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

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT03474887

Collaborator

Doctrin (Other), Capio Group (Other), Capio Go (Other), Lund University (Other)

4,057

Enrollment

Location

44.7

Actual Duration (Months)

90.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sore Throat Dysuria Cough Common Cold Influenza	Other: Physical Consultation Other: Online 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 Design

Study Type:

Observational

Actual Enrollment :

4057 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 30, 2018

Actual Primary Completion Date :

Dec 6, 2019

Actual Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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.
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.
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.
Ordering of labs for sore throat [24 hours]
Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome
Ordering of labs for dysuria [24 hours]
Defined as urinalysis, including outcomes of leukocytes and nitrate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.