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

Summary

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.

Conditions

• Amyotrophic Lateral Sclerosis
• GI Cancer
• Pancreatic Cancer

Interventions

OTHER

TAILORED Patient Family Decision Making

Patient-family dyads will receive TAILORED intervention on health decision making

OTHER

standard of care

Patient-family dyads will receive standard of care in health decision-making

Sponsors & Collaborators

• University of Chicago

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Johns Hopkins University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-26

Primary Completion

2014-03-26

Completion

2014-03-26

Countries

• United States

Study Locations