Clinical trial NCT00393419: Federal Study of Adherence to Medications in the Elderly (FAME)
Official title: Federal Study of Adherence to Medications in the Elderly (FAME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Hypertension
Hyperlipidemia
Keywords: hypertension
hyperlipidemia
adherence
pharmacist
elderly
medication
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: American Society of Health-System Pharmacists
First posted: 2006-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.

Detailed description: Poor medication adherence is prevalent, difficult to manage, and diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications which places them at increased risk for medication nonadherence. Effective strategies to improve adherence in the elderly are lacking, and improved health outcomes in this population have not been demonstrated.

Objective: We tested the efficacy of a comprehensive pharmacy care program including patient education and an adherence aid (medications custom-packaged in blister packs) to improve medication adherence and its associated effects on blood pressure and low density lipoprotein cholesterol.

This is a Multi-phase, prospective observational and randomized controlled trial. We enrolled community-based patients aged ≥ 65 years old taking ≥ 4 chronic medications per day.

Intervention: After a 2-month run-in phase during which baseline medication adherence (via pill counts), blood pressure, and low-density lipoprotein cholesterol were measured, participants entered a 6-month intervention phase during which standardized medication education and regular follow-up by a clinical pharmacist was provided and medications were dispensed in daily, time-specific blister packs. Following the intervention phase, participants were randomized to continued pharmacy care/blister packs versus usual care (return to their original method of medication administration) for an additional 6 months.

Main Outcome Measures: The primary endpoint of the observation phase was the change in the proportion of pills taken compared to baseline; secondary endpoints were the associated changes in low-density lipoprotein cholesterol and blood pressure. The primary endpoint of the randomized trial was the between-group comparison of medication persistence analyzed according to intention to treat.

Eligibility criteria: Inclusion Criteria:

* 65 years or older taking 4 or more chronic medications independently living

Exclusion Criteria:

* assisted living or nursing home residents presence of any serious medical condition for which 1-year survival was expected to be unlikely

Primary outcomes:
measure: Change in proportion of pills taken compared to baseline (0-2months) at 8months
measure: Between-group comparison of medication persistence at 14months
Secondary outcomes:
measure: Change in blood pressure and low-density lipoprotein cholesterol at 8months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Allen J Taylor, MD
role: STUDY_DIRECTOR
affiliation: Walter Reed Army Medical Center
name: Jeannie K Lee, Pharm.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blackburn DF, Dobson RT, Blackburn JL, Wilson TW. Cardiovascular morbidity associated with nonadherence to statin therapy. Pharmacotherapy. 2005 Aug;25(8):1035-43. doi: 10.1592/phco.2005.25.8.1035.
citation: Abughosh SM, Kogut SJ, Andrade SE, Larrat P, Gurwitz JH. Persistence with lipid-lowering therapy: influence of the type of lipid-lowering agent and drug benefit plan option in elderly patients. J Manag Care Pharm. 2004 Sep-Oct;10(5):404-11. doi: 10.18553/jmcp.2004.10.5.404.
citation: Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002 Jul 24-31;288(4):462-7. doi: 10.1001/jama.288.4.462.
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.
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.