Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications
NCT ID: NCT02604901
Last Updated: 2015-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1091 participants
INTERVENTIONAL
2012-06-30
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
NONE
Study Groups
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Screening and Brief Intervention (BI)
Screening and Brief Intervention (BI) at initial prescription fill and at each additional refill.
Screening and Brief Intervention (BI)
Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR\*S (BI). BI was considered an active intervention method.
Pill Box (PB)
Pill Box (PB) and information about their medications at the initial fill and at each additional refill.
Pill Box (PB)
Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method.
Brief Intervention + Pill Box (BI+PB)
Screening and Brief Intervention (BI) and Pill Box (PB) at initial prescription fill and at each additional refill.
Screening and Brief Intervention (BI)
Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR\*S (BI). BI was considered an active intervention method.
Pill Box (PB)
Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method.
Standard Care (SC)
The Standard Care (SC) arm administered traditional dispensing and counseling by Rite Aid® pharmacists.
No interventions assigned to this group
Interventions
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Screening and Brief Intervention (BI)
Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR\*S (BI). BI was considered an active intervention method.
Pill Box (PB)
Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Rite Aid Corp.
INDUSTRY
RTI International
OTHER
Pharmacy Quality Alliance
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
University of Pittsburgh
OTHER
Responsible Party
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Jan Pringle
Associate Professor
Principal Investigators
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Janice L Pringle, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Newell McElwee, PharmD, MSPH
Role: STUDY_CHAIR
Merck Sharp & Dohme LLC
Locations
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Rite Aid® Corporation
Marietta, Georgia, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
Stefanacci RG, Guerin S. Why medication adherence matters to patients, payers, providers. Manag Care. 2013 Jan;22(1):37-9. No abstract available.
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.
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.
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.
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.
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.
Other Identifiers
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ECOPHIL
Identifier Type: -
Identifier Source: org_study_id
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