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

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome, GI Disorders

Intervention / Treatment
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* Behavioral: GUT LINK SmartPath


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Care pathway, Care delivery, virtual