Clinical trial NCT06092866: Digital Versus Telephone Symptom Assessment and Triage in Primary Care
Official title: Digital Versus Telephone Symptom Assessment and Triage in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infections
Injuries
Psychiatric Disorder
Gastro-Intestinal Disorder
Skin Diseases
Keywords: triage
primary care
digital
remote
health care consumption
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older who is listed at the health center

Exclusion Criteria:

* Patients \<18 years or parents seeking advice for their children

  * Cannot communicate in Swedish or other communication difficulties in language or writing
  * Patients without a mobile Bank identification (to log in to the platform)
  * Administrative issues, e.g. rebooking of time

Primary outcomes:
measure: Recruitment rate as percentage of patients included in the study measured using data from the primary health care center
timeFrame: 6 months
measure: Drop-out rate as percentage of patients that drop-out from the trial
timeFrame: 6 months
measure: Eligibility criteria in percentage of patients being eligible to be included in the study
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to recommended health care level as percentage of patients that adhere to recommended care level
timeFrame: 2 months
measure: Interrater reliability
timeFrame: 2 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Veronica Milos Nymberg
state: Region Skane
Study officials:
affiliation: Lund University
name: Veronica V Milos Nymberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: