Primary Health CareNCT05715151
Continuous Quality Improvement Cohorts on Advanced Access
A study testing CQI intervention and Audit and Feedback in people with Primary Health Care, run by Université de Sherbrooke at 18 sites in Canada.
Trial summary
The goal of this clinical trial is to compare the implementation and effects of CQI cohorts on AA for PHC clinics. The main questions it aims to answer are to assess the effectiveness of CQI cohorts on AA outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Health Care
- What is being tested?
- CQI intervention and Audit and Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 18 sitesCanada
- Study dates
- 21 Sep 2022to 1 Jun 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinics must offer interprofessional care.
- At least 50 % of all team members should accept to take part in the study.
Who cannot join
- Solo Practice Physicians
- Physician-nurse only model
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Canada18 sites, 18 recruiting
- Recruiting
CISSS de la Gaspésie
Gaspé, Quebec
Mylaine Breton
- Recruiting
CISSS de l'Outaouais
Gatineau, Quebec, J8T 4J3
819 966-6000 ext. 339199, 07_CISSSO_CER@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CISSS de Lanaudière
Joliette, Quebec
recherche.cissslan@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CISSS de Laval
Laval, Quebec
Chantal Legris
- Recruiting
CISSS de Chaudière-Appalaches
Lévis, Quebec
418 835-7121 ext. 11360, gur.cisss-ca@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CIUSSS de Montérégie-Centre
Longueuil, Quebec
Helene Langelier, 450 466.5000 ext. 3894, helene.langelier.cisssmc16@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4
Sara Appadu, 514 252-3400 ext. 5708, cer.cemtl@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CIUSSS de l'Ouest-de-l'Île-de-Montréal
Montreal, Quebec
Mylaine Breton
- Recruiting
CIUSSS du Centre-Ouest-de-l'Île-de-Montréal
Montreal, Quebec
Serina Giagnotti, 514-340-8222 ext. 26785, convenance@jgh.mcgill.ca
- Recruiting
CIUSSS du Centre-Sud-de-l'Île-de-Montréal
Montreal, Quebec
- Recruiting
CIUSSS du Nord-de-l'Île-de-Montréal
Montreal, Quebec
- Recruiting
CIUSSS de la Capitale-Nationale
Québec, G1M 3X7
Olivier Contensou, olivier.contensou.ciussscn@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CISSS de l'Abitibi-Témiscamingue
Rouyn-Noranda, Quebec, J9X 2A9
Mylaine Breton
- Recruiting
CISSS de la Montérégie-Ouest
Saint-Hubert, Quebec, J3Y 6W9
Valerie Barbin, (450) 445-2431 ext. 2281, valerie.barbin.cisssmo16@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CISSS de la Montérégie-Est
Saint-Hyacinthe, Quebec, J2S 4Y8
Julie Desormeau, julie.desormeau.cisssme16@ssss.gouv.qc.ca
Sonia Drolet, sonia.drolet.cisssme16@ssss.gouv.qc.ca
- Recruiting
CISSS des Laurentides
Saint-Jérôme, Quebec
Marie-Ève Lapointe, cer.cissslau@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec
Lisa Veilleux, lisa.veilleux.ciussse-chus@ssss.gouv.qc.ca
Mylaine Breton
- Recruiting
CIUSSS de la Mauricie et Centre-du-Québec
Trois-Rivières, Quebec
819 478-6464 ext. 26478, 04ethiqueciusssmcq@ssss.gouv.qc.ca
Mylaine Breton
About this study
Official title: Impact of Externally Facilitated Continuous Quality Improvement Cohorts on Advanced Access to Support Primary Healthcare Teams
The goal of this clinical trial is to compare the implementation and effects of CQI cohorts on AA for PHC clinics. The main questions it aims to answer are to assess the effectiveness of CQI cohorts on AA outcomes.
Read the detailed description
SIGNIFICANCE AND PURPOSE: Timely access to primary healthcare is one cornerstone of strong primary healthcare. Across Canada, timely access remains a significant challenge. One of the most highly recommended models around the world to improve timely access is advanced access (AA). Over the last two decades, AA has become increasingly popular in Canada. AA model has been widely promoted by the College of Family Physicians of Canada and several other provincial organizations and professional associations. Some tools to support the implementation of AA to PHC providers and practices have been developed such as workbook by Health Quality Ontario and Doctor of BC. However, those tools are important assets to initiate a reflection to improve, they are often not sufficient. Eight PHC teams interested in improving and expanding the implementation of AA have been coached through several PDSA cycles. However, the personalized support model used is very demanding in terms of capacity and resources. These findings guided the research team in developing and evaluating a Continuous Quality Improvement (CQI) Cohort program on advanced access to support Primary healthcare (PHC) teams.This study aims to develop knowledge on an externally facilitated CQI pan-Canadian cohort program that could potentially be transferred to provincial organizations or professional associations wishing to support clinics in quality improvement projects.
OBJECTIVE: Assess the effectiveness of CQI cohorts on AA outcomes.
QI INTERVENTION PROGRAM: PHC teams will participate in an externally facilitated CQI program focusing on AA. The proposed program consists of cycle of three key activities; 1) Interprofessional reflective sessions and need prioritization, 2) Group mentoring and PDSA Cycles and 3) Cohort cross-learning exchange opportunities.
METHODS: This study will be based on the cluster-controlled trial of a CQI program of PHC teams on AA. 48 PHC teams from Quebec will participate to the externally facilitated CQI cohort intervention. Volunteer clinics from the intervention regions will receive the CQI intervention for 18 months. Intervention clinics will be matched to PHC clinics located in other regions to compose the control group. The match will be based on the clinic level (1 to 10, based on the number of patients registered and services offered. Clinics in the control group will receive an audit on a selection of AA indicators and will be offered the intervention 12 to 18 months following their recruitment. Data collection and analysis will include quantitative data based on a comprehensive assessment of both AA processes and outcomes. These will be measured through a self-reflective survey for PHC team members, EMR data and patients related outcomes questionnaire on access. Qualitative data based on semi-structured interviews with key stakeholders, observations of the CQI activities and analysis of plans of action of documents plan of action will take place.
- Conditions
- Primary Health Care
- Being tested
- CQI intervention, Audit and Feedback
- Keywords
- Advanced Access, Primary Health Care, Quality improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CQI interventionOther
Activity 1: Reflective sessions and problem prioritisation. Activity 2: PDSA cycles. Activity 3: Group mentoring.
Audit and FeedbackOther
Audit and Feedback on six key AA indicators, patients reported experience about access and selected AA processes.
| Study group | Role | What they receive |
|---|---|---|
| CQI intervention | Experimental | The proposed CQI cohort consists of three activities carried out iteratively until the improvement objectives are achieved. Receives: Other: CQI intervention |
| Audit and feedback | Active comparator | Clinics in the control group will receive feedback on six key AA indicators, patients reported experience about access and selected AA processes. Receives: Other: Audit and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
3rd next available appointment (weekly)
Delay before the 3rd next available appointment. The 3rd next available appointment is used (rather than the 1st or 2nd) to decrease variation.
Measured: 18 month
Percent of relational continuity (monthly)
Total number of medical consultations with a patient's attached family physician (or specialised nurse) out of the total number of consultations with any family physician (or specialised nurse) from the clinic. Evaluates relational continuity between the provider and their registered patients.
Measured: 18 month
Secondary outcomes (6)
Percent of 48-hour open slots (weekly)
Proportion of appointments available in the next 48 hours. Provides an overview of the provider's ability to respond to urgent care demands.
Measured: 18 month
Use of walk-in (monthly)
Proportion of walk-in visits by registered patients to each professional.
Measured: 18 month
Proportion of multidisciplinary involvement (monthly)
Evaluates the proportion of involvement of different types of providers (social workers, nurses, pharmacists, etc.) with registered patients.
Measured: 18 month
Discontinuity for chronic patients (monthly)
Proportion of chronic patients without any consultations within the last 12 months.
Measured: 18 month
3rd next available appointment (weekly)
Delay before the 3rd next available appointment. The 3rd next available appointment is used (rather than the 1st or 2nd) to decrease variation.
Measured: 12 month
Percent of relational continuity (monthly)
Total number of medical consultations with a patient's attached family physician (or specialised nurse) out of the total number of consultations with any family physician (or specialised nurse) from the clinic. Evaluates relational continuity between the provider and their registered patients.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start21 Sep 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Health 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Isabelle Gaboury, Mike Green, Tara Kiran, Janusz Kaczorowski, Maude Laberge
- Responsible party
- Principal investigator, Mylaine Breton, Université de Sherbrooke
- Investigators
- Mylaine Breton, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715151
- Sponsor's protocol ID
- MP-04-2022-696
- Status last verified
- Feb 2023
- First submitted
- 21 Dec 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breton M, Gaboury I, Martin E, Green ME, Kiran T, Laberge M, Kaczorowski J, Ivers N, Deville-Stoetzel N, Bordeleau F, Beaulieu C, Descoteaux S. Impact of externally facilitated continuous quality improvement cohorts on Advanced Access to support primary healthcare teams: protocol for a quasi-randomized cluster trial. BMC Prim Care. 2023 Apr 11;24(1):97. doi: 10.1186/s12875-023-02048-y.
PubMed 37038126
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Externally Facilitated Continuous Quality Improvement Cohorts on Advanced Access to Support Primary Healthcare Teams
- ClinicalTrials.gov ID
- NCT05715151
- Acronym / sponsor ID
- MP-04-2022-696
- Conditions
- Primary Health Care
- Keywords
- Advanced Access, Primary Health Care, Quality improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Isabelle Gaboury, Mike Green, Tara Kiran, Janusz Kaczorowski, Maude Laberge
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 6 Feb 2023 (actual)
- 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 goal of this clinical trial is to compare the implementation and effects of CQI cohorts on AA for PHC clinics. The main questions it aims to answer are to assess the effectiveness of CQI cohorts on AA outcomes.
Detailed description
SIGNIFICANCE AND PURPOSE: Timely access to primary healthcare is one cornerstone of strong primary healthcare. Across Canada, timely access remains a significant challenge. One of the most highly recommended models around the world to improve timely access is advanced access (AA). Over the last two decades, AA has become increasingly popular in Canada. AA model has been widely promoted by the College of Family Physicians of Canada and several other provincial organizations and professional associations. Some tools to support the implementation of AA to PHC providers and practices have been developed such as workbook by Health Quality Ontario and Doctor of BC. However, those tools are important assets to initiate a reflection to improve, they are often not sufficient. Eight PHC teams interested in improving and expanding the implementation of AA have been coached through several PDSA cycles. However, the personalized support model used is very demanding in terms of capacity and resources. These findings guided the research team in developing and evaluating a Continuous Quality Improvement (CQI) Cohort program on advanced access to support Primary healthcare (PHC) teams.This study aims to develop knowledge on an externally facilitated CQI pan-Canadian cohort program that could potentially be transferred to provincial organizations or professional associations wishing to support clinics in quality improvement projects.
OBJECTIVE: Assess the effectiveness of CQI cohorts on AA outcomes.
QI INTERVENTION PROGRAM: PHC teams will participate in an externally facilitated CQI program focusing on AA. The proposed program consists of cycle of three key activities; 1) Interprofessional reflective sessions and need prioritization, 2) Group mentoring and PDSA Cycles and 3) Cohort cross-learning exchange opportunities.
METHODS: This study will be based on the cluster-controlled trial of a CQI program of PHC teams on AA. 48 PHC teams from Quebec will participate to the externally facilitated CQI cohort intervention. Volunteer clinics from the intervention regions will receive the CQI intervention for 18 months. Intervention clinics will be matched to PHC clinics located in other regions to compose the control group. The match will be based on the clinic level (1 to 10, based on the number of patients registered and services offered. Clinics in the control group will receive an audit on a selection of AA indicators and will be offered the intervention 12 to 18 months following their recruitment. Data collection and analysis will include quantitative data based on a comprehensive assessment of both AA processes and outcomes. These will be measured through a self-reflective survey for PHC team members, EMR data and patients related outcomes questionnaire on access. Qualitative data based on semi-structured interviews with key stakeholders, observations of the CQI activities and analysis of plans of action of documents plan of action will take place.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CQI intervention | Experimental | Other: CQI interventionThe proposed CQI cohort consists of three activities carried out iteratively until the improvement objectives are achieved. |
| Audit and feedback | Active comparator | Other: Audit and FeedbackClinics in the control group will receive feedback on six key AA indicators, patients reported experience about access and selected AA processes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinics must offer interprofessional care.
- At least 50 % of all team members should accept to take part in the study.
Key exclusion criteria (2 listed)
- Solo Practice Physicians
- Physician-nurse only model
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 |
|---|---|---|
| CQI interventionActivity 1: Reflective sessions and problem prioritisation. Activity 2: PDSA cycles. Activity 3: Group mentoring. | Other | CQI intervention |
| Audit and FeedbackAudit and Feedback on six key AA indicators, patients reported experience about access and selected AA processes. | Other | Audit and feedback |
Primary outcome
3rd next available appointment (weekly)
Time frame: 18 month
Delay before the 3rd next available appointment. The 3rd next available appointment is used (rather than the 1st or 2nd) to decrease variation.
Percent of relational continuity (monthly)
Time frame: 18 month
Total number of medical consultations with a patient's attached family physician (or specialised nurse) out of the total number of consultations with any family physician (or specialised nurse) from the clinic. Evaluates relational continuity between the provider and their registered patients.
6 secondary outcomes
Percent of 48-hour open slots (weekly)
Time frame: 18 month
Use of walk-in (monthly)
Time frame: 18 month
Proportion of multidisciplinary involvement (monthly)
Time frame: 18 month
Discontinuity for chronic patients (monthly)
Time frame: 18 month
3rd next available appointment (weekly)
Time frame: 12 month
Percent of relational continuity (monthly)
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 37038126Breton M, Gaboury I, Martin E, Green ME, Kiran T, Laberge M, Kaczorowski J, Ivers N, Deville-Stoetzel N, Bordeleau F, Beaulieu C, Descoteaux S. Impact of externally facilitated continuous quality improvement cohorts on Advanced Access to support primary healthcare teams: protocol for a quasi-randomized cluster trial. BMC Prim Care. 2023 Apr 11;24(1):97. doi: 10.1186/s12875-023-02048-y.
- Individual participant dataSharing planned: No
Related trials for Primary Health Care
Enrolling by invitation
TimelyCare - A Proactive Primary Care Model: Delivering the Right Care at the Right Time for Individuals at Risk of High Care Consumption
Multimorbidity, Integrated Care
Recruiting
Testing the Impact of the MOHR Follow-up Support
Primary Care Patients, Primary Care Center
Not yet recruiting
HERE: Health Empowerment and Resources After Pregnancy
Cardiovascular Health
Not yet recruiting
Study Comparing Osteoarthritis Programs
Osteoarthritis
Not yet recruitingObservational study
Clinical Governance of Home Care and 30-Day Stability
Home Care Services, Quality of Health Care
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.
Mylaine Breton, PhD principal investigator
Université de Sherbrooke
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CQI intervention and Audit and Feedback in people with Primary Health Care, run by Université de Sherbrooke at 18 sites 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 2 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: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Martin, Ph.D(c) (5147799926, elisabeth.martin@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3rd next available appointment (weekly) (time frame: 18 month). 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 NCT05715151, which also lists 1 linked publication.
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 6 Feb 2023.