Ambulatory CareNCT05892666
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
An observational study of Ambulatory Care and Emergency Services, Hospital, run by Simon Berthelot at 7 sites in Canada.
Trial summary
INTRODUCTION Whereas low-acuity ambulatory patients have been cited as a source of emergency department (ED) overuse or misuse, it is argued that patient evaluation in the ED may end up being more cost-effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulatory Care, Emergency Services, Hospital, Quality of Care
- What is being tested?
- On-site recruitment (information and consent) following a random sampling recruitment schedule, First phone call 1-3 days after the initial visit and Second phone call 8-14 days after the initial visit
- How many people
- 4,000 participants
- Where
- 7 sitesCanada
- Study dates
- 15 Jun 2023to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our assessment will focus on patients presenting with acute ambulatory conditions, which share the common feature of being potentially treatable in EDs, walk-in clinics or primary care practices.
We shall include patients:
- aged 18 years and over;
- seen in person or via telemedicine in an ED, a walk-in clinic, or the primary care practice where they are registered;
- ambulatory during the entire visit or consultation;
- with one of the following presenting complaints:
- acute diarrheas, defined as at least one day (24h) reported with three or more loose or liquid stools in the last seven days;
- Sore throat;
- Nasal congestion;
- Increased or purulent nasal discharge;
- Earache or ear discharge;
- Shortness of breath;
- Cough;
- Increased or purulent sputum;
- Muscle aches;
- Anosmia;
- Dysgeusia;
- Burning urine;
- Urinary frequency and urgency;
- Dysuria;
- Limb traumatic injury;
- Cervical, thoracic or lumbar back pain;
- Fever.
We shall exclude patients:
- transported by ambulance;
- not covered by the provincial health insurance plan;
- having consulted for a similar problem in the previous 30 days since patients with refractory disease represent a population with different care needs.;
- living in a long-term healthcare facility or incarcerated;
- with cognitive impairment that prevents reliable answers to the research questions;
- receiving palliative care.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Not yet recruiting
CISSS de Lanaudière
Joliette, Quebec, J6E 5X7
Jean-Sébastien Paquette, MD MSc, jspaquette.lab@gmail.com
- Not yet recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Danielle Blouin, MD PhD FRCPC, blouind@queensu.ca
- Not yet recruiting
Queen's Family Health Team
Kingston, Ontario, K7L 5E9
Colleen Grady, MBA DBA, colleen.grady@queensu.ca
- Not yet recruiting
CIUSSS-Nord de Montréal
Montreal, Quebec, H4J 1C5
Judy Morris, MD MSc FRCPC, judy.morris@umontreal.ca
- Not yet recruiting
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Jeff Perry, MD MSC CCFP-EM, jperry@ohri.ca
- Not yet recruiting
CIUSSS de la Capitale-Nationale
Québec, G1J 0A4
Simon Berthelot, MD MSc FRCPC, simon.berthelot@crchudequebec.ulaval.ca
- Recruiting
Centre de recherche CHU de Québec - Université Laval
Québec, G1V 4G2
Simon Berthelot, MD MSc FRCPC, 418 525-4444 ext. 46095, simon.berthelot@crchudequebec.ulaval.ca
Simon Berthelot, MD MSc FRCPC
About this study
INTRODUCTION Whereas low-acuity ambulatory patients have been cited as a source of emergency department (ED) overuse or misuse, it is argued that patient evaluation in the ED may end up being more cost-effective. The COVID-19 pandemic has complicated the debate by shifting primary care practices (PCP) and walk-in clinics (WIC) towards telemedicine, a consultation modality presumed to be more efficient under the circumstances.
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
Read more
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.
- Conditions
- Ambulatory Care, Emergency Services, Hospital, Quality of Care, Costs
- Being tested
- On-site recruitment (information and consent) following a random sampling recruitment schedule, First phone call 1-3 days after the initial visit, Second phone call 8-14 days after the initial visit
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site recruitment (information and consent) following a random sampling recruitment scheduleOther
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 visitOther
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 visitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Emergency department | ED care for acute ambulatory conditions by physicians unfamiliar with the patients. Receives: Other: On-site recruitment (information and consent) following a random sampling recruitment schedule; Other: First phone call 1-3 days after the initial visit; Other: Second phone call 8-14 days after the initial visit | |
| 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. Receives: Other: On-site recruitment (information and consent) following a random sampling recruitment schedule; Other: First phone call 1-3 days after the initial visit; Other: Second phone call 8-14 days after the initial visit | |
| 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. Receives: Other: On-site recruitment (information and consent) following a random sampling recruitment schedule; Other: First phone call 1-3 days after the initial visit; Other: Second phone call 8-14 days after the initial visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median PROM-ED scores
The adapted PROM-ED provides a measurement of patient-reported outcome expressed as scores for symptom relief, reassurance and having a plan for care. Responses for each dimension are aggregated reported as a percentage, with a higher percentage signifying better health outcomes according to the patient
Measured: At 7 days after the initial visit measured at the 8-14 day follow-up call
Secondary outcomes (14)
Patient-reported experience measure (PREM) scores
The PREM evaluates the patient's view of care delivery and measures various dimensions of patient experience (e.g., attitude of providers). The main question for this primary outcome measure will be: "Would you recommend this place to your friends and family"? Most PREM questions are on a 5-level Likert scale.
Measured: At the end of the initial visit measured at the 1-3 day follow-up call
Mean cost of disease for patients (CoPaQ)
The adapted CoPaQ measures patients' and caregivers' out-of-pocket expenses (e.g., travel) and indirect costs (e.g., loss of income).
Measured: At 7 days measured at the 8-14 day follow-up call
Incidence of return visit
Proportion of patients returning to any ED or outpatient clinic at 72 h and 7 days after the initial visit. Return visit occurrences will be identified via provincial physician billing databases.
Measured: At 7 days after the initial visit
Mean cost of care - Health care system perspective
Cost per care episode from the public payer's perspective calculated by summing the costs of all care processes delivered to a patient during the initial visit plus the costs of return visits and/or admissions at 72 hours and 7 days. Costs will be measured with a time-driven activity-based costing method with data extracted from electronic medical records review and provincial billing databases.
Measured: At 72 hours and 7 days after the initial visit
Incidences of admission/intensive care unit/mortality
Proportions of patients who were admitted to hospital or to the intensive care unit or died within 30 days after the initial visit. Obtained via electronic medical records review and provincial databases (Institut de la statistique du Québec and ICES).
Measured: At 7 and 30 days after the initial visit
Wait times
Median/mean length of stay and time spent waiting to see a physician obtained via electronic medical records
Measured: For the initial visit
Incidence of oral corticosteroid prescription
Proportion of patients with exacerbated asthma or COPD who received a prescription for oral corticosteroids. Obtained via electronic medical records
Measured: For the initial visit
Incidence of antibiotic or antiviral medication prescription
Proportions of patients with URTI, otitis media, influenza or bronchitis who received a prescription for antibiotics or antiviral medication. Obtained via electronic medical records.
Measured: For the initial visit
Incidence of narcotic prescription
Proportions of patients with cervical, thoracic and lumbar back pain who received a prescription for narcotics. Obtained via electronic medical records.
Measured: For the initial visit
Incidence of chest X-ray use
Proportions of patients with URTI, bronchitis, asthma and back pain who had a chest X-ray performed. Obtained via electronic medical records.
Measured: For the initial visit
Incidence of spine X-ray, CT scan or MRI use
Proportions of patients with back pain who had a spine X-ray, CT scan or a magnetic resonance imaging (MRI) performed or prescribed. Obtained via electronic medical records.
Measured: For the initial visit
Compliance to guidelines on use of antibiotics
Proportions of compliance to provincial recommendations of antibiotic prescriptions for pneumonia, tonsillitis, acute exacerbation of COPD and urinary tract infection. Obtained via electronic medical records.
Measured: For the initial visit
Incidence of diagnostic spirometry prescription
Proportions of spirometry prescribed for long-term >40-year-old smokers (current or past) undiagnosed with COPD who present for an acute lower respiratory tract infection. Obtained via electronic medical records.
Measured: For the initial visit
Mean greenhouse gas (GHG) emissions from patient transportation to consultation site
Calculated following the Québec Ministry of Environment "Guide to quantifying greenhouse gas emissions". Fuel consumption (in liters) will be estimated from patient transport modality and travel distance (in km) between home and consultation site. GHS emissions in kg of CO2 equivalent will be calculated by multiplying fuel consumption (L) by the appropriate emission coefficient (kg CO2 eq./L) depending on the transport modality used (e.g. car, bus). Distance obtained at the 8-14 day follow-up call.
Measured: For the initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start15 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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 Ambulatory 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Berthelot
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simon Berthelot, CHU de Quebec-Universite Laval
- Investigators
- Simon Berthelot, MD MSc FRCPC CCMF(MU), Principal investigator, CHU de Québec-Université LavalMylaine Breton, PhD, Principal investigator, Université de SherbrookeJason R. Guertin, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892666
- Sponsor's protocol ID
- Value trial
- Status last verified
- Aug 2024
- First submitted
- 1 May 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33616548
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05892666
- Acronym / sponsor ID
- Value trial
- Conditions
- Ambulatory Care, Emergency Services, Hospital, Quality of Care, Costs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Simon BerthelotUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jun 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.
INTRODUCTION Whereas low-acuity ambulatory patients have been cited as a source of emergency department (ED) overuse or misuse, it is argued that patient evaluation in the ED may end up being more cost-effective. The COVID-19 pandemic has complicated the debate by shifting primary care practices (PCP) and walk-in clinics (WIC) towards telemedicine, a consultation modality presumed to be more efficient under the circumstances.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emergency department | – | Other: On-site recruitment (information and consent) following a random sampling recruitment schedule, Other: First phone call 1-3 days after the initial visit, Other: Second phone call 8-14 days after the initial visitED care for acute ambulatory conditions by physicians unfamiliar with the patients. |
| Walk-in clinics | – | Other: On-site recruitment (information and consent) following a random sampling recruitment schedule, Other: First phone call 1-3 days after the initial visit, Other: Second phone call 8-14 days after the initial visitIn-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. |
| Primary care practice | – | Other: On-site recruitment (information and consent) following a random sampling recruitment schedule, Other: First phone call 1-3 days after the initial visit, Other: Second phone call 8-14 days after the initial visitIn-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our assessment will focus on patients presenting with acute ambulatory conditions, which share the common feature of being potentially treatable in EDs, walk-in clinics or primary care practices.
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 |
|---|---|---|
| On-site recruitment (information and consent) following a random sampling recruitment scheduleA 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). | Other | Emergency department, Primary care practice, Walk-in clinics |
| First phone call 1-3 days after the initial visitOnce 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. | Other | Emergency department, Primary care practice, Walk-in clinics |
| Second phone call 8-14 days after the initial visitA 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. | Other | Emergency department, Primary care practice, Walk-in clinics |
Primary outcome
Median PROM-ED scores
Time frame: At 7 days after the initial visit measured at the 8-14 day follow-up call
The adapted PROM-ED provides a measurement of patient-reported outcome expressed as scores for symptom relief, reassurance and having a plan for care. Responses for each dimension are aggregated reported as a percentage, with a higher percentage signifying better health outcomes according to the patient
14 secondary outcomes
Patient-reported experience measure (PREM) scores
Time frame: At the end of the initial visit measured at the 1-3 day follow-up call
Mean cost of disease for patients (CoPaQ)
Time frame: At 7 days measured at the 8-14 day follow-up call
Incidence of return visit
Time frame: At 7 days after the initial visit
Mean cost of care - Health care system perspective
Time frame: At 72 hours and 7 days after the initial visit
Incidences of admission/intensive care unit/mortality
Time frame: At 7 and 30 days after the initial visit
Wait times
Time frame: For the initial visit
Incidence of oral corticosteroid prescription
Time frame: For the initial visit
Incidence of antibiotic or antiviral medication prescription
Time frame: For the initial visit
Incidence of narcotic prescription
Time frame: For the initial visit
Incidence of chest X-ray use
Time frame: For the initial visit
Incidence of spine X-ray, CT scan or MRI use
Time frame: For the initial visit
Compliance to guidelines on use of antibiotics
Time frame: For the initial visit
Incidence of diagnostic spirometry prescription
Time frame: For the initial visit
Mean greenhouse gas (GHG) emissions from patient transportation to consultation site
Time frame: For the initial visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 33616548Berthelot 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.
- 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.
Simon Berthelot, MD MSc FRCPC CCMF(MU) principal investigator
CHU de Québec-Université Laval
Mylaine Breton, PhD principal investigator
Université de Sherbrooke
Jason R. Guertin, PhD principal investigator
Laval University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ambulatory Care and Emergency Services, Hospital, run by Simon Berthelot at 7 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?
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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Simon Berthelot, MD MSc FRCPC (418 525-4444 ext. 46095, simon.berthelot@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median PROM-ED scores (time frame: At 7 days after the initial visit measured at the 8-14 day follow-up call). 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 NCT05892666, 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 12 Aug 2024.