Clinical trial · Interventional
Communication During Hospitalization About Resuscitation Trial
NCT02984124CI-TRIAL-00112913CHARTcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients with severe life-limiting illness or severe functional impairment.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| End Stage Renal Disease | — | UNRESOLVED | — |
| Severe Functional Impairment | — | UNRESOLVED | — |
| Severe Life-limiting Cirrhosis | — | UNRESOLVED | — |
| Severe Life-limiting COPD | — | UNRESOLVED | — |
| Severe Life-limiting Heart Failure | — | UNRESOLVED | — |
| Severe Life-limiting Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Informed Assent Discussion | Behavioral | — | UNRESOLVED |
| Usual Care with Attention Control | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Participants (n= approximately 100 plus family members) who are randomized to the intervention arm of the study will participate in a discussion about CPR with a study doctor.
- interventionNames
- Behavioral: Informed Assent Discussion
- type
- PLACEBO_COMPARATOR
- label
- Usual Care with Attention Control
- description
- Participants (n= approximately 100 plus family members) who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.
- interventionNames
- Behavioral: Usual Care with Attention Control
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. \>65 years old 2. English speaking 3. Must have one or more of the following: 1. Chronic life-limiting illness with median survival \<2 years defined as: 1) metastatic cancer or inoperable lung cancer; 2) COPD requiring oxygen; 3) New York Heart Association Class III or IV heart failure, 4) Child's Class C cirrhosis or MELD score of \>20, 5) End-stage renal disease (must be on dialysis and ≥ 75 years old), 6) Advanced pulmonary fibrosis/interstitial lung disease, 7) Advanced pulmonary hypertension 2. Severe functional impairment defined as dependence with \>4 activities of daily living (ADLs) on Katz Index of Independence in ADLs. Exclusion Criteria: 1. Has already definitively chosen DNR status 2. Unable to provide informed consent 3. Refused consent 4. Currently listed on a transplant list (awaiting transplant) 5. Inappropriate for study enrollment per clinician 6. Known to have a left ventricular assist device (LVAD) 7. Research team unavailable 8. Patient discharged from hospital prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.