An observational study in Sore Throat, Dysuria and Cough, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Region Skane · Observational
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.
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.
The investigators seek to emulate a primary care cohort in order to make the evaluation of physical and online consultations comparable.
Exclusion Criteria:
Patients choosing to seek primary care through an online consultation with chief complaint sore throat.
Other: Online Consultation
Patients choosing to seek primary care through an online consultation with chief complaint cough/common cold/influenza.
Other: Online Consultation
Patients choosing to seek primary care through an online consultation with chief complaint dysuria.
Other: Online 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.
Other: 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.
Other: 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.
Other: Physical Consultation
Regular physician consultation at the primary care clinic.
Also known as: Office Visit
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
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.
Time frame: 24 hours
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.
Time frame: 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.
Time frame: 24 hours
Patient Revisits
Number of healthcare-system visits following initial consultation (as documented in local registries). Includes outpatient as well as inpatient visits.
Time frame: 14 days
Type of Antibiotic Prescribed
ATC-codes of antibiotics prescribed in conjunction with the initial consultation.
Time frame: 24 hours
Registered Diagnosis
Diagnosis registered in with medical journal in conjunction with with initial consultation.
Time frame: 24 hours
Patient Satisfaction
Average scores documented on a 3 question survey, if documented.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
Ordering of labs for sore throat
Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome
Time frame: 24 hours
Ordering of labs for dysuria
Defined as urinalysis, including outcomes of leukocytes and nitrate
Time frame: 24 hours
Plan to share: Undecided
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Region Skane