NCT02820129

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2016

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

June 21, 2016

Last Update Submit

September 2, 2021

Conditions

Keywords

polypharmacywallet cardmedicationself-efficacypatient enablement

Outcome Measures

Primary Outcomes (2)

  • Patient Enablement Index

    Patient Enablement Index

    4 weeks

  • Patient Enablement Index

    Patient Enablement Index Repeated

    6 months

Secondary Outcomes (1)

  • Usability - Qualitative Data

    4 weeks

Study Arms (2)

Wallet Card Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

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.

Wallet Card Group

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."

Also known as: Placebo Intervention
Control Group

Eligibility Criteria

Age70 Years - 116 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Hillestad R, Bigelow J, Bower A, Girosi F, Meili R, Scoville R, Taylor R. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Aff (Millwood). 2005 Sep-Oct;24(5):1103-17. doi: 10.1377/hlthaff.24.5.1103.

    PMID: 16162551BACKGROUND
  • Varkey P, Cunningham J, Bisping DS. Improving medication reconciliation in the outpatient setting. Jt Comm J Qual Patient Saf. 2007 May;33(5):286-92. doi: 10.1016/s1553-7250(07)33033-x.

    PMID: 17503684BACKGROUND
  • Nassaralla CL, Naessens JM, Chaudhry R, Hansen MA, Scheitel SM. Implementation of a medication reconciliation process in an ambulatory internal medicine clinic. Qual Saf Health Care. 2007 Apr;16(2):90-4. doi: 10.1136/qshc.2006.021113.

    PMID: 17403752BACKGROUND
  • Gandhi TK, Weingart SN, Seger AC, Borus J, Burdick E, Poon EG, Leape LL, Bates DW. Outpatient prescribing errors and the impact of computerized prescribing. J Gen Intern Med. 2005 Sep;20(9):837-41. doi: 10.1111/j.1525-1497.2005.0194.x.

    PMID: 16117752BACKGROUND
  • Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1-26. doi: 10.1146/annurev.psych.52.1.1.

    PMID: 11148297BACKGROUND
  • Klein GL, Zenk KE. A Medical Allergy Profile (MAP) card. Ann Allergy. 1981 Jun;46(6):328-30.

    PMID: 7247083BACKGROUND
  • Chae SY, Chae MH, Isaacson N, James TS. The patient medication list: can we get patients more involved in their medical care? J Am Board Fam Med. 2009 Nov-Dec;22(6):677-85. doi: 10.3122/jabfm.2009.06.090059.

    PMID: 19897697BACKGROUND
  • 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.

    PMID: 21736729BACKGROUND

Study Officials

  • Ainsley Moore, MD

    McMaster University, Department of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 30, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share