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

Primary Purpose

Critical Illness, Family Members, Psychological Distress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Needs-focused mobile app
Usual care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring critical illness, palliative care, mobile app, psychological distress, depression, anxiety, informal caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mobile app group

Usual care

Arm Description

Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.

Usual ICU care

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Patient Health Questionnaire 9-Item scale (PHQ-9)
A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
Generalized Anxiety Disorder 7-Item scale (GAD-7)
An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
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)
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.
Post-randomization hospital length of stay
A measure of hospital days after randomization
Post-randomization intensive care unit length of stay
A measure of intensive care unit days after randomization
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.

Full Information

First Posted
April 9, 2018
Last Updated
July 13, 2022
Sponsor
Duke University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03506438
Brief Title
Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Acronym
ICUconnect
Official Title
Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
February 8, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Family Members, Psychological Distress, Informal Caregivers, Palliative Care
Keywords
critical illness, palliative care, mobile app, psychological distress, depression, anxiety, informal caregiver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The electronic study data system login/password arrangement will not allow any investigator to ascertain treatment group. The study data system will automatically send links to study surveys for participant self-completion, and therefore outcomes assessors will be blinded to the majority of post-randomization data collection.
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile app group
Arm Type
Experimental
Arm Description
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
Usual ICU care
Intervention Type
Behavioral
Intervention Name(s)
Needs-focused mobile app
Intervention Description
A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual ICU care
Primary Outcome Measure Information:
Title
Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score
Description
A palliative care needs instrument. Scores range from 0 (no needs) to 130 (higher needs)
Time Frame
Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire 9-Item scale (PHQ-9)
Description
A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
Time Frame
Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
Title
Generalized Anxiety Disorder 7-Item scale (GAD-7)
Description
An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
Time Frame
Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
Title
Post-Traumatic Stress Symptom (PTSS) inventory
Description
A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)
Time Frame
Time 1 (baseline) and Time 4 (3 months post-randomization)
Title
Goal concordant care
Description
A measure of the alignment between patient values and treatments received. This is a dichotomous scale; care is either concordant or discordant.
Time Frame
Time 1 (baseline) and Time 2 (target ~3 days post-randomization)
Title
Post-randomization hospital length of stay
Description
A measure of hospital days after randomization
Time Frame
Across the entire hospitalization after randomization (approximately 2 weeks)
Title
Post-randomization intensive care unit length of stay
Description
A measure of intensive care unit days after randomization
Time Frame
Across the entire hospitalization after randomization (approximately 2 weeks)
Title
Interpersonal Processes of Care (IPC) 18-Item Short Form Scale
Description
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.
Time Frame
Baseline (at time of randomization) and ~3 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Cox, MD'
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Addressing Palliative Care Needs Among Intensive Care Unit Family Members

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