- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07032818
- Original Trial
Adapted Hospital Discharge Intervention: the CONNECT Pilot (CONNECT)
Communication Outreach for Navigation and Needs-based Care Transitions (CONNECT): A Pilot Randomized Controlled Trial
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.
The 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kirsten Austad, MD MPH
- Phone Number: 617 414-2050
- Email: kirsten.austad@bmc.org
Study Contact Backup
- Name: Khushbu Patel, MA
- Phone Number: 617 414-6227
- Email: kfpatel@bu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Recruiting
- Boston Medical Center
-
Contact:
- Kirsten Austad, MD PhD
- Phone Number: 617-414-2050
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered language in Epic (written or spoken) is Spanish, Haitian Creole, Portuguese, Cape Verdean, or Vietnamese
- Admitted to medicine team at Boston Medical Center (BMC)
- Being discharged home (to the community)
Exclusion Criteria:
- On airborne infections precautions at time of recruitment
- On C diff precautions at time of recruitment
- On suicide precautions at time of recruitment
- Nurse report of participant displaying cognitive impairment, ongoing delirium, or aggression
- Discharge observed during a prior admission
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Educational intervention
Participants randomized into this arm will receive current hospital discharge education and an additional post-discharge educational call.
|
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.
|
|
No Intervention: Standard of care
Participants randomized into this arm will receive current hospital discharge education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention success by linguistic group
Time Frame: 12 months
|
Number of enrolled participants who completed all study assessments stratified by linguistic group.
|
12 months
|
|
Fidelity to the intervention
Time Frame: 12 months
|
The number of scheduled educations calls that were completed for participants in the intervention arm based on nursing documentation in Epic.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention
Time Frame: 12 months
|
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.
|
12 months
|
|
Feasibility of the intervention
Time Frame: 12 months
|
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.
|
12 months
|
|
Patient Understanding of Discharge Instruction (UDI) Scale
Time Frame: 12 months
|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kirsten Austad, MD MPH, Boston Medical Center, Family Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-45822
- K23MD019068-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Communication Research
-
Insel Gruppe AG, University Hospital BernSwiss National Science Foundation; University of Bern; Fachhochschule NordwestschweizRecruitingCommunication Research | Communication, MultidisciplinarySwitzerland, Austria
-
University of Wisconsin, MadisonUniversity of South Florida; University of Pittsburgh; University of Oklahoma; Duke... and other collaboratorsEnrolling by invitationCommunication Research | Communication ProgramsUnited States
-
University of AlbertaCompleted
-
University of Wisconsin, MadisonCompletedCommunication ResearchUnited States
-
Duke-NUS Graduate Medical SchoolCompletedCommunication ResearchSingapore
-
University of MinnesotaNational Cancer Institute (NCI)CompletedCommunication ResearchUnited States
-
St. Jude Children's Research HospitalRecruitingCancer Patients | Communication ResearchUnited States
-
University of Texas at AustinCompletedCommunication Research | Physician-Patient RelationsUnited States
-
Abu Dhabi Health Services CompanyCompletedKnowledge, Attitudes, Practice | Behavior, Consumer | Research, CommunicationUnited Arab Emirates
-
Abramson Cancer Center at Penn MedicineUniversity of FloridaCompletedCommunication Research | Adolescent Behavior | VapingUnited States
Clinical Trials on Additional post discharge phone call
-
NYU Langone HealthCompletedCare TransitionsUnited States
-
Komfo Anokye Teaching HospitalRecruiting
-
Baoshan Prefecture Center for Disease Control and...Prince of Songkla UniversityUnknownMedication AdherenceChina
-
Johns Hopkins UniversityNational Human Genome Research Institute (NHGRI)Active, not recruitingGenetic Counseling | Inherited Cardiac DiseaseUnited States
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingMild Traumatic Brain InjuryFrance
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
University of MonastirCompleted
-
Groupe Hospitalier de Bretagne SudCompletedProstate Cancer | RadiotherapyFrance
-
Hospices Civils de LyonCompletedPancreatic Cancer | Surgery | ElderlyFrance
-
University Hospital, ToulouseCompletedPost Traumatic Stress DisorderFrance