Clinical trial NCT02487810: Intuition vs. Deliberation in Medical Decision Making
Official title: Intuition Versus Deliberation in Decisions About Life-Sustaining Medical Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making About Life-sustaining Treatment in Patients With Serious Cardiac, Respiratory and Oncological Conditions Likely to Limit Life Expectancy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Leonard Davis Institute
First posted: 2015-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptance or Refusal of a Feeding Tube for Chronic Aspiration
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Acceptance or Refusal of Antibiotics
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Acceptance or Refusal of Breathing Machine
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Acceptance or Refusal of Tracheostomy
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
Secondary outcomes:
measure: Scores on Uncertainty Subscale of Decisional Conflict Scale
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
measure: Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death
timeFrame: The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.