Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2015-07-31
2016-03-31
Brief Summary
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The targeted population is inpatients at the Hospital of the University of Pennsylvania with serious medical problems. The study will involve facilitated interviews with patients using a survey instrument developed in Qualtrics.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intuitive
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.
Cognitive load
Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Deliberative
Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.
Deliberative instructions
Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions
Interventions
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Cognitive load
Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Deliberative instructions
Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions
Eligibility Criteria
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Inclusion Criteria
2. Currently an inpatient at Hospital of the University of Pennsylvania
3. Speaks and reads fluently in English
4. Either
1. Has one of the following medical conditions:
* Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry and/or eligible for long-term oxygen therapy
* Incurable interstitial lung disease with at least severe restriction on most recent pulmonary function tests and/or eligible for long-term oxygen therapy
* Congestive heart failure with NYHA Class III or higher and current hospitalization related to heart failure
* Acute myeloid leukemia
* Stage IV lymphoma
* Stage IIIB or Stage IV non-small cell lung cancer, cholangiocarcinoma, renal cell carcinoma, breast cancer, uterine cancer, cervical cancer, ovarian cancer, colorectal cancer, gastric cancer, pancreatic cancer, prostate cancer, urothelial cancer
* Stage C or D hepatocellular carcinoma
* Mesothelioma or any malignancy metastatic to the pleura; or
2. Is hospitalized on oncology, pulmonary or cardiology service and has been hospitalized at least one other time during the last year on the same service
5. Stable vital signs
Exclusion Criteria
2. Cognitive impairment to the point unable to give informed consent
3. Current feeding tube placement
4. Current tracheostomy
5. Severe pain, shortness of breath or other uncontrolled symptoms
6. Actively undergoing evaluation for solid organ transplant
7. First hospitalization after diagnosis of serious illness
60 Years
ALL
No
Sponsors
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Leonard Davis Institute
UNKNOWN
University of Pennsylvania
OTHER
Responsible Party
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Scott Halpern
Assistant Professor of Medicine
Principal Investigators
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Scott D Halpern, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Rubin EB, Buehler AE, Cooney E, Gabler NB, Mante AA, Halpern SD. Intuitive vs Deliberative Approaches to Making Decisions About Life Support: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e187851. doi: 10.1001/jamanetworkopen.2018.7851.
Other Identifiers
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UPenn 822238
Identifier Type: -
Identifier Source: org_study_id
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