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Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes

Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02222909
Acronym
CONNECT
Enrollment
6767
Registered
2014-08-22
Start date
2014-04-30
Completion date
2015-12-31
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes, Mental Health Disorder, Substance Abuse Disorder

Keywords

Community Based Organization, Reverse Innovation, Social Services, Referral, Chronic disease

Brief summary

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.

Detailed description

see above

Interventions

OTHERCo-developed IT intervention

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

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Emergency Department Visits + Hospital DaysPre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015The 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.

Countries

United States

Participant flow

Recruitment details

We used the IRS Master file of Tax Exempt Organizations to identify all non-profit organizations in our zip codes of interest, and the used the NTEE (National Taxonomy of Exempt Entities) Classification System to exclude organizations that were not involved in the direct delivery of health and human services to adults.

Participants by arm

ArmCount
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. Co-developed IT intervention: 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
2,637
Control CBOs
Community Based Organizations that are being followed for data collection only for the period of one year
4,130
Total6,767

Baseline characteristics

CharacteristicControl CBOsTotalIntervention CBOs
Age, Continuous62 years62 years62 years
Insurance Type
Medicare
2664 Participants4363 Participants1699 Participants
Insurance Type
PPMCO
1466 Participants2404 Participants938 Participants
Race/Ethnicity, Customized
Race/Ethnicity
African American
2089 Participants3530 Participants1441 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian
26 Participants48 Participants22 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Caucasian
1704 Participants2672 Participants968 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic
21 Participants36 Participants15 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Native American
10 Participants11 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
167 Participants281 Participants114 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Unknown
113 Participants189 Participants76 Participants
Sex/Gender, Customized
Gender
Female
2584 Participants4269 Participants1685 Participants
Sex/Gender, Customized
Gender
Male
1545 Participants2496 Participants951 Participants
Sex/Gender, Customized
Gender
Unknown
1 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Change in Emergency Department Visits + Hospital Days

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.

Time frame: Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015

Population: Data collected at the community-based organization level.

ArmMeasureValue (MEAN)Dispersion
Control CBOsChange in Emergency Department Visits + Hospital Days-0.0069 Diff in monthly hospital days+ED visitsStandard Deviation 0.513
Intervention CBOsChange in Emergency Department Visits + Hospital Days0.0113 Diff in monthly hospital days+ED visitsStandard Deviation 0.525
Comparison: The difference between the average sum of the number of days spent in the hospital and ED visits in the past month, pre- and post-intervention, adjusted for pre- intervention variables, was calculated for each patients. The average change scores among patients assigned to each CBO defined the CBO-level outcomes. We calculated a weighted average of the CBO outcomes separately for the iCBOs and cCBOs, defining the difference-in-differences statistic as the difference between the two averages.p-value: 0.6395% CI: [-0.12, 0.11]Randomization inference

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026