Critical Illness, Family Members, Informal Caregivers, Palliative Care, Psychological Distress
Conditions
Keywords
critical illness, palliative care, mobile app, psychological distress, depression, anxiety, informal caregiver
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
Interventions
BEHAVIORALNeeds-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.
OTHERUsual care
Usual ICU care as per the standards of the ICU attending
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms) |
| Post-Traumatic Stress Symptom (PTSS) Inventory | 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) |
| Number of Participants With Goal Concordant Care | 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. |
| 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) | A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms) |
| Post-randomization Intensive Care Unit Length of Stay (Days) | Across the entire hospitalization after randomization (approximately 2 months) | Patient intensive care unit length of stay post-randomization |
| Number of Participants Who Responded Usually or Always on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain | Baseline (at time of randomization) and ~3 days post-randomization | 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. |
| Post-randomization Hospital Length of Stay (Days) | Across the entire hospitalization after randomization (approximately 2 months) | Patient hospital length of stay measured in days post-randomization |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Family members were excluded post-enrollment if their baseline NEST score was \<15, representing low needs.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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 | 56 |
| 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. | 55 |
| 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 | 56 |
| 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. | 19 |
| 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 | 18 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 7 | 8 | 7 | 0 | 0 |
Baseline characteristics
| Characteristic | Patients in ICU Attending Usual Care Group | Patients in ICU Attending Physician Mobile App Group | Family Members in ICU Attending Physician Usual Care Group | Family Members in ICU Attending Physician Mobile App Group | Total | ICU Attendings in the ICU Attending Usual Care Group | ICU Attendings in the ICU Attending Mobile App Group |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 57.9 years | 55.7 years | 54 years | 51 years | 54.7 years | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 55 Participants | 56 Participants | 55 Participants | 256 Participants | 16 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Needs; existential concerns; symptoms; and therapeutic interaction (NEST) scale | — | — | 36.3 units on a scale STANDARD_DEVIATION 17.4 | 36.9 units on a scale STANDARD_DEVIATION 19 | 37.0 units on a scale STANDARD_DEVIATION 18 | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 18 Participants | 28 Participants | 19 Participants | 92 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 29 Participants | 36 Participants | 28 Participants | 36 Participants | 160 Participants | 16 Participants | 15 Participants |
| Region of Enrollment United States | 56 participants | 55 participants | 56 participants | 55 participants | 259 participants | 18 participants | 19 participants |
| Sex/Gender, Customized Gender self-described as man | 38 Participants | 28 Participants | 7 Participants | 12 Participants | 108 Participants | 11 Participants | 12 Participants |
| Sex/Gender, Customized Gender self-described as woman | 18 Participants | 27 Participants | 49 Participants | 43 Participants | 151 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 17 / 55 | 15 / 56 | 0 / 55 | 0 / 56 | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 0 / 55 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 55 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 19 | 0 / 18 |
Outcome results
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)
Time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | NEST day 3 | 26.5 score on a scale | Standard Deviation 19.1 |
| Family Members in the ICU Attending Mobile App Group | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | NEST baseline | 36.9 score on a scale | Standard Deviation 19 |
| Family Members in the ICU Attending Mobile App Group | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | NEST day 7 | 24.9 score on a scale | Standard Deviation 19.5 |
| Family Members in the ICU Attending Usual Care Group | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | NEST baseline | 36.3 score on a scale | Standard Deviation 17.4 |
| Family Members in the ICU Attending Usual Care Group | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | NEST day 3 | 32.3 score on a scale | Standard Deviation 22.1 |
| Family Members in the ICU Attending Usual Care Group | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | NEST day 7 | 29.6 score on a scale | Standard Deviation 20.2 |
p-value: 0.01895% CI: [-12.2, -1.2]Mixed Models Analysis
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)
Time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
Population: Data not collected on the the patient and ICU attendings Arms/Groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | GAD-7 baseline | 9.2 score on a scale | Standard Deviation 6.3 |
| Family Members in the ICU Attending Mobile App Group | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | GAD-7 3 days | 7.9 score on a scale | Standard Deviation 6.1 |
| Family Members in the ICU Attending Mobile App Group | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | GAD-7 month 3 | 6.1 score on a scale | Standard Deviation 5.2 |
| Family Members in the ICU Attending Usual Care Group | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | GAD-7 baseline | 8.4 score on a scale | Standard Deviation 5.9 |
| Family Members in the ICU Attending Usual Care Group | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | GAD-7 3 days | 7.4 score on a scale | Standard Deviation 5.4 |
| Family Members in the ICU Attending Usual Care Group | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | GAD-7 month 3 | 5.3 score on a scale | Standard Deviation 5 |
p-value: 0.7395% CI: [-1.4, 1]Mixed Models Analysis
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.
Time frame: Baseline (at time of randomization) and ~3 days post-randomization
Population: Data not collected on the the patient and ICU attendings Arms/Groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Number of Participants Who Responded Usually or Always on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain | Day 1 | 46 Participants |
| Family Members in the ICU Attending Mobile App Group | Number of Participants Who Responded Usually or Always on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain | Day 3 | 49 Participants |
| Family Members in the ICU Attending Usual Care Group | Number of Participants Who Responded Usually or Always on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain | Day 1 | 47 Participants |
| Family Members in the ICU Attending Usual Care Group | Number of Participants Who Responded Usually or Always on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain | Day 3 | 44 Participants |
p-value: 0.08Regression, Logistic
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.
Time frame: Time 1 (baseline) and Time 2 (target ~3 days post-randomization)
Population: Data not collected on the the patient and ICU attendings Arms/Groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Number of Participants With Goal Concordant Care | Baseline | 37 Participants |
| Family Members in the ICU Attending Mobile App Group | Number of Participants With Goal Concordant Care | Day 3 | 47 Participants |
| Family Members in the ICU Attending Usual Care Group | Number of Participants With Goal Concordant Care | Baseline | 50 Participants |
| Family Members in the ICU Attending Usual Care Group | Number of Participants With Goal Concordant Care | Day 3 | 47 Participants |
p-value: 0.2995% CI: [0.6, 5.2]Regression, Logistic
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)
Time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
Population: Data not collected on the the patient and ICU attendings Arms/Groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Patient Health Questionnaire 9-Item Scale (PHQ-9) | PHQ-9 baseline | 8.0 score on a scale | Standard Deviation 3.5 |
| Family Members in the ICU Attending Mobile App Group | Patient Health Questionnaire 9-Item Scale (PHQ-9) | PHQ-9 day 3 | 6.9 score on a scale | Standard Deviation 3.7 |
| Family Members in the ICU Attending Mobile App Group | Patient Health Questionnaire 9-Item Scale (PHQ-9) | PHQ-9 3 months | 6.0 score on a scale | Standard Deviation 3.4 |
| Family Members in the ICU Attending Usual Care Group | Patient Health Questionnaire 9-Item Scale (PHQ-9) | PHQ-9 baseline | 7.7 score on a scale | Standard Deviation 3.6 |
| Family Members in the ICU Attending Usual Care Group | Patient Health Questionnaire 9-Item Scale (PHQ-9) | PHQ-9 day 3 | 6.4 score on a scale | Standard Deviation 3.1 |
| Family Members in the ICU Attending Usual Care Group | Patient Health Questionnaire 9-Item Scale (PHQ-9) | PHQ-9 3 months | 6.0 score on a scale | Standard Deviation 3.4 |
p-value: 0.4895% CI: [-0.5, 1.1]Mixed Models Analysis
Secondary
Post-randomization Hospital Length of Stay (Days)
Patient hospital length of stay measured in days post-randomization
Time frame: Across the entire hospitalization after randomization (approximately 2 months)
Population: Data not collected on the the patient and ICU attendings Arms/Groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Post-randomization Hospital Length of Stay (Days) | 37.2 days | Standard Deviation 21.2 |
| Family Members in the ICU Attending Usual Care Group | Post-randomization Hospital Length of Stay (Days) | 38.6 days | Standard Deviation 21.2 |
p-value: 0.47Wilcoxon (Mann-Whitney)
Secondary
Post-randomization Intensive Care Unit Length of Stay (Days)
Patient intensive care unit length of stay post-randomization
Time frame: Across the entire hospitalization after randomization (approximately 2 months)
Population: Data not collected on the the patient and ICU attendings Arms/Groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Post-randomization Intensive Care Unit Length of Stay (Days) | 21.2 days | Standard Deviation 16.4 |
| Family Members in the ICU Attending Usual Care Group | Post-randomization Intensive Care Unit Length of Stay (Days) | 21.2 days | Standard Deviation 12 |
p-value: 0.39Wilcoxon (Mann-Whitney)
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)
Time frame: Time 1 (baseline) and Time 4 (3 months post-randomization)
Population: Data not collected on the the patient and ICU attendings Arms/Groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family Members in the ICU Attending Mobile App Group | Post-Traumatic Stress Symptom (PTSS) Inventory | PTSS baseline | 26.2 score on a scale | Standard Deviation 14.8 |
| Family Members in the ICU Attending Mobile App Group | Post-Traumatic Stress Symptom (PTSS) Inventory | PTSS month 3 | 25.4 score on a scale | Standard Deviation 15.7 |
| Family Members in the ICU Attending Usual Care Group | Post-Traumatic Stress Symptom (PTSS) Inventory | PTSS baseline | 24.5 score on a scale | Standard Deviation 13.6 |
| Family Members in the ICU Attending Usual Care Group | Post-Traumatic Stress Symptom (PTSS) Inventory | PTSS month 3 | 23.0 score on a scale | Standard Deviation 13.9 |
p-value: 0.4795% CI: [-1, 2.1]Mixed Models Analysis