Impact on Patient COmpliance With Medication Using Pre-packaged Blisters for Long-term Medical therapY

NCT04236817 | Completed DMC

• 1 other identifier: 14-1554
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of packaging interventions like pillboxes or blister packs has been shown to significantly improve medication adherence. The purpose of this study is to assess the effect of home-delivered pill packs on medication adherence in a low-income population. This is an open-lab randomized controlled trial taking four or more medication doses daily, randomized either to the intervention group or the control group. Patients in the intervention group received prescriptions pre-packaged in individual packets that were delivered by the pharmacy. Patients in the control group continued to receive medications from pharmacies as they did prior to enrollment. The primary outcome was the percentage of missed pills in the intervention group versus the control group after four months of enrollment.

Conditions

Medication Adherence; Medication Compliance

Keywords

Medication Adherence; Medication compliance; Pill-packaging

Outcome Measures

Primary Outcomes (1)

• Percentage of missed pills

  The primary outcome was the percentage of missed pills in the intervention group versus the control group after four months of enrollment.

  4 month follow-up

Secondary Outcomes (1)

• Percentage of missed doses

  4 month follow-up

Study Arms (2)

Pre-packed blisters for distribution of medications

EXPERIMENTAL

Patients in the intervention group received prescriptions pre-packaged in individual packets that were delivered by the pharmacy.

Behavioral: Pre-packed blisters for distribution of medications

Routine distribution of medications

PLACEBO COMPARATOR

Patients in the control group continued to receive medications from pharmacies as they did prior to enrollment.

Behavioral: Routine distribution of medications

Interventions

Pre-packed blisters for distribution of medications BEHAVIORAL

Pre-packed blisters for distribution of medications

Routine distribution of medications BEHAVIORAL

Routine distribution of medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or older
• Covered by Medicaid insurance
• Seen in clinic at least two times within the past year, follow-up appointment scheduled between January and May 2015
• Prescribed a minimum of four medications daily

You may not qualify if:

• Nursing home patients
• Patients with planned hospital stays during the study period
• Patients who were already receiving medications in pre-packed blisters or pill packs prior to study enrollment

Sponsors & Collaborators

• The Cleveland Clinic: lead
• The Huron Foundation: collaborator

Related Publications (24)

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Related Links

• Health US, 2013 With Special Feature on Prescription Drugs

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: Open label randomized controlled trial. The patient population included 114 patients, followed by primary care physicians at the Cleveland Clinic Stephanie Tubbs Jones Health Center, taking four or more medication doses daily. They were randomized either to the intervention group or the control group. Patients in the intervention group received prescriptions pre-packaged in individual packets that were delivered by the pharmacy. Patients in the control group continued to receive medications from pharmacies as they did prior to enrollment. The primary outcome was the percentage of missed pills in the intervention group versus the control group after four months of enrollment. The secondary outcome was the number of daily doses missed. The number and percentages of missed pills for each subject was calculated and summarized by group. The primary analysis compared the mean percentage of missed pills between the two groups using t-test analysis.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 22, 2020
• Study Start: January 1, 2015
• Primary Completion: May 30, 2015
• Study Completion: May 30, 2015
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share