A Patient Portal and PROMs to Improve Health Problem Detection and Retention in HIV Care: The DRHIVe Study

NCT ID: NCT06928961

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-12-31

Brief Summary

Too often, people living with HIV (PLHIV) face challenges, including additional health and psychosocial problems, that complicate self-care, like medication-taking and medical appointment attendance. Healthcare providers are not always aware when patients face these difficulties. A 'patient portal' is an online application that can give patients access to their medical records, appointment reminders, and questionnaires to inform providers about their health and wellbeing. Patient portals in HIV care can help providers detect patient problems and improve care. At the McGill University Health Centre's (MUHC) HIV care service, a survey showed great interest in a patient portal among both PLHIV and healthcare providers. Yet, little is known on how best to integrate a portal in HIV care settings and ensure it is accessible to patients. This project will be conducted at the MUHC's HIV care service in Montreal, Quebec which has over 2,000 patients. Participating patients will log on to a patient portal through a smartphone application and have a calendar of their HIV care appointments, health questionnaires to complete (previously chosen by people with HIV and healthcare providers), reminders for both and access to educational material. HIV physicians will be able to see their patients' questionnaire results to discuss them during clinic appointments. The project's objectives are to better understand what is needed to successfully integrate a portal in similar HIV practices with diverse patients and learn how acceptable and usable it is for HIV patients and doctors. The project will also examine how patient portal use impacts satisfaction, attendance, and physician detection of specific health problems. Furthemore, it will consider how patient sex, age, and ethnicity influence the results. People with HIV, providers, and staff at the study site will be involved in decision-making about this project. Over its 5-year duration, knowledge will be gained and shared on how to expand portal use efficiently and equitably in similar HIV care centers.

Detailed Description

Background HIV care involves challenges; people living with HIV (PLHIV) face greater risks of several comorbidities and psychosocial difficulties, which often impede medication adherence, appointment attendance, and other aspects of HIV self-management. For providers, detection of many of these issues (e.g., symptoms, depression, substance use) largely relies on patients reporting them and they may go untreated. Evidence shows that patient portals and patient-reported outcome measures (PROMs) can help improve HIV management. How best to implement and ensure equitable access to these tools is less clear.

Aims This project will deploy a patient portal with a standard set of PROMs previously chosen through HIV stakeholder consultations led by the research team (PLHIV, healthcare professionals…). The study site, the Chronic Viral Illness Service (CVIS) of the McGill University Health Centre, serves over 2,000 PLHIV and is the largest university hospital-based HIV center in Montreal, Quebec. The study trial will assess an implementation strategy and patient and physician perceptions of the intervention (Aim 1) and evaluate the effectiveness of available portal functions (patient lab results, appointment calendar, PROMs, reminders, educational material) in improving health service and patient outcomes (Aim 2). HIV stakeholders will be engaged throughout this 5-year project, with representation of underserved HIV communities.

Methods A single-site, multi-method, 24-month unblinded trial will be led, with a hybrid type 2 effectiveness-implementation design and progressive intervention roll-out to all participants. Nine HIV physicians will participate with 360 of their patients, setting targets for sex, age, and race/ethnicity (factors tied to differential portal use). Patients will be trained to use the portal. Appointment and PROMs-completion reminders will be automated. Patients receiving the intervention will fill out PROMs prior to meeting their HIV physician at 6-month intervals. Physicians will be trained to consult the data via an online dashboard.

For Aim 1, study questionnaires (every 6 months), will assess patient and physician satisfaction with the intervention and perceived acceptability and usability. Portal metadata, trial data (e.g., recruitment rate) and qualitative data (e.g., semi-structured interviews, coordinator fieldnotes, meeting minutes) will be analyzed, in part, to determine fidelity and feasibility. For Aim 2, outcomes will be measured every six months. Patient outcomes include satisfaction with care and medical appointment attendance which will be based on questionnaire data and study site data, respectively. Service outcomes include physician detection of health-related problems screened for with the PROMs and patient-centered care which will be obtained from physician consultation notes and questionnaire data, respectively. Data will be analyzed, in part, with an implementation framework (NASSS) and attend to equity. The engagement approach used includes an executive committee with patient-partners and physician-champions, and a patient advisory committee. The multidisciplinary research team includes experts in all relevant areas, including implementation science.

Expected outcomes This project will build knowledge on how to implement portals and PROMs efficiently and inclusively in similar HIV centers while potentially benefiting thousands of PLHIV at the CVIS.

Conditions

HIV; Patient-Reported Outcomes (PRO); Screening; Patient Portals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Arm 1

In this arm, the control period will be 6 months followed by 18 months of intervention.

Group Type: EXPERIMENTAL

Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material

Intervention Type: OTHER

Patients in the intervention will be trained to register on and use the patient portal. The following portal features will be used and studied in this project: the appointment calendar, PROMs administration, reminders (e.g., for appointments), educational materials, and access to personal lab results. Educational materials in the portal will include information on what to expect during HIV clinic visits, how to interpret HIV lab reports, and instructional videos on using the portal. Prior to visiting their HIV physician, patients will have continuous access to several portal features (calendar, education, and lab results, if applicable), and receive reminders (within 48 hours) of their clinic appointment and to complete the PROMs. Physicians will acquire their patients' PROM scores via the patient portal and receive training on how to do so. Patients and physicians are expected to review the PROM results and consider them during each clinic visit.

Arm 2

In this arm, the control period will be 12 months followed by 12 months of intervention.

Group Type: EXPERIMENTAL

Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material

Intervention Type: OTHER

Patients in the intervention will be trained to register on and use the patient portal. The following portal features will be used and studied in this project: the appointment calendar, PROMs administration, reminders (e.g., for appointments), educational materials, and access to personal lab results. Educational materials in the portal will include information on what to expect during HIV clinic visits, how to interpret HIV lab reports, and instructional videos on using the portal. Prior to visiting their HIV physician, patients will have continuous access to several portal features (calendar, education, and lab results, if applicable), and receive reminders (within 48 hours) of their clinic appointment and to complete the PROMs. Physicians will acquire their patients' PROM scores via the patient portal and receive training on how to do so. Patients and physicians are expected to review the PROM results and consider them during each clinic visit.

Arm 3

In this arm, the control period will be 18 months, followed by 6 months of intervention.

Group Type: EXPERIMENTAL

Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material

Intervention Type: OTHER

Patients in the intervention will be trained to register on and use the patient portal. The following portal features will be used and studied in this project: the appointment calendar, PROMs administration, reminders (e.g., for appointments), educational materials, and access to personal lab results. Educational materials in the portal will include information on what to expect during HIV clinic visits, how to interpret HIV lab reports, and instructional videos on using the portal. Prior to visiting their HIV physician, patients will have continuous access to several portal features (calendar, education, and lab results, if applicable), and receive reminders (within 48 hours) of their clinic appointment and to complete the PROMs. Physicians will acquire their patients' PROM scores via the patient portal and receive training on how to do so. Patients and physicians are expected to review the PROM results and consider them during each clinic visit.

Interventions

Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material

Patients in the intervention will be trained to register on and use the patient portal. The following portal features will be used and studied in this project: the appointment calendar, PROMs administration, reminders (e.g., for appointments), educational materials, and access to personal lab results. Educational materials in the portal will include information on what to expect during HIV clinic visits, how to interpret HIV lab reports, and instructional videos on using the portal. Prior to visiting their HIV physician, patients will have continuous access to several portal features (calendar, education, and lab results, if applicable), and receive reminders (within 48 hours) of their clinic appointment and to complete the PROMs. Physicians will acquire their patients' PROM scores via the patient portal and receive training on how to do so. Patients and physicians are expected to review the PROM results and consider them during each clinic visit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed living with HIV
• Adult (at least 18 years old)
• Literate in English or French
• Patient at the study site

Exclusion Criteria

• Cognitive impairment or medical instability that prevents participation
• Insufficient mastery of French or English to participate (e.g., complete PROMs, study questionnaires)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Programme National de Mentorat sur le VIH et les Hépatites (PNMVH)

UNKNOWN

Sponsor Role: collaborator

Portail VIH/sida du Québec

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Unité de Soutien SSA Québec

UNKNOWN

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Bertrand Lebouche

Clinician-Scientist and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bertrand P Lebouché, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine, McGill University

Locations

Chronic Viral Illness Service, Division of Infectious Disease, Department of Medicine, McGill University Health Centre - Glen Site

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Kim Engler, PhD

Role: CONTACT

kimcengler@gmail.com

514 934-1934 ext. 32126

David Lessard, PhD

Role: CONTACT

david.lessard2@mail.mcgill.ca

Facility Contacts

Bertrand P Lebouché, MD, PhD

Role: primary

bertrand.lebouche@mcgill.ca

514-843-2090

References

Engler K, Lessard D, Lacombe K, Palich R, Lebouche B. Development of a core patient-reported outcome set for use in HIV care at the individual patient level in Montreal: protocol for a two-phased multimethod project. BMJ Open. 2025 Jan 15;15(1):e088822. doi: 10.1136/bmjopen-2024-088822.

Reference Type: BACKGROUND

PMID: 39819929 (View on PubMed)

Other Identifiers

186089_1

Identifier Type: -

Identifier Source: org_study_id