Communication During Hospitalization About Resuscitation Trial

NCT02984124 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CHRMS 16-227
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Severe Life-limiting COPD; Severe Life-limiting Heart Failure; Severe Life-limiting Cirrhosis; Severe Life-limiting Malignancy; Severe Functional Impairment; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

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

  Patient-Assessed Quality of Communication about CPR

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

Secondary Outcomes (16)

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

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

• 5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation

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

• 5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation

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

• Hospital Anxiety and Depression Survey (HADS)

  Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months

• Hospital Anxiety and Depression Survey (HADS)

  Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Informed Assent Discussion

Usual Care with Attention Control

PLACEBO COMPARATOR

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.

Behavioral: Usual Care with Attention Control

Interventions

Informed Assent Discussion BEHAVIORAL

Participants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps: 1. Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated 2. Description of CPR and dying process provided 3. Personalized explanation provided about probable lack of achieving any reasonable therapeutic goal with CPR (i.e. why s/he is a poor candidate for CPR due to underlying illness) 4. Patient and family informed that due to severe underlying illness and high likelihood that CPR will be burdensome/harmful and will not provide benefit, CPR will not be offered unless they disagree (except in rare circumstance where overall therapeutic goals from step 1 are to preserve life regardless of quality of that life) Assessment of patient's and family's understanding of issues discussed; patients may actively disagree and request CPR be performed, but CPR not explicitly offered

Intervention

Usual Care with Attention Control BEHAVIORAL

Participants 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.

Usual Care with Attention Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• University of Washington: collaborator
• Medical University of South Carolina: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (4)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Renee Stapleton, MD PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (4)