Effects of Frequent Decision Making Among Patients With Serious Illnesses

Chemotherapy Clinical Trial

Official title:

Pilot Study of Repeated Decision Making in Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722123
• Other study ID #: UPenn -816696
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: August 11, 2017
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy

Intervention

Other:
• Hypothetical scenarios and related decisions
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.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Medicine at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vohs KD, Baumeister RF, Schmeichel BJ, Twenge JM, Nelson NM, Tice DM. Making choices impairs subsequent self-control: a limited-resource account of decision making, self-regulation, and active initiative. J Pers Soc Psychol. 2008 May;94(5):883-98. doi: 10.1037/0022-3514.94.5.883. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroop test score	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	Evidence of status quo bias	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