Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities

NCT02621476 | Completed Results DMC

• 2 other identifiers: CN-14-1947R18DK104249
• Study Type: interventional
• Target: 63,012
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standardized intervention

EXPERIMENTAL

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

Behavioral: Standardized intervention

Usual care

EXPERIMENTAL

Usual care

Behavioral: Usual care

Interventions

Standardized intervention BEHAVIORAL

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

Standardized intervention

Usual care BEHAVIORAL

Usual care

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Harvard Pilgrim Health Care: collaborator

Study Sites (1)

Division of Research

Oakland, California, 94501, United States

Location

Related Publications (43)

• 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.

  PMID: 30985875 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.

  PMID: 29903012 BACKGROUND

• 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.

  PMID: 27524885 BACKGROUND

• 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.

  PMID: 17000939 BACKGROUND

• 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.

  PMID: 15333476 BACKGROUND

• 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.

  PMID: 15908846 BACKGROUND

• 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.

  PMID: 21397776 BACKGROUND

• 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.

  PMID: 9813921 BACKGROUND

• 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.

  PMID: 9600480 BACKGROUND

• 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.

  PMID: 17893306 BACKGROUND

• 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.

  PMID: 19200387 BACKGROUND

• 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.

  PMID: 16895275 BACKGROUND

• 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.

  PMID: 18000177 BACKGROUND

• 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.

  PMID: 21309834 BACKGROUND

• 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.

  PMID: 19480090 BACKGROUND

• 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.

  PMID: 15076819 BACKGROUND

• 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.

  PMID: 17439645 BACKGROUND

• 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.

  PMID: 12472329 BACKGROUND

• 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.

  PMID: 17101639 BACKGROUND

• 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.

  PMID: 20148603 BACKGROUND

• 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.

  PMID: 21773848 BACKGROUND

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

  PMID: 22354211 BACKGROUND

• 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.

  PMID: 21728913 BACKGROUND

• 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.

  PMID: 20345227 BACKGROUND

• 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.

  PMID: 27783552 BACKGROUND

• 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.

  PMID: 17330973 BACKGROUND

• 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.

  PMID: 15991755 BACKGROUND

• 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.

  PMID: 25131156 BACKGROUND

• 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.

  PMID: 31238950 BACKGROUND

• 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.

  PMID: 23774515 BACKGROUND

• 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.

  PMID: 28124501 BACKGROUND

• 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.

  PMID: 30816817 BACKGROUND

• 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.

  PMID: 23229831 BACKGROUND

• 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.

  PMID: 21247826 BACKGROUND

• 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.

  PMID: 11242426 BACKGROUND

• 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.

  PMID: 18443882 BACKGROUND

• 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.

  PMID: 21951257 BACKGROUND

• 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.

  PMID: 23244358 BACKGROUND

• 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.

  PMID: 22270266 BACKGROUND

• 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.

  PMID: 18301951 BACKGROUND

• 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.

  PMID: 20205493 BACKGROUND

• 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.

  PMID: 33849937 DERIVED

• Ramachandran B, Trinacty CM, Wharam JF, Duru OK, Dyer WT, Neugebauer RS, Karter AJ, Brown SD, Marshall CJ, Wiley D, Ross-Degnan D, Schmittdiel JA. A Randomized Encouragement Trial to Increase Mail Order Pharmacy Use and Medication Adherence in Patients with Diabetes. J Gen Intern Med. 2021 Jan;36(1):154-161. doi: 10.1007/s11606-020-06237-8. Epub 2020 Oct 1.

  PMID: 33001334 DERIVED

Related Links

• American Diabetes Association (ADA). Statistics About Diabetes

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Julie Schmittdiel, PhD, MA
• Organization: Kaiser Permanente Northern California

Julie.A.Schmittdiel@kp.org

5108913872

Study Officials

• Julie A Schmittdiel

  Research Scientist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 3, 2015
• Study Start: February 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2022
• Last Updated: August 8, 2023
• Results First Posted: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)