Clinical trial NCT02820129: Effectiveness of a Medication Wallet Card
Official title: Effectiveness of a Medication Wallet Card
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Comorbidity
Medication Therapy Management
Polypharmacy
Keywords: polypharmacy
wallet card
medication
self-efficacy
patient enablement
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Maximum age (years): 116
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Enablement Index
timeFrame: 4 weeks
measure: Patient Enablement Index
timeFrame: 6 months
Secondary outcomes:
measure: Usability - Qualitative Data
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University, Department of Family Medicine
name: Ainsley Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hudon C, Fortin M, Rossignol F, Bernier S, Poitras ME. The Patient Enablement Instrument-French version in a family practice setting: a reliability study. BMC Fam Pract. 2011 Jul 7;12:71. doi: 10.1186/1471-2296-12-71.