Health ServicesFMGNCT02963636
Proximity Work in Family Medicine Groups : the Impact of Pharmacists
A study testing Pharmacist clinical intervention in people with Health Services, run by Laval University at 1 site in Canada.
Trial summary
The project objective is to evaluate the impact of the recent addition of pharmacists within family medicine groups (FMGs) on organizational and clinical parameters. The process by which changes occur and the level of pharmacists' activities will also be assessed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Services
- What is being tested?
- Pharmacist clinical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Apr 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing to meet with the pharmacist and;
- Consuming drugs of four or more different pharmacological classes or having to take at least four doses per day and;
- aged 70 or over with at least two criteria of vulnerability or aged less than 70 with at least 3 criteria of vulnerability or had a recent loss of autonomy or in post- hospitalization with medication changes in the hospital.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The project objective is to evaluate the impact of the recent addition of pharmacists within family medicine groups (FMGs) on organizational and clinical parameters. The process by which changes occur and the level of pharmacists' activities will also be assessed. The ultimate goal of the project is the development of an accompanying guide to facilitate the work of the pharmacist in monitoring complex patients in primary care medical clinics.
- Conditions
- Health Services
- Being tested
- Pharmacist clinical intervention
- Keywords
- family medicine group, pharmacists, primary health care, pharmaceutical services, interprofessional relations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist clinical interventionOther
Pharmacists will make a clinical intervention with patients. They will review patient drug therapy already prescribed in their usual care. This includes a medication reconciliation, an assessment of drug related problems, an assessment of the regimen complexity and adherence to treatment. A care plan will be elaborated. Moreover, immediate and future interventions with the patient or other health professionals will be implemented and monitored. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist clinical intervention | Experimental | Patients exposed to the pharmacist intervention Receives: Other: Pharmacist clinical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drug related problems
Measured: 3 to 6 months
Secondary outcomes (3)
Regimen complexity
Medication regimen complexity index (MRCI)
Measured: 3 to 6 months
Medication adherence
Proportion of days covered (PDC)
Measured: 3 to 6 months
Quality of care provided by the clinical team (pharmacists, doctors, nurses, etc.)
Quality indicators (proposed by INESSS)
Measured: 3 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 posted15 Nov 2016 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health ServicesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Fonds de la Recherche en Santé du Québec, Université de Sherbrooke
- Responsible party
- Principal investigator, Line Guénette, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963636
- Sponsor's protocol ID
- 106238
- Acronym
- FMG
- Status last verified
- Nov 2016
- First submitted
- 17 Feb 2016
- Last updated
- 15 Nov 2016
- 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 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximity Work in Family Medicine Groups : the Impact of Pharmacists
- ClinicalTrials.gov ID
- NCT02963636
- Acronym / sponsor ID
- FMG / 106238
- Conditions
- Health Services
- Keywords
- family medicine group, pharmacists, primary health care, pharmaceutical services, interprofessional relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- McGill University, Fonds de la Recherche en Santé du Québec, Université de Sherbrooke
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Nov 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.
The project objective is to evaluate the impact of the recent addition of pharmacists within family medicine groups (FMGs) on organizational and clinical parameters. The process by which changes occur and the level of pharmacists' activities will also be assessed. The ultimate goal of the project is the development of an accompanying guide to facilitate the work of the pharmacist in monitoring complex patients in primary care medical clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist clinical intervention | Experimental | Other: Pharmacist clinical interventionPatients exposed to the pharmacist intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to meet with the pharmacist and;
- Consuming drugs of four or more different pharmacological classes or having to take at least four doses per day and;
- aged 70 or over with at least two criteria of vulnerability or aged less than 70 with at least 3 criteria of vulnerability or had a recent loss of autonomy or in post- hospitalization with medication changes in the hospital.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Pharmacist clinical interventionPharmacists will make a clinical intervention with patients. They will review patient drug therapy already prescribed in their usual care. This includes a medication reconciliation, an assessment of drug related problems, an assessment of the regimen complexity and adherence to treatment. A care plan will be elaborated. Moreover, immediate and future interventions with the patient or other health professionals will be implemented and monitored. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist. | Other | Pharmacist clinical intervention |
Primary outcome
Number of drug related problems
Time frame: 3 to 6 months
3 secondary outcomes
Regimen complexity
Time frame: 3 to 6 months
Medication adherence
Time frame: 3 to 6 months
Quality of care provided by the clinical team (pharmacists, doctors, nurses, etc.)
Time frame: 3 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 15 Nov 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist clinical intervention in people with Health Services, run by Laval University 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 3 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 15 Nov 2016. 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?
Number of drug related problems (time frame: 3 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 15 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.