Addressing Palliative Care Needs Among Intensive Care Unit Family Members

Study Overview
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Brief Summary
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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.

Detailed Description
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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, psychological distress symptoms, and patient-centered care; (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

Official Title
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Addressing Palliative Care Needs Among Intensive Care Unit Family Members

Conditions
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Critical Illness, Family Members, Psychological Distress, Informal Caregivers, Palliative Care

Intervention / Treatment
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* Behavioral: Needs-focused mobile app
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Unit of randomization is the ICU attending physician. We anticipate 15-25 ICU physicians for intervention and 15-25 for control. Therefore each clinician will likely have 5-12 family members each.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICU physician mobile app group<br>Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. | Behavioral: Needs-focused mobile app<br>* A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.<br>|
| Placebo Comparator: ICU physician usual care group<br>Usual ICU care in an ICU as per the standards of the ICU attending | Other: Usual care<br>* Usual ICU care as per the standards of the ICU attending<br>|

What is the study measuring?
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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 that assesses palliative care needs across all 8 domains of palliative care quality. Scores on this 13-item instrument can 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) | 
| Number of Participants With 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 (Days) | Patient hospital length of stay measured in days post-randomization | Across the entire hospitalization after randomization (approximately 2 months) | 
| Post-randomization Intensive Care Unit Length of Stay (Days) | Patient intensive care unit length of stay post-randomization | Across the entire hospitalization after randomization (approximately 2 months) | 
| Number of Participants Who Responded Usually or Always on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain | The IPC-18 is a measure of the interpersonal aspects of care. Interpersonal processes of care are the social-psychological aspects of the patient-physician interaction. These components of quality of care may help explain disparities in health between minority patients and their counterparts. The elicited concerns, responded scale within the Communication domain is used here. All items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' A higher score indicates better processes. | Baseline (at time of randomization) and  3 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical illness, palliative care, psychological distress, depression, anxiety, informal caregiver, mobile app