Medicaid Incentives for the Prevention of Chronic Diseases: Diabetes Prevention

NCT03139019 | Completed

• 1 other identifier: 818842-1
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetes Prevention

Keywords

Diabetes prevention; Weight loss; Lifestyle change

Outcome Measures

Primary Outcomes (2)

• Process measure: measurement of activities related to diabetes prevention (attending DPP class attendance

  Number of completed education sessions in a16-week DPP program

  During a 16 week program once enrolled

• Outcome measure: Measure of decrease in weight loss across 16 weeks

  Weight loss during program.

  During a 16 week period once enrolled

Study Arms (4)

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.

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.

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.

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.

Interventions

Process incentives BEHAVIORAL

Participants will receive cash based incentives for achieving process based measures (class attendance).

Process incentives

Outcome incentives BEHAVIORAL

Participants will receive cash based incentives for outcome based measures (weight loss).

Outcome incentives

Process and Outcome incentives BEHAVIORAL

Participants will receive cash based incentives for both achieving process based measures (class attendance) and outcome based measures (weight loss).

Process and Outcome incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Pennsylvania: lead
• New York State Department of Health: collaborator
• Centers for Medicare and Medicaid Services: collaborator

Study Sites (1)

NYS Department of Health

Albany, New York, 12201, United States

Location

Related Publications (37)

• NYS Medicaid Complete Plan Enrollment, 2010

  BACKGROUND

• NCQA Patient-Centered Medical Home 2011 Overview. Accessed April 20, 2011. http://www.ncqa.org/tabid/631/default.aspx

  BACKGROUND

• 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

  BACKGROUND

• U.S. Census 2010

  BACKGROUND

• 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

  BACKGROUND

• 2009 Medicaid Claims data

  BACKGROUND

• State Health Facts. Kaiser Family Foundation. Accessed March 28, 2011 http://www.statehealthfacts.org/profileind.jsp?ind=177&cat=4&rgn=34

  BACKGROUND

• NYS DOH Prevention Quality Indicators. Accessed April 26, 2011. https://apps.nyhealth.gov/statistics/prevention/quality_indicators/start.map;jsessionid=87AA57B85B9BAF52A09F024D8D784077

  BACKGROUND

• American Legacy Foundation. Saving Lives, Saving Money II: Tobacco-free states spend less on Medicaid. November 2007. Accessed March 28, 2011

  BACKGROUND

• 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

  BACKGROUND

• 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/

  PMID: 20821851 BACKGROUND

• UnitedHealth Center for Health Reform and Modernization. "The United State of Diabetes: Challenges and opportunities in the decade ahead." Working Paper 5 November 2010.

  BACKGROUND

• New York State Tobacco Control Program. Leading the way toward a tobacco-free society 2010-2013

  BACKGROUND

• Centers for Disease Control and Prevention, 2006

  BACKGROUND

• 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

  BACKGROUND

• Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System, 2009

  BACKGROUND

• Heil SH, Higgins ST, Bernstein IM, Solomon LJ, Rogers RE, Thomas CS, Badger GJ, Lynch ME. Effects of voucher-based incentives on abstinence from cigarette smoking and fetal growth among pregnant women. Addiction. 2008 Jun;103(6):1009-18. doi: 10.1111/j.1360-0443.2008.02237.x.

  PMID: 18482424 BACKGROUND

• Liu F. Quit attempts and intention to quit cigarette smoking among Medicaid recipients in the USA. Public Health. 2010 Oct;124(10):553-8. doi: 10.1016/j.puhe.2010.05.015. Epub 2010 Sep 15.

  PMID: 20832833 BACKGROUND

• McMenamin SB, Halpin HA, Bellows NM. Knowledge of Medicaid coverage and effectiveness of smoking treatments. Am J Prev Med. 2006 Nov;31(5):369-74. doi: 10.1016/j.amepre.2006.07.015. Epub 2006 Sep 25.

  PMID: 17046407 BACKGROUND

• Centers for Disease Control and Prevention. Leading Causes of Deaths. Accessed March 29, 2011 http://www.cdc.gov/nchs/fastats/lcod.htm

  BACKGROUND

• NYS (county level) Data Source: NYS Department of Health, Expanded Behavioral Risk Factor Surveillance System (Expanded BRFSS), http://www.nyhealth.gov/statistics/brfss/expanded/. 2008-2009

  BACKGROUND

• Elzubier AG, Husain AA, Suleiman IA, Hamid ZA. Drug compliance among hypertensive patients in Kassala, eastern Sudan. East Mediterr Health J. 2000 Jan;6(1):100-5.

  PMID: 11370321 BACKGROUND

• Shaya FT, Du D, Gbarayor CM, Frech-Tamas F, Lau H, Weir MR. Predictors of compliance with antihypertensive therapy in a high-risk medicaid population. J Natl Med Assoc. 2009 Jan;101(1):34-9. doi: 10.1016/s0027-9684(15)30808-7.

  PMID: 19245070 BACKGROUND

• Ormond BA, Spillman BC, Waidmann TA, Caswell KJ, Tereshchenko B. Potential national and state medical care savings from primary disease prevention. Am J Public Health. 2011 Jan;101(1):157-64. doi: 10.2105/AJPH.2009.182287. Epub 2010 Nov 18.

  PMID: 21088270 BACKGROUND

• National Diabetes Information Clearing House Accessed March 30, 2011 http://diabetes.niddk.nih.gov/dm/pubs/statistics/#dud

  BACKGROUND

• U.S. Preventive Services Task Force. The Guide to Clinical Preventive Services 2010 - 2011: Recommendations of the U.S. Preventive Services Task Force. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Aug. Report No.: 10-05145. Available from http://www.ncbi.nlm.nih.gov/books/NBK56707/

  PMID: 21850778 BACKGROUND

• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, Hoskin M, Kriska AM, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner J, Venditti B, Wylie-Rosett J. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006 Sep;29(9):2102-7. doi: 10.2337/dc06-0560.

  PMID: 16936160 BACKGROUND

• Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Am J Prev Med. 2008 Oct;35(4):357-63. doi: 10.1016/j.amepre.2008.06.035.

  PMID: 18779029 BACKGROUND

• Amundson HA, Butcher MK, Gohdes D, Hall TO, Harwell TS, Helgerson SD, Vanderwood KK; Montana Cardiovascular Disease and Diabetes Prevention Program Workgroup. Translating the diabetes prevention program into practice in the general community: findings from the Montana Cardiovascular Disease and Diabetes Prevention Program. Diabetes Educ. 2009 Mar-Apr;35(2):209-10, 213-4, 216-20 passim. doi: 10.1177/0145721709333269.

  PMID: 19321807 BACKGROUND

• Sjostrom CD, Lissner L, Wedel H, Sjostrom L. Reduction in incidence of diabetes, hypertension and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS Intervention Study. Obes Res. 1999 Sep;7(5):477-84. doi: 10.1002/j.1550-8528.1999.tb00436.x.

  PMID: 10509605 BACKGROUND

• Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.

  PMID: 19102784 BACKGROUND

• Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.

  PMID: 19066383 BACKGROUND

• Volpp KG, Pauly MV, Loewenstein G, Bangsberg D. P4P4P: an agenda for research on pay-for-performance for patients. Health Aff (Millwood). 2009 Jan-Feb;28(1):206-14. doi: 10.1377/hlthaff.28.1.206.

  PMID: 19124872 BACKGROUND

• Balamurugan A, Ohsfeldt R, Hughes T, Phillips M. Diabetes self-management education program for Medicaid recipients: a continuous quality improvement process. Diabetes Educ. 2006 Nov-Dec;32(6):893-900. doi: 10.1177/0145721706294787.

  PMID: 17102156 BACKGROUND

• Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. doi: 10.2337/diacare.24.3.561.

  PMID: 11289485 BACKGROUND

• Chin JY, Matson J, McCauley S, Anarella J, Gesten F, Roohan P. The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state. Contemp Clin Trials. 2020 Apr;91:105960. doi: 10.1016/j.cct.2020.105960. Epub 2020 Feb 19.

  PMID: 32087338 DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Microscopy, Electron, Scanning Transmission

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microscopy, Electron, Transmission; Microscopy, Electron; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kevin Volpp, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: May 3, 2017
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)