Critical IllnessICUconnectNCT03506438
Addressing Palliative Care Needs Among Intensive Care Unit Family Members
A study testing Needs-focused mobile app in people with Critical Illness and Family Members, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Family Members, Psychological Distress
- What is being tested?
- Needs-focused mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 18 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Needs-focused mobile app, Usual care
- Keywords
- critical illness, palliative care, mobile app, psychological distress, depression, anxiety, informal caregiver
- Medical subject headings
- Critical Illness, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needs-focused mobile appBehavioural
A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
Usual careOther
Usual ICU care as per the standards of the ICU attending
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
Measured: 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)
An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline (at time of randomization) and ~3 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start10 Apr 2019
- Primary completion8 Feb 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Christopher Cox, MD', Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506438
- Sponsor's protocol ID
- Pro00090202
- Other IDs
- 1U54MD012530
- Acronym
- ICUconnect
- Status last verified
- Oct 2023
- First submitted
- 9 Apr 2018
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38175648
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Palliative Care Needs Among Intensive Care Unit Family Members
- ClinicalTrials.gov ID
- NCT03506438
- Acronym / sponsor ID
- ICUconnect / Pro00090202
- Conditions
- Critical Illness, Family Members, Psychological Distress, Informal Caregivers, Palliative Care
- Keywords
- critical illness, palliative care, mobile app, psychological distress, depression, anxiety, informal caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ICU physician mobile app group | Experimental | Behavioral: Needs-focused mobile appClinicians 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 | Other: Usual careUsual ICU care in an ICU as per the standards of the ICU attending |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needs-focused mobile appA mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs. | Behavioural | ICU physician mobile app group |
| Usual careUsual ICU care as per the standards of the ICU attending | Other | ICU physician usual care group |
Primary outcome
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
Time frame: 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)
7 secondary outcomes
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)
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)
Post-Traumatic Stress Symptom (PTSS) Inventory
Time frame: Time 1 (baseline) and Time 4 (3 months post-randomization)
Number of Participants With Goal Concordant Care
Time frame: Time 1 (baseline) and Time 2 (target ~3 days post-randomization)
Post-randomization Hospital Length of Stay (Days)
Time frame: Across the entire hospitalization after randomization (approximately 2 months)
Post-randomization Intensive Care Unit Length of Stay (Days)
Time frame: 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
Time frame: Baseline (at time of randomization) and ~3 days post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38175648Cox 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Cox, MD' principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needs-focused mobile app in people with Critical Illness and Family Members, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score (time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.