Communication During Hospitalization About Resuscitation Trial (CHART)

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Severe Life-limiting COPD; Severe Life-limiting Heart Failure; Severe Life-limiting Cirrhosis; Severe Life-limiting Malignancy; Severe Functional Impairment
• Intervention / Treatment: Behavioral: Informed Assent Discussion; Behavioral: Usual Care with Attention Control

Detailed Description

Increasing evidence suggests that high quality palliative care in older patients improves quality of care, patient and family satisfaction, and costs of care. However, while some specific palliative care interventions have been investigated, exactly how we should provide this care remains unclear. One important component of high quality provider-patient communication is discussing cardiopulmonary resuscitation (CPR) within the context of the patient's values and goals of care. Unfortunately, these conversations are often rushed, focused only on the procedure rather than the patient's goals and values, and CPR is often offered as if a choice on a menu. Elderly hospitalized patients are unlikely to have made decisions about CPR prior to hospitalization, and these discussions often leave patients and families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in chronically ill older patients continue to be very poor, despite decades of efforts toward improvement.

The investigators aim to change the paradigm of CPR discussions with older adults unlikely to benefit from CPR. This study is a randomized controlled trial comparing an innovative "informed assent" approach to discussing CPR versus usual care with attention control for older hospitalized adults with life-limiting illness or severe functional impairment, enrolling patients and family members at three different study sites. Informed assent includes: 1) eliciting values and goals, 2) explaining CPR in the context of illness, and 3) a caring statement that the patient should not receive CPR if values include avoiding burdensome therapies unlikely to provide benefit. Thus, the provider can elicit values, convey information, and state an assessment, while allowing the patient or family to disagree. The investigators hypothesize that informed assent will improve quality of and satisfaction with communication about CPR; reduce the burden of potentially harmful CPR discussions, including reduced patient and family symptoms of depression and anxiety; and reduce intensity of care and health care utilization. The intervention builds on prior work investigating CPR outcomes in older adults and performing pilot studies of the informed assent intervention in both inpatients and outpatients.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Participants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps: Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated; Description of CPR and dying process provided; 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); 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
Placebo Comparator: Usual Care with Attention Control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation	Family-Assessed Quality of Communication about CPR	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	Patient-Assessed Satisfaction with Communication about CPR	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	Family-Assessed Satisfaction with Communication about CPR	Study day 5 +/- 1 or hospital discharge, whichever is earlier
Hospital Anxiety and Depression Survey (HADS)	Patient Depressive and Anxiety Symptoms	Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Hospital Anxiety and Depression Survey (HADS)	Family Depressive and Anxiety Symptoms	Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Do-Not-Resuscitate Orders (yes/no)		Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Time to Do-Not-Resuscitate Orders		To 6 months post-randomization
Admission to the intensive care unit (ICU) 9yes/no)		Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
ICU length of stay (days)		Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Tracheostomy placement (yes/no)		Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Gastrostomy tube placement (yes/no)		Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of mechanical ventilation (yes/no)		Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of renal replacement therapy (yes/no)		Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of cardiopulmonary resuscitation (yes/no)		Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Cost of health care after initial hospitalization	Repeat hospital admissions, ICU admissions, nursing home says, hospice care stays, and use of home health care will be assessed, and if they occurred, duration will be recorded. A standardized value (costs, not charges) will be applied to these measures to determine overall cost.	3 months and 6 months post-randomization
Mortality (dead or alive)		To 6 months post-randomization

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Medical University of South Carolina; University of Washington; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Renee Stapleton, MD PhD, University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic
• Other Study ID Numbers: CHRMS 16-227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study includes quantitative data that the investigators plan to share with other researchers with interests in the quality of care provided to older hospitalized seriously ill patients and their families. De-identified questionnaire data, medical record data, and administrative data will be made available in the form of datasets with no personally identifying characteristics retained, to protect the identity of the respondents.