- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222909
Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes (CONNECT)
June 9, 2023 updated by: Johns Hopkins Bloomberg School of Public Health
Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD.
Half of these organizations were randomly assigned to the intervention group using a constrained cluster randomization process.
The remaining 11 are a part of the control intervention group.
The intervention is a co-developed set of IT tools hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care facilities and CBO clients.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
see above
Study Type
Interventional
Enrollment (Actual)
6767
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Zip codes surrounding Johns Hopkins Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Community Based Organization; 501-C3 status; Located within zip codes surrounding Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center; Provides direct services to clients
Exclusion Criteria:
Part of Johns Hopkins Medicine or Baltimore City Agency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Intervention CBOs
Will receive "co-developed IT intervention" developed together with intervention group community based members.
Set of primarily web based tools to improve connection with clients, Johns Hopkins Medicine and one another, referrals, and volunteer services.
|
The IT-based intervention is being co-developed with the community based organizations in the intervention group, and comprises tools to improve referral and tracking of clients, use of volunteers, and direct communication with hospital staff members
Other Names:
|
|
No Intervention: Control CBOs
Community Based Organizations that are being followed for data collection only for the period of one year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Emergency Department Visits + Hospital Days
Time Frame: Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015
|
The change in the average number of monthly emergency department visits and days spent in the hospital from the pre- intervention to the post-intervention period for J-CHiP patients assigned to each of the CBOs, adjusted for baseline prognostic variables.
|
Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Albert W Wu, MD MPH, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wu AW, Weston CM, Ibe CA, Ruberman CF, Bone L, Boonyasai RT, Hwang S, Gentry J, Purnell L, Lu Y, Liang S, Rosenblum M. The Baltimore Community-Based Organizations Neighborhood Network: Enhancing Capacity Together (CONNECT) Cluster RCT. Am J Prev Med. 2019 Aug;57(2):e31-e41. doi: 10.1016/j.amepre.2019.03.013. Epub 2019 Jun 25.
- Ibe CA, Basu L, Gooden R, Syed SB, Dadwal V, Bone LR, Ephraim PL, Weston CM, Wu AW; Baltimore CONNECT Project Team. From Kisiizi to Baltimore: cultivating knowledge brokers to support global innovation for community engagement in healthcare. Global Health. 2018 Feb 9;14(1):19. doi: 10.1186/s12992-018-0339-8.
- Lowe D, Ryan R, Schonfeld L, Merner B, Walsh L, Graham-Wisener L, Hill S. Effects of consumers and health providers working in partnership on health services planning, delivery and evaluation. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013373. doi: 10.1002/14651858.CD013373.pub2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
August 18, 2014
First Submitted That Met QC Criteria
August 20, 2014
First Posted (Estimated)
August 22, 2014
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD-12-11-4948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share IPD with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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