Multicenter HomeVENT: Home Values and Experiences Navigation Track
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English- or Spanish-speaking
Males and females; Age 18 and over.
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).
Provision of signed and dated informed consent form (parent) or completion of oral consent (physician)
Disqualifiers
Excluding children as they cannot be legal decision-makers
Non-English or Non-Spanish speaking parents, as the intervention website/ videos are only available in those two languages.
Trial design
Design model
Sequential
Treatments tested in this trial
HomeVENT decision support tool
Other interventionWeb-based decision support tool that describes diverse family experiences with making decisions about pediatric chronic home ventilation
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale.
The Preparedness for Decision Making scale has a possible score range of 0-100. Higher score means more prepared.
Time frame
1 month2
Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale
The CollaboRATE-Parent version scale is a 3 item measure. Score range 0-27. Higher score means better shared decision making.
Time frame
1 month3
Shared Decision Making among parents making decisions about home ventilation as assessed by the Consumer Assessment of Healthcare Providers and Systems (CAHPS-SDM) survey
The Consumer Assessment of Healthcare Providers and Systems scale is an 8 item measure. Score range 0-23. Higher score means better shared decision making.
Time frame
1 month4
Shared decision making about home ventilation for physicians as assessed by the Shared Decision Making Questionnaire - Physician (SDM-Q-DOC) version
The Shared Decision Making Questionnaire - Physician questionnaire is a 9 item measure. Score range 0-54. Higher score meaning better shared decision making.
Time frame
1 monthSecondary outcomes
1
Change in decision making regret among parents who chose for or against home ventilation as assessed by the Decision Regret Scale
The Decision Regret Scale is a 5 item scale. Score range 1-25, with higher score meaning more regret.
Time frame
6 months, 12 months2
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
The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Time frame
6 months, 12 months3
Change in Impact of decision about home on daily life of child/ family as assessed by a qualitative interview
Time frame
6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov