An interventional study of Parent-to-parent coaching in Invasive Mechanical Ventilation, Children With Medical Complexity and Home Nursing, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Chicago · Not applicable, Interventional, and Other
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.
The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with IMV as parent coaches. Parent coaches will advise parents of children with IMV awaiting hospital discharge on strategies for advocating for home nursing. Parents and parent coaches will meet as needed and engagement will be tailored to parent preference: text messaging, video or phone conferencing, or in-person visiting in the family home or hospital. Points of contact, issues addressed, and time required will be collected as needs assessment data to appropriately size and scale a future intervention. Enrollment and exit assessments will include completion of the Family Empowerment Scale (FES) and a brief structured interview about parents' perceived impact and acceptability, which will provide pilot data to inform a future intervention. The investigator hypothesizes that parents will gain self-advocacy skills specific to recruiting home health nurses and improve the size of their home nursing workforce through this coaching model.
154 studies on the registry are indexed under Empowerment; 31 are open to participants now.
This study's enrollment of 10 is below the median of 141 across 132 interventional studies indexed under Empowerment.
Browse Empowerment studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
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Exclusion Criteria:
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
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.
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.
Time frame: Baseline and repeated at exit (length of program involvement was median (range) 6 (2-8) months)
Number of Participants That Completed Nursing Agency Selection
Parents will have selected a nursing agency for the home health nursing care of their child.
Time frame: At study exit (length of program involvement was a median (range) 6 (2-8) months)
Categorical Rating of Met Nursing Needs
Participants were asked to rate their perception of met nursing needs (Not staffed, somewhat staffed, mostly staffed, or fully staffed).
Time frame: 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 exit from the study participants were asked how many days per week they have a filled nursing shift. We counted each day with at least one nursing shift filled as a day with home health nursing.
Time frame: At study exit (length of program involvement was a median (range) 6 (2-8) months)
Satisfaction With Coaching Program
Parents will complete a structured interview about their experience with the parent to parent coaching program and likelihood of recommending it to a family in a similar circumstance.
Time frame: At study exit (length of program involvement was median (range) 6 (2-8) months)
Participants were recruited for this pilot intervention through the Division of Specialized Care for Children (DSCC), the state of Illinois Title V agency which provides care coordination for children with medical complexity. DSCC staff introduced the coaching program to parents of children with IMV highlighted as hard-to-staff cases awaiting hospital discharge or those living at home with incomplete home nursing. The study team contacted interested parents for consent and enrollment.
| Milestone | Parent Coaching |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
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.
| Family Empowerment Scale Score | Parent Coaching |
|---|---|
| Change in Parent Empowerment as Measured by the Family Empowerment Scale (FES) | 5.2 (2.2 to 13.3) |
Parents will have selected a nursing agency for the home health nursing care of their child.
| Participants | Parent Coaching |
|---|---|
| Number of Participants That Completed Nursing Agency Selection | 8 |
Participants were asked to rate their perception of met nursing needs (Not staffed, somewhat staffed, mostly staffed, or fully staffed).
| participants | Parent Coaching |
|---|---|
| Not Staffed | 1 |
| Somewhat staffed | 3 |
| Mostly/fully staffed | 5 |
At exit from the study participants were asked how many days per week they have a filled nursing shift. We counted each day with at least one nursing shift filled as a day with home health nursing.
| Participants | Parent Coaching |
|---|---|
| 0 days of home health nursing | 1 |
| 1-4 days of home health nursing | 0 |
| 5 days of home health nursing | 4 |
| 6 days of home health nursing | 2 |
| 7 days of home health nursing | 2 |
Parents will complete a structured interview about their experience with the parent to parent coaching program and likelihood of recommending it to a family in a similar circumstance.
| Participants | Parent Coaching |
|---|---|
| Satisfaction With Coaching Program | 9 |
Collected over From enrollment to exit (length of program involvement was median(range) of 6 (2-8) months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parent Coaching | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
10 parents were enrolled in the program.
| Age, Categorical(Participants) | Parent Coaching |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Sex: Female, Male(Participants) | Parent Coaching |
|---|---|
| Female | 10 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Parent Coaching |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Parent Coaching |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Family Empowerment Scale Score(Family Empowerment Scale Score) | Parent Coaching |
|---|---|
| Median | 142 (136 to 154) |
Plan to share: No — No Individual Participant Data(IPD) will be shared.
Ran from Jun 2023 to primary completion in May 2025, 22 months.
Results were first posted in Jul 2026, 1 year 2 months after primary completion.
Of 82 non-industry interventional studies with no phase under Empowerment, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 22 months is close to that.
Counting every sponsor, half of 82 studies reached it within 22 months; a quarter within 11 and three quarters within 45.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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