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ComorbidityPhase 1NCT02820129

Effectiveness of a Medication Wallet Card

A Phase 1 study testing Medication Wallet Card and Reminder Card in people with Comorbidity and Medication Therapy Management, run by McMaster University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 to 116 yearsHealthy volunteers can take part
What is being tested?
Medication Wallet Card and Reminder Card
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
No sites listed yet
Study dates
Jul 2016to Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 116 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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.

Read the 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.

Being tested
Medication Wallet Card, Reminder Card
Keywords
polypharmacy, wallet card, medication, self-efficacy, patient enablement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication Wallet CardDevice

    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.

  • Reminder CardDevice

    Also called Placebo Intervention

    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."

Study groups in NCT02820129
Study groupRoleWhat they receive
Wallet Card GroupExperimentalThe intervention arm is comprised of: Patients from the TAPER study who receive a medication wallet card with their medications and medical conditions listed.
Receives: Device: Medication Wallet Card
Control GroupPlacebo comparatorStandard 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."
Receives: Device: Reminder Card

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Enablement Index

    Patient Enablement Index

    Measured: 4 weeks

  2. Patient Enablement Index

    Patient Enablement Index Repeated

    Measured: 6 months

Secondary outcomes (1)

  1. Usability - Qualitative Data

    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?

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820129
Sponsor's protocol ID
TAPER-Wallet-Card-002-May-23
Status last verified
Sep 2021
First submitted
21 Jun 2016
Last updated
10 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16162551

  • 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.

    PubMed 17503684

  • 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.

    PubMed 17403752

  • 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.

    PubMed 16117752

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

    PubMed 11148297

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

    PubMed 7247083

  • 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.

    PubMed 19897697

  • 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.

    PubMed 21736729

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Medication Wallet Card and Reminder Card in people with Comorbidity and Medication Therapy Management, run by McMaster University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Enablement Index (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820129, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.

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