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.

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