Intuition vs. Deliberation in Medical Decision Making

NCT02487810 | Completed Results

• 1 other identifier: UPenn 822238
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Acceptance or Refusal of a Feeding Tube for Chronic Aspiration

  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 acceptance of a feeding tube for chronic aspiration. In this hypothetical scenario, patients are presented with a situation in which they are unable to eat or drink safely such that small amounts of food or liquid go to their lungs and cause trouble with breathing. 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.

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

• Acceptance or Refusal of Antibiotics

  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 acceptance of antibiotics. In this hypothetical scenario, patients are presented with an illness severity such that they drift in and out of consciousness some days and are expected to die in several months. 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.

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

• Acceptance or Refusal of Breathing Machine

  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 acceptance of a breathing machine. In this hypothetical scenario, patients are presented with a life-threatening illness with 50% chance of survival provided that they receive support from a breathing machine for two weeks. 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.

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

• Acceptance or Refusal of Tracheostomy

  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 acceptance of a tracheostomy and support from a breathing machine for at least two months to survive. 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.

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

Secondary Outcomes (9)

• Scores on Uncertainty Subscale of Decisional Conflict Scale

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

• Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

• Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

• Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

• Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death

  The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

Study Arms (2)

Intuitive

EXPERIMENTAL

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.

Behavioral: Cognitive load

Deliberative

EXPERIMENTAL

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.

Behavioral: Deliberative instructions

Interventions

Cognitive load BEHAVIORAL

Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.

Intuitive

Deliberative instructions BEHAVIORAL

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

Deliberative

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 and older
• Currently an inpatient at Hospital of the University of Pennsylvania
• Speaks and reads fluently in English
• Either
• 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
• 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
• Stable vital signs

You may not qualify if:

• Notation of code status limitation in electronic medical record
• Cognitive impairment to the point unable to give informed consent
• Current feeding tube placement
• Current tracheostomy
• Severe pain, shortness of breath or other uncontrolled symptoms
• Actively undergoing evaluation for solid organ transplant
• First hospitalization after diagnosis of serious illness

Sponsors & Collaborators

• University of Pennsylvania: lead
• Leonard Davis Institute: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 30681717 DERIVED

Results Point of Contact

• Title: Beth Cooney, Assistant Director of FIELDS Program
• Organization: Fostering Improvement in End-of-Life Decision Science (FIELDS) Program

elcooney@exchange.upenn.edu

215-573-9461

Study Officials

• Scott D Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Locations

US (1)