New treatment option for Critical Illness
Official title Improving Needs Among Older Adults
ClinicalTrials.gov ID: NCT06588556
What this study is testing
- What it's testing
- Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients (who are not interviewed but whose characteristics prompt enrollment of family members)
- Adult aged ≥18 years
- Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU
- Serious acute illness associated with a need for invasive mechanical ventilation
- ICU team expect patient to require mechanical ventilation for 2 or more days Family members
You likely can't join if
- Patients
- Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely
- Palliative care consultative team and/or palliative care specialists are currently involved in the patient's care. Rationale: this would dilute the...
- ICU length of stay \>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of...
- Low palliative care need burden (i.e., NEST scale score \<15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot...
- Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions...
See the full eligibility criteria
- Patients (who are not interviewed but whose characteristics prompt enrollment of family members)
- Adult aged ≥18 years
- Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU
- Serious acute illness associated with a need for invasive mechanical ventilation
- ICU team expect patient to require mechanical ventilation for 2 or more days Family members
- Adult aged ≥18 years
- Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of...
- Adult aged ≥18 years
- ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent
- Patients
- Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely
- Palliative care consultative team and/or palliative care specialists are currently involved in the patient's care. Rationale: this would dilute the intervention's effect.
- ICU length of stay \>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization. 6\. Imprisoned person...
- Low palliative care need burden (i.e., NEST scale score \<15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST).
- Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions. Rationale: the app has not been translated into other languages; also, many...
- Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection. Rationale: this indicates a serious level of distress that will require professional assistance beyond that...
- Patient regains decisional capacity after informed consent but before the first family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would...
- The ICU clinician changes from a consented clinician to a non-consented clinician before the first family meeting. Rationale: in this circumstance the intervention cannot be fully deployed. ICU clinicians None
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Charleston, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; New York, New York, United States; Durham, North Carolina, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.