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

Overview

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.

Interventions

• 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 wil
• 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 (Usch
• 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.

Primary outcome measures

• Median PROM-ED scores [Time frame: At 7 days after the initial visit measured at the 8-14 day follow-up call]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Canada · 7 centers

• Kingston Health Sciences Centre — Kingston
• Queen's Family Health Team — Kingston
• Ottawa Hospital — Ottawa
• CISSS de Lanaudière — Joliette
• CIUSSS-Nord de Montréal — Montreal
• CIUSSS de la Capitale-Nationale — Québec
• Centre de recherche CHU de Québec - Université Laval — Québec

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-Ba PMID 33616548

Identifiers

NCT: NCT05892666 · Value trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗