Diabetes MellitusNCT02621476
Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities
A study testing Standardized intervention in people with Diabetes Mellitus, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Standardized intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63,012 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 30 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Standardized intervention, Usual care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized interventionBehavioural
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
Usual careBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Standardized intervention | Experimental | Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service Receives: Behavioral: Standardized intervention |
| Usual care | Experimental | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months following the date of outreach into the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start1 Feb 2017
- Primary completion30 May 2018
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Harvard Pilgrim Health Care
- Responsible party
- Sponsor
- Investigators
- Julie A Schmittdiel, Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621476
- Sponsor's protocol ID
- CN-14-1947
- Other IDs
- R18DK104249
- Status last verified
- Aug 2023
- First submitted
- 19 Nov 2015
- Last updated
- 8 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30985875Lin 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.
PubMed 29903012Polonsky WH, Henry RR. Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient Prefer Adherence. 2016 Jul 22;10:1299-307. doi: 10.2147/PPA.S106821. eCollection 2016.
PubMed 27524885Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, Magid DJ. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006 Sep 25;166(17):1836-41. doi: 10.1001/archinte.166.17.1836.
PubMed 17000939Lau DT, Nau DP. Oral antihyperglycemic medication nonadherence and subsequent hospitalization among individuals with type 2 diabetes. Diabetes Care. 2004 Sep;27(9):2149-53. doi: 10.2337/diacare.27.9.2149.
PubMed 15333476Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care. 2005 Jun;43(6):521-30. doi: 10.1097/01.mlr.0000163641.86870.af.
PubMed 15908846Asche C, LaFleur J, Conner C. A review of diabetes treatment adherence and the association with clinical and economic outcomes. Clin Ther. 2011 Jan;33(1):74-109. doi: 10.1016/j.clinthera.2011.01.019.
PubMed 21397776Feldman R, Bacher M, Campbell N, Drover A, Chockalingam A. Adherence to pharmacologic management of hypertension. Can J Public Health. 1998 Sep-Oct;89(5):I16-8. doi: 10.1007/BF03404494.
PubMed 9813921Avorn J, Monette J, Lacour A, Bohn RL, Monane M, Mogun H, LeLorier J. Persistence of use of lipid-lowering medications: a cross-national study. JAMA. 1998 May 13;279(18):1458-62. doi: 10.1001/jama.279.18.1458.
PubMed 9600480Heisler M, Faul JD, Hayward RA, Langa KM, Blaum C, Weir D. Mechanisms for racial and ethnic disparities in glycemic control in middle-aged and older Americans in the health and retirement study. Arch Intern Med. 2007 Sep 24;167(17):1853-60. doi: 10.1001/archinte.167.17.1853.
PubMed 17893306Trinacty CM, Adams AS, Soumerai SB, Zhang F, Meigs JB, Piette JD, Ross-Degnan D. Racial differences in long-term adherence to oral antidiabetic drug therapy: a longitudinal cohort study. BMC Health Serv Res. 2009 Feb 7;9:24. doi: 10.1186/1472-6963-9-24.
PubMed 19200387Shenolikar RA, Balkrishnan R, Camacho FT, Whitmire JT, Anderson RT. Race and medication adherence in Medicaid enrollees with type-2 diabetes. J Natl Med Assoc. 2006 Jul;98(7):1071-7.
PubMed 16895275Tseng CW, Tierney EF, Gerzoff RB, Dudley RA, Waitzfelder B, Ackermann RT, Karter AJ, Piette J, Crosson JC, Ngo-Metzger Q, Chung R, Mangione CM. Race/ethnicity and economic differences in cost-related medication underuse among insured adults with diabetes: the Translating Research Into Action for Diabetes Study. Diabetes Care. 2008 Feb;31(2):261-6. doi: 10.2337/dc07-1341. Epub 2007 Nov 13.
PubMed 18000177Peeters B, Van Tongelen I, Boussery K, Mehuys E, Remon JP, Willems S. Factors associated with medication adherence to oral hypoglycaemic agents in different ethnic groups suffering from type 2 diabetes: a systematic literature review and suggestions for further research. Diabet Med. 2011 Mar;28(3):262-75. doi: 10.1111/j.1464-5491.2010.03133.x.
PubMed 21309834Duru OK, Gerzoff RB, Selby JV, Brown AF, Ackermann RT, Karter AJ, Ross S, Steers N, Herman WH, Waitzfelder B, Mangione CM. Identifying risk factors for racial disparities in diabetes outcomes: the translating research into action for diabetes study. Med Care. 2009 Jun;47(6):700-6. doi: 10.1097/mlr.0b013e318192609d.
PubMed 19480090
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities
- ClinicalTrials.gov ID
- NCT02621476
- Acronym / sponsor ID
- CN-14-1947
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63,012 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Harvard Pilgrim Health Care
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Posted 8 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized intervention | Experimental | Behavioral: Standardized interventionStandardized intervention to encourage mail order use and provide easily accessible information on how to access the service |
| Usual care | Experimental | Behavioral: Usual careUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized interventionStandardized intervention to encourage mail order use and provide easily accessible information on how to access the service | Behavioural | Standardized intervention |
| Usual careUsual care | Behavioural | Usual care |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30985875Gregg 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.
- Background: PubMed 29903012Lin 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.
- Background: PubMed 27524885Polonsky WH, Henry RR. Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient Prefer Adherence. 2016 Jul 22;10:1299-307. doi: 10.2147/PPA.S106821. eCollection 2016.
- Background: PubMed 17000939Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, Magid DJ. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006 Sep 25;166(17):1836-41. doi: 10.1001/archinte.166.17.1836.
- Background: PubMed 15333476Lau DT, Nau DP. Oral antihyperglycemic medication nonadherence and subsequent hospitalization among individuals with type 2 diabetes. Diabetes Care. 2004 Sep;27(9):2149-53. doi: 10.2337/diacare.27.9.2149.
- Background: PubMed 15908846Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care. 2005 Jun;43(6):521-30. doi: 10.1097/01.mlr.0000163641.86870.af.
- Background: PubMed 21397776Asche C, LaFleur J, Conner C. A review of diabetes treatment adherence and the association with clinical and economic outcomes. Clin Ther. 2011 Jan;33(1):74-109. doi: 10.1016/j.clinthera.2011.01.019.
- Background: PubMed 9813921Feldman R, Bacher M, Campbell N, Drover A, Chockalingam A. Adherence to pharmacologic management of hypertension. Can J Public Health. 1998 Sep-Oct;89(5):I16-8. doi: 10.1007/BF03404494.
- Background: PubMed 9600480Avorn J, Monette J, Lacour A, Bohn RL, Monane M, Mogun H, LeLorier J. Persistence of use of lipid-lowering medications: a cross-national study. JAMA. 1998 May 13;279(18):1458-62. doi: 10.1001/jama.279.18.1458.
- Background: PubMed 17893306Heisler M, Faul JD, Hayward RA, Langa KM, Blaum C, Weir D. Mechanisms for racial and ethnic disparities in glycemic control in middle-aged and older Americans in the health and retirement study. Arch Intern Med. 2007 Sep 24;167(17):1853-60. doi: 10.1001/archinte.167.17.1853.
- Background: PubMed 19200387Trinacty CM, Adams AS, Soumerai SB, Zhang F, Meigs JB, Piette JD, Ross-Degnan D. Racial differences in long-term adherence to oral antidiabetic drug therapy: a longitudinal cohort study. BMC Health Serv Res. 2009 Feb 7;9:24. doi: 10.1186/1472-6963-9-24.
- Background: PubMed 16895275Shenolikar RA, Balkrishnan R, Camacho FT, Whitmire JT, Anderson RT. Race and medication adherence in Medicaid enrollees with type-2 diabetes. J Natl Med Assoc. 2006 Jul;98(7):1071-7.
- Centers for Disease Control and Prevention (CDC). About DiabetesLink provided by the sponsor.
- American Diabetes Association (ADA). Statistics About DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Schmittdiel principal investigator
Research Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized intervention in people with Diabetes Mellitus, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Using Mail Order Pharmacy (MOP) After Intervention (time frame: 12 months following the date of outreach into the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02621476, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.