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

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ClinicalTrials.gov Identifier: NCT04236817
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
The Huron Foundation
Information provided by (Responsible Party):
Andrei Brateanu, MD, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Medication Adherence Medication Compliance Behavioral: Pre-packed blisters for distribution of medications Behavioral: Routine distribution of medications Not Applicable

Detailed Description:

For patients in the study group, new prescriptions with three refills were electronically scripted to local compliance packaging pharmacy, ExactCare pharmacy, LLC, Valley View, Ohio, 44125. ExactCare is a local packaging pharmacy that pre-packs medications for patients so that each day's medications come in a separate paper compartment that can be discarded after daily use. They also deliver medications to the patients' homes. At the initiation of the study, ExactCare provided medications in pill packs for all patient medications in a 30-day supply (Figure 2). Pill bottle medications were provided for medications that would run out prior to the initial supply date. Inhalers, nebulizers, injectable medications, as needed medications and medications that required frequent dose changes were not included in the pill packs but were sent separately within the 30-day supply box.

If the patient was started on a new medication by their PCP, the local compliance packaging pharmacy packed this medication in pill packs for the next 30-day box supply and sent pill bottles containing enough pills to last the patient till the next 30-day box. Every pill in the pill pack was coded with an identification number. If the patient's physician discontinued or changed the dose of any medication, the patient was advised to remove the pill from the pack using its identification number and either discard it or make the dose change accordingly.

A study investigator counted the pills left in the control group prior to the study start date. After the study start date, patients in the control group continued to receive their medications the same way they were getting them before being enrolled in this study using either electronic or printed prescriptions. They received instructions about the timing and frequency of medication administration from their physicians and nurses, and picked up their medications from their local pharmacy.

Patients from both groups had a follow-up PCP visit approximately four months from enrollment. Patients received telephone calls prior to their follow-up appointments to remind them to bring their medications from home. During the appointment, the study investigator counted the medications remaining in the pill packs for the study group patients and the pills remaining in pill bottles for the control group patients.

ExactCare provided the initial start date for each patient receiving their pill packs in 30-day supply. Refill dates were accessed from local pharmacies and the EMR for patients in the control group. This information was used to calculate the number of pills expected to remain with each patient at the end of the study and to compare to the actual number of pills remaining. New medications, discontinued medications, and modified-dose medications were not included in the study analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact on Patient COmpliance With Medication Using Pre-packaged Blisters for Long-term Medical therapY
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : May 30, 2015
Actual Study Completion Date : May 30, 2015

Arm Intervention/treatment
Experimental: Pre-packed blisters for distribution of medications
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
Placebo Comparator: Routine distribution of medications
Patients in the control group continued to receive medications from pharmacies as they did prior to enrollment.
Behavioral: Routine distribution of medications



Primary Outcome Measures :
  1. Percentage of missed pills [ Time Frame: 4 month follow-up ]
    The primary outcome was the percentage of missed pills in the intervention group versus the control group after four months of enrollment.


Secondary Outcome Measures :
  1. Percentage of missed doses [ Time Frame: 4 month follow-up ]
    The secondary outcome was the number of daily doses missed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Study Documents (Full-Text)

Documents provided by Andrei Brateanu, MD, The Cleveland Clinic:

Additional Information:
Publications:

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Responsible Party: Andrei Brateanu, MD, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04236817    
Other Study ID Numbers: 14-1554
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrei Brateanu, MD, The Cleveland Clinic:
Medication Adherence
Medication compliance
Pill-packaging
Additional relevant MeSH terms:
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Blister
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical