Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-26 @ 11:58 PM
Study NCT ID:
NCT06092866
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Versus Telephone Symptom Assessment and Triage in Primary Care
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Digital Versus Telephone Symptom Assessment and Triage in Primary Care
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 'digital-first' approach is currently under implementation in several Swedish regions.
The principles behind implementing an online service as an access way to primary care are based on an expectation that it can make access easier, direct people to appropriate levels of care, and increase both availability of heath care and cost efficiency. However, a recent Swedish report concluded that digital triage in primary care has not been investigated in a clinical real-world setting, including real patients, meaning that the benefits and risks for patients as well as on a system level remain unclear.
The aim of this trial is to study the feasibility of a larger trial that will compare digital triage and traditional telephone triage on adherence to triaged health care level, in a randomized controlled study (feasibility study, RCT). The study will recruit a total of 120 patients, of which half will be randomized to telephone triage and half to digital triage.
The principles behind implementing an online service as an access way to primary care are based on an expectation that it can make access easier, direct people to appropriate levels of care, and increase both availability of heath care and cost efficiency. However, a recent Swedish report concluded that digital triage in primary care has not been investigated in a clinical real-world setting, including real patients, meaning that the benefits and risks for patients as well as on a system level remain unclear.
The aim of this trial is to study the feasibility of a larger trial that will compare digital triage and traditional telephone triage on adherence to triaged health care level, in a randomized controlled study (feasibility study, RCT). The study will recruit a total of 120 patients, of which half will be randomized to telephone triage and half to digital triage.
Detailed Description:
Ten regions in Sweden are currently collaborating in the implementation of a new digital platform for digital symptom assessment and triage.
The patient's path is as following:
1. Triage to self-care. The patient will start his/her health care contact at the website www.1177.se with mobile bank identification. An algorithm-based computerized symptom checker performs the initial assessment, based on patient's self-reported complains. This initial triage can result in an auto-triage with self-care advice for non-complicated health issues.
2. Triage to digital assessment by chat with a nurse. Patients with more complex needs will be directed to the primary health care center (PHCC) where the patient is listed. There is also a central back-up unit that manages patients during out of office hours. The triage nurse can supplement the patient history with additional questions and finally determine the level of care.
3. Patients in need of further assessment are booked to a physical visit to a doctor or other health care staff, or referral to an emergency room.
Study design
Design: Feasibility study, randomized controlled study Patients: Patients referred by the online symptom checker to digital triage with a nurse and patients receiving traditional telephone triage. This study is planned to be carried out at one or more health centers where both traditional telephone triage and digital triage are used. The study will be conducted initially as a feasibility study with 30 participants in each arm and the inclusion period will continue until this number is met. A larger RCT is planned in the future, based on the feasibility study. The consent to participate will be filled in electronically by the participants in the digital triage group, and by the nurse in the telephone group (and documented in the electronic medical record).
The patient's path is as following:
1. Triage to self-care. The patient will start his/her health care contact at the website www.1177.se with mobile bank identification. An algorithm-based computerized symptom checker performs the initial assessment, based on patient's self-reported complains. This initial triage can result in an auto-triage with self-care advice for non-complicated health issues.
2. Triage to digital assessment by chat with a nurse. Patients with more complex needs will be directed to the primary health care center (PHCC) where the patient is listed. There is also a central back-up unit that manages patients during out of office hours. The triage nurse can supplement the patient history with additional questions and finally determine the level of care.
3. Patients in need of further assessment are booked to a physical visit to a doctor or other health care staff, or referral to an emergency room.
Study design
Design: Feasibility study, randomized controlled study Patients: Patients referred by the online symptom checker to digital triage with a nurse and patients receiving traditional telephone triage. This study is planned to be carried out at one or more health centers where both traditional telephone triage and digital triage are used. The study will be conducted initially as a feasibility study with 30 participants in each arm and the inclusion period will continue until this number is met. A larger RCT is planned in the future, based on the feasibility study. The consent to participate will be filled in electronically by the participants in the digital triage group, and by the nurse in the telephone group (and documented in the electronic medical record).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: