Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life
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.
Interventional
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care
family decision-making self-efficacy
at 8 weeks after the interavention
No
United States: Institutional Review Board
5R01NR010733-02
NCT01160367
August 2009
June 2014
Name | Location |
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Johns Hopkins University | Baltimore, Maryland 21205 |