Clinical trial NCT04147832: Epividian / AHF: Positive Pathways - HIV Retention in Care
Official title: Epividian, Inc. and AIDS Healthcare Foundation: Positive Pathways - HIV Retention in Care RIC-20190212 (Pro00037143)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Lead sponsor: Epividian
Sponsor class: INDUSTRY
Collaborators: name: AIDS Healthcare Foundation
name: ViiV Healthcare
First posted: 2019-11-01
Enrollment: 10521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HIV-1 diagnosis who are in care at AHF and seen at least once in the last 2 years.

Brief summary: The primary objective of this study is to evaluate the effectiveness of a clinical decision support system (CDSS) combined with enhanced patient contact to retain HIV+ patients in care with AIDS Healthcare Foundation. Specifically, the study aims to evaluate the effectiveness of having the patient's primary caregiver (or dedicated case manager) telephone the patient when the patient is identified as a significant risk to loss of follow-up (at-risk patients) based upon pre-defined criteria. The secondary objective Gain a better understanding about the implementation of the study's procedures in clinical practice by evaluating survey responses delivered to participating healthcare providers and AHF staff members engaging with the study's intervention.

Detailed description: Retention in care and re-engagement in care is a primary concern in HIV treatment today and a major obstacle in the US to reach the UNAIDS 90-90-90 goal \[1\]. The U.S. CDC supports the use of HIV surveillance data to identify not-in-care (NIC) patients and re-link them to care (Data-to-Care). The optimal strategy for identifying patients for Data-to-Care is unknown. It has been postulated that by increasing follow up of high-risk patients not meeting the retention in care measures, the number of people living with HIV being retained in care may be increased by 10%.

Multiple HIV clinics within the AHF organization in the US are eligible for study participation. "Primary" HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective EHRs and identified through CHORUS, a 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.

The CDSS will generate alerts to the providers warning of suboptimal patient attendance among the population. The alerts will be generated using the following four criteria of at-risk of loss to follow-up:

* At Risk #1: No visit in the previous 4 months and no scheduled appointment in the subsequent 2 months.
* High Risk #2: Single appointment in the previous year, a missed appointment in the previous month and no scheduled appointment in the next 2 months.
* High Risk #3: Those with 2 missed sequential appointments, and no scheduled appointment in the subsequent 7 days.
* High Risk #4: Those with an attended appointment \>3 months ago and their most recent viral load \>1000 copies/ml.

Eligibility criteria: Inclusion Criteria:

* HIV-1+
* 18 years old or older
* Any sex
* Seen at least once in a US-based AHF clinic in the last 2 years with care documented in the EHR

Exclusion Criteria:

* Patients known to have left the practice
* Patients who choose not to be contacted about their care via telephone

Primary outcomes:
measure: Rate of Kept Appointments
timeFrame: 16 months, 01-Nov-2019 to 30-Apr-2021
Secondary outcomes:
measure: Viral suppression
timeFrame: 16 months, 01-Nov-2019 to 30-Apr-2021
measure: Ranked Scoring of Implementation effectiveness
timeFrame: 16 months, 01-Nov-2019 to 30-Apr-2021
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AHF
state: California
Study officials:
affiliation: AIDS Healthcare Foundation
name: Michael Wohlfeiler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kazanjian P. UNAIDS 90-90-90 Campaign to End the AIDS Epidemic in Historic Perspective. Milbank Q. 2017 Jun;95(2):408-439. doi: 10.1111/1468-0009.12265.
citation: 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.
citation: 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.
citation: 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.
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;2007:359-63.
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. doi: 10.1197/jamia.M2436. Epub 2007 Jun 28.
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. doi: 10.1197/jamia.M1669. Epub 2004 Oct 18.
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. doi: 10.1001/jama.293.10.1223.
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;2003:1072.
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.
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. doi: 10.1111/j.1365-2710.2007.00801.x.
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. doi: 10.1080/01421590410001730967.
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. doi: 10.1089/dia.2006.8.576.
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. doi: 10.1197/jamia.M1556. Epub 2004 Aug 6.
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.
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.
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. doi: 10.1111/j.1525-1497.2005.00268.x.
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.
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(Suppl 2):S50-7. doi: 10.1111/j.1525-1497.2006.00363.x.
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.
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.
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. doi: 10.1016/s1532-0464(03)00037-6.
citation: Crawford TN. Poor retention in care one-year after viral suppression: a significant predictor of viral rebound. AIDS Care. 2014;26(11):1393-9. doi: 10.1080/09540121.2014.920076. Epub 2014 May 21.
citation: Yehia BR, French B, Fleishman JA, Metlay JP, Berry SA, Korthuis PT, Agwu AL, Gebo KA; HIV Research Network. Retention in care is more strongly associated with viral suppression in HIV-infected patients with lower versus higher CD4 counts. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):333-9. doi: 10.1097/QAI.0000000000000023.
citation: Robertson M, Laraque F, Mavronicolas H, Braunstein S, Torian L. Linkage and retention in care and the time to HIV viral suppression and viral rebound - New York City. AIDS Care. 2015;27(2):260-7. doi: 10.1080/09540121.2014.959463. Epub 2014 Sep 22.
citation: Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.