N/A
N=259
Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Critical Illness · Family Members · Psychological Distress · Informal Caregivers · Palliative Care
Bottom Line
View on ClinicalTrials.gov: NCT03506438 ↗Enrolled (actual)
259
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score — 36.9; 36.3; 26.5; 32.3 score on a scale — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Needs-focused mobile app (Behavioral); Usual care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score |
36.9; 36.3; 26.5; 32.3; 24.9; 29.6 | 0.018 sig |
| SECONDARY Patient Health Questionnaire 9-Item Scale (PHQ-9) |
8.0; 7.7; 6.9; 6.4; 6.0; 6.0 | 0.48 |
| SECONDARY Generalized Anxiety Disorder 7-Item Scale (GAD-7) |
9.2; 8.4; 7.9; 7.4; 6.1; 5.3 | 0.73 |
| SECONDARY Post-Traumatic Stress Symptom (PTSS) Inventory |
26.2; 24.5; 25.4; 23.0 | 0.47 |
| SECONDARY Number of Participants With Goal Concordant Care |
37; 50; 47; 47 | 0.29 |
| SECONDARY Post-randomization Hospital Length of Stay (Days) |
37.2; 38.6 | 0.47 |
| SECONDARY Post-randomization Intensive Care Unit Length of Stay (Days) |
21.2; 21.2 | 0.39 |
| SECONDARY Number of Participants Who Responded "Usually" or "Always" on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain |
46; 47; 49; 44 | 0.08 |
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.
Eligibility Criteria
PATIENTS
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
- No known family or surrogate
- Care assumed by a non-study ICU attending after consent by patient/family but before T1
- Care assumed by non-study ICU attending 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.
Data sourced from ClinicalTrials.gov (NCT03506438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.