NCT02658604

Brief Summary

RATIONALE: Several examples in the literature describe the types of medication management issues uncovered during the course of home-based medication reviews. For example, the investigators previously reported the outcomes of home medication reviews of 43 homebound community pharmacy patients, finding that 58% of patients were keeping medications in the home that were expired, duplicates of other current medications, or no longer therapeutically appropriate. Many of these issues, due to their nature, could be considered to be "hidden", i.e. issues that are unlikely to be adequately detected or resolved during the course of routine interactions between patients and pharmacists in the community pharmacy setting. Currently, only homebound patients in Ontario are eligible to receive government-funded home medication review services from pharmacists. This limitation in funding eligibility is problematic as it reduces the likelihood that non-homebound patients will receive home medication reviews, even though this population may also benefit from these services. Indeed, evidence in the literature is not limited exclusively to homebound patients, and suggests that non-homebound patients are also at risk from home-centered medication management issues and may also benefit from home medication reviews. PURPOSE: Our study aims to characterize the prevalence and nature of "hidden in the home" medication management issues in non-homebound patients. To our knowledge, this study would be the first of its kind to focus specifically on this patient population and lend direct evidence in support of expanding funding of home medication review services in Ontario to include non-homebound patients. HYPOTHESIS: A subset of ambulatory, non-homebound patients who regularly attend community pharmacies are affected by medication management issues that cannot be adequately identified and resolved during the course of a typical medication review taking place within the pharmacy. These patients would benefit from a full medication review taking place in their own homes, similar to what is presently provided under Ontario's MedsCheck at Home program, for which only homebound patients in Ontario are eligible. RESEARCH QUESTIONS/OBJECTIVES:

  1. 1.What is the frequency of, and what type(s) and severity of, drug-related problems are detected during pharmacist visits to patients' homes who would not otherwise qualify for a MedsCheck at Home service?
  2. 2.Based on the findings from this study, which criteria would best assist community pharmacists in identifying ambulatory patients who may stand to benefit most from a home-based medication review?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

January 13, 2016

Last Update Submit

April 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean number of drug therapy problems (DTP) identified per patient

    DTP definitions based on those of Hepler and Strand (1990)

    At time of home visit (cross-section), up to 6 months

Secondary Outcomes (1)

  • Frequency distribution of drug therapy problem (DTP) type(s) across patient population

    At time of home visit (cross-section), up to 6 months

Other Outcomes (1)

  • Mean number of high-risk medications used per patient

    At time of home visit (cross-section), up to 6 months

Study Arms (1)

Home visit by pharmacist

Patients of participating pharmacies age 65 or older, who are on 5 or more chronic prescription medications, and who have a need for, and agree to, a home visit by a pharmacist for a medication review.

Other: Home medication review by a pharmacist

Interventions

Patients will receive a home visit from a pharmacist, including a medication review and the identification and addressing of drug therapy problems through patient education, the provision of pharmacologic and/or non-pharmacologic advice, or the adaptation of therapy or communication of recommendations to prescribers. All activities are within the current scope of practice for pharmacists in Ontario. A detailed assessment of the patient's medication inventory and organization/storage practices will be conducted, followed by a medication cabinet cleanup to help the patient organize their medications and discard any expired or discontinued medications. A list of inappropriate medications found in the home will be documented, detailing the reasons why they are inappropriate and if/how the patient is currently using these medications. With patient consent, inappropriate medications will be removed from the home and returned to the pharmacy for safe disposal.

Home visit by pharmacist

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current patients of participating pharmacies who are aged 65 and older, live at home, and are on 5 or more medications.

You may qualify if:

  • Age 65 or older
  • On 5 or more chronic prescription medications
  • Score of 3/8 or higher on screening questionnaire
  • Live at home and are ambulatory
  • Willingness to have a pharmacist conduct a medication review in their home

You may not qualify if:

  • Unable to converse with the pharmacist in a language they both can communicate in

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shoppers Drug Mart #500

Toronto, Ontario, M4C1H6, Canada

Location

Study Officials

  • John Papastergiou, BSc, BScPhm

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 20, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations