Effects of Frequent Decision Making Among Patients With Serious Illnesses

NCT01722123 | Completed

• 1 other identifier: UPenn -816696
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy

Keywords

Decision fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evidence of status quo bias

  Approximately 10 minutes

Study Arms (4)

DLST Only

NO INTERVENTION

Patients will complete the Stroop test then answer the hypothetical life sustaining therapy (LST)

Contemplate only

EXPERIMENTAL

Patients will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question

Other: Hypothetical scenarios and related decisions

Decide with advice

EXPERIMENTAL

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.

Other: Hypothetical scenarios and related decisions

Decide without advice

EXPERIMENTAL

Patients will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question.

Other: Hypothetical scenarios and related decisions

Interventions

Hypothetical scenarios and related decisions OTHER

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.

Contemplate only; Decide with advice; Decide without advice

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman Center for Advanced Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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.

  PMID: 18444745 BACKGROUND

Study Officials

• Scott D. Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

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, Epidemiology, Health Policy and Medical Ethics

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

US (1)