Treatment of IBS in Primary Health Care.

Irritable Bowel Syndrome Clinical Trial

Official title:

Treatment of IBS in Primary Health Care: Adherence to Guidelines

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05144581
• Other study ID #: 277071
• Status: Not yet recruiting
• Start date: November 29, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2021
• Source: Region Örebro County
• Contact: Jussi Rauma, M.D.
• Phone: +460702484167
• Email: jussi.rauma[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to guidelines of pharmacological treatment of IBS within primary care	The proportion of patients that have received pharmacological treatment according to guidelines for IBS within primary care.	2013-2017
Primary	Adherence to guidelines of non-pharmacological treatment of IBS within primary care	The proportion of patients that have received non-pharmacological treatment according to guidelines for IBS within primary care.	2013-2017
Secondary	Efficacy of treatment of IBS	Used treatments of IBS will be categorized in grade of recommendation as well as in strenght of evidence.	2013-2017
Secondary	Use of inappropriate treatments of IBS	The prevalence of inappropriate treatment strategies of IBS within primary care will be recorded.	2013-2017