NCT05725954

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
31mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Feb 2024Dec 2028

First Submitted

Initial submission to the registry

January 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

January 23, 2023

Last Update Submit

April 7, 2026

Conditions

Irritable Bowel SyndromeGI Disorders

Keywords

Care pathwayCare deliveryvirtual

Outcome Measures

Primary Outcomes (12)

  • Number of users

    Number of users (an indicator of prototype acceptability)

    month 3

  • Number of users

    Number of users (an indicator of prototype acceptability)

    month 6

  • Number of referrals

    Number of referrals from GPs to GI Department (an indicator of prototype acceptability)

    month 3

  • Number of referrals

    Number of referrals from GPs to GI Department (an indicator of prototype acceptability)

    month 6

  • Number of referrals per week

    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)

    month 3

  • Number of referrals per week

    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)

    month 6

  • Number of referrals per user

    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)

    month 3

  • Number of referrals per user

    Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)

    month 6

  • Number of clicks per referral

    Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)

    month 3

  • Number of clicks per referral

    Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)

    month 6

  • Primary Healthcare Provider Satisfaction

    Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.

    baseline (month 0)

  • Primary Healthcare Provider Satisfaction

    Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.

    month 6

Secondary Outcomes (18)

  • Number referrals received as per prototype

    month 3

  • Number referrals received as per prototype

    month 6

  • Number of referrals received requiring troubleshooting

    month 3

  • Number of referrals received requiring troubleshooting

    month 6

  • Number of referrals aborted

    month 3

  • +13 more secondary outcomes

Study Arms (2)

GUT LINK SmartPath

EXPERIMENTAL

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

Behavioral: GUT LINK SmartPath

control

NO INTERVENTION

physicians will provide care and refer as per their usual practices

Interventions

GUT LINK SmartPathBEHAVIORAL

A virtual care delivery and referral support tool for primary healthcare providers.

GUT LINK SmartPath

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3N 2Z6, Canada

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeDigestive System Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gastroenterologist, Assistant Professor, Department of Medicine, Dalhousie University

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 13, 2023

Study Start

February 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CA(1)