Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator

NCT05880953 | Completed Results

• 2 other identifiers: IRB23-0348P50MD017349
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with Invasive Mechanical Ventilation (IMV) as parent coaches.

Conditions

Invasive Mechanical Ventilation; Children With Medical Complexity; Home Nursing; Empowerment

Outcome Measures

Primary Outcomes (1)

• Change in Parent Empowerment as Measured by the Family Empowerment Scale (FES)

  Parents completed the Family Empowerment Scale (FES), a 34-item Likert-scale questionnaire with three domains: family, service system, and community. Scores on the FES range from 1 (not true at all) to 5 (very true), with higher scores indicating greater self-perceived advocacy skills, confidence in navigating systems and community resources, and ability to engage in decision making for their child. The FES has been tested for reliability (0.87-0.88) and internal consistency for test-test reliability (0.77-0.85). The FES had been used previously to characterize changes in empowerment after an advocacy intervention for parents of children with disabilities. The maximum potential total score being 170 and the minimum being 34. We compared scores between enrollment and exit and report the median(IQR) change in score over the study period.

  Baseline and repeated at exit (length of program involvement was median (range) 6 (2-8) months)

Secondary Outcomes (4)

• Number of Participants That Completed Nursing Agency Selection

  At study exit (length of program involvement was a median (range) 6 (2-8) months)

• Categorical Rating of Met Nursing Needs

  At study exit (length of program involvement was a median (range) 6 (2-8) months)

• Days Per Week Where at Least One Home Health Nursing Shift Was Filled

  At study exit (length of program involvement was a median (range) 6 (2-8) months)

• Satisfaction With Coaching Program

  At study exit (length of program involvement was median (range) 6 (2-8) months)

Study Arms (1)

Parent Coaching

EXPERIMENTAL

Participants will be involved for about 6 months or until they feel that they no longer need the parent-to-parent support. Parents will participate in the following contact attempts: * Introductions and rapport building which will include a demographic survey with a needs assessment, and the Family Empowerment Scale (FES) * A series of coaching points which may include some or all of the following topics * Interviewing and selecting a home health agency * Expectation setting for home based nursing care * Tips for finding home health professionals from inpatient nursing * Tips for using personal and professional care networks to find and recruit home health team members * An exit interview assessment including the FES and components of the demographic survey that may have changed

Behavioral: Parent-to-parent coaching

Interventions

Parent-to-parent coaching BEHAVIORAL

Parents and parent coaches will meet as needed via the family's preferred method. Engagement may include text messaging, phone conferencing, Zoom conferencing, or occasional in-home or hospital visiting as preferred. Coaching sessions will vary based on family desired frequency and location, but may include: on-site in the family home or hospital room, telephone or video conferencing, or asynchronous contacts via email or text messaging. The template for the intervention includes an initial introductory session which is intended to build rapport and orient the parent to our program. Subsequent session topics may include: addressing specific needs including topics of interviewing and selecting home health agencies, expectation setting for home based nursing care, recruiting for home health team from inpatient settings, and recruiting for home health team from professional and personal networks.

Parent Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of children with a tracheostomy and ventilator awaiting hospital discharge in Illinois.
• Parents must live or have their child hospitalized within approximately a 1 hour radius of the University of Chicago.
• The child must be enrolled in, or in the process of enrolling in the Division of Specialized Care for Children (DSCC) Home Care Program.
• The parent/legal guardian must have legal custody of the child and plan on living with the child in the home.

You may not qualify if:

• Wards of the state

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Limitations and Caveats

Findings from this small pilot study should be interpreted cautiously. Broad conclusions to larger populations are limited by our small sample size within a single geographic region. Additionally, we intentionally targeted families identified as hard to staff with nursing care, many of whom were already receiving maximal support from hospital and community-based programs.

Results Point of Contact

• Title: Sarah A. Sobotka, MD MSCP
• Organization: University of Chicago

ssobotka@bsd.uchicago.edu

7737021187

Study Officials

• Sarah Sobotka, MD, MSCP

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 30, 2023
• Study Start: June 12, 2023
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: July 21, 2026
• Results First Posted: July 21, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)