Clinical trial NCT03836612: Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease
Official title: Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
name: University of Surrey
First posted: 2019-02-11
Enrollment: 95055
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: Prevalence of Anxiety Episodes (Crohn's Disease)
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Prevalence of Anxiety Episodes (Ulcerative Colitis)
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Prevalence of Depressive Episodes (Crohn's Disease)
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Prevalence of Depressive Episodes (Ulcerative Colitis)
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Number of People With Depressive Disorder in People With and Without Crohn's Disease
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Number of People With Depressive Disorder in People With and Without Ulcerative Colitis
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis
timeFrame: Measured over 5 years - 2014 to 2018 inclusive
measure: Number of People With at Least One Infection Event in Those With and Without Crohn's Disease
timeFrame: Measured over 5 years - 2014 to 2019 inclusive
measure: Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis
timeFrame: Measured over 5 years - 2014 to 2019 inclusive
measure: Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease
timeFrame: Measured over 5 years - 2014 to 2019 inclusive
Secondary outcomes:
measure: Healthcare Resource Utilization - Primary Care Visits
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Healthcare Resource Utilization - Secondary Care Emergency Attendances
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Healthcare Resource Utilization - Fitness for Work Notes
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)
timeFrame: Measured over five years - 2014 to 2018 inclusive
measure: Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications
timeFrame: Measured over five years - 2014 to 2018 inclusive
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data Ltd
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References:
citation: 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.