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

Influenza Clinical Trial

— DOCACUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474887
• Other study ID #: 2017/948
• Status: Completed
• Start date: March 30, 2018
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4057
• Est. completion date: December 20, 2021
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold
• Cough
• Dysuria
• Influenza
• Pharyngitis
• Sore Throat

Intervention

Other:
• Physical Consultation
Regular physician consultation at the primary care clinic.
• 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.

Locations

Country	Name	City	State
Sweden	Capio Go	Malmö

Sponsors (5)

Lead Sponsor	Collaborator
Region Skane	Capio Go, Capio Group, Doctrin, Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient Revisits	Number of healthcare-system visits following initial consultation (as documented in local registries). Includes outpatient as well as inpatient visits.	14 days
Secondary	Type of Antibiotic Prescribed	ATC-codes of antibiotics prescribed in conjunction with the initial consultation.	24 hours
Secondary	Registered Diagnosis	Diagnosis registered in with medical journal in conjunction with with initial consultation.	24 hours
Secondary	Patient Satisfaction	Average scores documented on a 3 question survey, if documented.	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Ordering of labs for sore throat	Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome	24 hours
Secondary	Ordering of labs for dysuria	Defined as urinalysis, including outcomes of leukocytes and nitrate	24 hours