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

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ClinicalTrials.gov Identifier: NCT03506438
Recruitment Status : Not yet recruiting
First Posted : April 24, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Critical Illness Family Members Psychological Distress Informal Caregivers Palliative Care Behavioral: Needs-focused mobile app Other: Usual care Not Applicable

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] 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, PCneeds will reduce family members' unmet needs, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Unit of randomization is the ICU clinician. We anticipate 15 clinicians for intervention and 15 for control. Therefore each clinician will likely have 6-12 family members each.
Masking: Double (Investigator, Outcomes 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.

Primary Purpose: Supportive Care
Official Title: Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Estimated Study Start Date : February 18, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Mobile app group
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
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.

Placebo Comparator: Usual care
Usual ICU care
Other: Usual care
Usual ICU care




Primary Outcome Measures :
  1. Change in the Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score [ Time Frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization) ]
    A palliative care needs instrument. Scores range from 0 (no needs) to 130 (higher needs)


Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire 9-Item scale (PHQ-9) [ Time Frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization) ]
    A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)

  2. Change in Generalized Anxiety Disorder 7-Item scale (GAD-7) [ Time Frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization) ]
    An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)

  3. Change in Post-Traumatic Stress Symptom (PTSS) inventory [ Time Frame: Time 1 (baseline) and Time 4 (3 months post-randomization) ]
    A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)

  4. Change in goal concordant care [ Time Frame: Time 1 (baseline) and Time 2 (target ~3 days post-randomization) ]
    A measure of the alignment between patient values and treatments received. This is a dichotomous scale; care is either concordant or discordant.

  5. Post-randomization hospital length of stay [ Time Frame: Across the entire hospitalization after randomization (approximately 2 weeks) ]
    A measure of hospital days after randomization

  6. Post-randomization intensive care unit length of stay [ Time Frame: Across the entire hospitalization after randomization (approximately 2 weeks) ]
    A measure of intensive care unit days after randomization

  7. Change in Interpersonal Processes of Care (IPC) 18-Item Short Form Scale [ Time Frame: Baseline (at time of randomization) and ~3 days post-randomization ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PATIENTS

Inclusion Criteria:

  • ≥18 years of age
  • in a study ICU for ≥24 hours
  • mechanical ventilation for ≥2 calendar days
  • extubation from mechanical ventilation not expected within 24 hours
  • death not expected within 24 hours

Exclusion Criteria:

  • Decisional capacity
  • Mechanical ventilation for ≥7 days (e.g., ventilation at outside facility before transfer)

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:

  • low need burden (NEST score <20)
  • lack a knowledge of English such that the potential participant is not confident that they could complete study tasks (app viewing, surveys)

ICU PHYSICIANS

Inclusion Criteria:

  • ≥18 years of age
  • caring for patient of interest on day of family member informed consent

Exclusion Criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506438


Contacts
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Contact: Mary Key, MPH 9196812995 mary.key@duke.edu
Contact: Christopher Cox, MD 9196817232 christopher.cox@duke.edu

Locations
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United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Christopher E Cox, MD         
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03506438     History of Changes
Other Study ID Numbers: Pro00090202
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
critical illness
palliative care
mobile app
psychological distress
depression
anxiety
informal caregiver

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes