Clinical trial NCT06588556: Improving Needs Among Older Adults
Official title: Improving Needs Among Older Adults: the ICUconnect 2 Primary Palliative Care RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Illness
Palliative Care
Older Adults
Informal Caregivers
Care Delivery Model
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-09-19
Enrollment: 350
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
timeFrame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
Secondary outcomes:
measure: Patient Health Questionnaire 9-Item scale (PHQ-9)
timeFrame: Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)
measure: Generalized Anxiety Disorder 7-Item scale (GAD-7)
timeFrame: Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)
measure: Post-Traumatic Stress Symptom (PTSS) inventory
timeFrame: Time 1 (baseline) and Time 4 (3 months post-randomization)
measure: Goal concordant care
timeFrame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
measure: Patient-Perceived Patient-Centeredness (PPPC) scale
timeFrame: Time 3 (target ~1 week post-randomization)
Other outcomes:
measure: Intensive Care Unit Length of Stay
timeFrame: From randomization to discharge from the ICU, up to approximately 10 days
measure: Post-randomization Hospital Length of Stay
timeFrame: From randomization to discharge from the ICU, up to approximately 10 days
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Duke
name: Christopher Cox
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox CE, Ashana DC, Riley IL, Olsen MK, Casarett D, Haines KL, O'Keefe YA, Al-Hegelan M, Harrison RW, Naglee C, Katz JN, Yang H, Pratt EH, Gu J, Dempsey K, Docherty SL, Johnson KS. Mobile Application-Based Communication Facilitation Platform for Family Members of Critically Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2349666. doi: 10.1001/jamanetworkopen.2023.49666.