Communication During Hospitalization About Resuscitation Trial

Phase 2

Active, not recruiting

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

• Registration Number: NCT02984124
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study First Submitted: 2016-11-28
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-06
• Primary Completion: 2023-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 182

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care with Attention Control	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.
Intervention	Informed Assent Discussion	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.

Primary Outcome Measures

Name	Time	Method
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation	Study day 5 +/- 1 or hospital discharge, whichever is earlier	Patient-Assessed Quality of Communication about CPR

Secondary Outcome Measures

Name	Time	Method
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation	Study day 5 +/- 1 or hospital discharge, whichever is earlier	Family-Assessed Quality of Communication about CPR
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.
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.
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
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	Family-Assessed Satisfaction with Communication about CPR
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.
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 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.
Cost of health care after initial hospitalization	3 months and 6 months post-randomization	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.
Hospital Anxiety and Depression Survey (HADS)	Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months	Family Depressive and Anxiety Symptoms
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.
Mortality (dead or alive)	To 6 months post-randomization

Trial Locations

Locations (4)

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