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

GUT LINK: A Pilot Study to Evaluate the Comparative Effectiveness of an Evidence-based Care Pathway Across Primary and GI Specialty Care

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.

Study Overview

• Status: Withdrawn
• Conditions: Irritable Bowel Syndrome; GI Disorders
• Intervention / Treatment: Behavioral: GUT LINK SmartPath

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3N 2Z6
      • QEII Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GUT LINK SmartPath; physicians will use the interactive GUT LINK Smartpath tool in virtual hallway platform to guide their care and referral practices	Behavioral: GUT LINK SmartPath; A virtual care delivery and referral support tool for primary healthcare providers.
No Intervention: control; physicians will provide care and refer as per their usual practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number referrals received as per prototype	Number referrals received as per prototype (an implementation metric)	month 3
Number referrals received as per prototype	Number referrals received as per prototype (an implementation metric)	month 6
Number of referrals received requiring troubleshooting	Number of referrals received requiring troubleshooting (an implementation metric)	month 3
Number of referrals received requiring troubleshooting	Number of referrals received requiring troubleshooting (an implementation metric)	month 6
Number of referrals aborted	Number of referrals aborted (an implementation metric)	month 3
Number of referrals aborted	Number of referrals aborted (an implementation metric)	month 6
Type of consult	Type of consult (Full consult, specialist telephone advice, eConsult)	month 3
Type of consult	Type of consult (Full consult, specialist telephone advice, eConsult)	month 6
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	month 3
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	month 6
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.	month 3
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.	month 6
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.	month 3
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.	month 6
Time from referral to specialist consultation	Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)	month 3
Time from referral to specialist consultation	Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)	month 6
Time from referral to diagnosis and treatment	Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)	month 3
Time from referral to diagnosis and treatment	Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)	month 6

Collaborators and Investigators

• Sponsor: Michael Stewart
• Collaborators: Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: virtual; Care pathway; Care delivery
• Additional Relevant MeSH Terms: Intestinal Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Digestive System Diseases
• Other Study ID Numbers: 50762

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No