Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities
NCT ID: NCT02621476
Last Updated: 2023-08-08
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
63012 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-02-01
Study Completion Date
2022-05-30
Brief Summary
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The investigators propose a randomized encouragement trial to encourage use of the existing mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor medications in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim, and Kaiser Permanente Hawaii.
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Detailed Description
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Adherence to effective cardiovascular disease (CVD) risk factor medications is associated with improved CVD risk factor control, fewer hospitalizations, and lower mortality in patients with diabetes. However, many patients are poorly adherent to medications, and there are persistent racial/ethnic and socioeconomic disparities in medication adherence. Traditional clinical trials of interventions to improve medication adherence are often resource-intensive, and focus exclusively on patient-level barriers to behavior change. Unsurprisingly, these trials have not led to sustainable, cost-effective approaches to improve adherence. Health system-level medication adherence interventions that can be implemented, "scaled up," and sustained across a wide range of health care delivery settings are urgently needed. The investigators propose a randomized encouragement trial to encourage use of existing mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor medications and who only use retail pharmacies in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim, and Kaiser Permanente Hawaii. These combined systems include approximately 300,000 patients with diabetes with diverse racial/ethnic and socioeconomic backgrounds. Patients with no history of mail order pharmacy use will be randomized into 2 arms. In addition to examining the impact of the intervention on medication adherence and CVD risk factor control, the investigators will examine factors affecting the sustainability and dissemination of the intervention, assess the intervention's impact on utilization and health care costs, and determine whether the intervention's impact differs across racial/ethnic and socioeconomic subgroups. This research will provide a foundation for developing sustainable, system-level approaches to addressing medication adherence in diabetes patients that can be widely disseminated and implemented across a diverse array of health care systems.
Conditions
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Diabetes Mellitus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Standardized intervention
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
Group Type
EXPERIMENTAL
Standardized intervention
Intervention Type
BEHAVIORAL
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
Usual care
Usual care
Group Type
EXPERIMENTAL
Usual care
Intervention Type
BEHAVIORAL
Usual care
Interventions
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Standardized intervention
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
Intervention Type
BEHAVIORAL
Usual care
Usual care
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Diabetes patients who are users of CVD risk factor medications (antihypertensive therapies, antihyperlipidemics therapies, and oral antihyperglycemic therapies),
* Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months
* Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months
* Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months
* Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months
Exclusion Criteria
* Pregnancy or Dementia/Traumatic Brain Injury diagnosis in the prior 12 months
* Hospitalized, in Skilled Nursing Facility, Hospice, or Home Health at the time of randomization.
* Hospitalized, in Skilled Nursing Facility, Hospice, or Home Health at the time of randomization.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
Harvard Pilgrim Health Care
OTHER
Sponsor Role
collaborator
Kaiser Permanente
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Julie A Schmittdiel
Role: PRINCIPAL_INVESTIGATOR
Research Scientist
Locations
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Division of Research
Oakland, California, United States
Site Status
Countries
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United States
References
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Duru OK, Schmittdiel JA, Dyer WT, Parker MM, Uratsu CS, Chan J, Karter AJ. Mail-order pharmacy use and adherence to diabetes-related medications. Am J Manag Care. 2010 Jan;16(1):33-40.
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BACKGROUND
Schmittdiel JA, Karter AJ, Dyer W, Parker M, Uratsu C, Chan J, Duru OK. The comparative effectiveness of mail order pharmacy use vs. local pharmacy use on LDL-C control in new statin users. J Gen Intern Med. 2011 Dec;26(12):1396-402. doi: 10.1007/s11606-011-1805-7. Epub 2011 Jul 20.
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Zhang L, Zakharyan A, Stockl KM, Harada AS, Curtis BS, Solow BK. Mail-order pharmacy use and medication adherence among Medicare Part D beneficiaries with diabetes. J Med Econ. 2011;14(5):562-7. doi: 10.3111/13696998.2011.598200. Epub 2011 Jul 6.
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Fernandez EV, McDaniel JA, Carroll NV. Examination of the Link Between Medication Adherence and Use of Mail-Order Pharmacies in Chronic Disease States. J Manag Care Spec Pharm. 2016 Nov;22(11):1247-1259. doi: 10.18553/jmcp.2016.22.11.1247.
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BACKGROUND
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Karter AJ, Parker MM, Duru OK, Schillinger D, Adler NE, Moffet HH, Adams AS, Chan J, Herman WH, Schmittdiel JA. Impact of a pharmacy benefit change on new use of mail order pharmacy among diabetes patients: the Diabetes Study of Northern California (DISTANCE). Health Serv Res. 2015 Apr;50(2):537-59. doi: 10.1111/1475-6773.12223. Epub 2014 Aug 15.
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Schmittdiel JA, Marshall CJ, Wiley D, Chau CV, Trinacty CM, Wharam JF, Duru OK, Karter AJ, Brown SD. Opportunities to encourage mail order pharmacy delivery service use for diabetes prescriptions: a qualitative study. BMC Health Serv Res. 2019 Jun 25;19(1):422. doi: 10.1186/s12913-019-4250-7.
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Raebel MA, Schmittdiel J, Karter AJ, Konieczny JL, Steiner JF. Standardizing terminology and definitions of medication adherence and persistence in research employing electronic databases. Med Care. 2013 Aug;51(8 Suppl 3):S11-21. doi: 10.1097/MLR.0b013e31829b1d2a.
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Schmittdiel JA, Adams SR, Goler N, Sanna RS, Boccio M, Bellamy DJ, Brown SD, Neugebauer RS, Ferrara A. The impact of telephonic wellness coaching on weight loss: A "Natural Experiments for Translation in Diabetes (NEXT-D)" study. Obesity (Silver Spring). 2017 Feb;25(2):352-356. doi: 10.1002/oby.21723.
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Schwab P, Racsa P, Rascati K, Mourer M, Meah Y, Worley K. A Retrospective Database Study Comparing Diabetes-Related Medication Adherence and Health Outcomes for Mail-Order Versus Community Pharmacy. J Manag Care Spec Pharm. 2019 Mar;25(3):332-340. doi: 10.18553/jmcp.2019.25.3.332.
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Adams AS, Uratsu C, Dyer W, Magid D, O'Connor P, Beck A, Butler M, Ho PM, Schmittdiel JA. Health system factors and antihypertensive adherence in a racially and ethnically diverse cohort of new users. JAMA Intern Med. 2013 Jan 14;173(1):54-61. doi: 10.1001/2013.jamainternmed.955.
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Lewis LM, Ogedegbe C, Ogedegbe G. Enhancing adherence of antihypertensive regimens in hypertensive African-Americans: current and future prospects. Expert Rev Cardiovasc Ther. 2012 Nov;10(11):1375-80. doi: 10.1586/erc.12.138.
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Schoenthaler A, Allegrante JP, Chaplin W, Ogedegbe G. The effect of patient-provider communication on medication adherence in hypertensive black patients: does race concordance matter? Ann Behav Med. 2012 Jun;43(3):372-82. doi: 10.1007/s12160-011-9342-5.
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Nichols GA, Bell TJ, Pedula KL, O'Keeffe-Rosetti M. Medical care costs among patients with established cardiovascular disease. Am J Manag Care. 2010 Mar;16(3):e86-e93.
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BACKGROUND
Thomas TW, Dyer WT, Yassin M, Neugebauer R, Karter AJ, Schmittdiel JA. Is Shelter-in-Place Policy Related to Mail Order Pharmacy Use and Racial/Ethnic Disparities for Patients With Diabetes? Diabetes Care. 2021 Jun;44(6):e113-e114. doi: 10.2337/dc20-2686. Epub 2021 Apr 13. No abstract available.
Reference Type
DERIVED
Ramachandran B, Trinacty CM, Wharam JF, Duru OK, Dyer WT, Neugebauer RS, Karter AJ, Brown SD, Marshall CJ, Wiley D, Ross-Degnan D, Schmittdiel JA. A Randomized Encouragement Trial to Increase Mail Order Pharmacy Use and Medication Adherence in Patients with Diabetes. J Gen Intern Med. 2021 Jan;36(1):154-161. doi: 10.1007/s11606-020-06237-8. Epub 2020 Oct 1.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://diabetes.org/diabetes-basics/statistics/
American Diabetes Association (ADA). Statistics About Diabetes
Other Identifiers
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CN-14-1947
Identifier Type: -
Identifier Source: org_study_id
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