A Video Intervention to Decrease Patient Fear of Colonoscopy After a Positive Fecal Immunochemical Test

Study Overview
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Brief Summary
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This clinical trial compares an educational video intervention versus usual care of no video intervention in decreasing patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT). The lack of a follow-up colonoscopy after an abnormal FIT result is associated with an increased risk of colorectal cancer mortality, advanced-stage colorectal cancer, among other complications, compared to the completion of a follow-up colonoscopy. An educational video may reduce patient fear and increase knowledge, self-efficacy, and intent to complete a colonoscopy compared to the usual care of no video intervention.

Detailed Description
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OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy. ARM 2: Patients receive usual care and do not watch the educational video. After completion of study, patients are followed for 12 months after their abnormal FIT result.

Official Title
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A Pilot Video Intervention to Decrease Fear of Colonoscopy in a Safety-Net Healthcare System

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Other: Media Intervention
* Other: Best Practice
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-75 Have an assigned primary care provider in our partnering safety-net health system Have a billable primary care encounter between 2019-2022 Have an abnormal FIT result for colorectal cancer (CRC) screening without a colonoscopy within 1 year Ability to communicate in English due to initial videos being available in English Exclusion Criteria: Adults < age 45 or > age 75 Patients who receive care at other University of Washington (UW) medicine sites (non-safety-net patients) Individuals without a primary care encounter between 2019-2022 Individuals whose primary language is not English

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (educational video)<br>Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy. | Other: Media Intervention<br>* Watch an educational video<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm 2 (usual care)<br>Patients receive usual care and do not watch the educational video. | Other: Best Practice<br>* Receive usual care<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by study accrual | Feasibility will be measured by recruitment as the proportion of invited participants who consent and complete the pilot study. | Up to 12 months post-abnormal fecal immunochemical test (FIT) result | 
| Feasibility: number of contacts needed to reach target enrollment | Feasibility will be measured by recruitment as the number of contacts required to reach target enrollment. | Up to 12 months post-abnormal FIT result | 
| Feasibility: time to reach recruitment | Feasibility will be measured by recruitment as the time required to reach target enrollment. Time to reach recruitment target will be measured in days and described using medians and interquartile range (IQR). | Up to 12 months post-abnormal FIT result | 
| Acceptability of the video intervention assessed by a survey | Intervention arm patients will complete a post-intervention survey to assess acceptability of the intervention using the Acceptability of Intervention Measure (AIM), a 4-item measure. Items are rated on a 5-point Likert Scale (1, completely disagree; 5, completely agree). Mean scores will be calculated to generate an average AIM score, where higher scores will indicate higher levels of acceptability. | Up to 12 months post-abnormal FIT result | 
| Incidence of fear related to colonoscopy | Intervention arm patients will complete a pre- and post-intervention survey that will include questions about fear of colonoscopy. Usual care patients will complete a baseline survey on the same measures. Fear will be assessed using Manne's 6-item fear of colonoscopy scale. Items are rated on a 5-point Likert scale (1, not at all fearful; 5, extremely fearful). Mean scores will be calculated to generate average fear per participant, with higher scores indicating higher levels of fear. | Up to 12 months post-abnormal FIT result | 
| Knowledge about colonoscopy | Intervention arm patients will complete a pre- and post-intervention survey that will include questions about knowledge about colon cancer screening. Usual care patients will complete a baseline survey on the same measures. Knowledge will be measured using 8 validated questions. Incorrect answers will be scored as 0 and correct answers scored as 1. Higher scores will indicate higher levels of knowledge. | Up to 12 months post-abnormal FIT result | 
| Self-efficacy related to colonoscopy | Intervention arm patients will complete a pre- and post-intervention survey that will include questions about self-efficacy related to a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Self-efficacy will be assessed by adopting an 8-item self-efficacy scale for colonoscopy completion in patients with inflammatory bowel diseases and responses will be recorded on a 5-point scale. Higher scores will indicate higher levels of self-efficacy. | Up to 12 months post-abnormal FIT result | 
| Intent to complete a colonoscopy | Intervention arm patients will complete a pre- and post-intervention survey that will include questions about intent to complete a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Intent will be measured using a single validated question on a nominal scale with 5 options. Responses will be dichotomized to affirmative intent (definitely will do, will do) or uncertain intent (don't know, will not do, and definitely will not do). | Up to 12 months post-abnormal FIT result | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of completed colonoscopies | Through review of the electronic health records (EHR), the investigators will determine rates of completed colonoscopy 6 months after randomization to assess preliminary efficacy. | At 6 months post randomization |