NCT03474887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,057

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

March 16, 2018

Last Update Submit

January 8, 2022

Conditions

Keywords

TelemedicineRemote consultationMobile healthTelehealthmhealtheVisitseConsultationehealth

Outcome Measures

Primary Outcomes (1)

  • Antibiotics Prescription After Sore Throat

    Proportion of patients prescribed an antibiotics (as documented in medical records) in conjunction with their initial visit with chief complaint sore throat.

    24 hours

Secondary Outcomes (11)

  • Antibiotics Prescription After Cough/Common Cold/Influenza

    24 hours

  • Antibiotics Prescription After Dysuria

    24 hours

  • Patient Revisits

    14 days

  • Type of Antibiotic Prescribed

    24 hours

  • Registered Diagnosis

    24 hours

  • +6 more secondary outcomes

Study Arms (6)

DIGI-Throat

Patients choosing to seek primary care through an online consultation with chief complaint sore throat.

Other: Online Consultation

DIGI-Resp

Patients choosing to seek primary care through an online consultation with chief complaint cough/common cold/influenza.

Other: Online Consultation

DIGI-Dysuria

Patients choosing to seek primary care through an online consultation with chief complaint dysuria.

Other: Online Consultation

PHYSI-Throat+CONTROL-Throat

Patients choosing to seek primary care through physical consultation with chief complaint sore throat. \+ Patients seeking primary care prior to implementation of online consultations, with a chief complaint of sore throat.

Other: Physical Consultation

PHYSI-Resp+CONTROL-Resp

Patients choosing to seek primary care through physical consultation with chief complaint cough/common cold/influenza. \+ Patients seeking primary care prior to implementation of online consultations, with a chief complaint of cough/common cold/influenza.

Other: Physical Consultation

PHYSI-Dysuria+CONTROL-Dysuria

Patients choosing to seek primary care through physical consultation with chief complaint dysuria \+ Patients seeking primary care prior to implementation of online consultations, with a chief complaint of dysuria.

Other: Physical Consultation

Interventions

Regular physician consultation at the primary care clinic.

Also known as: Office Visit
PHYSI-Dysuria+CONTROL-DysuriaPHYSI-Resp+CONTROL-RespPHYSI-Throat+CONTROL-Throat

An online platform for communicating with a physician digitally. Patients answer a series of algorithm-based questions after specifying chief complaint, after which contact is established with a physician who can communicate through short messages. The physician can then order labs, prescribe relevant medication or book the patient for a physical consultation if need be.

Also known as: eVisit, Capio Go, Lakarbesok online
DIGI-DysuriaDIGI-RespDIGI-Throat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capio Go

Malmo, Sweden

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

PharyngitisDysuriaCoughCommon ColdInfluenza, Human

Interventions

Office Visits

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratoryPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesOrthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Jan Sundkvist, Professor

    CPF, Department of Clinical Sciences, Malmö

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 23, 2018

Study Start

March 30, 2018

Primary Completion

December 6, 2019

Study Completion

December 20, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations