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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Medical University of South Carolina | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| 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 |
| 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 |
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Inclusion Criteria:
>65 years old
English speaking
Must have one or more of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee Stapleton, MD PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States | ||
| Medical University of South Carolina |
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.
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|
| 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. |
|
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 |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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