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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK104249 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Harvard Pilgrim Health Care | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized intervention | Experimental | Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service |
|
| Usual care | Experimental | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized intervention | Behavioral | Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months following the date of outreach into the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Schmittdiel | Research Scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Research | Oakland | California | 94501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985875 | Background | Gregg EW, Hora I, Benoit SR. Resurgence in Diabetes-Related Complications. JAMA. 2019 May 21;321(19):1867-1868. doi: 10.1001/jama.2019.3471. No abstract available. | |
| 29903012 | Background | Lin J, Thompson TJ, Cheng YJ, Zhuo X, Zhang P, Gregg E, Rolka DB. Projection of the future diabetes burden in the United States through 2060. Popul Health Metr. 2018 Jun 15;16(1):9. doi: 10.1186/s12963-018-0166-4. |
| Label | URL |
|---|---|
| Centers for Disease Control and Prevention (CDC). About Diabetes | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standardized Intervention | Participants in the standardized intervention arm received outreach encouraging mail order pharmacy use. |
| FG001 | Control | Participants in the control arm received usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standardized Intervention | Participants in the standardized intervention arm received outreach encouraging mail order pharmacy use. |
| BG001 | Control | Participants in the control arm received usual care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months following the date of outreach into the intervention |
|
12 months for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standardized Intervention | Participants in the standardized intervention arm received outreach encouraging mail order pharmacy use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Schmittdiel, PhD, MA | Kaiser Permanente Northern California | 5108913872 | Julie.A.Schmittdiel@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2020 | Aug 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Usual care | Behavioral | Usual care |
|
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| 33849937 | Derived | 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. |
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| American Diabetes Association (ADA). Statistics About Diabetes | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Has Mail Order Incentive | Count of Participants | Participants |
|
| Has Secure Messaging | This measure applies only to KPNC and KPHI participants. | This measure applies only to KPNC and KPHI participants. | Count of Participants | Participants |
|
| Had Oral Diabetes Mellitus (DM) Drug Fill | Count of Participants | Participants |
|
| Had Oral Dyslipidemia (DL) Drug Fill | Count of Participants | Participants |
|
| Had Oral Hypertension (HT) Drug Fill | Count of Participants | Participants |
|
| Total Number of Oral Cardiovascular Disease (CVD) Drug Fills | Mean | Standard Deviation | Oral CVD drug fills |
|
| Total Number of Oral HT Drug Fills | Mean | Standard Deviation | Oral HT drug fills |
|
| Total Number of Oral DM Drug Fills | Mean | Standard Deviation | Oral DM drug fills |
|
| # of classes of Oral CVD Drugs | Mean | Standard Deviation | Classes of Oral CVD drug fills |
|
| # of drug classes poorly adherent to | Mean | Standard Deviation | Drug classes poorly adhered to |
|
| % of Oral CVD drug classes poorly adherent to | Mean | Standard Deviation | % of Oral CVD drug classes poorly adhere |
|
| Diabetes Identification | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 599 |
| 31,493 |
| 0 |
| 31,493 |
| 0 |
| 31,493 |
| EG001 | Control | Participants in the control arm received usual care. | 582 | 31,519 | 0 | 31,519 | 0 | 31,519 |
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