Amyotrophic Lateral SclerosisNCT01160367
Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life
A study testing TAILORED Patient Family Decision Making in people with Amyotrophic Lateral Sclerosis and GI Cancer, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, GI Cancer, Pancreatic Cancer
- What is being tested?
- TAILORED Patient Family Decision Making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2010to 26 Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria
- 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
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- 5.G.2. Family Inclusion Criteria
- 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.
Who cannot join
- Patient Exclusion Criteria
- 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.
- G.4. Family Exclusion Criteria
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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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis, GI Cancer, Pancreatic Cancer
- Being tested
- TAILORED Patient Family Decision Making, standard of care
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Gastrointestinal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAILORED Patient Family Decision MakingOther
Patient-family dyads will receive TAILORED intervention on health decision making
standard of careOther
Patient-family dyads will receive standard of care in health decision-making
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: standard of care |
| TAILORED intervention | Experimental | Patients and family members who receive the TAILORED Decision Making Intervention Receives: Other: TAILORED Patient Family Decision Making |
What is being measured
The primary outcome is the main question the study is designed to answer.
family decision-making self-efficacy
Measured: at 8 weeks after the intervention
Secondary outcomes (1)
family psychological outcomes (depression, caregiver burden, decision making distress)
Measured: 8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start26 Aug 2010
- Primary completion26 Mar 2014
- Study completion26 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160367
- Sponsor's protocol ID
- NA_00010044
- Other IDs
- 5R01NR010733-02
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2010
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28712987
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life
- ClinicalTrials.gov ID
- NCT01160367
- Acronym / sponsor ID
- NA_00010044
- Conditions
- Amyotrophic Lateral Sclerosis, GI Cancer, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Chicago, National Institute of Nursing Research (NINR)
- Study start
- 26 Aug 2010 (actual)
- Primary completion
- 26 Mar 2014 (actual)
- Study completion
- 26 Mar 2014 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care health decision making | Active comparator | Other: standard of carePatient-family dyads will receive the standard of care for support of patient and family members health care decision making during a clinic appointment. |
| TAILORED intervention | Experimental | Other: TAILORED Patient Family Decision MakingPatients and family members who receive the TAILORED Decision Making Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient Inclusion Criteria
- 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.
Key exclusion criteria (10 listed)
- Patient Exclusion Criteria
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAILORED Patient Family Decision MakingPatient-family dyads will receive TAILORED intervention on health decision making | Other | TAILORED intervention |
| standard of carePatient-family dyads will receive standard of care in health decision-making | Other | standard of care health decision making |
Primary outcome
family decision-making self-efficacy
Time frame: at 8 weeks after the intervention
1 secondary outcome
family psychological outcomes (depression, caregiver burden, decision making distress)
Time frame: 8 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 28712987Sulmasy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAILORED Patient Family Decision Making in people with Amyotrophic Lateral Sclerosis and GI Cancer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
family decision-making self-efficacy (time frame: at 8 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.