Effectiveness of a Medication Wallet Card

September 2, 2021 updated by: McMaster University
This study evaluates whether or not the use of a medication wallet card in patients over 70 taking 5 or more medications promotes self-efficacy with regards to coping with illness, understanding medications, and staying healthy. Half of the participants will receive an individualized medication wallet card with their medications and medical conditions listed while the other half will receive a simple reminder card.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In order to prevent medication errors and subsequent ADEs, a complete and accurate medication list must be maintained. Although electronic healthcare records, maintained by healthcare providers, have been praised for their potential to decrease medication errors, studies show that the sole implementation of a paperless system is not sufficient to eliminate medication recording and prescription errors. Hence, an approach to maintain complete medication lists will need to involve the cooperation of both health care providers and patients. A previous study showed that an integrated approach including all members of the healthcare team and the patient improved the completeness and accuracy of medication list from 7.7% to 18.5%. One way to increase patient involvement in medication reconciliation is by allowing the patients to become more informed about their health and medications.

According to the Bandura's Social Cognitive Theory of Self-Efficacy, the beliefs a person holds regarding his or her power to influence situations strongly affects the agency a person has to face challenges capably. A tool such as an up-to-date MWC that has a list of the medications and dosages in addition to medical conditions listed may help older patients to better understand and manage their health. Furthermore, a wallet card has been an effective tool with many benefits. For example, a study showed that a Medication Allergy Profile card increased patient's knowledge of their drug regimens, decreased medication errors, decreased drug interactions, and improved patients' compliance.

No randomized control trials currently show the the impact of a medication wallet card/list on patient enablement. One study showed that a significant percentage of the patients were willing to use a self-maintained wallet-sized medication list. In addition, those who used the medication list showed an improved sense of knowledge about their medical problems and medication, and also exhibited an enhanced sense of responsibility in maintaining their medication lists. However, the study considered a relatively young population that only included patients over the age of 40 and did not stipulate a minimum number of medications for the patients to be taking. In addition, the study was not a randomized control trial, and used the Patient Medication Scale (PMS) to measure outcomes.

Hence, a randomized control trial employing a standardized questionnaires to investigate an older population (age greater than 70) experiencing polypharmacy is needed to asses the impact of a medical wallet card in promoting self efficacy and patient enablement.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 116 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 70 years of age or older
  • Participating family doctor as most responsible provider
  • Patient of McMaster Family Health Team
  • Currently taking 5 or more medications
  • Have not had a recent comprehensive medication review
  • Patient consents

Exclusion Criteria:

  • English language or cognitive skills inadequate to understand and respond to rating scales
  • Terminal illness or other circumstance precluding 13 month study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wallet Card Group

The intervention arm is comprised of:

Patients from the TAPER study who receive a medication wallet card with their medications and medical conditions listed.
Device: Medication Wallet Card
A medication wallet card will be given to the intervention group. This will be personalized for each patient and will include the patient's medications, dosages, and medical conditions. It will be personally given to a patient after a medical appointment with their family physician.
Placebo Comparator: Control Group
Standard of care as well as wait list control. These participants will receive a "reminder" wallet card which states, "Remember to keep an up-to-date listing of your medications and bring your medications to your doctor's appointments."
Device: Reminder Card
A reminder card will be given to this group. The card will not be personal and will be mailed to patients. It will state, "Remember to keep an up-to-date listing of your medications and bring your medications to your doctor's appointments."
Other Names:
  • Placebo Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Enablement Index
Time Frame: 4 weeks
Patient Enablement Index
4 weeks
Patient Enablement Index
Time Frame: 6 months
Patient Enablement Index Repeated
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability - Qualitative Data
Time Frame: 4 weeks
Survey questions by telephone assessing the usability of a medication wallet card. Questions include: How clear was your medication wallet card? How did you use your medication wallet card over the past four weeks? Did your medication wallet card help you over the past four weeks? If so, how? Do you intend on continuing to carry your medication wallet card?
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Ainsley Moore, MD, McMaster University, Department of Family Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TAPER-Wallet-Card-002-May-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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