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

Completed

Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Crohn Disease

Interventions: Other: No intervention

Registration Number: NCT03836612

Lead Sponsor: Momentum Data

Brief Summary: 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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 95055

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	No intervention	Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period
People with inflammatory bowel disease	No intervention	Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period

Primary Outcome Measures

Name	Time	Method
Prevalence of Anxiety Episodes (Ulcerative Colitis)	Measured over five years - 2014 to 2018 inclusive	Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis. Number of people with at least one anxiety episode
Prevalence of Depressive Episodes (Ulcerative Colitis)	Measured over five years - 2014 to 2018 inclusive	Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis. Number of people with at least one depressive episode.
Number of People With Depressive Disorder in People With and Without Ulcerative Colitis	Measured over five years - 2014 to 2018 inclusive	Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease	Measured over 5 years - 2014 to 2019 inclusive	Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis	Measured over 5 years - 2014 to 2018 inclusive	Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Prevalence of Anxiety Episodes (Crohn's Disease)	Measured over five years - 2014 to 2018 inclusive	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.
Prevalence of Depressive Episodes (Crohn's Disease)	Measured over five years - 2014 to 2018 inclusive	Compare the prevalence of depressive episodes in people with and without Crohn's disease. Number of people with at least one depressive episode
Number of People With Depressive Disorder in People With and Without Crohn's Disease	Measured over five years - 2014 to 2018 inclusive	Compare the prevalence of depressive disorder in people with and without Crohn's disease.
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis	Measured over 5 years - 2014 to 2019 inclusive	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
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease	Measured over 5 years - 2014 to 2019 inclusive	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

Secondary Outcome Measures

Name	Time	Method
Healthcare Resource Utilization - Secondary Care Emergency Attendances	Measured over five years - 2014 to 2018 inclusive	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.
Healthcare Resource Utilization - Fitness for Work Notes	Measured over five years - 2014 to 2018 inclusive	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.
Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)	Measured over five years - 2014 to 2018 inclusive	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.
Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications	Measured over five years - 2014 to 2018 inclusive	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.
Healthcare Resource Utilization - Primary Care Visits	Measured over five years - 2014 to 2018 inclusive	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.