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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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.

Locations
Other Locations
Canada
CISSS de Lanaudière
NOT_YET_RECRUITING
Joliette
Kingston Health Sciences Centre
NOT_YET_RECRUITING
Kingston
Queen's Family Health Team
NOT_YET_RECRUITING
Kingston
CIUSSS-Nord de Montréal
NOT_YET_RECRUITING
Montreal
Ottawa Hospital
NOT_YET_RECRUITING
Ottawa
Centre de recherche CHU de Québec - Université Laval
RECRUITING
Québec
CIUSSS de la Capitale-Nationale
NOT_YET_RECRUITING
Québec
Contact Information
Primary
Simon Berthelot, MD MSc FRCPC
simon.berthelot@crchudequebec.ulaval.ca
418 525-4444
Backup
Ariane Bluteau, MSc
ariane.bluteau@crchudequebec.ulaval.ca
418 525-4444
Time Frame
Start Date: 2023-06-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 4000
Treatments
Emergency department
ED care for acute ambulatory conditions by physicians unfamiliar with the patients.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Simon Berthelot

This content was sourced from clinicaltrials.gov