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

NCT05892666 | Recruiting

• 1 other identifier: Value trial
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At the end of the initial visit measured at the 1-3 day follow-up call

• Mean cost of disease for patients (CoPaQ)

  At 7 days measured at the 8-14 day follow-up call

• Incidence of return visit

  At 7 days after the initial visit

• Mean cost of care - Health care system perspective

  At 72 hours and 7 days after the initial visit

• Incidences of admission/intensive care unit/mortality

  At 7 and 30 days after the initial visit

Study Arms (3)

Emergency department

ED care for acute ambulatory conditions by physicians unfamiliar with the patients.

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.

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.

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

Interventions

On-site recruitment (information and consent) following a random sampling recruitment schedule OTHER

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).

Emergency department; Primary care practice; Walk-in clinics

First phone call 1-3 days after the initial visit OTHER

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.

Emergency department; Primary care practice; Walk-in clinics

Second phone call 8-14 days after the initial visit OTHER

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.

Emergency department; Primary care practice; Walk-in clinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Simon Berthelot: lead

Study Sites (7)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

NOT YET RECRUITING

Queen's Family Health Team

Kingston, Ontario, K7L 5E9, Canada

NOT YET RECRUITING

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

CISSS de Lanaudière

Joliette, Quebec, J6E 5X7, Canada

NOT YET RECRUITING

CIUSSS-Nord de Montréal

Montreal, Quebec, H4J 1C5, Canada

NOT YET RECRUITING

CIUSSS de la Capitale-Nationale

Québec, G1J 0A4, Canada

NOT YET RECRUITING

Centre de recherche CHU de Québec - Université Laval

Québec, G1V 4G2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33616548 BACKGROUND

MeSH Terms

Conditions

Emergencies

Interventions

Consent Forms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Informed Consent; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Records; Organization and Administration; Health Services Administration; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Simon Berthelot, MD MSc FRCPC CCMF(MU)

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

• Mylaine Breton, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Jason R. Guertin, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Berthelot, MD MSc FRCPC

CONTACT

418 525-4444; simon.berthelot@crchudequebec.ulaval.ca

Ariane Bluteau, MSc

CONTACT

418 525-4444; ariane.bluteau@crchudequebec.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Emergency Physician, CHU de Québec-Université Laval; Associate Professor, Faculté of medicine, Université Laval

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: June 7, 2023
• Study Start: June 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)