Addressing Palliative Care Needs Among Intensive Care Unit Family Members

NCT03506438 | Completed Results DMC

• 2 other identifiers: Pro000902021U54MD012530
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

critical illness; palliative care; mobile app; psychological distress; depression; anxiety; informal caregiver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient Health Questionnaire 9-Item Scale (PHQ-9)

  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)

  Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)

• Post-Traumatic Stress Symptom (PTSS) Inventory

  Time 1 (baseline) and Time 4 (3 months post-randomization)

• Number of Participants With Goal Concordant Care

  Time 1 (baseline) and Time 2 (target ~3 days post-randomization)

• Post-randomization Hospital Length of Stay (Days)

  Across the entire hospitalization after randomization (approximately 2 months)

Study Arms (2)

ICU physician mobile app group

EXPERIMENTAL

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

Behavioral: Needs-focused mobile app

ICU physician usual care group

PLACEBO COMPARATOR

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

Other: Usual care

Interventions

Needs-focused mobile app 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 mobile app group

Usual care OTHER

Usual ICU care as per the standards of the ICU attending

ICU physician usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• ≥18 years of age

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 38175648 DERIVED

MeSH Terms

Conditions

Critical Illness; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Christopher Cox
• Organization: Duke

christopher.cox@duke.edu

9196817232

Study Officials

• Christopher Cox, MD'

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 24, 2018
• Study Start: April 10, 2019
• Primary Completion: February 8, 2022
• Study Completion: May 18, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)