Evaluating the Implementation of the Diabetes Prevention Program in an Integrated Health System

NCT03249077 | Completed

• 1 other identifier: 1R01DK115237
• Study Type: observational
• Target: 8,198
• Locations: 1 country
• Sites: 1

Brief Summary

In preparation for the roll out of the Medicare Diabetes Prevention Program (DPP) in 2018, Kaiser Permanente Northwest (KPNW), a large, integrated health care system, plans to pilot the implementation of DPP starting in April 2017. Patients 19-75 years old at high risk for diabetes will be offered DPP online or DPP in-person. A pragmatic, rigorous, quantitative and qualitative evaluation will be conducted to compare patients enrolled in DPP (either online or in-person) to those not enrolled to better inform future implementation efforts of DPP within and outside of KPNW. This study is a natural experiment project.

Conditions

Diabetes

Keywords

Prevention; Medicare

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight obtained from the electronic health record

  Baseline through 12 months

Secondary Outcomes (4)

• HbA1c

  Baseline through 12 months

• Cost-effectiveness

  Baseline through 12 months; and Baseline through 24 months (for digital DPP comparison to usual care only).

• Weight (24-month for digital DPP)

  Baseline through 24 months

• HbA1c (24-month for digital DPP)

  Basaeline through 24 months

Other Outcomes (9)

• Dietary Intake

  Baseline, 6 month follow-up, and 12 month follow-up

• Depression

  Baseline, 6 month follow-up, and 12 month follow-up

• Quality of Life

  Baseline, 6 month follow-up, and 12 month follow-up

Study Arms (3)

Digital DPP enrolled

The DPP online program is a CDC-certified translation of the DPP lifestyle intervention delivered in an online small group format of 10-15 participants.

Behavioral: Digital DPP

In-person DPP enrolled

In-person DPP participants will attend group sessions of \~20 participants in size at KPNW clinics. The group facilitator will use the CDC National DPP curriculum,

Behavioral: In-person DPP

DPP not enrolled (usual care)

Access to usual care services without restrictions.

Other: DPP not enrolled

Interventions

Digital DPP BEHAVIORAL

The online DPP program is 12 months in duration with 16 core sessions delivered over 16-26 weeks and 6 maintenance sessions delivered over 6 months.

Digital DPP enrolled

In-person DPP BEHAVIORAL

The in-person DPP program is 12 months and consists of weekly sessions for the first 6 months and monthly sessions for the remaining 6 months.

In-person DPP enrolled

DPP not enrolled OTHER

Access to usual care services without restrictions.

DPP not enrolled (usual care)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

KPNW adult members with prediabetes and obesity.

You may qualify if:

• Age 19-75
• BMI ≥ 30; and
• HbA1c 5.7-6.4%.

You may not qualify if:

• \) Diagnosis of diabetes prior to the study's recruitment efforts

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (23)

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• Ackermann RT, Kenrik Duru O, Albu JB, Schmittdiel JA, Soumerai SB, Wharam JF, Ali MK, Mangione CM, Gregg EW; NEXT-D Study Group. Evaluating diabetes health policies using natural experiments: the natural experiments for translation in diabetes study. Am J Prev Med. 2015 Jun;48(6):747-54. doi: 10.1016/j.amepre.2014.12.010.

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• Ali MK, Wharam F, Kenrik Duru O, Schmittdiel J, Ackermann RT, Albu J, Ross-Degnan D, Hunter CM, Mangione C, Gregg EW; NEXT-D Study Group. Advancing Health Policy and Program Research in Diabetes: Findings from the Natural Experiments for Translation in Diabetes (NEXT-D) Network. Curr Diab Rep. 2018 Nov 20;18(12):146. doi: 10.1007/s11892-018-1112-3.

  PMID: 30456479 BACKGROUND

• Chambers EC, Rehm CD, Correra J, Garcia LE, Marquez ME, Wylie-Rosett J, Parsons A. Factors in Placement and Enrollment of Primary Care Patients in YMCA's Diabetes Prevention Program, Bronx, New York, 2010-2015. Prev Chronic Dis. 2017 Mar 30;14:E28. doi: 10.5888/pcd14.160486.

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• Venkataramani M, Pollack CE, Yeh HC, Maruthur NM. Prevalence and Correlates of Diabetes Prevention Program Referral and Participation. Am J Prev Med. 2019 Mar;56(3):452-457. doi: 10.1016/j.amepre.2018.10.005. Epub 2019 Jan 17.

  PMID: 30661888 BACKGROUND

• Ali MK, McKeever Bullard K, Imperatore G, Benoit SR, Rolka DB, Albright AL, Gregg EW. Reach and Use of Diabetes Prevention Services in the United States, 2016-2017. JAMA Netw Open. 2019 May 3;2(5):e193160. doi: 10.1001/jamanetworkopen.2019.3160.

  PMID: 31074808 BACKGROUND

• Ackermann RT, O'Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Curr Diab Rep. 2020 Feb 20;20(3):9. doi: 10.1007/s11892-020-1293-4.

  PMID: 32080770 BACKGROUND

• Moin T, Damschroder LJ, AuYoung M, Maciejewski ML, Havens K, Ertl K, Vasti E, Weinreb JE, Steinle NI, Billington CJ, Hughes M, Makki F, Youles B, Holleman RG, Kim HM, Kinsinger LS, Richardson CR. Results From a Trial of an Online Diabetes Prevention Program Intervention. Am J Prev Med. 2018 Nov;55(5):583-591. doi: 10.1016/j.amepre.2018.06.028. Epub 2018 Sep 24.

  PMID: 30262149 BACKGROUND

• Sepah SC, Jiang L, Ellis RJ, McDermott K, Peters AL. Engagement and outcomes in a digital Diabetes Prevention Program: 3-year update. BMJ Open Diabetes Res Care. 2017 Sep 7;5(1):e000422. doi: 10.1136/bmjdrc-2017-000422. eCollection 2017.

  PMID: 28948027 BACKGROUND

• Sepah SC, Jiang L, Peters AL. Long-term outcomes of a Web-based diabetes prevention program: 2-year results of a single-arm longitudinal study. J Med Internet Res. 2015 Apr 10;17(4):e92. doi: 10.2196/jmir.4052.

  PMID: 25863515 BACKGROUND

• Kim SE, Castro Sweet CM, Cho E, Tsai J, Cousineau MR. Evaluation of a Digital Diabetes Prevention Program Adapted for Low-Income Patients, 2016-2018. Prev Chronic Dis. 2019 Nov 27;16:E155. doi: 10.5888/pcd16.190156.

  PMID: 31775010 BACKGROUND

• Castro Sweet CM, Chiguluri V, Gumpina R, Abbott P, Madero EN, Payne M, Happe L, Matanich R, Renda A, Prewitt T. Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk Reduction in a Medicare Population. J Aging Health. 2018 Jun;30(5):692-710. doi: 10.1177/0898264316688791. Epub 2017 Jan 24.

  PMID: 28553807 BACKGROUND

• Chen F, Su W, Becker SH, Payne M, Castro Sweet CM, Peters AL, Dall TM. Clinical and Economic Impact of a Digital, Remotely-Delivered Intensive Behavioral Counseling Program on Medicare Beneficiaries at Risk for Diabetes and Cardiovascular Disease. PLoS One. 2016 Oct 5;11(10):e0163627. doi: 10.1371/journal.pone.0163627. eCollection 2016.

  PMID: 27706216 BACKGROUND

• Lee PG, Damschroder LJ, Holleman R, Moin T, Richardson CR. Older Adults and Diabetes Prevention Programs in the Veterans Health Administration. Diabetes Care. 2018 Dec;41(12):2644-2647. doi: 10.2337/dc18-1141. Epub 2018 Oct 30.

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• Joiner KL, Nam S, Whittemore R. Lifestyle interventions based on the diabetes prevention program delivered via eHealth: A systematic review and meta-analysis. Prev Med. 2017 Jul;100:194-207. doi: 10.1016/j.ypmed.2017.04.033. Epub 2017 Apr 27.

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  PMID: 27623463 BACKGROUND

• Diabetes Prevention Program Research Group. Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes. Diabetes Care. 2003 Sep;26(9):2518-23. doi: 10.2337/diacare.26.9.2518.

  PMID: 12941712 BACKGROUND

• Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care. 2012 Apr;35(4):723-30. doi: 10.2337/dc11-1468.

  PMID: 22442395 BACKGROUND

• Herman WH. The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study. Clin Diabetes Endocrinol. 2015 Sep 2;1:9. doi: 10.1186/s40842-015-0009-1. eCollection 2015.

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• Hoerger TJ, Hicks KA, Sorensen SW, Herman WH, Ratner RE, Ackermann RT, Zhang P, Engelgau MM. Cost-effectiveness of screening for pre-diabetes among overweight and obese U.S. adults. Diabetes Care. 2007 Nov;30(11):2874-9. doi: 10.2337/dc07-0885. Epub 2007 Aug 13.

  PMID: 17698614 BACKGROUND

• Krukowski RA, Pope RA, Love S, Lensing S, Felix HC, Prewitt TE, West D. Examination of costs for a lay health educator-delivered translation of the Diabetes Prevention Program in senior centers. Prev Med. 2013 Oct;57(4):400-2. doi: 10.1016/j.ypmed.2013.06.027. Epub 2013 Jul 2.

  PMID: 23831492 BACKGROUND

• Zhou X, Siegel KR, Ng BP, Jawanda S, Proia KK, Zhang X, Albright AL, Zhang P. Cost-effectiveness of Diabetes Prevention Interventions Targeting High-risk Individuals and Whole Populations: A Systematic Review. Diabetes Care. 2020 Jul;43(7):1593-1616. doi: 10.2337/dci20-0018.

  PMID: 33534726 BACKGROUND

Related Links

• Centers for Medicare \& Medicaid Services. Federal Register, Vol. 81, No. 136, July 15, 2016, Proposal Rules. Pages 46413-46418 Accessed 11/09/2016
• Hinnant L, Razi S, Lewis R, et al. Evaluation of the Health Care Innovation Awards: Community Resource Planning, Prevention, and Monitoring Annual Report 2015. Awardee-Level Findings: YMCA of the USA. Accessed 11/09/2016

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephanie L Fitzpatrick, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2017
• Study Start: July 1, 2017
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

US (1)