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OpenTrials
Completed

NCT Number: NCT02621476

Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Research

Oakland, California, 94501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

Standardized intervention

Behavioral

Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service

Usual Care

Behavioral

Usual care

Primary outcomes

  1. Percent of Participants Using Mail Order Pharmacy (MOP) After Intervention

    Time frame: 12 months following the date of outreach into the intervention

    users of the mail order pharmacy service - if they utilized the mail order system to deliver medications anytime in the 12 months following the date of outreach into the intervention

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Harvard Pilgrim Health Care
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Dec 3, 2015
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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