Addressing Palliative Care Needs Among Intensive Care Unit Family Members

NCT ID: NCT03506438

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2022-05-18

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, 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

ICU physician mobile app group

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

Group Type: EXPERIMENTAL

Needs-focused mobile app

Intervention Type: BEHAVIORAL

A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.

ICU physician usual care group

Usual ICU care in an ICU as per the standards of the ICU attending

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: OTHER

Usual ICU care as per the standards of the ICU attending

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care

Usual ICU care as per the standards of the ICU attending

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥18 years of age
• Receive mechanical ventilation in a study ICU for ≥48 hours under care of a study ICU physician

• ≥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)

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

Exclusion Criteria

• 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

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

FAMILY MEMBER

• 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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Cox, MD'

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38175648 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1U54MD012530

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00090202

Identifier Type: -

Identifier Source: org_study_id