Communication During Hospitalization About Resuscitation Trial

End Stage Renal Disease Clinical Trial

— CHART  

Official title:

Communication During Hospitalization About Resuscitation Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02984124
• Other study ID #: CHRMS 16-227
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: December 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Severe Functional Impairment
• Severe Life-limiting Cirrhosis
• Severe Life-limiting COPD
• Severe Life-limiting Heart Failure
• Severe Life-limiting Malignancy

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Vermont	Medical University of South Carolina, University of North Carolina, Chapel Hill, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Do-Not-Resuscitate Orders (yes/no)		Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Secondary	Time to Do-Not-Resuscitate Orders		To 6 months post-randomization
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Mortality (dead or alive)		To 6 months post-randomization