Active — Not RecruitingPhase 2/3

Communication During Hospitalization About Resuscitation Trial

United States182 participantsStarted 2016-12

Plain-language summary

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.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \>65 years old
✓. English speaking
✓. Must have one or more of the following:
✓. 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
✓. Severe functional impairment defined as dependence with \>4 activities of daily living (ADLs) on Katz Index of Independence in ADLs.

Exclusion criteria

✕. Has already definitively chosen DNR status
✕. Unable to provide informed consent
✕. Refused consent
✕. Currently listed on a transplant list (awaiting transplant)
✕. Inappropriate for study enrollment per clinician
✕. Known to have a left ventricular assist device (LVAD)
✕. Research team unavailable
✕. Patient discharged from hospital prior to enrollment

What they're measuring

Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation

Timeframe: Study day 5 +/- 1 or hospital discharge, whichever is earlier

Trial details

NCT IDNCT02984124

SponsorUniversity of Vermont

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03

View on ClinicalTrials.gov More Severe Life-limiting COPD trials