IBD Shared Decision Making Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-07-19

Brief Summary

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The purpose of this clinical trial is to implement a multi-component shared decision making intervention for families of children with IBD. The main objective of this research will be to assess the acceptability, feasibility and clinical and decision outcomes of a multi-component decision support intervention targeted at families of children with IBD who are making decisions about treatment with TNFαi agents.

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Detailed Description

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Research has shown that when making decisions about treatment with anti-tumor necrosis factor-α (TNFαi) agents, parents of children with inflammatory bowel disease (IBD) experience high levels of decisional conflict. This extreme level of conflict is due to the challenge of considering an effective treatment that has potentially serious side-effects. Elevated levels of decisional conflict have been associated with delays in decision making and failures to implement treatment plans. Given that such delays may lead to worse clinical outcomes, there is an urgent need to improve the decision-making process around TNFαi therapy. The use of structured decision support to help inform and guide parents through this challenging decision may improve the decision-making process. Such structure facilitates high-quality decision making by providing balanced, accurate information, helping individuals clarify what is most important to them, and facilitating conversations between families and healthcare providers. Based the investigators' prior research into the TNFαi decision process, the investigators developed a multi-component decision support intervention designed to improve the TNFαi decision process. This intervention will be tested in a controlled pilot trial designed to assess the acceptability and feasibility of a multi-component intervention and to determine the effect size of the multi-component intervention on both clinical and decision outcomes in children and adolescents with IBD and their parents.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

This clinical trial uses prospective repeated measures in a before-after study design. Following enrollment of the usual care group (i.e., 50% recruitment goal has been reached), physicians will be trained to use the intervention. We will then enroll the intervention group.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Shared Decision Making Intervention

Group Type EXPERIMENTAL

SDM Intervention

Intervention Type OTHER

Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call

Usual Care Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SDM Intervention

Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinician anticipates discussing TNFai treatment at clinic visit; parent and patient willing to have visit video-recorded

Exclusion Criteria

* patient over age 17; prior use of TNFai; unable to read and speak English; clinic visit not conducted in English; previous participation in this study; known major mental illness in parent or adolescent patient; medical instability at scheduled visit; patient's gastroenterologist is a study investigator

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No