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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54MD012530 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| ICU physician usual care group | Placebo Comparator | Usual ICU care in an ICU as per the standards of the ICU attending |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Generalized Anxiety Disorder 7-Item Scale (GAD-7) |
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PATIENTS
Inclusion Criteria:
Exclusion Criteria (pre-consent):
Exclusion Criteria (post-consent):
FAMILY MEMBER
Inclusion Criteria:
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*
Exclusion criteria (post-consent):
ICU PHYSICIANS
Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cox, MD' | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38175648 | Derived | 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. |
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Family members were excluded post-enrollment if their baseline NEST score was <15, representing low needs.
This was a cluster randomized trial with randomization at the level of the ICU physician. Cluster size was 4 family member-patient dyads (2 Black and 2 White family members). Patients were used to determine family member eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Family Members in ICU Attending Physician Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. |
| FG001 | Family Members in ICU Attending Physician Usual Care Group | Usual ICU care Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal |
| FG002 | Patients in ICU Attending Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. |
| FG003 | Patients in the ICU Attending Usual Care Group | Usual ICU care Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal |
| FG004 | ICU Attendings in the ICU Attending Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. |
| FG005 | ICU Attendings in the ICU Attending Usual Care Group | Usual ICU care Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Family members of patients managed in an ICU, patients managed in an ICU, and ICU attending physicians working in adult ICUs.
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| ID | Title | Description |
|---|---|---|
| BG000 | Family Members in ICU Attending Physician Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not collected for ICU attending physicians. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | score on a scale | Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization) |
|
3 months
Note that adverse event data (death, hospitalization) was collected on patients included in the trial. Note also that patients were not formally included in the trial in the sense that they completed no surveys, etc., but rather were the starting point for ascertaining eligibility for their family members.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients in ICU Attending Physician Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Cox | Duke | 9196817232 | christopher.cox@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2021 | Feb 3, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2021 | Feb 3, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2022 | Feb 3, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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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.
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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.
| Usual care | Other | Usual ICU care as per the standards of the ICU attending |
|
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| BG001 |
| Family Members in ICU Attending Physician Usual Care Group |
Usual ICU care Usual care: Usual ICU care is standard care from an ICU attending in an ICU setting per the standards of the care area without a mobile app |
| BG002 | Patients in ICU Attending Physician Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. |
| BG003 | Patients in ICU Attending Usual Care Group | Usual ICU care Usual care: Usual ICU care is standard care from an ICU attending in an ICU setting per the standards of the care area without a mobile app |
| BG004 | ICU Attendings in the ICU Attending Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. |
| BG005 | ICU Attendings in the ICU Attending Usual Care Group | Usual ICU care Usual care: Usual ICU care is standard care from an ICU attending in an ICU setting per the standards of the care area without a mobile app |
| BG006 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | This trial only enrolled non-Hispanic White and Black family members given the focus on racial disparities. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Needs; existential concerns; symptoms; and therapeutic interaction (NEST) scale | This is a measure completed by family members (not patients and not ICU physicians) that assesses palliative care need across 8 domains of palliative care quality. It is the primary study outcome. | Note that the NEST was completed by family members only in this study (i.e., NOT by patients and NOT by ICU physicians). For this reason, these sections are blank. | Mean | Standard Deviation | units on a scale |
|
| Family Members in the ICU Attending Usual Care Group |
Usual ICU care Usual care: Usual ICU care per the standards of the ICU attending |
|
|
|
| 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) | Data not collected on the the patient and ICU attendings Arms/Groups. | Posted | Mean | Standard Deviation | score on a scale | 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) | Data not collected on the the patient and ICU attendings Arms/Groups. | Posted | Mean | Standard Deviation | score on a scale | 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) | Data not collected on the the patient and ICU attendings Arms/Groups. | Posted | Mean | Standard Deviation | score on a scale | 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. | Data not collected on the the patient and ICU attendings Arms/Groups. | Posted | Count of Participants | Participants | 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 | Data not collected on the the patient and ICU attendings Arms/Groups. | Posted | Mean | Standard Deviation | days | 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 | Data not collected on the the patient and ICU attendings Arms/Groups. | Posted | Mean | Standard Deviation | days | 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. | Data not collected on the the patient and ICU attendings Arms/Groups. | Posted | Count of Participants | Participants | Baseline (at time of randomization) and ~3 days post-randomization |
|
|
|
|
| 17 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Patients in ICU Attending Physician Usual Care Group | Usual ICU care Usual care: Usual ICU care per the standards of the ICU attending | 15 | 56 | 0 | 56 | 0 | 56 |
| EG002 | Family Members in ICU Attending Physician Mobile App Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. 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. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG003 | Family Members in ICU Attending Physician Usual Care Group | Usual ICU care Usual care: Usual ICU care per the standards of the ICU attending | 0 | 56 | 0 | 56 | 0 | 56 |
| EG004 | ICU Attending in the ICU Attending Group | Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content. Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their | 0 | 19 | 0 | 19 | 0 | 19 |
| EG005 | ICU Attending in the ICU Attending Usual Care Group | Usual ICU care Usual care: Usual ICU care per the standards of the ICU attending | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001519 | Behavior |
| D001523 | Mental Disorders |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| PHQ-9 3 months |
|
| GAD-7 month 3 |
|