Treatment of IBS in Primary Health Care.

Sponsor
Region Örebro County (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05144581
Collaborator
(none)
3,000
30

Study Details

Study Description

Brief Summary

The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The defining features of IBS comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the Rome IV criteria. The spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. Despite the prevalence of IBS, its management remains a challenge for global healthcare systems.

    Treatment of IBS comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. Pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics.

    Since the majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (GPs) to recommended therapeutic approaches for IBS.

    In this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in Örebro Region. Patients will be identified by ICD-code K.58. The used treatments will be categorized in grade of recommendation as well as in strength of evidence. The efficacy of the used treatments will be evaluated, if possible. Over the counter agents, and lifestyle adjustments will not be evaluated.

    The used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). The eventual use of inappropriate treatments will be recorded as well. The efficacy of the used treatments will be, if possible, evaluated from the patient registers. The standardized and validated questionnaires IBS-Symptom Severity Score and IBS-Quality of Life scores are not routinely used within the primary health care. For this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect".

    Descriptive statistics will be used.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Treatment of IBS in Primary Health Care: Adherence to Guidelines
    Anticipated Study Start Date :
    Nov 29, 2021
    Anticipated Primary Completion Date :
    May 31, 2023
    Anticipated Study Completion Date :
    May 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients diagnosed with IBS

    Patients diagnosed with IBS within primary care in Region Örebro County 2013-2017, identified by ICD-code K.58.

    Outcome Measures

    Primary Outcome Measures

    1. Adherence to guidelines of pharmacological treatment of IBS within primary care [2013-2017]

      The proportion of patients that have received pharmacological treatment according to guidelines for IBS within primary care.

    2. Adherence to guidelines of non-pharmacological treatment of IBS within primary care [2013-2017]

      The proportion of patients that have received non-pharmacological treatment according to guidelines for IBS within primary care.

    Secondary Outcome Measures

    1. Efficacy of treatment of IBS [2013-2017]

      Used treatments of IBS will be categorized in grade of recommendation as well as in strenght of evidence.

    2. Use of inappropriate treatments of IBS [2013-2017]

      The prevalence of inappropriate treatment strategies of IBS within primary care will be recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2013-2017.
    Exclusion Criteria:
    • Patients < 18 years or > 65 years.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Region Örebro County

    Investigators

    • Principal Investigator: Michiel van Nieuwenhoven, M.D. Ph.D., Region Örebro County

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Region Örebro County
    ClinicalTrials.gov Identifier:
    NCT05144581
    Other Study ID Numbers:
    • 277071
    First Posted:
    Dec 3, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Region Örebro County
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021