Charlotte Retention in Care Study

October 27, 2021 updated by: Epividian

Charlotte Retention in Care Study - Clinical Decision Support System Prompts

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

6500

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

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Atrium Health
      • Charlotte, North Carolina, United States, 28215
        • Amity Group Foundation
      • Charlotte, North Carolina, United States, 28215
        • Ballantyne Family Medicine
      • Huntersville, North Carolina, United States, 28078
        • Rosedale Medical

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

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

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months, 01-Nov-2018 to 31-Oct-2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months, 01-Nov-2018 to 31-Oct-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epividian

Collaborators

ViiV Healthcare

Investigators

  • Principal Investigator: Michael Leonard, MD, Atrium Health (Carolinas HealthCare System)

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

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 (Actual)

July 1, 2018

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HO-18-19095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

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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