Addressing Palliative Care Needs Among Intensive Care Unit Family Members (ICUconnect)

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Psychological Distress; Informal Caregivers; Palliative Care; Family Members
• Intervention / Treatment: Behavioral: Needs-focused mobile app; Other: Usual care

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 [as measured by the NEST scale], psychological distress symptoms [as measured by the PHQ-9, GAD-7, and PTSS scales], and patient-centered care [as measured by the IPC scale]; (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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 <3 days after T1 but before T2
• Study ICU attending physicians from different groups (i.e., intervention or control) caring for patient change <3 days after T1 completed by family

Exclusion Criteria (post-consent):

• Patient regains decision making capacity before T2
• Patient dies before T2

FAMILY MEMBER

Inclusion Criteria:

• ≥18 years of age
• Self-described as the individual (related or unrelated) who provides the most support and with whom the patient has a significant relationship (per definition of 'family' described in the Society of Critical Care Medicine 2016 Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU)

Exclusion Criteria (pre-consent):

• Lack a knowledge of English such that the potential participant is not confident that they could complete study tasks (app viewing, surveys)
• Imprisoned
• Unable to complete surveys for any reason
• Describe their race as neither White nor Black*

• Describe their ethnicity as Hispanic*

  • Note that this study explicitly targets issues of racial disparities in healthcare, particularly of Black / African-Americans. Hispanics are excluded because of the pervasive nature of US residents' general belief that 'Hispanic' is a racial category.

Exclusion criteria (post-consent):

• If the assigned randomized ICU attending physician either leaves ICU service or is replaced by a non-participating ICU physician <= 2 calendar days after family member completes T1 survey
• Low need burden (NEST score <15)*

ICU PHYSICIANS

Inclusion Criteria:

• ≥18 years of age
• Attending physician in a study ICU

Exclusion Criteria:

- None

*The NEST score cutoff was changed on June 26, 2019. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mobile app group; Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.	Behavioral: Needs-focused mobile app; A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
PLACEBO_COMPARATOR: Usual care; Usual ICU care	Other: Usual care; Usual ICU care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score	A palliative care needs instrument. Scores range from 0 (no needs) to 130 (higher needs)	Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
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 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
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 1 (baseline) and Time 4 (3 months post-randomization)
Goal concordant care	A measure of the alignment between patient values and treatments received. This is a dichotomous scale; care is either concordant or discordant.	Time 1 (baseline) and Time 2 (target ~3 days post-randomization)
Post-randomization hospital length of stay	A measure of hospital days after randomization	Across the entire hospitalization after randomization (approximately 2 weeks)
Post-randomization intensive care unit length of stay	A measure of intensive care unit days after randomization	Across the entire hospitalization after randomization (approximately 2 weeks)
Interpersonal Processes of Care (IPC) 18-Item Short Form Scale	A measure of the interpersonal aspects of care. We will use the Communication (elicited concerns), Decision Making, and Discriminated due to race/ethnicity subscales. Scores will be evaluated primarily by subscales, though also a summary measure of these subscales.	Baseline (at time of randomization) and ~3 days post-randomization

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Christopher Cox, MD', Duke University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2019
• Primary Completion (ACTUAL): February 8, 2022
• Study Completion (ACTUAL): May 18, 2022

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (ACTUAL): April 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: palliative care; informal caregiver; depression; anxiety; critical illness; psychological distress; mobile app
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Pro00090202; 1U54MD012530 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No