Decision Making Support for Parents and Caregivers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neonatal Critical Illness
- Sponsor
- Duke University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Enrollment Rate (Critically Ill Infants)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
Detailed Description
In this single-arm mixed methods prospective feasibility study, we will enroll infants, parents, and clinicians. The intervention is a paper-based decision guide that contains a values clarification exercise and question prompt list.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Enrollment Rate (Critically Ill Infants)
Time Frame: At enrollment (approximately 9 months)
Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.
Complete Data Collection (Critically Ill Infants)
Time Frame: approximately 9 months
Complete data collection defined as all eligible infant, parent, and clinician data points collected for a given case and was determined at the level of the critically ill infant. Data points for which the participant withdrew prior to relevant data collection were excluded. Intervention and study procedures considered feasible if complete data collection rate is greater than or equal to 80%.
Secondary Outcomes
- Parent and Clinician Acceptability(Up to 4 weeks following use of the tool)
- Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, and up to 4 weeks following use of the tool)
- Parent Preparation for Decision Making, as Measured by the PrepDM(Up to 4 weeks following use of the tool)