IBD Shared Decision Making Intervention

NCT03228615 | Completed

• 1 other identifier: 2016-8792
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases

Keywords

shared decision making

Outcome Measures

Primary Outcomes (3)

• Acceptability of multi-component intervention: OPTION scale

  Measures observed shared decision making based on review of the video-recorded visit

  Baseline

• Feasibility of multi-component intervention: Receipt of intervention components

  The percentage of participants who receive each individual component (i.e., pre-visit email/letter, in-clinic decision support, follow-up phone call)

  1 month post baseline

• Feasibility of multi-component intervention: Length of clinic visit

  Measures the length of the clinic visit with in-clinic decision support intervention

  Baseline

Study Arms (2)

Shared Decision Making Intervention

EXPERIMENTAL

Other: SDM Intervention

Usual Care Group

NO INTERVENTION

Interventions

SDM Intervention OTHER

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

Shared Decision Making Intervention

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 25, 2017
• Study Start: September 1, 2017
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)