Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 240
Summary
- Conditions
- Critical Illness
- Family Members
- Informal Caregivers
- Palliative Care
- Psychological Distress
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Unit of randomization is the ICU attending physician. We anticipate 15-25 ICU physicians for intervention and 15-25 for control. Therefore each clinician will likely have 5-12 family members each.Masking: Double (Investigator, Outcomes Assessor)Masking Description: The electronic study data system login/password arrangement will not allow any investigator to ascertain treatment group. The study data system will automatically send links to study surveys for participant self-completion, and therefore outcomes assessors will be blinded to the majority of post-randomization data collection.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The quality of palliative care is highly variable in an intensive care unit (ICU) setting. These markers of poor quality are even more common among Black patients and families than among Whites. To address these challenges, the investigators developed a mobile app that allows families to both give a...
The quality of palliative care is highly variable in an intensive care unit (ICU) setting. These markers of poor quality are even more common among Black patients and families than among Whites. To address these challenges, the investigators developed a mobile app that allows families to both give and receive information relevant to palliative care and for ICU clinicians to visualize patient/family data and therefore better support them. To determine the effect of this intervention,the investigators propose to conduct a randomized clinical trial (RCT) comparing the intervention to usual care to address four specific aims: (1) Using a cluster randomized clinical trial, determine the effect of the intervention vs usual care on unmet needs [as measured by the NEST scale], psychological distress symptoms [as measured by the PHQ-9, GAD-7, and PTSS scales], and patient-centered care [as measured by the IPC scale]; (2) Determine the impact of the intervention on unmet needs and patient-centered care based across different racial groups; and (3) Explore family member and clinician experiences with intervention using mixed methods to understand mechanisms within unique case contexts [exploratory aim]. The investigators hypothesize that compared to usual care, ICUconnect will reduce family members' unmet needs, reduce family member psychological distress, increase the patient-centeredness care, and reduce hospital length of stay overall--though the magnitude of effect will be greater among Blacks compared to Whites.
Tracking Information
- NCT #
- NCT03506438
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Investigators
- Principal Investigator: Christopher Cox, MD' Duke University
Get Well Soon