Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life

Completed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis, GI Cancer, Pancreatic Cancer

In brief

Specific Aims and Hypotheses: Aim 1: To test the effect of the "Trial of Ascertaining Individual preferences for Loved Ones' Role in End-of-life Decisions" (TAILORED) Intervention on family decision-making self-efficacy at 8 weeks both with respect to the patient's present situation and in a hypothetical situation in which the patient lacks decision-making capacity. Hypotheses 1a: Family decision-making self-efficacy will be greater at 8 weeks in pairs that have undergone the TAILORED Intervention than in pairs receiving the standard information on advance directives in the patient's present situation. Hypotheses 1b: Family decision-making self-efficacy will be greater at 8 weeks in pairs that have undergone the TAILORED Intervention than in pairs receiving the standard information on advance directives in the hypothetical situation in which the patient lacks decision making capacity. Aim 2: To test the effect of the TAILORED Intervention on family psychological outcomes (depression, caregiver burden, decision making distress). Hypotheses 2a: Depression will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives. Hypotheses 2b: Caregiver burden will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives. Hypotheses 2c: Decision-making distress will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives. Aim 3: To test the effect of the TAILORED Intervention on patient and family satisfaction with family decision-making involvement. Hypothesis 3a: Patient satisfaction with family decision involvement will be greater at 8 weeks in patients who have undergone the TAILORED Intervention than in patients receiving the standard information on advance directives. Hypothesis 3b: Family member satisfaction with decision involvement will be greater at 8 weeks in family members who have undergone the TAILORED Intervention than in family members receiving the standard information on advance directives. Aim 4: To explore family decision-making self-efficacy and perceptions of the TAILORED Intervention.

Key facts

Study ID: NCT01160367
Run by: Johns Hopkins University
People needed: 431
Starts: 2010-08-26
Expected to finish: 2014-03-26
Last updated by the study team: 2018-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patient Inclusion Criteria
Age 18 or older
Speaks and reads English
Diagnosed by a specialist at either Johns Hopkins Medical Institutions or University of Chicago Medical Center as having ALS or stage III or IV GI or pancreatic cancer.
Accompanied to clinic by a family member who may participate in the patient's health care decisions and who patient gives permission to approach for participation in study.
Lives within a 2-hour drive of The Johns Hopkins Medical Institutions or The University of Chicago Medical Center
G.2. Family Inclusion Criteria
Age 18 or older
Speaks and reads English
Identified by the patient-subject as a family member whom the patient may involve in health care decision making in the present and/or should the patient become too ill to make health care decisions.
Person who the patient-subject has granted investigators permission to approach for participation in this study.

You may not qualify if…

Patient Exclusion Criteria
Severe visual impairment that would limit ability to visualize instrument illustrations
Cognitive impairment indicated by a Short Portable Mental Status Questionnaire adjusted error score of >5
Has no family member who might assist in decision making or family member declines to participate.
Is not accompanied to the clinic by family member.
G.4. Family Exclusion Criteria
Declines to participate.
Severe visual impairment that would limit ability to visualize instrument illustrations.
Cognitive impairment indicated by a Short Portable Mental Status Questionnaire adjusted error score of >5

Where it is running

Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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