Implementation of a Patient Portal and Tailored Patient-Reported Outcome Measures to Improve Health Problem Detection and Retention in HIV Care: The DRHIVe Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Acceptability of the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed living with HIV
- •Adult (at least 18 years old)
- •Literate in English or French
- •Patient at the study site
排除标准
- •Cognitive impairment or medical instability that prevents participation
- •Insufficient mastery of French or English to participate (e.g., complete PROMs, study questionnaires)
研究组 & 干预措施
Arm 1
In this arm, the control period will be 6 months followed by 18 months of intervention.
干预措施: Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material (Other)
Arm 2
In this arm, the control period will be 12 months followed by 12 months of intervention.
干预措施: Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material (Other)
Arm 3
In this arm, the control period will be 18 months, followed by 6 months of intervention.
干预措施: Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material (Other)
结局指标
主要结局
Acceptability of the intervention
时间窗: During the intervention at months 6, 12, 18, and 24
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.
Satisfaction with care
时间窗: At baseline, then at months 6, 12, 18 and 24
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.
次要结局
- Feasibility of the intervention -Consent rate(At baseline)
- Fidelity of the intervention -PROM data reviewed by providers(During the intervention at months 6, 12, 18, and 24)
- 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 -Retention rate(From baseline to 24 months)
- Fidelity of the intervention -PROM completion by patients(During the intervention at months 6, 12, 18, and 24)
- Patient management -Provider detection of PROM-related problems(At baseline, then at months 6, 12, 18 and 24)
- Patient-centered care(At baseline, then at months 6, 12, 18 and 24)
- Self-management -Appointment attendance(At baseline, then at months 6, 12, 18 and 24)
研究者
Dr. Bertrand Lebouche
Clinician-Scientist and Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre