Impact on Patient COmpliance With Medication Using Pre-packaged Blisters for Long-term Medical therapY (I-COMPLY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04236817|
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|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)|
|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|
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
- 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.
- Percentage of missed doses [ Time Frame: 4 month follow-up ]The secondary outcome was the number of daily doses missed.