Effects of Repeated Decision Making Among Surrogates of Seriously Ill Patients

NCT ID: NCT01723436

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-04-30

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. Surrogates are at risk for decision fatigue yet it has not been studied. We propose a randomized study in the outpatient setting in surrogates and patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on surrogate self-control and subsequent choices.

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. 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 in this population. To elucidate these questions, we propose a four-arm study of surrogates and patients in a population at high risk for making complex decisions. Surrogates 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.

Conditions

Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

DLST Only

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Contemplate only

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

Group Type: EXPERIMENTAL

Hypothetical scenarios and related decisions

Intervention Type: OTHER

Surrogates 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.

Decide with advice

Surrogates will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question. Within this arm, surrogates 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.

Group Type: EXPERIMENTAL

Hypothetical scenarios and related decisions

Intervention Type: OTHER

Surrogates 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.

Decide without advice

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

Group Type: EXPERIMENTAL

Hypothetical scenarios and related decisions

Intervention Type: OTHER

Surrogates 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.

Interventions

Hypothetical scenarios and related decisions

Surrogates 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients must have one of the following diagnoses: 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.
• Patients must have at least one surrogate at their clinic visit who is willing to enroll with them as a pair to be included.
• Surrogates are eligible if an eligible patient identifies them as as a surrogate and both consent for the study.
• All participants must be over the age 18
• All participants must be fluent in English

Exclusion Criteria

• Patients and surrogates will be excluded if they are illiterate or have a medical condition known to alter Stroop performance. These include individuals who are visually impaired such that they cannot read a computer screen, blind or colorblind, patients given sedating medications during their appointment and individuals with past medical history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness.
• Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the mechanical ventilation hypothetical scenario and the hypothetical life sustaining therapy question.
• Surrogates and patients are ineligible if their paired participant is excluded for any of the above reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Scott Halpern

Assistant Professor of Medicine, Epidemiology, Health Policy and Medical Ethics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott D. Halpern, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Perelman Center for Advanced Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18444745 (View on PubMed)

Other Identifiers

816697

Identifier Type: -

Identifier Source: org_study_id