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Digital Versus Telephone Symptom Assessment and Triage in Primary Care

Primary Purpose

Infections, Injuries, Psychiatric Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Digital triage
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infections focused on measuring triage, primary care, digital, remote, health care consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Digital triage

    Telephone triage

    Arm Description

    Patients are triaged with symptom assessment by a nurse using a digital platform. They are receiving either advice for self-care, referred to other care-level or booked to a digital or physical visit on the primary health care center.

    Patients are triaged with symptom assessment by a nurse using tradition telephone. They are receiving either advice for self-care, referred to other care-level or booked to a digital or physical visit on the primary health care center.

    Outcomes

    Primary Outcome Measures

    Recruitment rate as percentage of patients included in the study measured using data from the primary health care center
    Percentage of patients that accept to be included in the study of all patients that contact the primary care center during the studied period of time
    Drop-out rate as percentage of patients that drop-out from the trial
    Percentage of patients that drop-out from the trial
    Eligibility criteria in percentage of patients being eligible to be included in the study
    Age 18 years or older and listed on the primary care center

    Secondary Outcome Measures

    Adherence to recommended health care level as percentage of patients that adhere to recommended care level
    Within 2 months after the triage contact, data collected from the regional data base
    Interrater reliability
    agreement between the care-level suggested by the online symptom checker and the care-level suggested by the nurse, data collected from the electronic medical journals

    Full Information

    First Posted
    August 10, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Region Skane
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06092866
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 24, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Region Skane

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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. 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. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infections, Injuries, Psychiatric Disorder, Gastro-Intestinal Disorder, Skin Diseases
    Keywords
    triage, primary care, digital, remote, health care consumption

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomization 1:1
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Digital triage
    Arm Type
    Experimental
    Arm Description
    Patients are triaged with symptom assessment by a nurse using a digital platform. They are receiving either advice for self-care, referred to other care-level or booked to a digital or physical visit on the primary health care center.
    Arm Title
    Telephone triage
    Arm Type
    Active Comparator
    Arm Description
    Patients are triaged with symptom assessment by a nurse using tradition telephone. They are receiving either advice for self-care, referred to other care-level or booked to a digital or physical visit on the primary health care center.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Digital triage
    Other Intervention Name(s)
    Symptom assessment
    Intervention Description
    A registered nurse assesses the symptoms reported by the patient on the online platform and gives appropriate advice for further care using chat.
    Primary Outcome Measure Information:
    Title
    Recruitment rate as percentage of patients included in the study measured using data from the primary health care center
    Description
    Percentage of patients that accept to be included in the study of all patients that contact the primary care center during the studied period of time
    Time Frame
    6 months
    Title
    Drop-out rate as percentage of patients that drop-out from the trial
    Description
    Percentage of patients that drop-out from the trial
    Time Frame
    6 months
    Title
    Eligibility criteria in percentage of patients being eligible to be included in the study
    Description
    Age 18 years or older and listed on the primary care center
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Adherence to recommended health care level as percentage of patients that adhere to recommended care level
    Description
    Within 2 months after the triage contact, data collected from the regional data base
    Time Frame
    2 months
    Title
    Interrater reliability
    Description
    agreement between the care-level suggested by the online symptom checker and the care-level suggested by the nurse, data collected from the electronic medical journals
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Veronica V Milos Nymberg, PhD
    Phone
    0046767700240
    Email
    veronica.milos_nymberg@med.lu.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Veronica V Milos Nymberg, PhD
    Organizational Affiliation
    Lund University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data will be shared with researchers at Lund university or other universities upon reasonable request.

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