Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients

Study Overview
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Brief Summary
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A retrospective chart review and a six-month prospective outcome analysis aimed to evaluate the efficacy of a vaccination education intervention and vaccination adherence among IBD patients at Weill-Cornell Medical Center. It is hypothesized that a general vaccination education campaign will improve vaccination adherence rates for all IBD patients. Secondarily, it is hypothesized that an Human Papilloma Virus (HPV) vaccination intervention targeted at high-risk IBD patients will increase vaccination adherence among these patients.

Official Title
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Education Intervention on Vaccination Adherence Among IBD Patients at Weill Cornell Medical Center

Conditions
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Crohn Disease (CD), Ulcerative Colitis (UC), Indeterminate Colitis

Intervention / Treatment
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* Other: Vaccine Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at Weill-Cornell Medical Center with an in-person or virtual appointment between March 1 - August 30, 2021. Documentation of an IBD diagnosis (CD, UC, IC). Exclusion Criteria: No documentation of an IBD diagnosis. Pregnant or breastfeeding. No scheduled appointment between March 1-August 30, 2021.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine Education<br>Patients randomized to the Experimental arm will receive a baseline educational intervention on vaccination following a vaccination history survey. Patients will be followed 6-months after the intervention to record prospective clinical data. Evidence of vaccination-status will be documented. Besides standard of care visits and testing, no additional procedures will be carried out for the purpose of this study. | Other: Vaccine Education<br>* A baseline educational intervention on vaccination and its role in the health maintenance of patients with IBD will be provided to all participants. Those on immunosuppressive therapies and/or those age 65 or older will also be offered the pneumonia vaccine educational intervention. Finally, patients aged 18-26 and those 27-45 who have never been vaccinated for HPV or those with high risk for HPV will additionally receive the HPV educational intervention.<br>|
| No Intervention: No Vaccine Education<br>Patients randomized to the No Intervention arm will not receive the Vaccine Education. They will only complete the survey on their vaccination history. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Vaccination Adherence in Patients |  | Baseline; 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire. |  | Baseline; 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, HPV, Vaccination, IBD, Inflammatory Bowel Diseases, UC, CD