Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study

Abstract

Background: Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era.

Objective: We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort's data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes).

Methods: Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient's HIV care history.

Results: The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient's perspective (phase 2).

Conclusions: As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations.

Trial registration: ClinicalTrials.gov NCT03296202; https://ichgcp.net/clinical-trials-registry/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps).

Registered report identifier: RR1-10.2196/9439.

Keywords: HIV; health-related quality of life; patient-centered care; patient-generated health data; patient-reported outcomes.

Conflict of interest statement

Conflicts of Interest: DB has received a speaking fee from Gilead. FB declares to have received reimbursement for attending a symposium from ViiV Healthcare, Gilead, Bristol-Myers Squib, Merck and Janssen; speaking fee and consultancy fee from ViiV Healthcare, Gilead, Bristol-Myers Squib, Merck and Janssen; and funds for research from Gilead and ViiV Healthcare. The other authors do not have any conflicts of interest to declare.

©Diana Barger, Olivier Leleux, Valérie Conte, Vincent Sapparrart, Marie Gapillout, Isabelle Crespel, Marie Erramouspe, Sandrine Delveaux, Francois Dabis, Fabrice Bonnet. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.06.2018.

Figures

Figure 1

Integration of the QuAliV patient portal in the ANRS CO3 Aquitaine Cohort.

Figure 2

Hypothesized change to clinical decision making resulting from use of the ePRO system, adapted from Greenhalgh et al.