Home CareNCT02658604
Home Medication Reviews by Pharmacists in Ontario, Canada
An observational study of Home Care and Pharmacists, run by University of Waterloo at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Home Care, Pharmacists, Medication Therapy Management
- What is being tested?
- Home medication review by a pharmacist
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Apr 2017
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Current patients of participating pharmacies who are aged 65 and older, live at home, and are on 5 or more medications.
Who may be able to join
- 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
Who cannot join
- Unable to converse with the pharmacist in a language they both can communicate in
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Medication Review Services for Non-homebound Community Pharmacy Patients: Evaluation of Medication Management Issues in Non-homebound Patients and Characterization of Ideal Target Population for Home-based Medication Reviews.
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.
Read more
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:
- 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?
- 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?
- Conditions
- Home Care, Pharmacists, Medication Therapy Management
- Being tested
- Home medication review by a pharmacist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home medication review by a pharmacistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home medication review by a pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of drug therapy problems (DTP) identified per patient
DTP definitions based on those of Hepler and Strand (1990)
Measured: 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
DTP definitions based on those of Hepler and Strand (1990)
Measured: At time of home visit (cross-section), up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherilyn Houle, University of Waterloo
- Investigators
- John Papastergiou, BSc, BScPhm, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658604
- Sponsor's protocol ID
- 20836
- Status last verified
- Apr 2017
- First submitted
- 13 Jan 2016
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Medication Review Services for Non-homebound Community Pharmacy Patients: Evaluation of Medication Management Issues in Non-homebound Patients and Characterization of Ideal Target Population for Home-based Medication Reviews.
- ClinicalTrials.gov ID
- NCT02658604
- Acronym / sponsor ID
- 20836
- Conditions
- Home Care, Pharmacists, Medication Therapy Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home visit by pharmacist | – | Other: Home medication review by a pharmacistPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Current patients of participating pharmacies who are aged 65 and older, live at home, and are on 5 or more medications.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to converse with the pharmacist in a language they both can communicate in
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home medication review by a pharmacistPatients 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. | Other | Home visit by pharmacist |
Primary outcome
Mean number of drug therapy problems (DTP) identified per patient
Time frame: At time of home visit (cross-section), up to 6 months
DTP definitions based on those of Hepler and Strand (1990)
1 secondary outcome
Frequency distribution of drug therapy problem (DTP) type(s) across patient population
Time frame: At time of home visit (cross-section), up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Papastergiou, BSc, BScPhm principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Care and Pharmacists, run by University of Waterloo at 1 site in Canada.
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 5 inclusion and 1 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mean number of drug therapy problems (DTP) identified per patient (time frame: At time of home visit (cross-section), up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2017.