Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Duke University
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The quality of palliative care is highly variable for many patients treated in intensive care units (ICUs) and their family members. To address these challenges, the investigators will test the impact of a mobile app designed to help families navigate ICU-based palliative care vs. usual care. The investigators hypothesize that the intervention will reduce patient/family member unmet palliative care needs and improve the quality of clinical-family communication in racially/ethnically diverse populations.
Detailed 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 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, psychological distress symptoms, and patient-centered care; (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
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥18 years of age
- •Receive mechanical ventilation in a study ICU for ≥48 hours under care of a study ICU physician
- •Exclusion Criteria (pre-consent):
- •Decisional capacity
- •Death expected within 24 hours
- •Admission to an ICU at the index hospital \>14 days
- •Comfort care or withdrawal of treatment planned
- •Imprisoned
- •Extubated and possess decisional capacity prior to informed consent
- •Died before T2 survey complete
Exclusion Criteria
- •\*The NEST score cutoff was changed on June 26,
- •At this point, 3 patients had been randomized. This change was based on our review of data (NEST + psychological distress symptoms) from a parallel cohort study of \>50 family members of ICU patients who met nearly identical eligibility criteria as for the ICUconnect trial. This was a larger cohort than the pilot study on which we based the NEST cutoff.
Outcomes
Primary Outcomes
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
Time Frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
A palliative care needs instrument that assesses palliative care needs across all 8 domains of palliative care quality. Scores on this 13-item instrument can range from 0 (no needs) to 130 (higher needs)
Secondary Outcomes
- Patient Health Questionnaire 9-Item Scale (PHQ-9)(Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization))
- Post-randomization Intensive Care Unit Length of Stay (Days)(Across the entire hospitalization after randomization (approximately 2 months))
- Generalized Anxiety Disorder 7-Item Scale (GAD-7)(Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization))
- Post-Traumatic Stress Symptom (PTSS) Inventory(Time 1 (baseline) and Time 4 (3 months post-randomization))
- Number of Participants With Goal Concordant Care(Time 1 (baseline) and Time 2 (target ~3 days post-randomization))
- Post-randomization Hospital Length of Stay (Days)(Across the entire hospitalization after randomization (approximately 2 months))
- Number of Participants Who Responded "Usually" or "Always" on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain(Baseline (at time of randomization) and ~3 days post-randomization)