Implementation of an Electronic Patient-reported Measure of Barriers to Antiretroviral Therapy Adherence With the Opal Patient Portal: a Mixed Method Type 3 Hybrid Pilot Study at a Large Montreal HIV Clinic
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acceptability of the Intervention as assessed with the Acceptability E-scale
研究概览
简要总结
Adherence to antiretroviral therapy (ART) remains problematic. Our team has thus developed a new patient-reported measure of barriers to ART adherence (the I-Score) which will be completed by HIV patients through the Opal patient portal for routine HIV care. This 6-month mixed method pilot study will implement the I-Score/Opal intervention with 5 HIV physicians at the McGill University Health Centre (Montreal, Quebec) and 30 of their patients. The study's primary objectives are to assess patient and physician perceptions of the intervention (e.g., acceptability) and evaluate the implementation strategy. The data collected will help plan and determine the feasibility of a definitive effectiveness trial.
详细描述
Background: Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to facilitate the systematic capture of this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy.
Methods: This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Five HIV physicians and 30 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score in the Opal smartphone application, before meeting with their physician. Both patient and physician will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention's adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention's acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2-3) and patient interviews (Times 2-3) will help evaluate the implementation strategy and inform any methodological adaptations.
Discussion: This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •be aged 18 years or older
- •be diagnosed with HIV-1 infection
- •be treated with a combination antiretroviral therapy (composed of 2 to 3 different drugs)
- •be treated for HIV at the Chronic Viral Illness Service of the McGill University Health Centre
- •be able to speak and understand either French or English
- •possess a smartphone
- •be willing to download the smartphone app
排除标准
- •are participating in a clinical trial at the time of enrollment in this study
- •have a cognitive impairment or medical instability that prevents them from participating in the interview
- •have insufficient mastery of French or English to participate in the interview and complete the questionnaires
- •have insufficient ability to use the app with the technical support provided
- •are co-infected with hepatitis C and are being treated for it or have completed treatment 3 months or less ago
- •are co-infected with hepatitis B and are either not treated for it or are being treated for it with a medication other than their anti-HIV medication
结局指标
主要结局
Acceptability of the Intervention as assessed with the Acceptability E-scale
时间窗: Change from baseline (week 1) to study completion (week 24)
Score range: 6-30 (Threshold: M ≥ 24, indicates high acceptability)
Acceptability of the Intervention as indicated by the percent likely to recommend the I-Score
时间窗: Change from baseline (week 1) to study completion (week 24)
(Threshold: ≥ 80 percent)
Acceptability of the Intervention as assessed with the Net Promoter Score
时间窗: Change from baseline (week 1) to study completion (week 24)
Score range: -100 to 100 (Threshold: \> 0, indicates acceptability)
次要结局
- Appropriateness of the Intervention as assessed with the Appropriateness of Intervention Measure(Change from baseline (week 1) to study completion (week 24))
- Feasibility of the Intervention as indicated by the consent rate(At baseline)
- Feasibility of the Intervention as indicated by the retention rate(Cumulative until study completion (week 24))
- Appropriateness of the Intervention as assessed with the Perceived Compatibility subscale(Change from baseline (week 1) to study completion (week 24))
- Feasibility of the implementation strategy as indicated by the percentage of physicians who participate in the implementation activities(Cumulative until study completion (week 24))
- Fidelity of the Intervention as indicated by the percentage of patients who complete the I-Score on time(Cumulative until study completion (week 24))
- Fidelity of the Intervention as indicated by the percentage of physicians who review the I-Score results on time(Cumulative until study completion (week 24))
- Feasibility of the Intervention as indicated by the missing I-Score data rate(Cumulative until study completion (week 24))
- Feasibility of the Intervention as assessed with the Feasibility of Intervention Measure(Change from baseline (week 1) to study completion (week 24))
- Feasibility of the implementation strategy as indicated by the number of technical issues encountered(Cumulative until study completion (week 24))
研究者
Dr. Bertrand Lebouche
Clinical Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre