- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722123
Effects of Frequent Decision Making Among Patients With Serious Illnesses
August 11, 2017 updated by: Scott Halpern, University of Pennsylvania
Pilot Study of Repeated Decision Making in Patients
Decision making capacity fatigues after repeated decisions similar to skeletal muscle.
The result is decision fatigue, in which subsequent decisions are altered toward the status quo.
Patients are at risk for decision fatigue yet it has not been studied.
The Investigator proposes a randomized study in the outpatient setting in patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on participant self-control and subsequent choices.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made.
This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue.
(1) People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo.
By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities.
Patients and their surrogates often make complex medical decisions for which they may have little experience.
Although clearly at high risk, decision fatigue has not been studied this population.
To elucidate these questions, we propose a four arm study of patients in a population at high risk for making complex decisions.
Participants will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Perelman Center for Advanced Medicine at the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma
- All participants must be over the age 18
- All participants must be fluent in English
Exclusion Criteria:
- Any medical condition known to alter Stroop performance; i.e. significant visual impairment, blind or colorblind, sedating medications during appointment, history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness
- Patients will also be ineligible if they are illiterate
- Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the hypothetical medical scenarios/decisions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: DLST Only
Patients will complete the Stroop test then answer the hypothetical life sustaining therapy (LST)
|
|
Experimental: Contemplate only
Patients will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question
|
Patients are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
Experimental: Decide with advice
Patients will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question.
Within this arm, patients will receive two positive recommendations (i.e. to go ahead with the intervention) and two negative recommendations (i.e. to decline the intervention).
These positive and negative recommendations will be randomly assigned upon study enrollment.
With four hypothetical scenarios, there are six possible options for recommendation variations.
|
Patients are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
Experimental: Decide without advice
Patients will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question.
|
Patients are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroop test score
Time Frame: Approximately 15 minutes
|
Measurement of score will be done at the conclusion of instrument completion.
The Stroop test is a standard measure of self control that requires three tasks.
The last task is the most difficult where the participant must suppress the urge to read the word which is the easier task and instead say the color it is printed in.
Standard scoring is the number correct in the W trial minus the CW trials.
This data will be collected immediately following completion.
|
Approximately 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of status quo bias
Time Frame: Approximately 10 minutes
|
Evidence of status quo bias as assessed by hypothetical decision to limit life sustaining therapy or to continue treatment.
To assess for status quo bias, we will use the following technique: after the initial four hypothetical questions and Stroop testing, participants will be asked a hypothetical question about life sustaining therapy (LST).
In the question, continuing life sustaining therapy will be counted as maintaining the status quo.
This is based on current norms in American health care where life sustaining therapy is continued until a patient or surrogate specifically request otherwise.
|
Approximately 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott D. Halpern, MD, PhD, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
October 31, 2012
First Submitted That Met QC Criteria
November 2, 2012
First Posted (Estimate)
November 6, 2012
Study Record Updates
Last Update Posted (Actual)
August 15, 2017
Last Update Submitted That Met QC Criteria
August 11, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UPenn -816696
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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