Sore ThroatDOCACUPNCT03474887
Digital Online Consultations - Effects on Antibiotic Prescribing and Health Care Utilization in Primary Care
An observational study of Sore Throat and Dysuria, run by Region Skane at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat, Dysuria, Cough
- What is being tested?
- Physical Consultation and Online Consultation
- How many people
- 4,057 participants
- Where
- 1 siteSweden
- Study dates
- 30 Mar 2018to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators seek to emulate a primary care cohort in order to make the evaluation of physical and online consultations comparable.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sore Throat, Dysuria, Cough, Common Cold, Influenza
- Being tested
- Physical Consultation, Online Consultation
- Keywords
- Telemedicine, Remote consultation, Mobile health, Telehealth, mhealth, eVisits, eConsultation, ehealth
- Medical subject headings
- Pharyngitis, Dysuria, Cough, Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ConsultationOther
Also called Office Visit
Regular physician consultation at the primary care clinic.
Online ConsultationOther
Also called eVisit, Capio Go, Lakarbesok online
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.
| Study group | Role | What they receive |
|---|---|---|
| DIGI-Throat | Patients choosing to seek primary care through an online consultation with chief complaint sore throat. Receives: Other: Online Consultation | |
| DIGI-Resp | Patients choosing to seek primary care through an online consultation with chief complaint cough/common cold/influenza. Receives: Other: Online Consultation | |
| DIGI-Dysuria | Patients choosing to seek primary care through an online consultation with chief complaint dysuria. Receives: Other: Online Consultation | |
| 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. Receives: Other: Physical Consultation | |
| 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. Receives: Other: Physical Consultation | |
| 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. Receives: Other: Physical Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (11)
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.
Measured: 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.
Measured: 24 hours
Patient Revisits
Number of healthcare-system visits following initial consultation (as documented in local registries). Includes outpatient as well as inpatient visits.
Measured: 14 days
Type of Antibiotic Prescribed
ATC-codes of antibiotics prescribed in conjunction with the initial consultation.
Measured: 24 hours
Registered Diagnosis
Diagnosis registered in with medical journal in conjunction with with initial consultation.
Measured: 24 hours
Patient Satisfaction
Average scores documented on a 3 question survey, if documented.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Ordering of labs for sore throat
Defined as "StrepA" quick-test for group A Streptococcus (GAS)-tonsillitis, including outcome
Measured: 24 hours
Ordering of labs for dysuria
Defined as urinalysis, including outcomes of leukocytes and nitrate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start30 Mar 2018
- Primary completion6 Dec 2019
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,057 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Doctrin, Capio Group, Capio Go, Lund University
- Responsible party
- Sponsor
- Investigators
- Jan Sundkvist, Professor, Study chair, CPF, Department of Clinical Sciences, Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474887
- Sponsor's protocol ID
- 2017/948
- Acronym
- DOCACUP
- Status last verified
- Jan 2022
- First submitted
- 16 Mar 2018
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35036998Entezarjou 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.
PubMed 33720032
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Online Consultations - Effects on Antibiotic Prescribing and Health Care Utilization in Primary Care
- ClinicalTrials.gov ID
- NCT03474887
- Acronym / sponsor ID
- DOCACUP / 2017/948
- Conditions
- Sore Throat, Dysuria, Cough, Common Cold, Influenza
- Keywords
- Telemedicine, Remote consultation, Mobile health, Telehealth, mhealth, eVisits, eConsultation, ehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,057 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Doctrin, Capio Group, Capio Go, Lund University
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DIGI-Throat | – | Other: Online ConsultationPatients choosing to seek primary care through an online consultation with chief complaint sore throat. |
| DIGI-Resp | – | Other: Online ConsultationPatients choosing to seek primary care through an online consultation with chief complaint cough/common cold/influenza. |
| DIGI-Dysuria | – | Other: Online ConsultationPatients choosing to seek primary care through an online consultation with chief complaint dysuria. |
| PHYSI-Throat+CONTROL-Throat | – | Other: Physical ConsultationPatients 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. |
| PHYSI-Resp+CONTROL-Resp | – | Other: Physical ConsultationPatients 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. |
| PHYSI-Dysuria+CONTROL-Dysuria | – | Other: Physical ConsultationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators seek to emulate a primary care cohort in order to make the evaluation of physical and online consultations comparable.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ConsultationAlso: Office VisitRegular physician consultation at the primary care clinic. | Other | PHYSI-Dysuria+CONTROL-Dysuria, PHYSI-Resp+CONTROL-Resp, PHYSI-Throat+CONTROL-Throat |
| Online ConsultationAlso: eVisit, Capio Go, Lakarbesok onlineAn 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 | DIGI-Dysuria, DIGI-Resp, DIGI-Throat |
Primary outcome
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.
11 secondary outcomes
Antibiotics Prescription After Cough/Common Cold/Influenza
Time frame: 24 hours
Antibiotics Prescription After Dysuria
Time frame: 24 hours
Patient Revisits
Time frame: 14 days
Type of Antibiotic Prescribed
Time frame: 24 hours
Registered Diagnosis
Time frame: 24 hours
Patient Satisfaction
Time frame: 24 hours
Time to Physician Contact
Time frame: 14 days
Centor Criteria Documentation
Time frame: 24 hours
UTI Criteria Documentation
Time frame: 24 hours
Ordering of labs for sore throat
Time frame: 24 hours
Ordering of labs for dysuria
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 35036998Entezarjou 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.
- Derived from this study: PubMed 33720032Entezarjou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Sundkvist, Professor study chair
CPF, Department of Clinical Sciences, Malmö
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sore Throat and Dysuria, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotics Prescription After Sore Throat (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03474887, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.