Clinical trial NCT03474887: Digital Online Consultations - Effects on Antibiotic Prescribing and Health Care Utilization in Primary Care
Official title: Digital Online Consultations - Effects on Antibiotic Prescribing and Health Care Utilization in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sore Throat
Dysuria
Cough
Common Cold
Influenza
Keywords: Telemedicine
Remote consultation
Mobile health
Telehealth
mhealth
eVisits
eConsultation
ehealth
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Doctrin
name: Capio Group
name: Capio Go
name: Lund University
First posted: 2018-03-23
Enrollment: 4057
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators seek to emulate a primary care cohort in order to make the evaluation of physical and online consultations comparable.

Brief summary: BACKGROUND/SIGNIFICANCE: With developments in mobile health and the abundance of smartphones, online consultations have emerged as a popular form of primary care in Sweden. Controversy exists regarding diagnostic accuracy, appropriate prescription of antibiotics, and effects on care-seeking patient behavior following implementation of online consultations. As empirical research is lacking, the investigators seek to evaluate online primary care consultations compared to physical consultations with regards to non-inferiority of antibiotic prescription for chief complaint of sore throat.

METHODS: Medical record data is used to identify patients with a chief complaint of sore throat, cough/common cold/influenza, or dysuria after choosing online (DIGI) or physical (PHYSI) consultations. A cohort of patients with similar chief complaints prior to implementation of online consultations was used as a control group (CONTROL). Prospective data from local registries and medical records was gathered 14 days the consultation. The primary outcome was rate of antibiotic prescription after sore throat. Secondary outcomes included patient revisits (including hospital admissions), patient satisfaction, time to physician contact, registered diagnosis, and documentation or Centor Criteria and Urinary Tract Infection (UTI)-Criteria.

SIGNIFICANCE: Results will shed light on whether antibiotic prescription differs significantly between digital and physical primary care consultations. Hypotheses may also be generated as to how patients seek care in light of improved availability in a tax-sponsored healthcare system.

Detailed description: Due to limited recruitment of PHYSI and CONTROL patients, these cohorts will be combined into a single physical cohort to provide adequate power for analysis as per predefined required sample size.

Eligibility criteria: Inclusion Criteria:

* Patient seeking care at primary healthcare provider (Capio in Skåne or Capio Go)
* Patient who according to medical record presents with sore throat, cough/common cold/influenza, or dysuria

Exclusion Criteria:

* Patient who according to medical record presents with main symptom other than sore throat, cough/common cold/influenza, or dysuria.
* Patient under the age of 18.

Primary outcomes:
measure: Antibiotics Prescription After Sore Throat
timeFrame: 24 hours
Secondary outcomes:
measure: Antibiotics Prescription After Cough/Common Cold/Influenza
timeFrame: 24 hours
measure: Antibiotics Prescription After Dysuria
timeFrame: 24 hours
measure: Patient Revisits
timeFrame: 14 days
measure: Type of Antibiotic Prescribed
timeFrame: 24 hours
measure: Registered Diagnosis
timeFrame: 24 hours
measure: Patient Satisfaction
timeFrame: 24 hours
measure: Time to Physician Contact
timeFrame: 14 days
measure: Centor Criteria Documentation
timeFrame: 24 hours
measure: UTI Criteria Documentation
timeFrame: 24 hours
measure: Ordering of labs for sore throat
timeFrame: 24 hours
measure: Ordering of labs for dysuria
timeFrame: 24 hours
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Capio Go
Study officials:
affiliation: CPF, Department of Clinical Sciences, Malmö
name: Jan Sundkvist, Professor
role: STUDY_CHAIR
References:
citation: Entezarjou A, Sjobeck M, Midlov P, Nymberg VM, Vigren L, Labaf A, Jakobsson U, Calling S. Health care utilization following "digi-physical" assessment compared to physical assessment for infectious symptoms in primary care. BMC Prim Care. 2022 Jan 12;23:4. doi: 10.1186/s12875-021-01618-2. eCollection 2022.
citation: Entezarjou A, Calling S, Bhattacharyya T, Milos Nymberg V, Vigren L, Labaf A, Jakobsson U, Midlov P. Antibiotic Prescription Rates After eVisits Versus Office Visits in Primary Care: Observational Study. JMIR Med Inform. 2021 Mar 15;9(3):e25473. doi: 10.2196/25473.