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

Completed

• Conditions: Cough; Dysuria; Influenza; Sore Throat; Common Cold
• Interventions: Other: Online Consultation; Other: Physical Consultation

• Registration Number: NCT03474887
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Study Start: 2018-03-30
• Primary Completion: 2019-12-06
• Study Completion: 2021-12-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-08
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4057

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DIGI-Resp	Online Consultation	Patients choosing to seek primary care through an online consultation with chief complaint cough/common cold/influenza.
DIGI-Dysuria	Online Consultation	Patients choosing to seek primary care through an online consultation with chief complaint dysuria.
PHYSI-Resp+CONTROL-Resp	Physical Consultation	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.
PHYSI-Dysuria+CONTROL-Dysuria	Physical Consultation	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.
DIGI-Throat	Online Consultation	Patients choosing to seek primary care through an online consultation with chief complaint sore throat.
PHYSI-Throat+CONTROL-Throat	Physical Consultation	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.

Primary Outcome Measures

Name	Time	Method
Antibiotics Prescription After Sore Throat	24 hours	Proportion of patients prescribed an antibiotics (as documented in medical records) in conjunction with their initial visit with chief complaint sore throat.

Secondary Outcome Measures

Name	Time	Method
Antibiotics Prescription After Cough/Common Cold/Influenza	24 hours	Proportion of patients prescribed an antibiotics (as documented in medical records) in conjunction with their initial visit with chief complaint cough/common cold/influenza.
UTI Criteria Documentation	24 hours	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.
Antibiotics Prescription After Dysuria	24 hours	Proportion of patients prescribed an antibiotics (as documented in medical records) in conjunction with their initial visit with chief complaint dysuria.
Patient Revisits	14 days	Number of healthcare-system visits following initial consultation (as documented in local registries). Includes outpatient as well as inpatient visits.
Ordering of labs for sore throat	24 hours	Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome
Type of Antibiotic Prescribed	24 hours	ATC-codes of antibiotics prescribed in conjunction with the initial consultation.
Registered Diagnosis	24 hours	Diagnosis registered in with medical journal in conjunction with with initial consultation.
Patient Satisfaction	24 hours	Average scores documented on a 3 question survey, if documented.
Centor Criteria Documentation	24 hours	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.
Time to Physician Contact	14 days	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.
Ordering of labs for dysuria	24 hours	Defined as urinalysis, including outcomes of leukocytes and nitrate

Trial Locations

Locations (1)

Capio Go; 🇸🇪 Malmö, Sweden