Improving Needs Among Older Adults

Not Applicable

Not yet recruiting

• Conditions: Critical Illness; Palliative Care; Older Adults; Informal Caregivers; Care Delivery Model
• Interventions: Behavioral: ICUconnect; Other: Usual care

• Registration Number: NCT06588556
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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. Furthermore, there are few evidence-based interventions designed to help ICU clinicians provide primary palliative care themselves-and even fewer interventions tested among participants who adequately reflect the racial and ethnic diversity of the US.

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 a recent single-center cluster RCT with 111 patient-family member dyads (U54 MD012530), 42% of whom were Black, ICUconnect significantly improved unmet needs and goal concordance of care compared to usual care control. The investigators have since linguistically and culturally adapted the intervention to Latin American Spanish.

What is now needed is a multicenter RCT to test the intervention's efficacy in a population diverse in race, ethnicity, and geography that reflects the real-world experience of patients and family members. Therefore, 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Study Start: 2025-07
• Primary Completion: 2028-08
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Patients (who are not interviewed but whose characteristics prompt enrollment of family members)

1. Older adult aged ≥60 years

2. Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU for ≥48 hours

3. Serious acute cardiorespiratory condition, defined as ≥1 of the following:

   • mechanical ventilation via endotracheal tube for ≥48 hours continuously
   • non-invasive ventilation (CPAP, BiPAP) for ≥48 hours (breaks of up to 4 hours within each 12-hour period acceptable)*
   • high flow supplemental oxygen for ≥48 hours continuously*
   • use of vasopressors or inotropes for shock of any etiology for ≥48 hours continuously *note that non-invasive ventilation plus high flow supplemental oxygen together totaling ≥48 hours is also acceptable

4. ICU team expect patient to require ICU care for ≥3 more days

Family members

1. Adult aged ≥18 years
2. Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of family; Davidson J, et al. Crit Care Med, 45:103-128; 2017)

ICU clinicians

1. Adult aged ≥18 years
2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent

Exclusion Criteria

Patients*

1. Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely

2. Palliative care consultative team and/or palliative care specialists have followed the patient during the hospitalization.

   Rationale: this would dilute the intervention's effect.

3. 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.

4. ICU length of stay >7 days at an outside hospital's ICU before transfer to a study hospital ICU.

   Rationale: this scenario would represent an atypical outlier case of unique complexity.

5. Hospital length of stay >10 days at outside hospital (either on ward or ward plus ICU) before transfer to study hospital.

   Rationale: this scenario would represent an atypical outlier case of unique complexity.

6. Imprisoned person Rationale: this is a vulnerable population.

   • Note that decisional capacity is not an exclusion, as described in the Research Strategy. However, it is anticipated 75-80% of patients will lack decisional capacity due to their critical illness, delirium, and other factors based on our past work with similar eligibility criteria.

Family members

1. Low palliative care need burden (i.e., NEST scale score ≤15) at baseline (i.e., T1 data collection).

   Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST). Furthermore, specialist consultation could misdirect care from those with higher perceived needs in times of institutional staffing stresses. In past work, 15-25% of pilot participants had a NEST ≤15, and all had low levels of distress (see Research Strategy and Recruitment and Retention Plan).

2. Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions.

   Rationale: the app has not been translated into other languages; also, many outcome measures aren't validated in languages other than English and Spanish.

3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of T1 data collection.

   Rationale: this indicates a serious level of distress that will require professional assistance beyond that provided by the intervention (or control).

4. Patient regains decisional capacity after informed consent but before the family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would substantially change the nature of the interactions of family members and clinicians.

ICU clinicians None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICUconnect intervention	ICUconnect	ICUconnect 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 control	Usual care	Control 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.

Primary Outcome Measures

Name	Time	Method
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score	Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)	A palliative care needs instrument capturing all 8 domains of palliative care quality. Scores range from 0 (no needs) to 130 (higher needs).

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9-Item scale (PHQ-9)	Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)	A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
Generalized Anxiety Disorder 7-Item scale (GAD-7)	Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)	An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
Post-Traumatic Stress Symptom (PTSS) inventory	Time 1 (baseline) and Time 4 (3 months post-randomization)	A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)
Goal concordant care	Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)	A measure of hospital days after randomization
Patient-Perceived Patient-Centeredness (PPPC) scale	Time 3 (target ~1 week post-randomization)	A measure of patient-centeredness with scores that range from 12 (higher patient-centeredness) to 48 (lower patient-centeredness)

Trial Locations

Locations (4)

University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Columbia University; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States