Clinical trial · Interventional
Facilitating Communication Study
Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families: A Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injuries | — | UNRESOLVED | — |
| Cerebrovascular Disorders | — | UNRESOLVED | — |
| Chronic Disease | — | UNRESOLVED | — |
| Health Care Quality, Access, and Evaluation | — | UNRESOLVED | — |
| Heart Failure, Congestive | — | UNRESOLVED | — |
| Intensive Care Units | — | UNRESOLVED | — |
| Kidney Failure, Chronic | — | UNRESOLVED | — |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Lung Diseases | — | UNRESOLVED | — |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Multiple Organ Failure | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Facilitator-Based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Facilitator-Based Intervention
- description
- The 'Facilitator-Based Intervention' includes patient and family member subjects.
- interventionNames
- Behavioral: Facilitator-Based Intervention
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- The 'Usual Care' arm includes patient and family member subjects.
Primary outcomes (1)
- measure
- Depression Symptoms, Family (HADS-D)
- timeFrame
- 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PATIENTS. Eligible patients 18 years of age or older, English-speaking, with a chronic life-limiting illness suggesting a median survival of approximately 2 years or a severe acute illness with a risk of hospital mortality of at least 15%. Chronic life-limiting illnesses include: cancer with a poor prognosis (e.g. metastatic cancer); chronic pulmonary disease (e.g. COPD, restrictive lung disease); coronary artery disease (CAD); congestive heart failure (CHF); peripheral vascular disease (PVD); severe liver disease (e.g. cirrhosis); diabetes with end-organ damage; renal failure (e.g. ESRD); and dementia. Acute illness criteria include a SOFA, APACHE or trauma severity score predicting a 15% or greater risk of hospital mortality. Acute illnesses and conditions also include: age \>=80 years; acute respiratory distress syndrome (ARDS) with P/F ratio \<=300; subarachnoid hemorrhage (SAH) Fisher grade 3/4 with Glasgow coma score (GCS) \<=12; spontaneous hemorrhage (ICH, IPH, EDH, SDH) with GCS \<=12; stroke or cardiovascular accident (CVA) with GCS \<=12; decompressive/crash craniotomy (bone flap) with GCS \<=12; traumatic brain injury (TBI) or diffuse axonal injury (DAI) based on MRI \~day 10; or anoxic brain injury due to cardiac arrest \>48 hours. All potential participants screened for facility with English and absence of significant cognitive impairment (prior to their current hospitalization) that would limit their ability to complete survey instruments. * FAMILY. Eligible family subjects18 years of age or older, English-speaking, and identified as someone involved in patient's medical care or decision-making. Eligible family may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends. * CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. Eligible clinicians and administrators 18 years of age or older, English-speaking, employed at a participating hospital and have a familiarity with the study and the intervention. Exclusion Criteria: * PATIENTS. We will exclude patients with an anticipated ICU stay of less than 2 days, as assessed by the critical care attending physician or his/her designee. We will exclude patients who have been in the ICU for more than 14 days. * PATIENTS AND FAMILY. Reasons for exclusion for patient and family member subject groups include: legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires. * CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. n/a
References
Publications (0)
Data not yet available