Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT07032818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adapted Hospital Discharge Intervention: the CONNECT Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arm randomized controlled trial (2:1 intervention:control), Randomization stratified by language.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention success by linguistic group', 'timeFrame': '12 months', 'description': 'Number of enrolled participants who completed all study assessments stratified by linguistic group.'}, {'measure': 'Fidelity to the intervention', 'timeFrame': '12 months', 'description': 'The number of scheduled educations calls that were completed for participants in the intervention arm based on nursing documentation in Epic.'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the intervention', 'timeFrame': '12 months', 'description': 'The Acceptability of Intervention Measure (AIM) will be completed by participants in the intervention arm to assess acceptability. It has four questions with 5 Likert responses where 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree, The range of scores from 4 to 20 with higher scores indicating greater acceptability.'}, {'measure': 'Feasibility of the intervention', 'timeFrame': '12 months', 'description': 'Feasibility will be assessed by the number of participants in the intervention arm whose educational call was language concordant based on nursing documentation in Epic.'}, {'measure': 'Patient Understanding of Discharge Instruction (UDI) Scale', 'timeFrame': '12 months', 'description': 'Assessed by a composite score of six key domains of discharge instructions (primary diagnosis, self-care instructions, return precautions, medication changes, medication indications, follow-up) as determined by physician adjudicators (1=poor, 4 = near perfect). Higher scores demonstrate better understanding.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Discharge instructions', 'Non-English language preference', 'Adapting hospital discharge'], 'conditions': ['Communication Research']}, 'descriptionModule': {'briefSummary': 'Hospital discharge is a dangerous time for patients: one in five will suffer an adverse event, such as a medication error, and nearly 25% will be readmitted within 30 days. This time is even more dangerous for patients with who face communication barriers, including those with non-English language preference (NELP), low health literacy, and the elderly.\n\nThe investigators will pilot a post-discharge educational intervention to reinforce written discharge instructions (known as the After Visit Summary or AVS) using a randomized controlled trial design (2:1 intervention: control). The control group will receive current standard of care discharge education which includes a nurse reviewing their AVS and an automated call in English that allows patients to numerically select types of problems/questions that are then escalated to a nurse who should return their call within a few days. The intervention group will receive the standard of care discharge education with the AVS and an additional post-discharge educational call delivered by a registered nurse or other qualified health professional with the option to have written instructions professionally translated and sent via MyChart message--if available in their preferred language.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered language in Epic (written or spoken) is Spanish, Haitian Creole, Portuguese, Cape Verdean, or Vietnamese\n* Admitted to medicine team at Boston Medical Center (BMC)\n* Being discharged home (to the community)\n\nExclusion Criteria:\n\n* On airborne infections precautions at time of recruitment\n* On C diff precautions at time of recruitment\n* On suicide precautions at time of recruitment\n* Nurse report of participant displaying cognitive impairment, ongoing delirium, or aggression\n* Discharge observed during a prior admission'}, 'identificationModule': {'nctId': 'NCT07032818', 'acronym': 'CONNECT', 'briefTitle': 'Adapted Hospital Discharge Intervention: the CONNECT Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Communication Outreach for Navigation and Needs-based Care Transitions (CONNECT): A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-45822'}, 'secondaryIdInfos': [{'id': 'K23MD019068-01', 'link': 'https://reporter.nih.gov/quickSearch/K23MD019068-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Educational intervention', 'description': 'Participants randomized into this arm will receive current hospital discharge education and an additional post-discharge educational call.', 'interventionNames': ['Other: Additional post discharge phone call']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Participants randomized into this arm will receive current hospital discharge education.'}], 'interventions': [{'name': 'Additional post discharge phone call', 'type': 'OTHER', 'description': '24-72 hours after hospital discharge, a nurse will call participants to review the written After Visit Summary (AVS) given at discharge, including primary diagnosis, self-care instructions, emergency plan, medication changes, how and why to take medication, and scheduled follow up. These phone calls will take on average 10-15 minutes.', 'armGroupLabels': ['Educational intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Kirsten Austad, MD PhD', 'role': 'CONTACT', 'phone': '617-414-2050'}], 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Kirsten Austad, MD MPH', 'role': 'CONTACT', 'email': 'kirsten.austad@bmc.org', 'phone': '617 414-2050'}, {'name': 'Khushbu Patel, MA', 'role': 'CONTACT', 'email': 'kfpatel@bu.edu', 'phone': '617 414-6227'}], 'overallOfficials': [{'name': 'Kirsten Austad, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center, Family Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}