Respiratory FailureNCT06039501
The Family Perspectives Project Pilot Trial
A study testing Family Perspective Program in people with Respiratory Failure and Family Support, run by Matthew Modes at 1 site in United States.
Trial summary
The purpose of the study is to conduct a pilot randomized trial of a program designed to enhance equitable communication and emotional support for families of critically ill patients in order to determine feasibility, acceptability, and participant experience with the program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure, Family Support, Physician-Patient Relations
- What is being tested?
- Family Perspective Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient inclusion criteria:
- Individuals 18 years old or older.
- Individuals admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center.
- Individuals with acute respiratory failure, defined as >24 hours of invasive mechanical ventilation.
- Individuals who received invasive mechanical ventilation within 24 hours of admission to the MICU.
- Individuals expected to need invasive mechanical ventilation for >72 hours total, as determined by the patient's intensivist physician (fellow or attending).
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- Primary surrogate decision maker inclusion criteria:
- o Individuals 18 years old or older.
- Individual who self-identifies as the most responsible for making decisions for the enrolled patient (can be either family member or close friend).
- Proficiency in English language.
- ICU support counselor inclusion criteria:
- Individuals 18 years old or older.
- Individuals who work as hospital chaplains in the MICU.
- Physician (intensivist) inclusion criteria:
- Individuals 18 years old or older.
- Individuals who work as critical care physicians in the MICU (fellow or attending).
- Nurse inclusion criteria:
- Individuals 18 years old or older.
- Individuals who work as bedside nurses in the MICU.
- Social worker inclusion criteria:
- Individuals 18 years old or older.
- Individuals work as social workers in the MICU.
Who cannot join
- Patient exclusion criteria:
- o Any records flagged "break the glass" or "research opt out."
- o Individuals expected to die within 24 hours of potential enrollment, as determined by the patient's intensivist physician (fellow or attending).
- o Individuals on comfort care protocol or with clear preference for comfort care, as determined by the patient's intensivist physician (fellow or attending).
- Individuals who are chronically dependent on a ventilator prior to admission.
- Individuals with acute on chronic neuromuscular disease-related respiratory failure (e.g., Guillain Barre, Muscular Dystrophy, Myasthenia Gravis, etc.).
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- Individuals imminently awaiting organ transplant, as determined by the patient's intensivist physician (fellow or attending).
- Individuals with decisional capacity, as determined by the patient's intensivist physician (fellow or attending).
- Individuals who are unrepresented (i.e., patient has no surrogate decision maker).
- Individuals whose potential enrolled family member (primary surrogate decision maker) is not proficient in English.
- Individuals whose attending physician is the PI on this study at the time of potential enrollment.
- Individuals who are cared for by intensivist physicians (fellow and attending) who do not agree to participate in the study.
- Individuals who have a pre-existing relationship with a hospital chaplain who does not agree to participate in the study, as determined by that chaplain.
- Primary surrogate decision maker exclusion criteria:
- o Not proficient in English language. (Rationale: materials and intervention are not adapted in other languages.)
- ICU support counselor exclusion criteria:
- o None
- Physician (intensivist) exclusion criteria:
- o None
- Nurse exclusion criteria:
- o None
- Social worker exclusion criteria:
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Matthew Modes, MD, MPP, MS, 310-423-9017, matthew.modes@cshs.org
Bryan Gonzalez, 310-248-6716, bryan.gonzalez@cshs.org
About this study
The purpose of the study is to conduct a pilot randomized trial of a program designed to enhance equitable communication and emotional support for families of critically ill patients in order to determine feasibility, acceptability, and participant experience with the program.
The primary study procedures include: chart abstraction, questionnaires, meetings with ICU support counselors, meetings with ICU physicians and care team, audio recordings of these meetings (optional), and interviews with study participants (optional).
Study participants include: 70 critically ill patients with acute respiratory failure (enrolled with the consent of their Legally Authorized Representative) and their primary surrogate decision makers as well as ICU support counselors and ICU care teams (physicians, nurses, social workers).
- Being tested
- Family Perspective Program
- Medical subject headings
- Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Perspective ProgramBehavioural
The program involves regular meetings between families and an ICU support counselor. The ICU support counselor is a trained expert in providing culturally competent emotional and/or spiritual support. The ICU support counselor will support families and also learn and summarize family perspectives in a standardized report. ICU care team members will be prompted to perspective take as they review reports prior to regular routine meetings between families and the ICU care team.
| Study group | Role | What they receive |
|---|---|---|
| Family Perspective Program | Experimental | Families of critically ill patients will receive a program designed to enhance equitable communication and emotional support.
Questionnaires will be completed by primary surrogate decision makers, ICU support counselors, and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU support counselors will be audio recorded (optional). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional). Receives: Behavioral: Family Perspective Program |
| Usual Care | No intervention | Families of critically ill patients will receive usual care, which involves regular and routine meetings between families and the ICU care team. Questionnaires will be completed by primary surrogate decision makers and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing the program for families of patients with acute respiratory failure.
The proportion of enrolled primary surrogate decision makers randomized to the program who receive all program components. The study will be declared "feasible" if at least 70% of primary surrogate decision makers receive all program components (meeting with ICU support counselors, ICU support counselors generating standardized reports, reports being reviewed by ICU care team members prior to meeting with families).
Measured: 6 months
Secondary outcomes (5)
Feasibility of collecting data from families
The proportion of enrolled primary surrogate decision makers completing all questionnaires (enrollment, after meetings with ICU care team, 1-month post-enrollment, and 6 months post-enrollment) in each arm.
Measured: 6 months
Feasibility of collecting data from ICU support counselors
The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors.
Measured: 6 months
Feasibility of collecting data from ICU care team members
The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU care team members (physicians, nurses, social workers) in each arm.
Measured: 6 months
ICU support counselor perception of feasibility of implementing the program
Mean score on the validated 4-item Feasibility of Intervention Measure
Measured: 6 months
ICU care team member perception of feasibility of implementing the program
Mean score on the validated 4-item Feasibility of Intervention Measure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start13 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Modes
- Sponsor type
- University, hospital or other
- Collaborators
- National Palliative Care Research Center
- Responsible party
- Sponsor-investigator, Matthew Modes, Cedars-Sinai Medical Center
- Investigators
- Matthew Modes, MD, MPP, MS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039501
- Sponsor's protocol ID
- Study00002813
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Family Perspectives Project Pilot Trial
- ClinicalTrials.gov ID
- NCT06039501
- Acronym / sponsor ID
- Study00002813
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Matthew ModesUniversity, hospital or other
- Collaborators
- National Palliative Care Research Center
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to conduct a pilot randomized trial of a program designed to enhance equitable communication and emotional support for families of critically ill patients in order to determine feasibility, acceptability, and participant experience with the program.
The primary study procedures include: chart abstraction, questionnaires, meetings with ICU support counselors, meetings with ICU physicians and care team, audio recordings of these meetings (optional), and interviews with study participants (optional).
Study participants include: 70 critically ill patients with acute respiratory failure (enrolled with the consent of their Legally Authorized Representative) and their primary surrogate decision makers as well as ICU support counselors and ICU care teams (physicians, nurses, social workers).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Perspective Program | Experimental | Behavioral: Family Perspective ProgramFamilies of critically ill patients will receive a program designed to enhance equitable communication and emotional support. Questionnaires will be completed by primary surrogate decision makers, ICU support counselors, and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU support counselors will be audio recorded (optional). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional). |
| Usual Care | No intervention | –Families of critically ill patients will receive usual care, which involves regular and routine meetings between families and the ICU care team. Questionnaires will be completed by primary surrogate decision makers and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patient inclusion criteria:
- Primary surrogate decision maker inclusion criteria:
- o Individuals 18 years old or older.
- ICU support counselor inclusion criteria:
- Physician (intensivist) inclusion criteria:
Key exclusion criteria (23 listed)
- Patient exclusion criteria:
- o Any records flagged "break the glass" or "research opt out."
- o Individuals expected to die within 24 hours of potential enrollment, as determined by the patient's intensivist physician (fellow or attending).
- o Individuals on comfort care protocol or with clear preference for comfort care, as determined by the patient's intensivist physician (fellow or attending).
- Primary surrogate decision maker exclusion criteria:
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 |
|---|---|---|
| Family Perspective ProgramThe program involves regular meetings between families and an ICU support counselor. The ICU support counselor is a trained expert in providing culturally competent emotional and/or spiritual support. The ICU support counselor will support families and also learn and summarize family perspectives in a standardized report. ICU care team members will be prompted to perspective take as they review reports prior to regular routine meetings between families and the ICU care team. | Behavioural | Family Perspective Program |
Primary outcome
Feasibility of implementing the program for families of patients with acute respiratory failure.
Time frame: 6 months
The proportion of enrolled primary surrogate decision makers randomized to the program who receive all program components. The study will be declared "feasible" if at least 70% of primary surrogate decision makers receive all program components (meeting with ICU support counselors, ICU support counselors generating standardized reports, reports being reviewed by ICU care team members prior to meeting with families).
5 secondary outcomes
Feasibility of collecting data from families
Time frame: 6 months
Feasibility of collecting data from ICU support counselors
Time frame: 6 months
Feasibility of collecting data from ICU care team members
Time frame: 6 months
ICU support counselor perception of feasibility of implementing the program
Time frame: 6 months
ICU care team member perception of feasibility of implementing the program
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- 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.
Matthew Modes, MD, MPP, MS principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Perspective Program in people with Respiratory Failure and Family Support, run by Matthew Modes 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 22 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 15 Jun 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Modes, MD, MPP, MS (310-423-9017, matthew.modes@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing the program for families of patients with acute respiratory failure. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2025.