Patient Portal for HIV/AIDS

Overseen By David Lessard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Cognitive impairment, Medical instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

360 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Patient Portal for HIV/AIDS?

Research shows that patient portals can improve communication between patients and healthcare providers, increase patient satisfaction, and enhance patient engagement, which can lead to better health outcomes. These benefits have been observed in patients with chronic conditions like diabetes and heart disease, suggesting similar positive effects could be expected for HIV/AIDS patients using a patient portal. ^{1 2 3 4 5}

Is the Patient Portal for HIV/AIDS treatment safe for humans?

The Patient Portal is designed to improve communication about medication symptoms and reduce adverse drug events (unwanted side effects from medications), which suggests it is focused on enhancing safety in medication use. ^{6 7 8 9 10}

How is the Patient Portal treatment unique for HIV/AIDS care?

The Patient Portal is unique for HIV/AIDS care as it provides patients with access to their health information, educational materials, and a communication channel with healthcare providers, enhancing patient engagement and self-management. Unlike traditional treatments, it focuses on improving the coordination of care and patient-provider interaction rather than directly treating the virus. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Bertrand P Lebouché, MD, PhD

Principal Investigator

Department of Family Medicine, McGill University

Eligibility Criteria

This trial is for people living with HIV who are patients at the McGill University Health Centre's HIV care service. Participants need to be willing and able to use a smartphone application that includes a patient portal, which provides access to medical records, appointment reminders, health questionnaires, and educational material.

Inclusion Criteria

Confirmed living with HIV

Patient at the study site

I can read and write in English or French.

Exclusion Criteria

I do not have any cognitive issues or unstable health conditions that prevent me from participating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants are observed without intervention to establish baseline data

6-18 months

Intervention

Participants use the patient portal and complete PROMs every 6 months

6-18 months

Visits every 6 months

Follow-up

Participants are monitored for satisfaction, attendance, and health problem detection

6 months

Treatment Details

Interventions

• Patient Portal

Trial Overview The study tests how using a patient portal impacts healthcare for those with HIV. It involves logging into an app for appointment calendars, completing health questionnaires chosen by patients and providers alike, getting reminders, and accessing educational content. Doctors will review questionnaire results during clinic visits.

Participant Groups

Group I: Arm 3 Experimental Treatment 1 Intervention

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

Group II: Arm 2 Experimental Treatment 1 Intervention

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

Group III: Arm 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

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

Collaborator

Unité de Soutien SSA Québec

Collaborator

Trials

1

Recruited

80+

Portail VIH/sida du Québec

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

Trials

3,369

Recruited

57,400,000+

Findings from Research

The implementation of an electronic Web-based system at a pediatric hospital significantly improved the completion rate of interventions related to adverse drug events (ADEs), increasing from 21% to 44.7% after the system was introduced over a 5-month evaluation period.

The new system also enhanced documentation accuracy, reducing the rate of incomplete interventions from 77% to 43.7%, indicating that a streamlined electronic approach can effectively enhance patient safety in medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of medication event interventions through use of an electronic database. Merandi, J., Morvay, S., Lewe, D., et al.[2019]

The study involved 375 patients using an electronic patient portal called MedCheck, which aimed to improve communication about medication-related symptoms, but only 49% of patients responded to the messages.

Despite the potential of the portal to enhance communication, the trial found no significant difference in adverse drug events (ADEs) or health-care utilization between the intervention and control groups, indicating that further development is needed to improve medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. Weingart, SN., Carbo, A., Tess, A., et al.[2018]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

Patients can effectively identify adverse events (AEs) they experience after surgery, providing valuable information that can enhance patient safety and improve medical records, as shown in a study of 28 surgical patients.

The study found a moderate agreement (intraclass correlation coefficient of 0.35) between patients' reports of AEs and medical records, indicating that while patients can be reliable sources of information, there is still room for improvement in communication and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of information on adverse events provided by the surgical patient]. Mira, JJ., Vitaller, J., Guilabert, M., et al.[2012]

A new computer-based system has been developed for managing reports of adverse drug reactions and serious adverse events, featuring a network of three regional centers and a central database for efficient data handling.

This system is designed to be secure, reliable, and cost-effective, making it a potential model for future clinical health information networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. Swoboda, WJ., Göttler, M., Zinnhobler, K., et al.[2017]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Patient Portals: Who uses them? What features do they use? And do they reduce hospital readmissions? [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Patients' Perceptions of Portal Use Across Care Settings: Qualitative Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Relationships between patient portal activation and patient satisfaction scores among CG-CAHPS and HCAHPS respondents. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Patient Portals as Facilitators of Engagement in Patients With Diabetes and Chronic Heart Disease: Scoping Review of Usage and Usability. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Patient portal use and hospital outcomes. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Improvement of medication event interventions through use of an electronic database. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

[Quality of information on adverse events provided by the surgical patient]. [2012]

10. Germany pubmed.ncbi.nlm.nih.gov

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. [2017]

11. Northern Ireland pubmed.ncbi.nlm.nih.gov

A Survey of Patient's Perceptions and Proposed Provision of a 'Patient Portal' in Endocrine Outpatients. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptability of a Patient Portal (Opal) in HIV Clinical Care: A Feasibility Study. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

Communicating with Vulnerable Patient Populations: A Randomized Intervention to Teach Inpatients to Use the Electronic Patient Portal. [2020]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding the Risks and Benefits of a Patient Portal Configured for HIV Care: Patient and Healthcare Professional Perspectives. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

The Electronic Health Record and Patient Portals in HIV Medicine. [2018]