Irritable Bowel SyndromeNCT05725954
GUT LINK: A Study of a Care Pathway Across Primary and GI Specialty Care
A study testing GUT LINK SmartPath in people with Irritable Bowel Syndrome and GI Disorders, run by Michael Stewart at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, GI Disorders
- What is being tested?
- GUT LINK SmartPath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Irritable Bowel Syndrome, GI Disorders
- Being tested
- GUT LINK SmartPath
- Keywords
- Care pathway, Care delivery, virtual
- Medical subject headings
- Irritable Bowel Syndrome, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUT LINK SmartPathBehavioural
A virtual care delivery and referral support tool for primary healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| GUT LINK SmartPath | Experimental | physicians will use the interactive GUT LINK Smartpath tool in virtual hallway platform to guide their care and referral practices Receives: Behavioral: GUT LINK SmartPath |
| control | No intervention | physicians will provide care and refer as per their usual practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of users
Number of users (an indicator of prototype acceptability)
Measured: month 3
Number of users
Number of users (an indicator of prototype acceptability)
Measured: month 6
Number of referrals
Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 3
Number of referrals
Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 6
Number of referrals per week
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 3
Number of referrals per week
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 6
Number of referrals per user
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 3
Number of referrals per user
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 6
Number of clicks per referral
Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 3
Number of clicks per referral
Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
Measured: month 6
Primary Healthcare Provider Satisfaction
Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.
Measured: 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.
Measured: month 6
Secondary outcomes (18)
Number referrals received as per prototype
Number referrals received as per prototype (an implementation metric)
Measured: month 3
Number referrals received as per prototype
Number referrals received as per prototype (an implementation metric)
Measured: month 6
Number of referrals received requiring troubleshooting
Number of referrals received requiring troubleshooting (an implementation metric)
Measured: month 3
Number of referrals received requiring troubleshooting
Number of referrals received requiring troubleshooting (an implementation metric)
Measured: month 6
Number of referrals aborted
Number of referrals aborted (an implementation metric)
Measured: month 3
Number of referrals aborted
Number of referrals aborted (an implementation metric)
Measured: month 6
Type of consult
Type of consult (Full consult, specialist telephone advice, eConsult)
Measured: month 3
Type of consult
Type of consult (Full consult, specialist telephone advice, eConsult)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: month 6
Time from referral to specialist consultation
Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)
Measured: month 3
Time from referral to specialist consultation
Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)
Measured: 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)
Measured: 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)
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Feb 2024 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Intervention (GUT LINK Tool) was implemented outside of the context of a research study at our care centre, the QEII, as quality improvement. It became infeasible to consent all physicians to use the tool, and carry out this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Stewart
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Michael Stewart, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725954
- Sponsor's protocol ID
- 50762
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUT LINK: A Pilot Study to Evaluate the Comparative Effectiveness of an Evidence-based Care Pathway Across Primary and GI Specialty Care
- ClinicalTrials.gov ID
- NCT05725954
- Acronym / sponsor ID
- 50762
- Conditions
- Irritable Bowel Syndrome, GI Disorders
- Keywords
- Care pathway, Care delivery, virtual
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Intervention (GUT LINK Tool) was implemented outside of the context of a research study at our care centre, the QEII, as quality improvement. It became infeasible to consent all physicians to use the tool, and carry out this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael StewartUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUT LINK SmartPath | Experimental | Behavioral: GUT LINK SmartPathphysicians will use the interactive GUT LINK Smartpath tool in virtual hallway platform to guide their care and referral practices |
| control | No intervention | –physicians will provide care and refer as per their usual practices |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUT LINK SmartPathA virtual care delivery and referral support tool for primary healthcare providers. | Behavioural | GUT LINK SmartPath |
Primary outcome
Number of users
Time frame: month 3
Number of users (an indicator of prototype acceptability)
Number of users
Time frame: month 6
Number of users (an indicator of prototype acceptability)
Number of referrals
Time frame: month 3
Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
Number of referrals
Time frame: month 6
Number of referrals from GPs to GI Department (an indicator of prototype acceptability)
Number of referrals per week
Time frame: month 3
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Number of referrals per week
Time frame: month 6
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Number of referrals per user
Time frame: month 3
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Number of referrals per user
Time frame: month 6
Number of referrals per week from GPs to GI Department (an indicator of prototype acceptability)
Number of clicks per referral
Time frame: month 3
Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
Number of clicks per referral
Time frame: month 6
Number of clicks per referral from GPs to GI Department (an indicator of prototype acceptability)
Primary Healthcare Provider Satisfaction
Time frame: baseline (month 0)
Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.
Primary Healthcare Provider Satisfaction
Time frame: month 6
Thematic analysis of interviews of primary care providers will yield key themes related to satisfaction with the intervention.
18 secondary outcomes
Number referrals received as per prototype
Time frame: month 3
Number referrals received as per prototype
Time frame: month 6
Number of referrals received requiring troubleshooting
Time frame: month 3
Number of referrals received requiring troubleshooting
Time frame: month 6
Number of referrals aborted
Time frame: month 3
Number of referrals aborted
Time frame: month 6
Type of consult
Time frame: month 3
Type of consult
Time frame: month 6
Perceived appropriateness of the SmartPath
Time frame: month 3
Perceived appropriateness of the SmartPath
Time frame: month 6
physician self-efficacy rating
Time frame: month 3
physician self-efficacy rating
Time frame: month 6
Referral triage priority category
Time frame: month 3
Referral triage priority category
Time frame: month 6
Time from referral to specialist consultation
Time frame: month 3
Time from referral to specialist consultation
Time frame: month 6
Time from referral to diagnosis and treatment
Time frame: month 3
Time from referral to diagnosis and treatment
Time frame: month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUT LINK SmartPath in people with Irritable Bowel Syndrome and GI Disorders, run by Michael Stewart at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of users (time frame: month 3). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.