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

NCT01160367 | Completed

• 2 other identifiers: NA_000100445R01NR010733-02
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• family decision-making self-efficacy

  at 8 weeks after the intervention

Secondary Outcomes (1)

• family psychological outcomes (depression, caregiver burden, decision making distress)

  8 weeks after the intervention

Study Arms (2)

standard of care health decision making

ACTIVE COMPARATOR

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

TAILORED intervention

EXPERIMENTAL

Patients and family members who receive the TAILORED Decision Making Intervention

Other: TAILORED Patient Family Decision Making

Interventions

TAILORED Patient Family Decision Making OTHER

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

TAILORED intervention

standard of care OTHER

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

standard of care health decision making

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

• 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.
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• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Chicago: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 28712987 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Gastrointestinal Neoplasms; Pancreatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: August 26, 2010
• Primary Completion: March 26, 2014
• Study Completion: March 26, 2014
• Last Updated: September 5, 2018

Record last verified: 2018-08

Locations

US (1)