Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Common mental health conditions [Measured over five years - 2014 to 2018 inclusive]
Compare the prevalence of common mental health conditions in people with and without inflammatory bowel disease (IBD) in a community setting, and stratifying by IBD type. Common mental health conditions comprise; depressive episodes, recurrent depressive disorder, and anxiety.
- Infection prevalence in people with inflammatory bowel disease [Measured over five years - 2014 to 2018 inclusive]
Describe the prevalence of common, gastrointestinal and viral infections in older people with inflammatory bowel disease. We will also assess factors associated with infection risk.
Secondary Outcome Measures
- Healthcare resource utilization [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 comprises primary care attendances, prescriptions of depression and anxiety, prescriptions for IBD, secondary care attendances, and issue of statements of fitness for work.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Momentum Data Ltd | London | United Kingdom | WC1X 8QT |
Sponsors and Collaborators
- Momentum Data
- Pfizer
- University of Surrey
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- P003