NJ: Rutgers University Press; 1965.
- BackgroundCenters for Disease Control and Prevention. Measuring Healthy Days: Population Assessment of Health-Related Quality of Life. Atlanta, GA; 2000.
- Background: PubMed 26097010Duke 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.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- BackgroundGraham 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.
- Background: PubMed 14727785Hargraves 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. doi: 10.1111/j.1475-6773.2003.00190.x.
- Background: PubMed 18752852Kroenke 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.
- BackgroundProchaska 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.
- BackgroundProchaska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A Levesque, Ph.D. principal investigator
Pro-Change Behavior Systems
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCPHC in people with Risk Behavior, run by Pro-Change Behavior Systems at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah A Levesque, Ph.D (401-360-2975, dlevesque@prochange.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of cancer risk behaviors (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02755636, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.