Digital Online Consultations - Effects on Antibiotic Prescribing and Health Care Utilization in Primary Care (DOCACUP)

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.

Study Overview

• Status: Completed
• Conditions: Cough; Influenza; Common Cold; Sore Throat; Dysuria
• Intervention / Treatment: Other: Online Consultation; Other: Physical Consultation

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.

• Study Type: Observational
• Enrollment (Actual): 4057

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Capio Go

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DIGI-Throat; Patients choosing to seek primary care through an online consultation with chief complaint sore throat.	Other: Online Consultation; 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.; Other Names: eVisit; Capio Go; Lakarbesok online
DIGI-Resp; Patients choosing to seek primary care through an online consultation with chief complaint cough/common cold/influenza.	Other: Online Consultation; 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.; Other Names: eVisit; Capio Go; Lakarbesok online
DIGI-Dysuria; Patients choosing to seek primary care through an online consultation with chief complaint dysuria.	Other: Online Consultation; 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.; Other Names: eVisit; Capio Go; Lakarbesok online
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; Regular physician consultation at the primary care clinic.; Other Names: Office Visit
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; Regular physician consultation at the primary care clinic.; Other Names: Office Visit
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; Regular physician consultation at the primary care clinic.; Other Names: Office Visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotics Prescription After Cough/Common Cold/Influenza	Proportion of patients prescribed an antibiotics (as documented in medical records) in conjunction with their initial visit with chief complaint cough/common cold/influenza.	24 hours
Antibiotics Prescription After Dysuria	Proportion of patients prescribed an antibiotics (as documented in medical records) in conjunction with their initial visit with chief complaint dysuria.	24 hours
Patient Revisits	Number of healthcare-system visits following initial consultation (as documented in local registries). Includes outpatient as well as inpatient visits.	14 days
Type of Antibiotic Prescribed	ATC-codes of antibiotics prescribed in conjunction with the initial consultation.	24 hours
Registered Diagnosis	Diagnosis registered in with medical journal in conjunction with with initial consultation.	24 hours
Patient Satisfaction	Average scores documented on a 3 question survey, if documented.	24 hours
Time to Physician Contact	DIGI: Time from patient log-in on the online platform to first speech-bubble from the physician. PHYSI and CONTROL: Time from registered telephone contact to registered physician contact.	14 days
Centor Criteria Documentation	Proportion of patients where Centor Criteria are fully documented in the medical record in conjunction with the initial consultation. Centor criteria: Tonsillar redness/exudates, Tender anterior cervical adenopathy, fever over 38,5° C, absence of cough.	24 hours
UTI Criteria Documentation	Proportion of patients where urinary tract infection criteria are fully documented in the medical record in conjunction with the initial consultation. UTI Criteria: increased pain, frequency, urgency. Lack of vaginal symptoms, fever or flank pain.	24 hours
Ordering of labs for sore throat	Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome	24 hours
Ordering of labs for dysuria	Defined as urinalysis, including outcomes of leukocytes and nitrate	24 hours

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University; Capio Group; Doctrin; Capio Go
• Investigators: Study Chair: Jan Sundkvist, Professor, CPF, Department of Clinical Sciences, Malmö

Publications and helpful links

General Publications

• 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. Erratum In: JMIR Med Inform. 2021 Nov 26;9(11):e34529.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Telehealth; mhealth; Mobile health; ehealth; Remote consultation; eVisits; eConsultation
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; Common Cold; Pharyngitis; Dysuria
• Other Study ID Numbers: 2017/948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No