Invasive Mechanical VentilationNCT05880953
Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator
A study testing Parent-to-parent coaching in people with Invasive Mechanical Ventilation and Children With Medical Complexity, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Invasive Mechanical Ventilation, Children With Medical Complexity, Home Nursing
- What is being tested?
- Parent-to-parent coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 9 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Wards of the state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator: an Empowerment Model for Home Health Nurse (HHN) Advocacy
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.
Read the detailed description
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.
- Conditions
- Invasive Mechanical Ventilation, Children With Medical Complexity, Home Nursing, Empowerment
- Being tested
- Parent-to-parent coaching
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-to-parent coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Parent-to-parent coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Parents will have selected a nursing agency for the home health nursing care of their child.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At study exit (length of program involvement was median (range) 6 (2-8) months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start12 Jun 2023
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Sarah Sobotka, MD, MSCP, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880953
- Sponsor's protocol ID
- IRB23-0348
- Other IDs
- P50MD017349
- Status last verified
- May 2026
- First submitted
- 11 May 2023
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Individual Participant Data(IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator: an Empowerment Model for Home Health Nurse (HHN) Advocacy
- ClinicalTrials.gov ID
- NCT05880953
- Acronym / sponsor ID
- IRB23-0348
- Conditions
- Invasive Mechanical Ventilation, Children With Medical Complexity, Home Nursing, Empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Posted 21 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent Coaching | Experimental | Behavioral: Parent-to-parent coachingParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Wards of the state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-to-parent coachingParents 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. | Behavioural | Parent Coaching |
Primary outcome
Change in Parent Empowerment as Measured by the Family Empowerment Scale (FES)
Time frame: Baseline and repeated at exit (length of program involvement was median (range) 6 (2-8) months)
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.
4 secondary outcomes
Number of Participants That Completed Nursing Agency Selection
Time frame: At study exit (length of program involvement was a median (range) 6 (2-8) months)
Categorical Rating of Met Nursing Needs
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
Time frame: At study exit (length of program involvement was a median (range) 6 (2-8) months)
Satisfaction With Coaching Program
Time frame: At study exit (length of program involvement was median (range) 6 (2-8) months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No Individual Participant Data(IPD) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Sobotka, MD, MSCP principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-to-parent coaching in people with Invasive Mechanical Ventilation and Children With Medical Complexity, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Empowerment as Measured by the Family Empowerment Scale (FES) (time frame: Baseline and repeated at exit (length of program involvement was median (range) 6 (2-8) months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.