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Charlotte Retention in Care Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03584048
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Epividian

Brief Summary:
The objective of the Charlotte Retention in Care study is to assess if clinical decision support systems (CDSS) that produce standardized alerts for measures of retention in care across clinics in the city of Charlotte, North Carolina have the ability to increase retention in care measures within clinics and in surveillance reports.

Condition or disease Intervention/treatment
HIV I Infection Other: Alert to provider

Detailed Description:
Multiple Charlotte HIV Clinic providers are participating. "Primary" HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective Electronic Health Record (EHR) system and identified through CHORUS, a Clinical Decision Support System (CDSS) developed by Epividian. The CDSS will track patient case status as active or inactive (loss to follow-up, transferred medical care, or deceased). Providers will be informed of the study and sites will be contracted to participate in this collaborative research study. This study was approved by the Advarra Institutional Review Board.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 17 Months
Official Title: Charlotte Retention in Care Study - Clinical Decision Support System Prompts
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV-1
HIV-1+, males, females, transgender, ≥18 years of age, residing in the Charlotte Metropolitan Area and with at least a single entry in the EHR in the last 2 years.
Other: Alert to provider
Providers receive alerts of sub-optimal patient attendance using 4 rules.




Primary Outcome Measures :
  1. Engagement level [ Time Frame: 12 months, 01-Nov-2018 to 31-Oct-2019 ]
    Pre and post-baseline engagement level. Engagement level is defined as patients with 0, 1, or 2+ visits to physician (identified as a visit that included the collection of 1 viral load and/or 1 CD4 count lab test).


Secondary Outcome Measures :
  1. Kept appointment [ Time Frame: 12 months, 01-Nov-2018 to 31-Oct-2019 ]
    Pre and post-baseline "kept appointment rate", the proportion of patients who attended their scheduled office visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
HIV-1+, males, females, transgender, ≥18 years of age, residing in the Charlotte Metropolitan Area and with at least a single entry in the EHR in the last 2 years.
Criteria

Inclusion Criteria:

  • HIV-1+
  • Any gender
  • 18 years old or older
  • Residing in the Charlotte, North Carolina metropolitan area
  • At least a single entry in the EHR in the last 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584048


Locations
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United States, North Carolina
Atrium Health
Charlotte, North Carolina, United States, 28209
Amity Group Foundation
Charlotte, North Carolina, United States, 28215
Ballantyne Family Medicine
Charlotte, North Carolina, United States, 28215
Rosedale Medical
Huntersville, North Carolina, United States, 28078
Sponsors and Collaborators
Epividian
ViiV Healthcare
Investigators
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Principal Investigator: Michael Leonard, MD Atrium Health (Carolinas HealthCare System)

Additional Information:

Publications:

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Responsible Party: Epividian
ClinicalTrials.gov Identifier: NCT03584048     History of Changes
Other Study ID Numbers: HO-18-19095
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Protected Health Information (PHI) is shared outside of clinic. De-identified data available only to authorized researchers via Epividian Clinical Advisory Board approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No