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

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ClinicalTrials.gov Identifier: NCT03474887

Recruitment Status : Completed

First Posted : March 23, 2018

Last Update Posted : January 25, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Doctrin

Capio Group

Capio Go

Lund University

Information provided by (Responsible Party):

Region Skane

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
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

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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 :	March 30, 2018
Actual Primary Completion Date :	December 6, 2019
Actual Study Completion Date :	December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sore Throat

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	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 Name: 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 Name: 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 Name: Office Visit

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.
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.
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.
Type of Antibiotic Prescribed [ Time Frame: 24 hours ]
ATC-codes of antibiotics prescribed in conjunction with the initial consultation.
Registered Diagnosis [ Time Frame: 24 hours ]
Diagnosis registered in with medical journal in conjunction with with initial consultation.
Patient Satisfaction [ Time Frame: 24 hours ]
Average scores documented on a 3 question survey, if documented.
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.
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.
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.
Ordering of labs for sore throat [ Time Frame: 24 hours ]
Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome
Ordering of labs for dysuria [ Time Frame: 24 hours ]
Defined as urinalysis, including outcomes of leukocytes and nitrate

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The investigators seek to emulate a primary care cohort in order to make the evaluation of physical and online consultations comparable.

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474887

Locations

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Sweden
Capio Go
Malmö, Sweden

Sponsors and Collaborators

Region Skane

Doctrin

Capio Group

Capio Go

Lund University

Investigators

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Study Chair:	Jan Sundkvist, Professor	CPF, Department of Clinical Sciences, Malmö

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Entezarjou A, Sjobeck M, Midlov P, Nymberg VM, Vigren L, Labaf A, Jakobsson U, Calling S. Health care utilization following "digi-physical" assessment compared to physical assessment for infectious symptoms in primary care. BMC Prim Care. 2022 Jan 12;23:4. doi: 10.1186/s12875-021-01618-2. eCollection 2022.

Entezarjou A, Calling S, Bhattacharyya T, Milos Nymberg V, Vigren L, Labaf A, Jakobsson U, Midlov P. Antibiotic Prescription Rates After eVisits Versus Office Visits in Primary Care: Observational Study. JMIR Med Inform. 2021 Mar 15;9(3):e25473. doi: 10.2196/25473. Erratum In: JMIR Med Inform. 2021 Nov 26;9(11):e34529.

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Responsible Party:	Region Skane
ClinicalTrials.gov Identifier:	NCT03474887
Other Study ID Numbers:	2017/948
First Posted:	March 23, 2018 Key Record Dates
Last Update Posted:	January 25, 2022
Last Verified:	January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Region Skane:


Telemedicine Remote consultation Mobile health Telehealth	mhealth eVisits eConsultation ehealth

Additional relevant MeSH terms:

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Pharyngitis Common Cold Dysuria Respiratory Tract Infections Infections Pharyngeal Diseases Stomatognathic Diseases	Respiratory Tract Diseases Otorhinolaryngologic Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases Lower Urinary Tract Symptoms Urological Manifestations

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