Addressing Palliative Care Needs Among Intensive Care Unit Family Members

Critical Illness Clinical Trial

— ICUconnect  

Official title:

Addressing Palliative Care Needs Among Intensive Care Unit Family Members

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506438
• Other study ID #: Pro00090202
• Secondary ID: 1U54MD012530
• Status: Completed
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: May 18, 2022

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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, 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: May 18, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Family Members
• Informal Caregivers
• Palliative Care
• Psychological Distress

Intervention

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.

Other:
• Usual care
Usual ICU care as per the standards of the ICU attending

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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