Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 1:53 AM
Study NCT ID:
NCT01160367
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2010-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 431}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2010-07-09', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'family decision-making self-efficacy', 'timeFrame': 'at 8 weeks after the intervention'}], 'secondaryOutcomes': [{'measure': 'family psychological outcomes (depression, caregiver burden, decision making distress)', 'timeFrame': '8 weeks after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis', 'GI Cancer', 'Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '28712987', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': 'Specific Aims and Hypotheses:\n\nAim 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.\n\nHypotheses 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.\n\nHypotheses 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.\n\nAim 2: To test the effect of the TAILORED Intervention on family psychological outcomes (depression, caregiver burden, decision making distress).\n\nHypotheses 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.\n\nHypotheses 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.\n\nHypotheses 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.\n\nAim 3: To test the effect of the TAILORED Intervention on patient and family satisfaction with family decision-making involvement.\n\nHypothesis 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.\n\nHypothesis 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.\n\nAim 4: To explore family decision-making self-efficacy and perceptions of the TAILORED Intervention.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient Inclusion Criteria\n\n1. Age 18 or older\n2. Speaks and reads English\n3. 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.\n4. 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.\n5. Lives within a 2-hour drive of The Johns Hopkins Medical Institutions or The University of Chicago Medical Center\n\n5.G.2. Family Inclusion Criteria\n\n1. Age 18 or older\n2. Speaks and reads English\n3. 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.\n4. Person who the patient-subject has granted investigators permission to approach for participation in this study.\n\nExclusion Criteria:\n\n* Patient Exclusion Criteria\n\n 1. Severe visual impairment that would limit ability to visualize instrument illustrations\n 2. Cognitive impairment indicated by a Short Portable Mental Status Questionnaire adjusted error score of \\>5\n 3. Has no family member who might assist in decision making or family member declines to participate.\n 4. Is not accompanied to the clinic by family member.\n 5. G.4. Family Exclusion Criteria\n\n <!-- -->\n\n 1. Declines to participate.\n 2. Severe visual impairment that would limit ability to visualize instrument illustrations.\n 3. Cognitive impairment indicated by a Short Portable Mental Status Questionnaire adjusted error score of \\>5"}, 'identificationModule': {'nctId': 'NCT01160367', 'briefTitle': "Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life", 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': "Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life", 'orgStudyIdInfo': {'id': 'NA_00010044'}, 'secondaryIdInfos': [{'id': '5R01NR010733-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01NR010733-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard of care health decision making', 'description': 'Patient-family dyads will receive the standard of care for support of patient and family members health care decision making during a clinic appointment.', 'interventionNames': ['Other: standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'TAILORED intervention', 'description': 'Patients and family members who receive the TAILORED Decision Making Intervention', 'interventionNames': ['Other: TAILORED Patient Family Decision Making']}], 'interventions': [{'name': 'TAILORED Patient Family Decision Making', 'type': 'OTHER', 'description': 'Patient-family dyads will receive TAILORED intervention on health decision making', 'armGroupLabels': ['TAILORED intervention']}, {'name': 'standard of care', 'type': 'OTHER', 'description': 'Patient-family dyads will receive standard of care in health decision-making', 'armGroupLabels': ['standard of care health decision making']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}