Clinical trial NCT06102330: Multicenter HomeVENT: Home Values and Experiences Navigation Track
Official title: Multicenter HomeVENT: Home Values and Experiences Navigation Track
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric ALL
Respiratory Insufficiency
Communication
Keywords: chronic ventilation
decision-making
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The first half of families at each site will be enrolled in the 'usual care' arm, the second half enrolled in the 'intervention' arm
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a multicenter study to test a decision-making support process for families and clinicians facing decisions about chronic home ventilation for a child. The investigators hypothesize that the intervention will increase family preparedness for decision-making and will improve clinician-family shared-decision making. Half of families will be assigned to "usual care" arm and half to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content. All families will be interviewed and surveyed at 1, 6 and 12 months after enrollment. Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed and surveyed at 1 month.

Detailed description: Across 4 centers, the investigators will recruit 150 English and/ or Spanish-speaking families (up to 2 parents per family) who are currently facing a decision about tracheostomy and home ventilation for the child. The investigators will also recruit up to 2 clinicians who are central to the decision for each child.

The first 50% of families will be assigned to "usual care" arm and the second 50% of families will be assigned to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content in an interview that could last up to 2 hours. All families will be interviewed at 1, 6 and 12 months after enrollment (each interview lasts 15-30 minutes). Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed at 1 month interviews last \~15 minutes).

This is a controlled trial of a communication intervention and requires careful attention to words used. The investigators support the intention of being inclusive, and have invested considerable effort in creating a Spanish intervention and diversifying the team to include more native Spanish-speakers. However, as a communication randomized control trial (RCT), the investigators are concerned that one-off efforts to translate the website as well as using a translator, may confound the investigators interpretation of the data. Most significantly, the investigators risk not finding differences between the two arms if the investigators include those who do not speak English or Spanish.

Primary endpoints:

The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will have increased preparedness for decision-making 1 month later.

The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later.

The investigators hypothesize that, compared to physicians of families who receive usual care related to decision-making about pediatric chronic home ventilation, physicians of families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later.

Eligibility criteria: Inclusion Criteria:

1. English- or Spanish-speaking
2. Males and females; Age 18 and over.
3. Parent of a child facing a decision about home ventilation within 30 days. A "parent" will be defined as any self-identified primary caregiver (parents, grandparents, etc).

   or Physician of a child whose parents are enrolled in the study; physician must be engaged in the home ventilation decision.
4. Provision of signed and dated informed consent form (parent) or completion of oral consent (physician)
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Access to necessary resources if choose to participate via internet or telephone

Exclusion Criteria:

1. Excluding children as they cannot be legal decision-makers
2. Non-English or Non-Spanish speaking parents, as the intervention website/ videos are only available in those two languages.

Primary outcomes:
measure: Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale.
timeFrame: 1 month
measure: Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale
timeFrame: 1 month
measure: Shared Decision Making among parents making decisions about home ventilation as assessed by the Consumer Assessment of Healthcare Providers and Systems (CAHPS-SDM) survey
timeFrame: 1 month
measure: Shared decision making about home ventilation for physicians as assessed by the Shared Decision Making Questionnaire - Physician (SDM-Q-DOC) version
timeFrame: 1 month
Secondary outcomes:
measure: Change in decision making regret among parents who chose for or against home ventilation as assessed by the Decision Regret Scale
timeFrame: 6 months, 12 months
measure: Change in Quality of Life expected vs. actual, among parents who faced choice about home ventilation as assessed by the Pediatric Quality of Life Family Impact Module (PEDSQL) scale
timeFrame: 6 months, 12 months
measure: Change in Impact of decision about home on daily life of child/ family as assessed by a qualitative interview
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Johns Hopkins All Childrens Hospital
state: Florida
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Seattle
country: United States
facility: Seattle Childrens Hospital
state: Washington
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Renee Boss, MD
role: PRINCIPAL_INVESTIGATOR
References: