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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725954
• Other study ID #: 50762
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Nova Scotia Health Authority
• Contact: Michael Stewart, MD
• Phone: 1(902) 473-2222 xt. 2526
• Email: Michael.Stewart[@]Dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• GI Disorders
• Irritable Bowel Syndrome

Intervention

Behavioral:
• GUT LINK SmartPath
A virtual care delivery and referral support tool for primary healthcare providers.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Michael Stewart	Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of users	Number of users (an indicator of prototype acceptability)	month 3
Primary	Number of users	Number of users (an indicator of prototype acceptability)	month 6
Primary	Number of referrals	Number of referrals from GPs to GI Department (an indicator of prototype acceptability)	month 3
Primary	Number of referrals	Number of referrals from GPs to GI Department (an indicator of prototype acceptability)	month 6
Primary	Number of referrals per week	Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)	month 3
Primary	Number of referrals per week	Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)	month 6
Primary	Number of referrals per user	Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)	month 3
Primary	Number of referrals per user	Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)	month 6
Primary	Number of clicks per referral	Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)	month 3
Primary	Number of clicks per referral	Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)	month 6
Primary	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	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	Number referrals received as per prototype	Number referrals received as per prototype (an implementation metric)	month 3
Secondary	Number referrals received as per prototype	Number referrals received as per prototype (an implementation metric)	month 6
Secondary	Number of referrals received requiring troubleshooting	Number of referrals received requiring troubleshooting (an implementation metric)	month 3
Secondary	Number of referrals received requiring troubleshooting	Number of referrals received requiring troubleshooting (an implementation metric)	month 6
Secondary	Number of referrals aborted	Number of referrals aborted (an implementation metric)	month 3
Secondary	Number of referrals aborted	Number of referrals aborted (an implementation metric)	month 6
Secondary	Type of consult	Type of consult (Full consult, specialist telephone advice, eConsult)	month 3
Secondary	Type of consult	Type of consult (Full consult, specialist telephone advice, eConsult)	month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time from referral to specialist consultation	Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)	month 3
Secondary	Time from referral to specialist consultation	Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)	month 6
Secondary	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
Secondary	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