Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities

Diabetes Mellitus Clinical Trial

Official title:

Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621476
• Other study ID #: CN-14-1947
• Secondary ID: R18DK104249
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63012
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Standardized intervention
Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
• Usual care
Usual care

Locations

Country	Name	City	State
United States	Division of Research	Oakland	California

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Harvard Pilgrim Health Care, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (41)

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. — View Citation

Asche 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. — View Citation

Avorn 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. — View Citation

Carroll NV, Brusilovsky I, York B, Oscar R. Comparison of costs of community and mail service pharmacy. J Am Pharm Assoc (2003). 2005 May-Jun;45(3):336-43. doi: 10.1331/1544345054003796. — View Citation

Chernew M, Gibson TB, Yu-Isenberg K, Sokol MC, Rosen AB, Fendrick AM. Effects of increased patient cost sharing on socioeconomic disparities in health care. J Gen Intern Med. 2008 Aug;23(8):1131-6. doi: 10.1007/s11606-008-0614-0. Epub 2008 Apr 29. — View Citation

Devine S, Vlahiotis A, Sundar H. A comparison of diabetes medication adherence and healthcare costs in patients using mail order pharmacy and retail pharmacy. J Med Econ. 2010;13(2):203-11. doi: 10.3111/13696991003741801. — View Citation

DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9. doi: 10.1097/01.mlr.0000114908.90348.f9. — View Citation

Duru 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. — View Citation

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. — View Citation

Feldman 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. — View Citation

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. — View Citation

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. — View Citation

Heisler 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. — View Citation

Ho 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. — View Citation

Johnsrud M, Lawson KA, Shepherd MD. Comparison of mail-order with community pharmacy in plan sponsor cost and member cost in two large pharmacy benefit plans. J Manag Care Pharm. 2007 Mar;13(2):122-34. doi: 10.18553/jmcp.2007.13.2.122. — View Citation

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. — View Citation

Lau 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. — View Citation

Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13. — View Citation

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. — View Citation

Liberman JN, Wang Y, Hutchins DS, Slezak J, Shrank WH. Revealed preference for community and mail service pharmacy. J Am Pharm Assoc (2003). 2011 Jan-Feb;51(1):50-7. doi: 10.1331/JAPhA.2011.09161. — View Citation

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. — View Citation

McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. doi: 10.1001/jama.288.22.2868. Erratum In: JAMA. 2003 Jun 25;289(24):3242. — View Citation

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. — View Citation

Osborn CY, Cavanaugh K, Wallston KA, Kripalani S, Elasy TA, Rothman RL, White RO. Health literacy explains racial disparities in diabetes medication adherence. J Health Commun. 2011;16 Suppl 3(Suppl 3):268-78. doi: 10.1080/10810730.2011.604388. — View Citation

Peeters 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. — View Citation

Polonsky 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. — View Citation

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. — View Citation

Saha S, Freeman M, Toure J, Tippens KM, Weeks C, Ibrahim S. Racial and ethnic disparities in the VA health care system: a systematic review. J Gen Intern Med. 2008 May;23(5):654-71. doi: 10.1007/s11606-008-0521-4. Epub 2008 Feb 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sharma KP, Taylor TN. Pharmacy effect on adherence to antidiabetic medications. Med Care. 2012 Aug;50(8):685-91. doi: 10.1097/MLR.0b013e318249d800. — View Citation

Shenolikar 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. — View Citation

Sokol 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. — View Citation

Tamblyn R, Laprise R, Hanley JA, Abrahamowicz M, Scott S, Mayo N, Hurley J, Grad R, Latimer E, Perreault R, McLeod P, Huang A, Larochelle P, Mallet L. Adverse events associated with prescription drug cost-sharing among poor and elderly persons. JAMA. 2001 Jan 24-31;285(4):421-9. doi: 10.1001/jama.285.4.421. — View Citation

Trinacty 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. — View Citation

Tseng 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. — View Citation

van Dulmen S, Sluijs E, van Dijk L, de Ridder D, Heerdink R, Bensing J. Patient adherence to medical treatment: a review of reviews. BMC Health Serv Res. 2007 Apr 17;7:55. doi: 10.1186/1472-6963-7-55. — View Citation

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. — View Citation

* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 months following the date of outreach into the intervention

External Links

•   American Diabetes Association (ADA). Statistics About Diabetes
•   Centers for Disease Control and Prevention (CDC). About Diabetes