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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Amyotrophic Lateral Sclerosis; GI Cancer
• Intervention / Treatment: Other: standard of care; Other: TAILORED Patient Family Decision Making

Detailed Description

Enhanced patient-family health care decision making is essential to improving the overall quality of end-of-life care (NIH State of the Science Conference Statement on Improving End-of-Life Care, 2004). Although most terminally ill patients desire shared family decision making, few family members are prepared for this and many report high levels of distress, and even the inability to make such decisions (Nolan, et al., 2005). Factors positively influencing the surrogates are: 1) previous experience with surrogate decision making, 2) knowing the patient's preferences, and 3) receiving positive reinforcement about decision making. The last two are amenable to change in "Trial of Ascertaining Individual preferences for Loved Ones' Role in End-of-life Decisions" (the "TAILORED" study). The TAILORED intervention is a simple clinic- based protocol involving an assessment of the confidence (self-efficacy) of family members for making health care decisions with or for a terminally ill loved one. Clinicians then tailor their guidance to patients and families about issues to discuss at home to better prepare family members for the desired decision-making role. This randomized clinical trial will include 132 patient-family dyads from two diagnostic groups: a group expected to retain (amyotrophic lateral sclerosis) or lose decisional capacity (advanced gastro-intestinal malignancy). A nurse will deliver the TAILORED intervention in the clinic at baseline and will call the family member in 4- weeks to encourage ongoing patient-family discussion. Outcomes will be assessed at 8-weeks. A subgroup of family members whose loved one has died will be interviewed in-depth about their end-of-life decision making and the impact of the TAILORED Intervention. Aim 1: To test the effect of the 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. Aim 2: To test the effect of the TAILORED intervention on family psychological outcomes (depression, caregiver burden, decision making distress). Aim 3: To test the effect of the TAILORED intervention on patient and family satisfaction with family decision-making involvement. Aim 4: To explore family decision-making self-efficacy and perceptions of the TAILORED intervention. PUBLIC HEALTH RELEVANCE: Although most terminally ill patients prefer to share health care decision making with family and want family to make decisions for them if they are too ill to do so, few family members are prepared for this role and many report high levels of distress and even the inability to make such decisions. "Trial of Ascertaining Individual preferences for Loved Ones' Role in End-of-life Decisions" (the "TAILORED" study) tests a simple clinic-based protocol that allows clinicians to assess the confidence (self-efficacy) of family members for making health care decisions with or for a terminally ill loved one. Clinicians then tailor their guidance to patients and families about what issues to discuss to better prepare family members for the decision making role desired by the patient.

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patient Inclusion Criteria

1. Age 18 or older
2. Speaks and reads English
3. 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.
4. 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.
5. Lives within a 2-hour drive of The Johns Hopkins Medical Institutions or The University of Chicago Medical Center

5.G.2. Family Inclusion Criteria

1. Age 18 or older
2. Speaks and reads English
3. 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.
4. Person who the patient-subject has granted investigators permission to approach for participation in this study.

Exclusion Criteria:

• Patient Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard of care health decision making; Patient-family dyads will receive the standard of care for support of patient and family members health care decision making during a clinic appointment.	Other: standard of care; Patient-family dyads will receive standard of care in health decision-making
Experimental: TAILORED intervention; Patients and family members who receive the TAILORED Decision Making Intervention	Other: TAILORED Patient Family Decision Making; Patient-family dyads will receive TAILORED intervention on health decision making

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
family decision-making self-efficacy	at 8 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
family psychological outcomes (depression, caregiver burden, decision making distress)	8 weeks after the intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Nursing Research (NINR); University of Chicago

Publications and helpful links

General Publications

• Sulmasy DP, Hughes MT, Yenokyan G, Kub J, Terry PB, Astrow AB, Johnson JA, Ho G, Nolan MT. The Trial of Ascertaining Individual Preferences for Loved Ones' Role in End-of-Life Decisions (TAILORED) Study: A Randomized Controlled Trial to Improve Surrogate Decision Making. J Pain Symptom Manage. 2017 Oct;54(4):455-465. doi: 10.1016/j.jpainsymman.2017.07.004. Epub 2017 Jul 14.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2010
• Primary Completion (Actual): March 26, 2014
• Study Completion (Actual): March 26, 2014

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (Estimate): July 12, 2010

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Death; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: NA_00010044; 5R01NR010733-02 (U.S. NIH Grant/Contract)