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2010-08-26
2014-03-26
2014-03-26
431
NCT01160367
Johns Hopkins University
Johns Hopkins University
INTERVENTIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-07-09 | N/A | 2018-08-31 |
2010-07-09 | N/A | 2018-09-05 |
2010-07-12 | N/A | 2018-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Single Group
Masking:
Single
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
|
| EXPERIMENTAL: TAILORED intervention Patients and family members who receive the TAILORED Decision Making Intervention | OTHER: TAILORED Patient Family Decision Making
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| family decision-making self-efficacy | at 8 weeks after the intervention |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| family psychological outcomes (depression, caregiver burden, decision making distress) | 8 weeks after the intervention |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
