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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03584048
Other study ID # HO-18-19095
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date October 31, 2019

Study information

Verified date October 2019
Source Epividian
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 surveillance reports.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6500
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Alert to provider
Providers receive alerts of sub-optimal patient attendance using 4 rules.

Locations

Country Name City State
United States Amity Group Foundation Charlotte North Carolina
United States Atrium Health Charlotte North Carolina
United States Ballantyne Family Medicine Charlotte North Carolina
United States Rosedale Medical Huntersville North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Epividian ViiV Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (23)

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. — View Citation

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. — View Citation

Bakken S. An informatics infrastructure is essential for evidence-based practice. J Am Med Inform Assoc. 2001 May-Jun;8(3):199-201. — View Citation

Bates DW, Gawande AA. Improving safety with information technology. N Engl J Med. 2003 Jun 19;348(25):2526-34. — View Citation

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. — View Citation

Cowen M, Halasyamani LK, McMurtrie D, Hoffman D, Polley T, Alexander JA. Organizational structure for addressing the attributes of the ideal healthcare delivery system. J Healthc Manag. 2008 Nov-Dec;53(6):407-18; discussion 419. — View Citation

Crosson FJ. The delivery system matters. Health Aff (Millwood). 2005 Nov-Dec;24(6):1543-8. — View Citation

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. — View Citation

Doebbeling BN, Chou AF, Tierney WM. Priorities and strategies for the implementation of integrated informatics and communications technology to improve evidence-based practice. J Gen Intern Med. 2006 Feb;21 Suppl 2:S50-7. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2004 Aug 6. — View Citation

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 11:359-63. — View Citation

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. — View Citation

Lester WT, Grant R, Barnett GO, Chueh H. Facilitated lipid management using interactive e-mail: preliminary results of a randomized controlled trial. Stud Health Technol Inform. 2004;107(Pt 1):232-6. — View Citation

Lester WT, Grant RW, Barnett GO, Chueh HC. Randomized controlled trial of an informatics-based intervention to increase statin prescription for secondary prevention of coronary disease. J Gen Intern Med. 2006 Jan;21(1):22-9. — View Citation

McGowan JJ, Cusack CM, Poon EG. Formative evaluation: a critical component in EHR implementation. J Am Med Inform Assoc. 2008 May-Jun;15(3):297-301. doi: 10.1197/jamia.M2584. Epub 2008 Feb 28. — View Citation

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. Epub 2004 Oct 18. — View Citation

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. — View Citation

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. 2003:1072. — View Citation

Rind DM, Safran C, Phillips RS, Wang Q, Calkins DR, Delbanco TL, Bleich HL, Slack WV. Effect of computer-based alerts on the treatment and outcomes of hospitalized patients. Arch Intern Med. 1994 Jul 11;154(13):1511-7. — View Citation

Ruland CM, Bakken S. Developing, implementing, and evaluating decision support systems for shared decision making in patient care: a conceptual model and case illustration. J Biomed Inform. 2002 Oct-Dec;35(5-6):313-21. — View Citation

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. Epub 2007 Jun 28. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 12 months, 01-Nov-2018 to 31-Oct-2019
Secondary Kept appointment 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
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