Communication During Hospitalization About Resuscitation Trial

NCT ID: NCT02984124

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2025-12-31

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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Informed Assent Discussion

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Usual Care with Attention Control

Intervention Type: 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.

Interventions

Informed Assent Discussion

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 Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Renee Stapleton

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renee Stapleton, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Vermont

Burlington, Vermont, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

CHRMS 16-227

Identifier Type: -

Identifier Source: org_study_id