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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Simon Berthelot · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ambulatory Care
• Emergency Services, Hospital
• Quality of Care
• Costs

Interventions

Type	Name	Description
OTHER	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).
OTHER	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.
OTHER	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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-06-07
• Last updated: 2024-08-12

Locations

7 sites across 1 country: Canada