Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02879357
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2015-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005183', 'term': 'Failure to Thrive'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Completion of eligible conversations', 'timeFrame': 'from date of clinician training study start to study end date, assessed for up to 18 months', 'description': 'Median percentage of eligible patients with completed conversations (will report for all intervention clinicians as a whole and also on individual clinician level)'}, {'measure': 'Length of conversation', 'timeFrame': 'from date of clinician training study start to study end date, assessed for up to 18 months', 'description': 'Median length of time per conversation in the intervention group as reported by clinician survey'}, {'measure': 'Clinician Confidence', 'timeFrame': 'at initial clinician training and end of study (an average of 18 months)', 'description': "Clinicians who are trained to use the Guide will have improved confidence in carrying out end-of-life conversations, compared to untrained clinicians. Confidence will be evaluated before training and at end of study and measured using a 22-question survey asking clinicians to quantify their confidence on a scale of 1-7. This survey was designed by study investigators based on national surveys used to evaluate a sample of medical students, residents, and attending physicians' attitudes about end-of-life care, as well as the Harvard Medical School Center for Palliative Care's national faculty development program."}, {'measure': 'Clinician Attitudes', 'timeFrame': 'at clinician training and end of study (an average of 18 months)', 'description': "Clinicians who are trained to use the Guide will have improved attitudes in carrying out end-of-life conversations, compared to untrained clinicians. Confidence will be evaluated before training and at end of study and measured using an 11-question survey asking clinicians to quantify their confidence on a scale of 1-5. This survey was designed by study investigators based on national surveys used to evaluate a sample of medical students, residents, and attending physicians' attitudes about end-of-life care, as well as the Harvard Medical School Center for Palliative Care's national faculty development program."}, {'measure': 'Utilization', 'timeFrame': 'at end of study (an average of 18 months)', 'description': 'Patients of clinicians who are trained to use the Guide will have higher rates of hospice usage, less health care utilization, and lower expenses near the end of life. We will measure utilization outcomes for those patients for whom we have claims data through risk contracts and the accountable care organization and will compare usage and trends between intervention and comparison patients.'}], 'primaryOutcomes': [{'measure': 'Percentage of eligible patients with documented goals of care conversations', 'timeFrame': 'from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months', 'description': "For patients whose death falls during the study period, the percentage of goals of care conversations completed and documented in the electronic medical record by clinicians in the intervention group and the control group. A completed conversation is defined by key elements being documented regarding goals of care in the patient's medical record."}], 'secondaryOutcomes': [{'measure': 'Median number of days before death of first documented goals of care conversation', 'timeFrame': 'from date of determination of eligibility to date of death during the study period, assessed for up to 18 months', 'description': 'For all patients whose death falls during the study period, the median number of days from the date of the first documented goals of care conversation to date of death in both the intervention and the control group.'}, {'measure': 'Percentage of eligible patients with more comprehensive documentation of goals of care before death', 'timeFrame': 'from date of determination of eligibility to date of death during study period, assessed for up to 18 months', 'description': 'For all patients whose death falls during the study period, the percentage of patients with more comprehensive goals of care documentation before death in both the intervention group and the control group. More comprehensive is defined as documentation of a goals of care conversation that addresses more than code status only and will be evaluated for completeness in containing more key elements of a Serious Illness Care Guide conversation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Care management', 'end of life', 'advanced care planning', 'palliative care'], 'conditions': ['Failure to Thrive']}, 'descriptionModule': {'briefSummary': 'The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life.', 'detailedDescription': 'The aim of the Serious Illness Care Program (SICP) is to provide clinicians with an evidence-based structure for eliciting and documenting vital information about preferences for patient driven care of their serious illness. It is designed to help open the door for patients, families, and clinicians to talk and reflect on end-of-life issues in an ongoing way. The hypothesis of the Serious Illness Care Program is that adherence to the conversation guide portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life. For this protocol specifically, the investigators are testing a pilot intervention of a quality improvement project; the investigators plan to train clinicians and assess the feasibility and impact of the Serious Illness Care Program, which includes patient identification, clinician training, "triggering" of clinicians to conduct the SICG conversation, and documentation, in the iCMP at the Brigham and Women\'s Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Clinician Inclusion Criteria:\n\n1. Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham \\& Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner\n2. Care for patients enrolled in Brigham and Women's Hospital integrated Care Management Program (iCMP)\n\nClinician Exclusion Criteria:\n\n1. Resident in Training\n2. Non-English Speaking Clinic (e.g. Spanish Clinic)\n\nPatient Inclusion Criteria:\n\n1. Over 18 years of age\n2. English Speaker\n3. Patient at Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham \\& Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner\n4. Enrolled in Brigham and Women's Hospital integrated Care Management Program\n\nPatient Exclusion Criteria:\n\n1\\. Patient at Dana-Farber Cancer Institute"}, 'identificationModule': {'nctId': 'NCT02879357', 'acronym': 'iCMP', 'briefTitle': 'Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients', 'orgStudyIdInfo': {'id': '2014P000211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trained Clinicians', 'description': 'Training in Serious Illness Communication Guide', 'interventionNames': ['Behavioral: Training']}, {'type': 'NO_INTERVENTION', 'label': 'Untrained Clinicians', 'description': 'No training in Serious Illness Communication Guide'}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'description': '1. Clinician training\n2. System for patient selection\n3. System of "triggering" and tracking conversations\n4. Training on how to use the Serious Illness Care Guide, a guide for patients about initiating conversations with family members about end-of-life goals and values\n5. Longitudinal Medical Record (LMR) documentation module to serve as a "Single source of truth" about advance care preferences in the LMR.', 'armGroupLabels': ['Trained Clinicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rachelle E Bernacki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}, {'name': 'Susan D Block, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}, {'name': 'Rebecca Cunningham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Joshua R Lakin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Partners HealthCare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rachelle Bernacki, M.D., M.S.', 'investigatorFullName': 'Bernacki, Rachelle E.,M.D.', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}