Federal Study of Adherence to Medications in the Elderly (FAME)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in proportion of pills taken compared to baseline (0-2months) at 8months []
- Between-group comparison of medication persistence at 14months []
Secondary Outcome Measures
- Change in blood pressure and low-density lipoprotein cholesterol at 8months []
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307 |
Sponsors and Collaborators
- Walter Reed Army Medical Center
- American Society of Health-System Pharmacists
Investigators
- Study Director: Allen J Taylor, MD, Walter Reed Army Medical Center
- Principal Investigator: Jeannie K Lee, Pharm.D, Walter Reed Army Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Blackburn DF, Dobson RT, Blackburn JL, Wilson TW. Cardiovascular morbidity associated with nonadherence to statin therapy. Pharmacotherapy. 2005 Aug;25(8):1035-43.
- 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.
- 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.
- 04-36002