Diabetes PreventionMIPCDNCT03139019
Medicaid Incentives for the Prevention of Chronic Diseases: Diabetes Prevention
A study testing Process incentives, Outcome incentives and Process and Outcome incentives in people with Diabetes Prevention, run by University of Pennsylvania at 1 site in United States.
Trial summary
The relative effectiveness of incentives based on process (e.g. medication adherence) vs. outcome (improvements in blood pressure) is unknown, leading to the key research question: Which approach is more effective? The incentive structure for this initiative is based on best practices in the use of process and outcome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Prevention
- What is being tested?
- Process incentives, Outcome incentives and Process and Outcome incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Have been diagnosed as pre-diabetic or high risk for diabetes
- Had a HbA1c test in the last year and if not are willing to get one now
- Medicaid enrolled in NYS
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The relative effectiveness of incentives based on process (e.g. medication adherence) vs. outcome (improvements in blood pressure) is unknown, leading to the key research question: Which approach is more effective? The incentive structure for this initiative is based on best practices in the use of process and outcome measures to address this fundamental question. A series of incentive designs will be conducted to examine the relative effectiveness of equivalent value incentives based on process (e.g. attending smoking cessation counseling sessions), outcomes (e.g. quitting smoking), or a combination of process and outcomes incentives (e.g. attending smoking cessation counseling sessions and quitting smoking). This will also provide an overarching framework for assessing the relative importance of process versus outcome incentives in different contexts and for different populations.
Read the detailed description
Although great potential exists to promote healthy behaviors through financial incentives, few studies have compared the efficacy and effectiveness of incentives in a Medicaid population. This is important because although financial incentives structured as rewards to individuals substantially improve rates of healthy behaviors, the absolute proportions of people adopting healthier behaviors remain low. Early approaches to financial incentives generally have reflected all-or-nothing thinking by showing that providing incentives is better than not providing incentives, and by assuming that incentives will work similarly across different types of people. But basic research in behavioral economics suggests that how you pay and whom you pay may be critical factors. Furthermore, the relative effectiveness of incentives based on processes vs. outcomes is unknown, and indeed, is one of the most fundamental unresolved questions in the incentive literature. Economists would argue that outcome-based incentives are likely to be more effective because they allow each person to figure out the most efficient path to achieve a desired result. On the other hand, behavioral economists would argue in favor of incentivizing processes because they are simpler and more concrete. Additionally, some ethicists argue that incentivizing processes is fairer because they are effort dependent, and because in some cases the ability to achieve improvements in outcomes may be related to factors people cannot control, such as their environment or their genes. Ultimately, the key question from a health and economic policy standpoint is which approach is more effective. In this regard, improvements in outcomes seem appropriate to incentivize directly because such results are required for incentive programs or other interventions to improve health and/or reduce health care spending. And indeed, there is some limited evidence suggesting that incentives for weight loss, for example, may be more effective than incentives for process measures (eg, attendance) in obesity programs.
The goal of the New York State Medicaid Incentives Plan is to improve clinical outcomes and decrease health expenditures by increasing smoking cessation, lowering high blood pressure, preventing diabetes onset, and enhancing diabetes self-management among Medicaid enrollees in New York State. Several incentive strategies will be explored to promote the use of under-utilized Medicaid benefits and regional resources. The New York State (NYS) Medicaid Incentives Program will target four prevention goals: 1) smoking cessation; 2) lowering high blood pressure; 3) diabetes onset prevention; and 4) diabetes management. For each prevention goal, four treatment arms have been defined. One treatment arm will receive incentives for process activities; one treatment arm will receive incentives for achieving desired outcomes; one treatment arm will receive incentives for both process activities and outcomes; and one arm will serve as a control, receiving no incentives. The smoking cessation incentive program will be piloted in western New York where smoking rates are higher than other regions of the state. Participants will receive direct cash payments for participating in smoking cessation counseling (process), filling nicotine replacement therapy prescriptions (process), and quitting smoking (outcome). 2,332 participants will be recruited for this study. The blood pressure control incentive program will be piloted in New York City where stakeholders are highly engaged and a large population of people at risk for inadequate blood pressure control reside. Participants will receive direct cash payments for attending primary care appointments (process), filling antihypertensive prescriptions (process), and decreasing or maintaining a decreased systolic blood pressure by 10mmHg or achieving another clinically appropriate target (outcome). 488 participants will be recruited for this study. The diabetes management incentive program will be piloted in New York City where the capacity of diabetes self management educators is the greatest. Participants will receive direct cash payment for attending primary care appointments (process), attending diabetes self-management education sessions (process), filling diabetes prescriptions (process), and decreasing their HbA1c by 0.6% or maintaining a level of 8.0% or less (outcome). 660 participants will be recruited for this study. The diabetes onset prevention incentive program will be piloted in western New York and New York City, where the capacity of YMCA Diabetes Prevention Programs is the greatest and well-integrated with stakeholders. Participants will receive lottery tickets for attending YMCA Diabetes Prevention Program sessions (process) and losing or maintaining a reduced weight (outcome). 596 participants will be recruited for this study. Other incentive approaches and research questions will be explored through rapid cycle evaluation.
- Conditions
- Diabetes Prevention
- Being tested
- Process incentives, Outcome incentives, Process and Outcome incentives
- Keywords
- Diabetes prevention, Weight loss, Lifestyle change
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process incentivesBehavioural
Participants will receive cash based incentives for achieving process based measures (class attendance).
Outcome incentivesBehavioural
Participants will receive cash based incentives for outcome based measures (weight loss).
Process and Outcome incentivesBehavioural
Participants will receive cash based incentives for both achieving process based measures (class attendance) and outcome based measures (weight loss).
| Study group | Role | What they receive |
|---|---|---|
| Process incentives | Experimental | Process incentives participants will receive incentives based on visit attendance in the YMCA DPP session. This incentive will be $ 15 for attending each session. Receives: Behavioral: Process incentives |
| Outcome incentives | Experimental | Outcome incentives participants will be weighed at 8 and 16 weeks after the program starts and if they have lost 2.5% of their body weight at each time point then they will receive $100 and $140 respectively. Receives: Behavioral: Outcome incentives |
| Process and Outcome incentives | Experimental | If assigned to the Process and Outcome arm participants will be informed that they can earn additional incentives for attending DPP classes and losing weight. Participants in this arm can earn $7.50 per DPP class (max 16) and $50 and $70 for achieving 2.5% weight loss at 8 and 16 weeks respectively. Receives: Behavioral: Process and Outcome incentives |
| Control arm | No intervention | If assigned to the Control arm participants will not be eligible for any additional incentives and will just learn the goals of the DPP program itself. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Process measure: measurement of activities related to diabetes prevention (attending DPP class attendance
Number of completed education sessions in a16-week DPP program
Measured: During a 16 week program once enrolled
Outcome measure: Measure of decrease in weight loss across 16 weeks
Weight loss during program.
Measured: During a 16 week period once enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Diabetes PreventionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health, Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- Kevin Volpp, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139019
- Sponsor's protocol ID
- 818842-1
- Acronym
- MIPCD
- Status last verified
- May 2017
- First submitted
- 12 Oct 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
NYS Medicaid Complete Plan Enrollment, 2010
NCQA Patient-Centered Medical Home 2011 Overview. Accessed April 20, 2011. http://www.ncqa.org/tabid/631/default.aspx
Office of the Governor Press Release "Governor Cuomo Accepts Recommendations from the Medicaid Redesign Team." February 24, 2011 http://www.governor.ny.gov/press/022411cuomoaccepts_medicaidredesignteam
U.S. Census 2010
2010 New York State Managed care Plan Enrollment: A report on managed care enrollment by health plan and county. New York State Department of Health
2009 Medicaid Claims data
State Health Facts. Kaiser Family Foundation. Accessed March 28, 2011 http://www.statehealthfacts.org/profileind.jsp?ind=177&cat=4&rgn=34
NYS DOH Prevention Quality Indicators. Accessed April 26, 2011. https://apps.nyhealth.gov/statistics/prevention/quality_indicators/start.map;jsessionid=87AA57B85B9BAF52A09F024D8D784077
American Legacy Foundation. Saving Lives, Saving Money II: Tobacco-free states spend less on Medicaid. November 2007. Accessed March 28, 2011
eQARR Quality Assurance Reporting Requirements New York State. Accessed April 4, 2011. http://www.health.state.ny.us/health_care/managed_care/reports/eqarr/2008/statewide/medicaid/managing_cardiovascular_respiratory_conditions.htm
National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda (MD): National Heart, Lung, and Blood Institute (US); 2004 Aug. Report No.: 04-5230. Available from http://www.ncbi.nlm.nih.gov/books/NBK9630/
PubMed 20821851UnitedHealth Center for Health Reform and Modernization. "The United State of Diabetes: Challenges and opportunities in the decade ahead." Working Paper 5 November 2010.
New York State Tobacco Control Program. Leading the way toward a tobacco-free society 2010-2013
Centers for Disease Control and Prevention, 2006
A guide to the New York State Clean Indoor Air Act. NYS DOH. Access March 28, 2011 http://www.health.state.ny.us/publications/3402/index.htm
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicaid Incentives for the Prevention of Chronic Diseases: Diabetes Prevention
- ClinicalTrials.gov ID
- NCT03139019
- Acronym / sponsor ID
- MIPCD / 818842-1
- Conditions
- Diabetes Prevention
- Keywords
- Diabetes prevention, Weight loss, Lifestyle change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- New York State Department of Health, Centers for Medicare and Medicaid Services
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 May 2017 (actual)
- 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.
The relative effectiveness of incentives based on process (e.g. medication adherence) vs. outcome (improvements in blood pressure) is unknown, leading to the key research question: Which approach is more effective? The incentive structure for this initiative is based on best practices in the use of process and outcome measures to address this fundamental question. A series of incentive designs will be conducted to examine the relative effectiveness of equivalent value incentives based on process (e.g. attending smoking cessation counseling sessions), outcomes (e.g. quitting smoking), or a combination of process and outcomes incentives (e.g. attending smoking cessation counseling sessions and quitting smoking). This will also provide an overarching framework for assessing the relative importance of process versus outcome incentives in different contexts and for different populations.
Detailed description
Although great potential exists to promote healthy behaviors through financial incentives, few studies have compared the efficacy and effectiveness of incentives in a Medicaid population. This is important because although financial incentives structured as rewards to individuals substantially improve rates of healthy behaviors, the absolute proportions of people adopting healthier behaviors remain low. Early approaches to financial incentives generally have reflected all-or-nothing thinking by showing that providing incentives is better than not providing incentives, and by assuming that incentives will work similarly across different types of people. But basic research in behavioral economics suggests that how you pay and whom you pay may be critical factors. Furthermore, the relative effectiveness of incentives based on processes vs. outcomes is unknown, and indeed, is one of the most fundamental unresolved questions in the incentive literature. Economists would argue that outcome-based incentives are likely to be more effective because they allow each person to figure out the most efficient path to achieve a desired result. On the other hand, behavioral economists would argue in favor of incentivizing processes because they are simpler and more concrete. Additionally, some ethicists argue that incentivizing processes is fairer because they are effort dependent, and because in some cases the ability to achieve improvements in outcomes may be related to factors people cannot control, such as their environment or their genes. Ultimately, the key question from a health and economic policy standpoint is which approach is more effective. In this regard, improvements in outcomes seem appropriate to incentivize directly because such results are required for incentive programs or other interventions to improve health and/or reduce health care spending. And indeed, there is some limited evidence suggesting that incentives for weight loss, for example, may be more effective than incentives for process measures (eg, attendance) in obesity programs.
The goal of the New York State Medicaid Incentives Plan is to improve clinical outcomes and decrease health expenditures by increasing smoking cessation, lowering high blood pressure, preventing diabetes onset, and enhancing diabetes self-management among Medicaid enrollees in New York State. Several incentive strategies will be explored to promote the use of under-utilized Medicaid benefits and regional resources. The New York State (NYS) Medicaid Incentives Program will target four prevention goals: 1) smoking cessation; 2) lowering high blood pressure; 3) diabetes onset prevention; and 4) diabetes management. For each prevention goal, four treatment arms have been defined. One treatment arm will receive incentives for process activities; one treatment arm will receive incentives for achieving desired outcomes; one treatment arm will receive incentives for both process activities and outcomes; and one arm will serve as a control, receiving no incentives. The smoking cessation incentive program will be piloted in western New York where smoking rates are higher than other regions of the state. Participants will receive direct cash payments for participating in smoking cessation counseling (process), filling nicotine replacement therapy prescriptions (process), and quitting smoking (outcome). 2,332 participants will be recruited for this study. The blood pressure control incentive program will be piloted in New York City where stakeholders are highly engaged and a large population of people at risk for inadequate blood pressure control reside. Participants will receive direct cash payments for attending primary care appointments (process), filling antihypertensive prescriptions (process), and decreasing or maintaining a decreased systolic blood pressure by 10mmHg or achieving another clinically appropriate target (outcome). 488 participants will be recruited for this study. The diabetes management incentive program will be piloted in New York City where the capacity of diabetes self management educators is the greatest. Participants will receive direct cash payment for attending primary care appointments (process), attending diabetes self-management education sessions (process), filling diabetes prescriptions (process), and decreasing their HbA1c by 0.6% or maintaining a level of 8.0% or less (outcome). 660 participants will be recruited for this study. The diabetes onset prevention incentive program will be piloted in western New York and New York City, where the capacity of YMCA Diabetes Prevention Programs is the greatest and well-integrated with stakeholders. Participants will receive lottery tickets for attending YMCA Diabetes Prevention Program sessions (process) and losing or maintaining a reduced weight (outcome). 596 participants will be recruited for this study. Other incentive approaches and research questions will be explored through rapid cycle evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Process incentives | Experimental | Behavioral: Process incentivesProcess incentives participants will receive incentives based on visit attendance in the YMCA DPP session. This incentive will be $ 15 for attending each session. |
| Outcome incentives | Experimental | Behavioral: Outcome incentivesOutcome incentives participants will be weighed at 8 and 16 weeks after the program starts and if they have lost 2.5% of their body weight at each time point then they will receive $100 and $140 respectively. |
| Process and Outcome incentives | Experimental | Behavioral: Process and Outcome incentivesIf assigned to the Process and Outcome arm participants will be informed that they can earn additional incentives for attending DPP classes and losing weight. Participants in this arm can earn $7.50 per DPP class (max 16) and $50 and $70 for achieving 2.5% weight loss at 8 and 16 weeks respectively. |
| Control arm | No intervention | –If assigned to the Control arm participants will not be eligible for any additional incentives and will just learn the goals of the DPP program itself. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Have been diagnosed as pre-diabetic or high risk for diabetes
- Had a HbA1c test in the last year and if not are willing to get one now
- Medicaid enrolled in NYS
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Process incentivesParticipants will receive cash based incentives for achieving process based measures (class attendance). | Behavioural | Process incentives |
| Outcome incentivesParticipants will receive cash based incentives for outcome based measures (weight loss). | Behavioural | Outcome incentives |
| Process and Outcome incentivesParticipants will receive cash based incentives for both achieving process based measures (class attendance) and outcome based measures (weight loss). | Behavioural | Process and Outcome incentives |
Primary outcome
Process measure: measurement of activities related to diabetes prevention (attending DPP class attendance
Time frame: During a 16 week program once enrolled
Number of completed education sessions in a16-week DPP program
Outcome measure: Measure of decrease in weight loss across 16 weeks
Time frame: During a 16 week period once enrolled
Weight loss during program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- BackgroundNYS Medicaid Complete Plan Enrollment, 2010
- BackgroundNCQA Patient-Centered Medical Home 2011 Overview. Accessed April 20, 2011. http://www.ncqa.org/tabid/631/default.aspx
- BackgroundOffice of the Governor Press Release "Governor Cuomo Accepts Recommendations from the Medicaid Redesign Team." February 24, 2011 http://www.governor.ny.gov/press/022411cuomoaccepts_medicaidredesignteam
- BackgroundU.S. Census 2010
- Background2010 New York State Managed care Plan Enrollment: A report on managed care enrollment by health plan and county. New York State Department of Health
- Background2009 Medicaid Claims data
- BackgroundState Health Facts. Kaiser Family Foundation. Accessed March 28, 2011 http://www.statehealthfacts.org/profileind.jsp?ind=177&cat=4&rgn=34
- BackgroundNYS DOH Prevention Quality Indicators. Accessed April 26, 2011. https://apps.nyhealth.gov/statistics/prevention/quality_indicators/start.map;jsessionid=87AA57B85B9BAF52A09F024D8D784077
- BackgroundAmerican Legacy Foundation. Saving Lives, Saving Money II: Tobacco-free states spend less on Medicaid. November 2007. Accessed March 28, 2011
- BackgroundeQARR Quality Assurance Reporting Requirements New York State. Accessed April 4, 2011. http://www.health.state.ny.us/health_care/managed_care/reports/eqarr/2008/statewide/medicaid/managing_cardiovascular_respiratory_conditions.htm
- Background: PubMed 20821851National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda (MD): National Heart, Lung, and Blood Institute (US); 2004 Aug. Report No.: 04-5230. Available from http://www.ncbi.nlm.nih.gov/books/NBK9630/
- BackgroundUnitedHealth Center for Health Reform and Modernization. "The United State of Diabetes: Challenges and opportunities in the decade ahead." Working Paper 5 November 2010.
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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.
Kevin Volpp, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Process incentives, Outcome incentives and Process and Outcome incentives in people with Diabetes Prevention, run by University of Pennsylvania at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Process measure: measurement of activities related to diabetes prevention (attending DPP class attendance (time frame: During a 16 week program once enrolled). The study lists 2 primary outcomes in all. 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 NCT03139019, which also lists 37 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 3 May 2017.