Intuition vs. Deliberation in Medical Decision Making

Intuition Versus Deliberation in Decisions About Life-Sustaining Medical Therapies

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.

Study Overview

• Status: Completed
• Conditions: Decision Making About Life-sustaining Treatment in Patients With Serious Cardiac, Respiratory and Oncological Conditions Likely to Limit Life Expectancy
• Intervention / Treatment: Behavioral: Cognitive load; Behavioral: Deliberative instructions

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Cognitive load; Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Experimental: 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.	Behavioral: Deliberative instructions; Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on Uncertainty Subscale of Decisional Conflict Scale	Decisional uncertainty will be evaluated using the uncertainty subscale of the Decisional Conflict Scale ranging from 0-100 such that 0 = extremely CERTAIN about best choice and 100 = extremely UNCERTAIN about the best choice. Higher values represent MORE UNCERTAINTY with decisions regarding feeding tubes, antibiotics, intubation, and tracheostomy while lower values represent LESS UNCERTAINTY.	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	This outcome measures the proportion of participants who accept tracheostomy AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	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.	This outcome measures the proportion of participants who accept antibiotics AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	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	This outcome measures the proportion of participants who accept tracheostomy AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	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	This outcome measures the proportion of participants who accept antibiotics AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	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 Living in a Nursing Home is Equal to or Worse Than Death	This outcome measures the proportion of participants who accept tracheostomy AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	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 Living in a Nursing Home is Equal to or Worse Than Death	This outcome measures the proportion of participants who accept antibiotics AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	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 Relying on a Breathing Machine is Equal to or Worse Than Death	This outcome measures the proportion of participants who accept tracheostomy AND indicate that relying on a breathing machine is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death	This outcome measures the proportion of participants who accept a feeding tube AND indicate that relying on a feeding tube is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Leonard Davis Institute
• Investigators: Principal Investigator: Scott D Halpern, MD, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UPenn 822238