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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • NYS Department of Health

    Albany, New York, 12201

Other trials in United States

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.

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 groups in NCT03139019
Study groupRoleWhat they receive
Process incentivesExperimentalProcess 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 incentivesExperimentalOutcome 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 incentivesExperimentalIf 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 armNo interventionIf 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.

  1. 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

  2. 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.

  1. First posted3 May 2017
  2. Study startJun 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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)
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 20821851
  • UnitedHealth 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

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.

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