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

NCT06928961 | Not Yet Recruiting

• 1 other identifier: 186089_1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV; Implementation; mHealth; Patient-reported outcome measures; PROMs; Screening; Patient portal; Mixed methods; Stakeholder engagement; Quebec; Canada; HIV care

Outcome Measures

Primary Outcomes (2)

• Acceptability of the intervention

  Acceptability of the intervention is the primary implementation outcome. It will be measured with the Acceptability E-Scale. The minimum and maximum scores on this measure are 6 and 30, respectively, where higher scores mean greater acceptability.

  During the intervention at months 6, 12, 18, and 24

• Satisfaction with care

  Satisfaction with care will be the primary effectiveness outcome measure. It will be assessed with the Short Assessment of Patient Satisfaction (SAPS) measure. The minimum and maximum scores on this measure are 0 and 28, respectively, where higher scores mean greater levels of patient satisfaction.

  At baseline, then at months 6, 12, 18 and 24

Secondary Outcomes (10)

• Technology usability -Ease of use

  During the intervention at months 6, 12, 18, and 24

• Technology usability -Perceived usefulness

  During the intervention at months 6, 12, 18, and 24

• Technology usability -Attitude

  During the intervention at months 6, 12, 18, and 24

• Feasibility of the intervention -Consent rate

  At baseline

• Feasibility of the intervention -Retention rate

  From baseline to 24 months

Study Arms (3)

Arm 1

EXPERIMENTAL

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

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

Arm 2

EXPERIMENTAL

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

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

Arm 3

EXPERIMENTAL

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

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

Interventions

Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material 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 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Programme National de Mentorat sur le VIH et les Hépatites (PNMVH): collaborator
• Portail VIH/sida du Québec: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• Unité de Soutien SSA Québec: collaborator

Study Sites (1)

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

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 39819929 BACKGROUND

MeSH Terms

Interventions

Patient Portals

Intervention Hierarchy (Ancestors)

Health Records, Personal; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Bertrand P Lebouché, MD, PhD

  Department of Family Medicine, McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Engler, PhD

CONTACT

514 934-1934; kimcengler@gmail.com

David Lessard, PhD

CONTACT

david.lessard2@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist and Associate Professor

Model Details: This is a single-site, unblinded, 24-month pragmatic trial using a hybrid type 2 implementation-effectiveness design. The intervention will be progressively rolled out at 6-month intervals, until all participants (9 physicians and 360 patients) receive it. For rollout, 9 clusters formed of 1 physician and 40 of their patients will be randomly assigned to a rollout schedule. From 0-6 months, all participants with be in the control condition. At months 6, 12, and 18, 3 distinct clusters will begin the intervention.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: April 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)