Intuition vs. Deliberation in Medical Decision Making

NCT ID: NCT02487810

Last Updated: 2019-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to determine whether there are systematic differences between the decisions patients make intuitively versus deliberatively about life-sustaining medical therapies.

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.

Detailed Description

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Conditions

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Decision Making About Life-sustaining Treatment in Patients With Serious Cardiac, Respiratory and Oncological Conditions Likely to Limit Life Expectancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Cognitive load

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Deliberative instructions

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Deliberative instructions

Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 60 and older
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

1. Notation of code status limitation in electronic medical record
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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leonard Davis Institute

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Scott Halpern

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 30681717 (View on PubMed)

Other Identifiers

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UPenn 822238

Identifier Type: -

Identifier Source: org_study_id

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