Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandardized intervention
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
BEHAVIORALUsual care
Usual care
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Harvard Pilgrim Health Care
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Using Mail Order Pharmacy (MOP) After Intervention | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standardized Intervention Participants in the standardized intervention arm received outreach encouraging mail order pharmacy use. | 31,493 |
| Control Participants in the control arm received usual care. | 31,519 |
| Total | 63,012 |
Baseline characteristics
| Characteristic | Standardized Intervention | Control | Total |
|---|---|---|---|
| Age, Customized <20 | 13 Participants | 16 Participants | 29 Participants |
| Age, Customized 20-29 | 235 Participants | 232 Participants | 467 Participants |
| Age, Customized 30-39 | 1323 Participants | 1261 Participants | 2584 Participants |
| Age, Customized 40-49 | 4429 Participants | 4692 Participants | 9121 Participants |
| Age, Customized 50-59 | 9198 Participants | 9406 Participants | 18604 Participants |
| Age, Customized 60-69 | 9132 Participants | 9028 Participants | 18160 Participants |
| Age, Customized 70-79 | 5092 Participants | 4981 Participants | 10073 Participants |
| Age, Customized 80-89 | 1890 Participants | 1743 Participants | 3633 Participants |
| Age, Customized >89 | 181 Participants | 160 Participants | 341 Participants |
| Diabetes Identification One Inpatient Diagnosis | 100 Participants | 79 Participants | 179 Participants |
| Diabetes Identification One Prescription Fill | 15802 Participants | 15760 Participants | 31562 Participants |
| Diabetes Identification Two Outpatient Diagnosis | 15591 Participants | 15680 Participants | 31271 Participants |
| Had Oral Diabetes Mellitus (DM) Drug Fill | 25370 Participants | 25400 Participants | 50770 Participants |
| Had Oral Dyslipidemia (DL) Drug Fill | 25924 Participants | 25939 Participants | 51863 Participants |
| Had Oral Hypertension (HT) Drug Fill | 26785 Participants | 26891 Participants | 53676 Participants |
| Has Mail Order Incentive | 20321 Participants | 20007 Participants | 40328 Participants |
| Has Secure Messaging | 15009 Participants | 15019 Participants | 30028 Participants |
| # of classes of Oral CVD Drugs | 3.5 Classes of Oral CVD drug fills STANDARD_DEVIATION 1.6 | 3.5 Classes of Oral CVD drug fills STANDARD_DEVIATION 1.6 | 3.5 Classes of Oral CVD drug fills STANDARD_DEVIATION 1.6 |
| # of drug classes poorly adherent to | 1.7 Drug classes poorly adhered to STANDARD_DEVIATION 1 | 1.7 Drug classes poorly adhered to STANDARD_DEVIATION 1 | 1.7 Drug classes poorly adhered to STANDARD_DEVIATION 1 |
| % of Oral CVD drug classes poorly adherent to | 57.6 % of Oral CVD drug classes poorly adhere STANDARD_DEVIATION 31 | 57.6 % of Oral CVD drug classes poorly adhere STANDARD_DEVIATION 31 | 57.6 % of Oral CVD drug classes poorly adhere STANDARD_DEVIATION 31 |
| Race/Ethnicity, Customized Asian | 5900 Participants | 5595 Participants | 11495 Participants |
| Race/Ethnicity, Customized Black | 3867 Participants | 3872 Participants | 7739 Participants |
| Race/Ethnicity, Customized HI/PI | 1315 Participants | 1314 Participants | 2629 Participants |
| Race/Ethnicity, Customized Hispanic | 7811 Participants | 7815 Participants | 15626 Participants |
| Race/Ethnicity, Customized Missing | 4977 Participants | 4915 Participants | 9892 Participants |
| Race/Ethnicity, Customized Native American | 123 Participants | 186 Participants | 309 Participants |
| Race/Ethnicity, Customized White | 7500 Participants | 7822 Participants | 15322 Participants |
| Region of Enrollment United States | 31493 participants | 31519 participants | 63012 participants |
| Sex: Female, Male Female | 14204 Participants | 14184 Participants | 28388 Participants |
| Sex: Female, Male Male | 17289 Participants | 17335 Participants | 34624 Participants |
| Total Number of Oral Cardiovascular Disease (CVD) Drug Fills | 13.5 Oral CVD drug fills STANDARD_DEVIATION 10.2 | 13.5 Oral CVD drug fills STANDARD_DEVIATION 10.2 | 13.5 Oral CVD drug fills STANDARD_DEVIATION 10.2 |
| Total Number of Oral DM Drug Fills | 5.3 Oral DM drug fills STANDARD_DEVIATION 4.2 | 5.3 Oral DM drug fills STANDARD_DEVIATION 4.1 | 5.3 Oral DM drug fills STANDARD_DEVIATION 4.2 |
| Total Number of Oral HT Drug Fills | 7.3 Oral HT drug fills STANDARD_DEVIATION 6.4 | 7.4 Oral HT drug fills STANDARD_DEVIATION 6.5 | 7.4 Oral HT drug fills STANDARD_DEVIATION 6.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 599 / 31,493 | 582 / 31,519 |
| other Total, other adverse events | 0 / 31,493 | 0 / 31,519 |
| serious Total, serious adverse events | 0 / 31,493 | 0 / 31,519 |
Outcome results
Primary
Percent of Participants Using Mail Order Pharmacy (MOP) After 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
Time frame: 12 months following the date of outreach into the intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standardized Intervention | Percent of Participants Using Mail Order Pharmacy (MOP) After Intervention | 10.6 percentage of participants |
| Control | Percent of Participants Using Mail Order Pharmacy (MOP) After Intervention | 9.3 percentage of participants |
p-value: <0.001Chi-squared