The Right Care, for the Right Patient, at the Right Time, by the Right Provider: A Value-based Comparison of the Management of Ambulatory Patients With Acute Health Concerns in walk-in Clinics, Primary Care Physician Practices and Emergency Departments
NCT ID: NCT05892666
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2023-06-15
2025-12-31
Brief Summary
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OBJECTIVES To compare, from patient and healthcare system perspectives, the value of the care received in person or by telemedicine in EDs, WICs and PCPs by ambulatory patients presenting with one the following complaints: 1) Acute diarrheas; 2) Sore throat; 3) Nasal congestion; 4) Increased or purulent nasal discharge; 5) Earache or ear discharge; 6) Shortness of breath; 7) Cough; 8) Increased or purulent sputum; 9) Muscle aches; 10) Anosmia; 11) Dysgeusia; 12) Burning urine; 13) Urinary frequency and urgency; 14) Dysuria; 15) Limb traumatic injury; 16) Cervical, thoracic or lumbar back pain; and 17) Fever
METHODS The investigators shall perform a multicenter prospective cohort study in Québec and Ontario. In phase 1, a time-driven activity-based costing method will be applied at each of 14 study sites. This method uses time as a cost driver to allocate direct costs (e.g. medication), consumable expenditures (e.g. needles, office supplies), overhead (e.g. building maintenance) and physician charges to patient care. The cost of a care episode thus will be proportional to the time spent receiving the care. At the end of this phase, a list of care process costs (e.g. triage, virtual medical assessment) will be generated and used to calculate the cost of each consultation during phase 2, in which a prospective cohort of patients will be monitored in order to compare the care received in EDs, WICs and PCPs. Research assistants will recruit eligible participants during the initial in-person or virtual visit. They will complete the collection using local medical records and provincial databases. Participants will be contacted by phone for follow-up questionnaires 1-3 and 8-14 days after their visit. Patients shall be aged 18 years and over, ambulatory throughout the care episode and have one of the targeted presenting complaints mentioned above. The estimated sample size is 3,906 patients. The primary outcome measurement for comparing the three types of care setting will be patient-reported outcome scores. The secondary outcome measurements will be: 1) patient-reported experience scores; 2) mean costs borne wholly by patients; 3) the proportion of return visits to any site 3 and 7 days after the initial visit; 4) the mean cost of care; 5) the incidences of mortality, hospital admissions and placement in intensive care within 30 days following the initial visit; 6) adherence to practice guidelines. Multilevel generalized linear models will be used to compare the care setting types and an overlap weights approach will be applied to adjust for confounding due to age, sex, gender, ethnicity, comorbidities, registration with a family physician, socioeconomic status and perceived severity of illness.
EXPERTISE This research project brings together a strong team with expertise in emergency and primary care, pneumonology, performance assessment, biostatistics, health economics, patient-oriented research, knowledge translation, administration and policymaking.
IMPORTANCE The endpoint of our program will be for policymakers, patients and care providers to be able to determine the most appropriate care setting for the management of ambulatory emergency conditions, based on the value of care associated with each alternative.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Emergency department
ED care for acute ambulatory conditions by physicians unfamiliar with the patients.
On-site recruitment (information and consent) following a random sampling recruitment schedule
A trained research assistant in collaboration with local clerks at each site will screen eligible patients after on-site registration or online scheduling, but prior to assessment by a physician, based on included presenting complaints. The research assistant or member of the care team, depending on the local rules, will approach the potentially eligible participants and present them the research project and information consent form. If the patient agrees to participate and is eligible, they will sign the information and consent form and the research assistant will take their vital signs (for onsite participants only).
First phone call 1-3 days after the initial visit
Once the patient has been discharged, a research assistant will call the patient within 72 hours following the initial visit. This phone call will allow to i) ensure that gender, ethnicity, comorbidities and disposition plans are fully documented; and ii) use our patient-reported experience measure tool and administer a questionnaire on motivation for choosing one care setting over the other. Motivation will be classified in the 6 domains of the Conceptual Model of Emergency Department Use (Uscher-Pines et al. 2019). Participants will be asked to specify whether their choice of care setting was based on accessibility, convenience, their perception of the severity of illness, their beliefs and knowledge regarding these care settings, referral/advice from a care professional or an acquaintance, or on costs.
Second phone call 8-14 days after the initial visit
A follow-up phone call will be made to all participants 8 days after the initial visit to evaluate primary and secondary outcome metrics. Patient-reported outcome (primary) and cost measures will be completed by the participants at this moment.
Walk-in clinics
In-person or virtual care in a walk-in clinic for acute ambulatory conditions by physicians unfamiliar with the patients. In-person and virtual care will be assessed together as part of the care offer in outpatient clinics, but separately as a sub-analysis.
On-site recruitment (information and consent) following a random sampling recruitment schedule
A trained research assistant in collaboration with local clerks at each site will screen eligible patients after on-site registration or online scheduling, but prior to assessment by a physician, based on included presenting complaints. The research assistant or member of the care team, depending on the local rules, will approach the potentially eligible participants and present them the research project and information consent form. If the patient agrees to participate and is eligible, they will sign the information and consent form and the research assistant will take their vital signs (for onsite participants only).
First phone call 1-3 days after the initial visit
Once the patient has been discharged, a research assistant will call the patient within 72 hours following the initial visit. This phone call will allow to i) ensure that gender, ethnicity, comorbidities and disposition plans are fully documented; and ii) use our patient-reported experience measure tool and administer a questionnaire on motivation for choosing one care setting over the other. Motivation will be classified in the 6 domains of the Conceptual Model of Emergency Department Use (Uscher-Pines et al. 2019). Participants will be asked to specify whether their choice of care setting was based on accessibility, convenience, their perception of the severity of illness, their beliefs and knowledge regarding these care settings, referral/advice from a care professional or an acquaintance, or on costs.
Second phone call 8-14 days after the initial visit
A follow-up phone call will be made to all participants 8 days after the initial visit to evaluate primary and secondary outcome metrics. Patient-reported outcome (primary) and cost measures will be completed by the participants at this moment.
Primary care practice
In-person or virtual care in a primary care clinic for acute ambulatory conditions (patients attached to a primary care practice, seen by their family physician or a colleague on a same-day appointment for urgent needs). In-person and virtual care will be assessed together as part of the care offer in outpatient clinics, but separately as a sub-analysis.
On-site recruitment (information and consent) following a random sampling recruitment schedule
A trained research assistant in collaboration with local clerks at each site will screen eligible patients after on-site registration or online scheduling, but prior to assessment by a physician, based on included presenting complaints. The research assistant or member of the care team, depending on the local rules, will approach the potentially eligible participants and present them the research project and information consent form. If the patient agrees to participate and is eligible, they will sign the information and consent form and the research assistant will take their vital signs (for onsite participants only).
First phone call 1-3 days after the initial visit
Once the patient has been discharged, a research assistant will call the patient within 72 hours following the initial visit. This phone call will allow to i) ensure that gender, ethnicity, comorbidities and disposition plans are fully documented; and ii) use our patient-reported experience measure tool and administer a questionnaire on motivation for choosing one care setting over the other. Motivation will be classified in the 6 domains of the Conceptual Model of Emergency Department Use (Uscher-Pines et al. 2019). Participants will be asked to specify whether their choice of care setting was based on accessibility, convenience, their perception of the severity of illness, their beliefs and knowledge regarding these care settings, referral/advice from a care professional or an acquaintance, or on costs.
Second phone call 8-14 days after the initial visit
A follow-up phone call will be made to all participants 8 days after the initial visit to evaluate primary and secondary outcome metrics. Patient-reported outcome (primary) and cost measures will be completed by the participants at this moment.
Interventions
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On-site recruitment (information and consent) following a random sampling recruitment schedule
A trained research assistant in collaboration with local clerks at each site will screen eligible patients after on-site registration or online scheduling, but prior to assessment by a physician, based on included presenting complaints. The research assistant or member of the care team, depending on the local rules, will approach the potentially eligible participants and present them the research project and information consent form. If the patient agrees to participate and is eligible, they will sign the information and consent form and the research assistant will take their vital signs (for onsite participants only).
First phone call 1-3 days after the initial visit
Once the patient has been discharged, a research assistant will call the patient within 72 hours following the initial visit. This phone call will allow to i) ensure that gender, ethnicity, comorbidities and disposition plans are fully documented; and ii) use our patient-reported experience measure tool and administer a questionnaire on motivation for choosing one care setting over the other. Motivation will be classified in the 6 domains of the Conceptual Model of Emergency Department Use (Uscher-Pines et al. 2019). Participants will be asked to specify whether their choice of care setting was based on accessibility, convenience, their perception of the severity of illness, their beliefs and knowledge regarding these care settings, referral/advice from a care professional or an acquaintance, or on costs.
Second phone call 8-14 days after the initial visit
A follow-up phone call will be made to all participants 8 days after the initial visit to evaluate primary and secondary outcome metrics. Patient-reported outcome (primary) and cost measures will be completed by the participants at this moment.
Eligibility Criteria
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Inclusion Criteria
1. aged 18 years and over;
2. seen in person or via telemedicine in an ED, a walk-in clinic, or the primary care practice where they are registered;
3. ambulatory during the entire visit or consultation;
4. with one of the following presenting complaints:
1. acute diarrheas, defined as at least one day (24h) reported with three or more loose or liquid stools in the last seven days;
2. Sore throat;
3. Nasal congestion;
4. Increased or purulent nasal discharge;
5. Earache or ear discharge;
6. Shortness of breath;
7. Cough;
8. Increased or purulent sputum;
9. Muscle aches;
10. Anosmia;
11. Dysgeusia;
12. Burning urine;
13. Urinary frequency and urgency;
14. Dysuria;
15. Limb traumatic injury;
16. Cervical, thoracic or lumbar back pain;
17. Fever.
We shall exclude patients:
1. transported by ambulance;
2. not covered by the provincial health insurance plan;
3. having consulted for a similar problem in the previous 30 days since patients with refractory disease represent a population with different care needs.;
4. living in a long-term healthcare facility or incarcerated;
5. with cognitive impairment that prevents reliable answers to the research questions;
6. receiving palliative care.
18 Years
ALL
No
Sponsors
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Simon Berthelot
OTHER
Responsible Party
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Simon Berthelot
Emergency Physician, CHU de Québec-Université Laval; Associate Professor, Faculté of medicine, Université Laval
Principal Investigators
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Simon Berthelot, MD MSc FRCPC CCMF(MU)
Role: PRINCIPAL_INVESTIGATOR
CHU de Québec-Université Laval
Mylaine Breton, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Jason R. Guertin, PhD
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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Kingston Health Sciences Centre
Kingston, Ontario, Canada
Queen's Family Health Team
Kingston, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
CISSS de Lanaudière
Joliette, Quebec, Canada
CIUSSS-Nord de Montréal
Montreal, Quebec, Canada
CIUSSS de la Capitale-Nationale
Québec, , Canada
Centre de recherche CHU de Québec - Université Laval
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Berthelot S, Breton M, Guertin JR, Archambault PM, Berger Pelletier E, Blouin D, Borgundvaag B, Duhoux A, Harvey Labbe L, Laberge M, Lachapelle P, Lapointe-Shaw L, Layani G, Lefebvre G, Mallet M, Matthews D, McBrien K, McLeod S, Mercier E, Messier A, Moore L, Morris J, Morris K, Ovens H, Pageau P, Paquette JS, Perry J, Schull M, Simon M, Simonyan D, Stelfox HT, Talbot D, Vaillancourt S. A Value-Based Comparison of the Management of Ambulatory Respiratory Diseases in Walk-in Clinics, Primary Care Practices, and Emergency Departments: Protocol for a Multicenter Prospective Cohort Study. JMIR Res Protoc. 2021 Feb 22;10(2):e25619. doi: 10.2196/25619.
Other Identifiers
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Value trial
Identifier Type: -
Identifier Source: org_study_id
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