IBD Shared Decision Making Intervention | NCT03228615

Studies
IBD Shared Decision Making Intervention

NCT03228615

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Completed

Last Update Posted

Jul 13, 2021Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Inflammatory Bowel Diseases

Interventions

SDM Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Jul 19, 2019Actual

Completion Date

Jul 19, 2019Actual

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2021

Last Update Posted Date

Jul 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ellen A. Lipstein MD, MPH, Assistant Professor, Children's Hospital Medical Center, CincinnatiPrincipal Investigator

Lead Sponsor

Children's Hospital Medical Center, CincinnatiOTHER

Collaborators

Name	Class
Crohn's and Colitis Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shared Decision Making Intervention	Experimental		Other: SDM Intervention
Usual Care Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SDM Intervention	Other	Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.