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Completed

NCT Number: NCT03474887

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

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.

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Key information

Conditions

Sore Throat Common Cold Cough Dysuria Infections Influenza Influenza, Human Lower Urinary Tract Symptoms Orthomyxoviridae Infections Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Picornaviridae Infections RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Stomatognathic Diseases Urological Manifestations Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Capio Go

Malmö, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Consultation

Other

Regular physician consultation at the primary care clinic.

Other names: Office Visit

Online Consultation

Other

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

Primary outcomes

  1. Antibiotics Prescription After Sore Throat

    Time frame: 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 outcomes

  1. Antibiotics Prescription After Cough/Common Cold/Influenza

    Time frame: 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.

  2. Antibiotics Prescription After Dysuria

    Time frame: 24 hours

    Proportion of patients prescribed an antibiotics (as documented in medical records) in conjunction with their initial visit with chief complaint dysuria.

  3. Patient Revisits

    Time frame: 14 days

    Number of healthcare-system visits following initial consultation (as documented in local registries). Includes outpatient as well as inpatient visits.

  4. Type of Antibiotic Prescribed

    Time frame: 24 hours

    ATC-codes of antibiotics prescribed in conjunction with the initial consultation.

  5. Registered Diagnosis

    Time frame: 24 hours

    Diagnosis registered in with medical journal in conjunction with with initial consultation.

  6. Patient Satisfaction

    Time frame: 24 hours

    Average scores documented on a 3 question survey, if documented.

  7. Time to Physician Contact

    Time frame: 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.

  8. Centor Criteria Documentation

    Time frame: 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.

  9. UTI Criteria Documentation

    Time frame: 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.

  10. Ordering of labs for sore throat

    Time frame: 24 hours

    Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome

  11. Ordering of labs for dysuria

    Time frame: 24 hours

    Defined as urinalysis, including outcomes of leukocytes and nitrate

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Capio Go
  • Capio Group
  • Doctrin
  • Lund University

Registry information

Acronym: DOCACUP

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Mar 23, 2018
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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