Improving Needs Among Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia).
The specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult aged ≥18 years
Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU
Serious acute illness associated with a need for invasive mechanical ventilation
ICU team expect patient to require mechanical ventilation for 2 or more days
Disqualifiers
Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely
Palliative care consultative team and/or palliative care specialists are currently involved in the patient's care.
ICU length of stay >4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization.
Low palliative care need burden (i.e., NEST scale score <15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST).
Trial design
Design model
Parallel
Treatments tested in this trial
ICUconnect
BehavioralICUconnect is essentially digital infrastructure for facilitating consistent person-centered communication. It is a web app platform that works on any digital device (smartphone, computer, tablet) and uses a series of automated and timed text messages and emails to direct family members and clinicians to perform timeline-driven tasks (e.g., surveys, content review, coaching features, family meetings) across the 7- to 10-day intervention period.
Usual care
Other interventionControl family participants will receive standard ICU care that includes the study team's suggestion to clinicians to conduct regular family meetings. While control participants will also report needs, all family meetings that occur, and other outcomes via texted or emailed links to surveys within the app platform, control group needs will not be visible to clinicians and ICUconnect content will not be visible to family members. However, basic study information and staff contacts will be available on a control group-specific website accessible via links sent by the platform at the time of each data collection.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: ICUconnect interventionExperimental treatment 1 intervention
Group B: Usual care controlOther 1 intervention
Trial outcomes
Primary outcomes
1
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
A palliative care needs instrument capturing all 8 domains of palliative care quality. Scores range from 0 (no needs) to 130 (higher needs).
Time frame
Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)Secondary outcomes
1
Patient Health Questionnaire 9-Item scale (PHQ-9)
A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
Time frame
Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)2
Generalized Anxiety Disorder 7-Item scale (GAD-7)
An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
Time frame
Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)3
Post-Traumatic Stress Symptom (PTSS) inventory
A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)
Time frame
Time 1 (baseline) and Time 4 (3 months post-randomization)4
Goal concordant care
A measure of hospital days after randomization
Time frame
Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)Other outcomes
1
Intensive Care Unit Length of Stay
A measure of intensive care unit days between the date of randomization and the date of discharge from the intensive care unit
Time frame
From randomization to discharge from the ICU, up to approximately 10 days2
Post-randomization Hospital Length of Stay
A measure of hospital days between the time of randomization and discharge from the hospital
Time frame
From randomization to discharge from the ICU, up to approximately 10 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov