Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications

NCT02604901 | Completed

• 1 other identifier: ECOPHIL
• Study Type: interventional
• Target: 1,091
• Locations: 1 country
• Sites: 2

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.

Conditions

Medication Adherence

Keywords

medication adherence; community pharmacies; screening and brief intervention

Outcome Measures

Primary Outcomes (1)

• Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia.

  Medication adherence was measured as a Proportion of Days Covered (PDC) by calculating (at the patient level) the denominator as the number of days between the first fill of the medication during a measurement period and the end of the measurement period and the numerator is calculated as the number of days covered by prescription fill date and days of supply. For each patient, the PDC was calculated at baseline and 9-months. The baseline PDC was compared to that at 9-months.

  At baseline and nine-months post-enrollment into the study.

Secondary Outcomes (7)

• Change in triglyerceride levels from baseline to 6- and 9-months.

  At baseline, six months and nine-months post-enrollment into the study.

• Change in cholesterol levels from baseline to 6- and 9-months.

  At baseline, six months and nine-months post-enrollment into the study.

• Change in high-density lipoprotein (HDL) levels from baseline to 6- and 9-months.

  At baseline, six months and nine-months post-enrollment into the study.

• Change in low-density lipoprotein (LDL) levels from baseline to 6- and 9-months.

  At baseline, six months and nine-months post-enrollment into the study.

• Change in glycated hemoglobin (HbA1c) levels from baseline to 6- and 9-months.

  At baseline, six months and nine-months post-enrollment into the study.

Study Arms (4)

Screening and Brief Intervention (BI)

EXPERIMENTAL

Screening and Brief Intervention (BI) at initial prescription fill and at each additional refill.

Behavioral: Screening and Brief Intervention (BI)

Pill Box (PB)

EXPERIMENTAL

Pill Box (PB) and information about their medications at the initial fill and at each additional refill.

Behavioral: Pill Box (PB)

Brief Intervention + Pill Box (BI+PB)

EXPERIMENTAL

Screening and Brief Intervention (BI) and Pill Box (PB) at initial prescription fill and at each additional refill.

Behavioral: Screening and Brief Intervention (BI); Behavioral: Pill Box (PB)

Standard Care (SC)

NO INTERVENTION

The Standard Care (SC) arm administered traditional dispensing and counseling by Rite Aid® pharmacists.

Interventions

Screening and Brief Intervention (BI) BEHAVIORAL

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.

Brief Intervention + Pill Box (BI+PB); Screening and Brief Intervention (BI)

Pill Box (PB) BEHAVIORAL

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); Pill Box (PB)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients taking oral medications for diabetes or hyperlipidemia
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Rite Aid Corp.: collaborator
• RTI International: collaborator
• Pharmacy Quality Alliance: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Rite Aid® Corporation

Marietta, Georgia, 30060, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (10)

• 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.

  PMID: 16079372 BACKGROUND

• 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.

  PMID: 19954264 BACKGROUND

• 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.

  PMID: 16732693 BACKGROUND

• 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.

  PMID: 23111664 BACKGROUND

• Stefanacci RG, Guerin S. Why medication adherence matters to patients, payers, providers. Manag Care. 2013 Jan;22(1):37-9. No abstract available.

  PMID: 23373139 BACKGROUND

• 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.

  PMID: 23032359 BACKGROUND

• 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.

  PMID: 18425859 BACKGROUND

• 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.

  PMID: 18537843 BACKGROUND

• 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.

  PMID: 24422970 BACKGROUND

• 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.

  PMID: 16355071 BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Janice L Pringle, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Newell McElwee, PharmD, MSPH

  Merck Sharp & Dohme LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 16, 2015
• Study Start: June 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

US (2)