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HIV I InfectionNCT03584048

Charlotte Retention in Care Study

An observational study of HIV I Infection, run by Epividian at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV I Infection
What is being tested?
Alert to provider
How many people
6,500 participants
Where
4 sitesUnited States
Study dates
1 Jul 2018to 31 Oct 2019
How long will I take part?
17 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Atrium Health

    Charlotte, North Carolina, 28209

  • Amity Group Foundation

    Charlotte, North Carolina, 28215

  • Ballantyne Family Medicine

    Charlotte, North Carolina, 28215

  • Rosedale Medical

    Huntersville, North Carolina, 28078

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV I Infection
Being tested
Alert to provider

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alert to providerOther

    Providers receive alerts of sub-optimal patient attendance using 4 rules.

Study groups in NCT03584048
Study groupRoleWhat they receive
HIV-1HIV-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.
Receives: Other: Alert to provider

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Engagement level

    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).

    Measured: 12 months, 01-Nov-2018 to 31-Oct-2019

Secondary outcomes (1)

  1. Kept appointment

    Pre and post-baseline "kept appointment rate", the proportion of patients who attended their scheduled office visits.

    Measured: 12 months, 01-Nov-2018 to 31-Oct-2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start1 Jul 2018
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,500 participants (actual)
Target duration
17 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03584048
Sponsor's protocol ID
HO-18-19095
Status last verified
Oct 2019
First submitted
17 May 2018
Last updated
4 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No Protected Health Information (PHI) is shared outside of clinic. De-identified data available only to authorized researchers via Epividian Clinical Advisory Board approval.

Publications

  • Bakken S. An informatics infrastructure is essential for evidence-based practice. J Am Med Inform Assoc. 2001 May-Jun;8(3):199-201. doi: 10.1136/jamia.2001.0080199.

    PubMed 11320064

  • Bates DW, Gawande AA. Improving safety with information technology. N Engl J Med. 2003 Jun 19;348(25):2526-34. doi: 10.1056/NEJMsa020847. No abstract available.

    PubMed 12815139

  • Bakken S, Cimino JJ, Hripcsak G. Promoting patient safety and enabling evidence-based practice through informatics. Med Care. 2004 Feb;42(2 Suppl):II49-56. doi: 10.1097/01.mlr.0000109125.00113.f4.

    PubMed 14734942

  • Jenders RA, Osheroff JA, Sittig DF, Pifer EA, Teich JM. Recommendations for clinical decision support deployment: synthesis of a roundtable of medical directors of information systems. AMIA Annu Symp Proc. 2007 Oct 11;2007:359-63.

    PubMed 18693858

  • Schulman J, Kuperman GJ, Kharbanda A, Kaushal R. Discovering how to think about a hospital patient information system by struggling to evaluate it: a committee's journal. J Am Med Inform Assoc. 2007 Sep-Oct;14(5):537-41. doi: 10.1197/jamia.M2436. Epub 2007 Jun 28.

    PubMed 17600095

  • Patel V, Abramson EL, Edwards A, Malhotra S, Kaushal R. Physicians' potential use and preferences related to health information exchange. Int J Med Inform. 2011 Mar;80(3):171-80. doi: 10.1016/j.ijmedinf.2010.11.008. Epub 2010 Dec 14.

    PubMed 21156351

  • Middleton B, Hammond WE, Brennan PF, Cooper GF. Accelerating U.S. EHR adoption: how to get there from here. recommendations based on the 2004 ACMI retreat. J Am Med Inform Assoc. 2005 Jan-Feb;12(1):13-9. doi: 10.1197/jamia.M1669. Epub 2004 Oct 18.

    PubMed 15492028

  • Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.

    PubMed 15755945

  • Poon EG, Wald J, Bates DW, Middleton B, Kuperman GJ, Gandhi TK. Supporting patient care beyond the clinical encounter: three informatics innovations from partners health care. AMIA Annu Symp Proc. 2003;2003:1072.

    PubMed 14728575

  • Bakken S, Roberts WD, Chen E, Dilone J, Lee NJ, Mendonca E, Markatou M. PDA-based informatics strategies for tobacco use screening and smoking cessation management: a case study. Stud Health Technol Inform. 2007;129(Pt 2):1447-51.

    PubMed 17911954

  • Bindoff IK, Tenni PC, Peterson GM, Kang BH, Jackson SL. Development of an intelligent decision support system for medication review. J Clin Pharm Ther. 2007 Feb;32(1):81-8. doi: 10.1111/j.1365-2710.2007.00801.x.

    PubMed 17286791

  • Dickey J, Girard DE, Geheb MA, Cassel CK. Using systems-based practice to integrate education and clinical services. Med Teach. 2004 Aug;26(5):428-34. doi: 10.1080/01421590410001730967.

    PubMed 15369883

  • Grant RW, Wald JS, Poon EG, Schnipper JL, Gandhi TK, Volk LA, Middleton B. Design and implementation of a web-based patient portal linked to an ambulatory care electronic health record: patient gateway for diabetes collaborative care. Diabetes Technol Ther. 2006 Oct;8(5):576-86. doi: 10.1089/dia.2006.8.576.

    PubMed 17037972

  • Hsieh TC, Kuperman GJ, Jaggi T, Hojnowski-Diaz P, Fiskio J, Williams DH, Bates DW, Gandhi TK. Characteristics and consequences of drug allergy alert overrides in a computerized physician order entry system. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):482-91. doi: 10.1197/jamia.M1556. Epub 2004 Aug 6.

    PubMed 15298998

  • Lester WT, Ashburner JM, Grant RW, Chueh HC, Barry MJ, Atlas SJ. Mammography FastTrack: an intervention to facilitate reminders for breast cancer screening across a heterogeneous multi-clinic primary care network. J Am Med Inform Assoc. 2009 Mar-Apr;16(2):187-95. doi: 10.1197/jamia.M2813. Epub 2008 Dec 11.

    PubMed 19074304

Questions about this trial

What is this clinical trial studying?

An observational study of HIV I Infection, run by Epividian at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engagement level (time frame: 12 months, 01-Nov-2018 to 31-Oct-2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03584048, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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