Clinical trial NCT02604901: Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications
Official title: Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: medication adherence
community pharmacies
screening and brief intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Rite Aid Corp.
name: RTI International
name: Pharmacy Quality Alliance
name: Merck Sharp & Dohme LLC
First posted: 2015-11-16
Enrollment: 1091
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a reminder device (Pillbox), and the combination of the two on adherence in adult patients who filled a prescription for oral medications to treat diabetes or hyperlipidemia.

Detailed description: Patients diagnosed with chronic diseases often fail to follow their prescribed medication regimens, (16355071,19954264,16732693,23111664) which accounts for up to 290 billion dollars per year in unnecessary medical costs, largely because medication nonadherence increases their risk of disease progression, hospitalization, and premature death.(16355071, 23373139, 23032359) A number of studies have investigated ways to improve medication adherence; (18425859, 18537843) however, few studies on interventions have demonstrated large improvements in adherence and few have used scientifically rigorous study methods such as randomized controlled trials (RCTs).(24422970) A recent systematic review identified a need for adherence interventions and suggested the use of factorial designs in RCTs to study multiple interventions and combinations within large patient populations.(24422970)

This study used a factorial-designed, four-armed, RCT to examine the impact of three pharmacy-based interventions versus standard care on improving medication adherence and health outcomes in patients with diabetes and hyperlipidemia. The three interventions used in this study were a behavioral intervention, a pillbox weekly reminder, and the combination of the two.

Pillboxes (PB) used in this study had compartments for each day (7X1) and for participants taking multiple medications, sub-compartments for each medication per day (7X4).

The behavioral intervention, called Screening and Brief Intervention (SBI or BI), consisted of a short 2-5 minute conversation between the patient and the provider aimed to encourage modification in the patient's health behavior. While BI has primarily been used to address unhealthy alcohol use in patients (11), the researchers hypothesized that this patient-centered approach can be particularly useful for improving medication adherence in chronically ill patients. In this study, motivational interviewing counseling principles were used for motivating patients to take more active roles in self-managing their health. Motivational interviewing can take many forms, however, in this study, the BIs used a schema of motivational interviewing originally developed by the principal investigator titled POLAR\*S™ .

The specific aims of this research study included testing the impact of three community pharmacy intervention for adult patients with diabetes or hyperlipidemia on: (1) medication adherence; (2) biologic outcomes associated with medication adherence; (3) self-reported health and psychosocial status; and (4) pharmacists' impressions on how BI could be scalable to community pharmacy settings.

Eligibility criteria: Inclusion Criteria:

* Patients taking oral medications for diabetes or hyperlipidemia
* 30-85 years of age
* Comfortable speaking in English
* Not institutionalized
* Not diagnosed with psychosis or dementia.
* Needed at least one prescription refill with the index medication picked up within 14 days of the index prescription fill

Exclusion Criteria:

-

Primary outcomes:
measure: Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia.
timeFrame: At baseline and nine-months post-enrollment into the study.
Secondary outcomes:
measure: Change in triglyerceride levels from baseline to 6- and 9-months.
timeFrame: At baseline, six months and nine-months post-enrollment into the study.
measure: Change in cholesterol levels from baseline to 6- and 9-months.
timeFrame: At baseline, six months and nine-months post-enrollment into the study.
measure: Change in high-density lipoprotein (HDL) levels from baseline to 6- and 9-months.
timeFrame: At baseline, six months and nine-months post-enrollment into the study.
measure: Change in low-density lipoprotein (LDL) levels from baseline to 6- and 9-months.
timeFrame: At baseline, six months and nine-months post-enrollment into the study.
measure: Change in glycated hemoglobin (HbA1c) levels from baseline to 6- and 9-months.
timeFrame: At baseline, six months and nine-months post-enrollment into the study.
measure: Change in self-reported healthcare utilization, using a study-designed standardized questionnaire, from baseline to 9-months.
timeFrame: At baseline and nine-months post-enrollment into the study.
measure: Change in self-reported psychosocial status, using a study-designed standardized questionnaire, from baseline to 9-months.
timeFrame: At baseline and nine-months post-enrollment into the study.
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Rite Aid® Corporation
state: Georgia
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Janice L Pringle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Merck Sharp & Dohme LLC
name: Newell McElwee, PharmD, MSPH
role: STUDY_CHAIR
References:
citation: Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
citation: Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. doi: 10.18553/jmcp.2009.15.9.728.
citation: Vik SA, Hogan DB, Patten SB, Johnson JA, Romonko-Slack L, Maxwell CJ. Medication nonadherence and subsequent risk of hospitalisation and mortality among older adults. Drugs Aging. 2006;23(4):345-56. doi: 10.2165/00002512-200623040-00007.
citation: Traynor K. Poor medication adherence remains a problem. Am J Health Syst Pharm. 2012 Nov 1;69(21):1850. doi: 10.2146/news120074. No abstract available.
citation: Stefanacci RG, Guerin S. Why medication adherence matters to patients, payers, providers. Manag Care. 2013 Jan;22(1):37-9. No abstract available.
citation: Williams J, Steers WN, Ettner SL, Mangione CM, Duru OK. Cost-related nonadherence by medication type among Medicare Part D beneficiaries with diabetes. Med Care. 2013 Feb;51(2):193-8. doi: 10.1097/MLR.0b013e318270dc52.
citation: Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.
citation: Williams A, Manias E, Walker R. Interventions to improve medication adherence in people with multiple chronic conditions: a systematic review. J Adv Nurs. 2008 Jul;63(2):132-43. doi: 10.1111/j.1365-2648.2008.04656.x.
citation: Viswanathan M, Golin CE, Jones CD, Ashok M, Blalock S, Wines RC, Coker-Schwimmer EJ, Grodensky CA, Rosen DL, Yuen A, Sista P, Lohr KN. Closing the quality gap: revisiting the state of the science (vol. 4: medication adherence interventions: comparative effectiveness). Evid Rep Technol Assess (Full Rep). 2012 Sep;(208.4):1-685.
citation: Babor TF, Kadden RM. Screening and interventions for alcohol and drug problems in medical settings: what works? J Trauma. 2005 Sep;59(3 Suppl):S80-7; discussion S94-100. doi: 10.1097/01.ta.0000174664.88603.21.