Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease

Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)

Ulcerative colitis and Crohn's disease are the commonest types of inflammatory bowel disease (IBD). Both conditions range in severity from no symptoms to being potentially fatal. Both conditions are treated with medications which suppress the immune system. It is not known whether this increases the risk for infections and cancers in these conditions. It is also recognised by healthcare professionals that these conditions cause a considerable amount of psychological distress. However, this has never been measured in a large population sample.

This study will investigate any associations with treatment and new onset infections and cancer. They will also examine the relationship between IBD and common mental health problems (specifically, depression and anxiety) and the impact that these have on the healthcare use (including number of general practitioner [GP] appointments, hospital attendances, and medication prescriptions. Combined, these studies should provide a better understanding of the impact of IBD on affected people and provide evidence to support the correct allocation of healthcare resources.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Other: No intervention

Detailed Description

Objective We aim to provide an accurate and contemporary measurement of the current healthcare resource utilisation in people with inflammatory bowel disease (IBD); namely ulcerative colitis (UC) and Crohn's disease (CD). We also aim to provide estimates of infection incidence in this population and the prevalence of common mental health conditions.

Method We will identify UC and CD using algorithms validated for accurately identifying these conditions from primary care records in the United Kingdom (UK). We will identify a prevalent cohort of adults with IBD with the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network over the last decade. We will identify a matched cohort of people without IBD; matched on age, gender and primary care practice. Across these cohorts we will compare healthcare resource utilisation (primary care attendances, number of primary care prescriptions for antidepressant and anxiolytic medications, number of primary care prescriptions for medications used in IBD, recorded secondary care attendances, and issue of statements of fitness for work), incident infections (any common infection, any viral infection, or any gastrointestinal infection), and common mental health conditions (depression and anxiety).

• Study Type: Observational
• Enrollment (Actual): 95055

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1X 8QT
    • Momentum Data Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All individuals with an existing or incident diagnosis of UC or CD during the study period (2013-2018), defined by the presence of at least one disease-specific diagnostic code will be eligible for inclusion in the IBD cohort. Controls will matched people without IBD matched on age, gender and primary care practice.

Description

Inclusion Criteria:

• Patients aged ≥18 years over the study period
• Registered with a contributing primary care practice for any duration during the study period

Exclusion Criteria:

• IBD not classifiable or of a type other than UC or Crohn's disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with inflammatory bowel disease; Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period	Other: No intervention; Observation of routine clinical practice
Controls; Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period	Other: No intervention; Observation of routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Anxiety Episodes (Crohn's Disease)	Compare the prevalence of anxiety episodes in people with and without Crohn's disease. Number of people with at least one anxiety episode in people.	Measured over five years - 2014 to 2018 inclusive
Prevalence of Anxiety Episodes (Ulcerative Colitis)	Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis. Number of people with at least one anxiety episode	Measured over five years - 2014 to 2018 inclusive
Prevalence of Depressive Episodes (Crohn's Disease)	Compare the prevalence of depressive episodes in people with and without Crohn's disease. Number of people with at least one depressive episode	Measured over five years - 2014 to 2018 inclusive
Prevalence of Depressive Episodes (Ulcerative Colitis)	Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis. Number of people with at least one depressive episode.	Measured over five years - 2014 to 2018 inclusive
Number of People With Depressive Disorder in People With and Without Crohn's Disease	Compare the prevalence of depressive disorder in people with and without Crohn's disease.	Measured over five years - 2014 to 2018 inclusive
Number of People With Depressive Disorder in People With and Without Ulcerative Colitis	Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.	Measured over five years - 2014 to 2018 inclusive
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis	Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.	Measured over 5 years - 2014 to 2018 inclusive
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease	Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.	Measured over 5 years - 2014 to 2019 inclusive
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis	Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection	Measured over 5 years - 2014 to 2019 inclusive
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease	Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection	Measured over 5 years - 2014 to 2019 inclusive

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Resource Utilization - Primary Care Visits	Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.	Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization - Secondary Care Emergency Attendances	Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.	Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization - Fitness for Work Notes	Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.	Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)	Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.	Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications	Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.	Measured over five years - 2014 to 2018 inclusive

Collaborators and Investigators

• Sponsor: Momentum Data
• Collaborators: Pfizer; University of Surrey
• Investigators: Study Director: Andrew McGovern, MD, Momentum Data Ltd

Publications and helpful links

General Publications

• Irving P, Barrett K, Tang D, Nijher M, de Lusignan S. Common infections, mental health problems and healthcare use in people with inflammatory bowel disease: a cohort study protocol. Evid Based Ment Health. 2021 May;24(2):82-87. doi: 10.1136/ebmental-2020-300167. Epub 2020 Sep 17.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: P003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual patient data (IPD) is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
• IPD Sharing Time Frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
• IPD Sharing Access Criteria: As above
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No