Clinical trial NCT05892666: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ambulatory Care
Emergency Services, Hospital
Quality of Care
Costs
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: We shall include patients:

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.

Primary outcomes:
measure: Median PROM-ED scores
timeFrame: At 7 days after the initial visit measured at the 8-14 day follow-up call
Secondary outcomes:
measure: Patient-reported experience measure (PREM) scores
timeFrame: At the end of the initial visit measured at the 1-3 day follow-up call
measure: Mean cost of disease for patients (CoPaQ)
timeFrame: At 7 days measured at the 8-14 day follow-up call
measure: Incidence of return visit
timeFrame: At 7 days after the initial visit
measure: Mean cost of care - Health care system perspective
timeFrame: At 72 hours and 7 days after the initial visit
measure: Incidences of admission/intensive care unit/mortality
timeFrame: At 7 and 30 days after the initial visit
measure: Wait times
timeFrame: For the initial visit
measure: Incidence of oral corticosteroid prescription
timeFrame: For the initial visit
measure: Incidence of antibiotic or antiviral medication prescription
timeFrame: For the initial visit
measure: Incidence of narcotic prescription
timeFrame: For the initial visit
measure: Incidence of chest X-ray use
timeFrame: For the initial visit
measure: Incidence of spine X-ray, CT scan or MRI use
timeFrame: For the initial visit
measure: Compliance to guidelines on use of antibiotics
timeFrame: For the initial visit
measure: Incidence of diagnostic spirometry prescription
timeFrame: For the initial visit
measure: Mean greenhouse gas (GHG) emissions from patient transportation to consultation site
timeFrame: For the initial visit
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Kingston
country: Canada
facility: Queen's Family Health Team
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Joliette
country: Canada
facility: CISSS de Lanaudière
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS-Nord de Montréal
state: Quebec
city: Québec
country: Canada
facility: CIUSSS de la Capitale-Nationale
city: Québec
country: Canada
facility: Centre de recherche CHU de Québec - Université Laval
Study officials:
affiliation: CHU de Québec-Université Laval
name: Simon Berthelot, MD MSc FRCPC CCMF(MU)
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Mylaine Breton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Jason R. Guertin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.