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GUT LINK: A Study of a Care Pathway Across Primary and GI Specialty Care

Primary Purpose

Irritable Bowel Syndrome, GI Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GUT LINK SmartPath
Sponsored by
Michael Stewart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Irritable Bowel Syndrome focused on measuring Care pathway, Care delivery, virtual

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Must be a general practitioner Have a family practice in Nova Scotia, Canada Utilize the platform 'virtual hallway' as part of current referral practices Deliver care to patients with lower GI complaints Exclusion Criteria: None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    GUT LINK SmartPath

    control

    Arm Description

    physicians will use the interactive GUT LINK Smartpath tool in virtual hallway platform to guide their care and referral practices

    physicians will provide care and refer as per their usual practices

    Outcomes

    Primary Outcome Measures

    Number of users
    Number of users (an indicator of prototype acceptability)
    Number of users
    Number of users (an indicator of prototype acceptability)
    Number of referrals
    Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
    Number of referrals
    Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
    Number of referrals per week
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Number of referrals per week
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Number of referrals per user
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Number of referrals per user
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Number of clicks per referral
    Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
    Number of clicks per referral
    Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
    Primary Healthcare Provider Satisfaction
    Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.
    Primary Healthcare Provider Satisfaction
    Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.

    Secondary Outcome Measures

    Number referrals received as per prototype
    Number referrals received as per prototype (an implementation metric)
    Number referrals received as per prototype
    Number referrals received as per prototype (an implementation metric)
    Number of referrals received requiring troubleshooting
    Number of referrals received requiring troubleshooting (an implementation metric)
    Number of referrals received requiring troubleshooting
    Number of referrals received requiring troubleshooting (an implementation metric)
    Number of referrals aborted
    Number of referrals aborted (an implementation metric)
    Number of referrals aborted
    Number of referrals aborted (an implementation metric)
    Type of consult
    Type of consult (Full consult, specialist telephone advice, eConsult)
    Type of consult
    Type of consult (Full consult, specialist telephone advice, eConsult)
    Perceived appropriateness of the SmartPath
    Thematic analysis of interviews of primary care providers will yield key themes related to the perceived appropriateness of the intervention
    Perceived appropriateness of the SmartPath
    Thematic analysis of interviews of primary care providers will yield key themes related to the perceived appropriateness of the intervention
    physician self-efficacy rating
    physician self-efficacy rating, measured using the 'New General Self Efficacy Scale' (an effectiveness metric of GUT LINK Smartpath). Min score: 1, max score: 8. A higher score indicates a greater self-efficacy.
    physician self-efficacy rating
    physician self-efficacy rating, measured using the 'New General Self Efficacy Scale' (an effectiveness metric of GUT LINK Smartpath). Min score: 1, max score: 8. A higher score indicates a greater self-efficacy.
    Referral triage priority category
    Referral triage priority category will be collected from referrals through the pathway (an effectiveness metric of GUT LINK Smartpath). Referral triage categories to the GI department are: emergent, semi urgent, and non-urgent.
    Referral triage priority category
    Referral triage priority category will be collected from referrals through the pathway (an effectiveness metric of GUT LINK Smartpath). Referral triage categories to the GI department are: emergent, semi urgent, and non-urgent.
    Time from referral to specialist consultation
    Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)
    Time from referral to specialist consultation
    Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)
    Time from referral to diagnosis and treatment
    Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)
    Time from referral to diagnosis and treatment
    Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)

    Full Information

    First Posted
    January 23, 2023
    Last Updated
    February 10, 2023
    Sponsor
    Michael Stewart
    Collaborators
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05725954
    Brief Title
    GUT LINK: A Study of a Care Pathway Across Primary and GI Specialty Care
    Official Title
    GUT LINK: A Pilot Study to Evaluate the Comparative Effectiveness of an Evidence-based Care Pathway Across Primary and GI Specialty Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Michael Stewart
    Collaborators
    Nova Scotia Health Authority

    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
    It can be challenging for Primary Healthcare Providers (PHCPs) to differentiate between IBS and more serious illnesses involving the GI tract, such as Crohn's disease, ulcerative colitis, or cancer. To help with diagnosis and treatment of IBS, evidence-based guidelines have been developed. However, they are not commonly used in primary care practice and PHCPs and patients often feel that GI specialist evaluation and endoscopy is required. The development of care pathways and clinical practice guidelines is essential to support the investigation and management of digestive diseases, such as IBS. The current pilot study is designed to assess the implementation and early comparative effectiveness of a Clinical Care Pathway for lower GI tract symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome, GI Disorders
    Keywords
    Care pathway, Care delivery, virtual

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    GUT LINK SmartPath
    Arm Type
    Experimental
    Arm Description
    physicians will use the interactive GUT LINK Smartpath tool in virtual hallway platform to guide their care and referral practices
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    physicians will provide care and refer as per their usual practices
    Intervention Type
    Behavioral
    Intervention Name(s)
    GUT LINK SmartPath
    Intervention Description
    A virtual care delivery and referral support tool for primary healthcare providers.
    Primary Outcome Measure Information:
    Title
    Number of users
    Description
    Number of users (an indicator of prototype acceptability)
    Time Frame
    month 3
    Title
    Number of users
    Description
    Number of users (an indicator of prototype acceptability)
    Time Frame
    month 6
    Title
    Number of referrals
    Description
    Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 3
    Title
    Number of referrals
    Description
    Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 6
    Title
    Number of referrals per week
    Description
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 3
    Title
    Number of referrals per week
    Description
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 6
    Title
    Number of referrals per user
    Description
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 3
    Title
    Number of referrals per user
    Description
    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 6
    Title
    Number of clicks per referral
    Description
    Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 3
    Title
    Number of clicks per referral
    Description
    Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
    Time Frame
    month 6
    Title
    Primary Healthcare Provider Satisfaction
    Description
    Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.
    Time Frame
    baseline (month 0)
    Title
    Primary Healthcare Provider Satisfaction
    Description
    Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.
    Time Frame
    month 6
    Secondary Outcome Measure Information:
    Title
    Number referrals received as per prototype
    Description
    Number referrals received as per prototype (an implementation metric)
    Time Frame
    month 3
    Title
    Number referrals received as per prototype
    Description
    Number referrals received as per prototype (an implementation metric)
    Time Frame
    month 6
    Title
    Number of referrals received requiring troubleshooting
    Description
    Number of referrals received requiring troubleshooting (an implementation metric)
    Time Frame
    month 3
    Title
    Number of referrals received requiring troubleshooting
    Description
    Number of referrals received requiring troubleshooting (an implementation metric)
    Time Frame
    month 6
    Title
    Number of referrals aborted
    Description
    Number of referrals aborted (an implementation metric)
    Time Frame
    month 3
    Title
    Number of referrals aborted
    Description
    Number of referrals aborted (an implementation metric)
    Time Frame
    month 6
    Title
    Type of consult
    Description
    Type of consult (Full consult, specialist telephone advice, eConsult)
    Time Frame
    month 3
    Title
    Type of consult
    Description
    Type of consult (Full consult, specialist telephone advice, eConsult)
    Time Frame
    month 6
    Title
    Perceived appropriateness of the SmartPath
    Description
    Thematic analysis of interviews of primary care providers will yield key themes related to the perceived appropriateness of the intervention
    Time Frame
    month 3
    Title
    Perceived appropriateness of the SmartPath
    Description
    Thematic analysis of interviews of primary care providers will yield key themes related to the perceived appropriateness of the intervention
    Time Frame
    month 6
    Title
    physician self-efficacy rating
    Description
    physician self-efficacy rating, measured using the 'New General Self Efficacy Scale' (an effectiveness metric of GUT LINK Smartpath). Min score: 1, max score: 8. A higher score indicates a greater self-efficacy.
    Time Frame
    month 3
    Title
    physician self-efficacy rating
    Description
    physician self-efficacy rating, measured using the 'New General Self Efficacy Scale' (an effectiveness metric of GUT LINK Smartpath). Min score: 1, max score: 8. A higher score indicates a greater self-efficacy.
    Time Frame
    month 6
    Title
    Referral triage priority category
    Description
    Referral triage priority category will be collected from referrals through the pathway (an effectiveness metric of GUT LINK Smartpath). Referral triage categories to the GI department are: emergent, semi urgent, and non-urgent.
    Time Frame
    month 3
    Title
    Referral triage priority category
    Description
    Referral triage priority category will be collected from referrals through the pathway (an effectiveness metric of GUT LINK Smartpath). Referral triage categories to the GI department are: emergent, semi urgent, and non-urgent.
    Time Frame
    month 6
    Title
    Time from referral to specialist consultation
    Description
    Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)
    Time Frame
    month 3
    Title
    Time from referral to specialist consultation
    Description
    Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)
    Time Frame
    month 6
    Title
    Time from referral to diagnosis and treatment
    Description
    Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)
    Time Frame
    month 3
    Title
    Time from referral to diagnosis and treatment
    Description
    Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)
    Time Frame
    month 6

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be a general practitioner Have a family practice in Nova Scotia, Canada Utilize the platform 'virtual hallway' as part of current referral practices Deliver care to patients with lower GI complaints Exclusion Criteria: None
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Stewart, MD
    Phone
    1(902) 473-2222 xt. 2526
    Email
    Michael.Stewart@Dal.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natalie Willett, BSc
    Phone
    902-473-7074
    Email
    natalie.willett@nshealth.ca

    12. IPD Sharing Statement

    Learn more about this trial

    GUT LINK: A Study of a Care Pathway Across Primary and GI Specialty Care

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