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

Sponsor
Michael Stewart (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05725954
Collaborator
Nova Scotia Health Authority (Other)
120
2
21.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: GUT LINK SmartPath
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
GUT LINK: A Pilot Study to Evaluate the Comparative Effectiveness of an Evidence-based Care Pathway Across Primary and GI Specialty Care
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of users [month 3]

    Number of users (an indicator of prototype acceptability)

  2. Number of users [month 6]

    Number of users (an indicator of prototype acceptability)

  3. Number of referrals [month 3]

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

  4. Number of referrals [month 6]

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

  5. Number of referrals per week [month 3]

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

  6. Number of referrals per week [month 6]

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

  7. Number of referrals per user [month 3]

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

  8. Number of referrals per user [month 6]

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

  9. Number of clicks per referral [month 3]

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

  10. Number of clicks per referral [month 6]

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

  11. Primary Healthcare Provider Satisfaction [baseline (month 0)]

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

  12. Primary Healthcare Provider Satisfaction [month 6]

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

Secondary Outcome Measures

  1. Number referrals received as per prototype [month 3]

    Number referrals received as per prototype (an implementation metric)

  2. Number referrals received as per prototype [month 6]

    Number referrals received as per prototype (an implementation metric)

  3. Number of referrals received requiring troubleshooting [month 3]

    Number of referrals received requiring troubleshooting (an implementation metric)

  4. Number of referrals received requiring troubleshooting [month 6]

    Number of referrals received requiring troubleshooting (an implementation metric)

  5. Number of referrals aborted [month 3]

    Number of referrals aborted (an implementation metric)

  6. Number of referrals aborted [month 6]

    Number of referrals aborted (an implementation metric)

  7. Type of consult [month 3]

    Type of consult (Full consult, specialist telephone advice, eConsult)

  8. Type of consult [month 6]

    Type of consult (Full consult, specialist telephone advice, eConsult)

  9. Perceived appropriateness of the SmartPath [month 3]

    Thematic analysis of interviews of primary care providers will yield key themes related to the perceived appropriateness of the intervention

  10. Perceived appropriateness of the SmartPath [month 6]

    Thematic analysis of interviews of primary care providers will yield key themes related to the perceived appropriateness of the intervention

  11. physician self-efficacy rating [month 3]

    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.

  12. physician self-efficacy rating [month 6]

    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.

  13. Referral triage priority category [month 3]

    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.

  14. Referral triage priority category [month 6]

    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.

  15. Time from referral to specialist consultation [month 3]

    Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)

  16. Time from referral to specialist consultation [month 6]

    Time from referral to specialist consultation, in weeks (an effectiveness metric of GUT LINK Smartpath)

  17. Time from referral to diagnosis and treatment [month 3]

    Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)

  18. Time from referral to diagnosis and treatment [month 6]

    Time from referral to diagnosis and treatment, in weeks (an effectiveness metric of GUT LINK Smartpath)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Michael Stewart
  • Nova Scotia Health Authority

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Stewart, Gastroenterologist, Assistant Professor, Department of Medicine, Dalhousie University, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT05725954
Other Study ID Numbers:
  • 50762
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Stewart, Gastroenterologist, Assistant Professor, Department of Medicine, Dalhousie University, Nova Scotia Health Authority
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023