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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Chicago
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01160367
First received: July 9, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Amyotrophic Lateral Sclerosis
GI Cancer
Pancreatic Cancer
Other: TAILORED Patient Family Decision Making
Other: standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • family decision-making self-efficacy [ Time Frame: at 8 weeks after the interavention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • family psychological outcomes (depression, caregiver burden, decision making distress) [ Time Frame: 8 weeks after the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160367

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Marie T Nolan, PhD    410-614-1684    mnolan@son.jhmi.edu   
Contact: Joan Kub, PhD         
Principal Investigator: Marie T Nolan, PhD         
Sponsors and Collaborators
Johns Hopkins University
University of Chicago
  More Information

No publications provided

Responsible Party: Marie T. Nolan, PhD, RN, School of Nursing, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01160367     History of Changes
Other Study ID Numbers: 5R01NR010733-02
Study First Received: July 9, 2010
Last Updated: July 9, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Pancreatic Neoplasms
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014