Assessing Differential Adherence to Medications and Quality of Life Among People Living With HIV and Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Self-reported adherence to antiretroviral therapy (ART)
研究概览
简要总结
The investigators propose to utilize quantitative and qualitative methodology to better understand the impact of multiple drug use (polypharmacy) on medication adherence as well as the driving forces behind differential adherence in people living with HIV (PLWH) with comorbidities. Since the clinical relevance of differential adherence to antiretroviral therapy (ART) medication has already been demonstrated and associated with virologic failure and a more rapid progression to AIDS and death, it is imperative to understand the driving forces behind differential adherence (selective drug taking) and its impact on treatment outcomes in PLWH with comorbidities. To this end, the investigators propose utilizing self-report adherence data and abstracted medical record data including pharmacy refills to assess medication adherence among PLWH with comorbidities. The information gained regarding patients' clinical outcomes as well as patients' reported treatment adherence, quality of life, beliefs about medications, and treatment satisfaction will provide the investigators with a comprehensive picture of what constitutes successful HIV treatment among those PLWH managing multiple medications. This is particularly important as non-successful treatment may result in low patient satisfaction, breach of patient-provider trust and reduced medication adherence.
详细描述
Primary Endpoints:
Medication adherence: The investigators will assess medication adherence at baseline and at six months using the following measures:
- Self-reported adherence to ART using the AIDS-ACTG questionnaire will be assessed at baseline and six months. To measure medication adherence to ART the investigators will use the validated AIDS Clinical Trials Group (ACTG) Adherence Questionnaire. This assessment is considered one of the "gold-standard" ART self-reported adherence questionnaires. The questionnaire assesses the number of doses missed per medication per day over a recall period of the previous four days. Mean number of doses missed is calculated for all ART medications over the four days. In addition, the ACTG questionnaire includes secondary assessments of adherence including a general time-frame question regarding the last time the participant missed taking any medications and an assessment of reasons as to why medications were skipped if they were skipped.
- Medication adherence using pharmacy refills will be assessed at baseline (using the prior 6 months of pharmacy refill data) and at six months post-intervention (to assess the study period pharmacy refill data). Since self-report measures can be biased by inaccurate patient recall or by social desirability, the investigators will also measure medication adherence using pharmacy refill data. Adherence using pharmacy refills has been correlated with a wide range of outcomes for patients with cardiovascular as well as other diseases. To measure medication adherence using pharmacy refills the investigators will use the proportion of days covered (PDC) which is used when multiple medications are used concomitantly. PDC = number of days covered by prescription fills/number of days between the first prescription fills during the measurement period and the end of the measurement period (180 days). The patients' will have two measurement periods: 1) 6 months prior to enrollment and 2) the study period beginning on the date of enrollment (index date) and extending through the last day of the study period (six months) or until the last day of follow-up due to death or disenrollment. It is important to note that PDC calculates the days when the patient is covered for all medications in a regimen for the particular study period. The investigators will assess not only the overall medication adherence, but also adherence to each medication. The research team has access to all Northwell-Vivo pharmacies' refill data as that information is linked to patients' electronic medical records. In addition, Investigators will be able to access other local pharmacy data (including Specialty Pharmacies) as well as mail-order pharmacy data. Moreover, if a patient is admitted to the hospital at any point during the study period and receives medications from hospital supply, the additional medications will be added.
The investigators will measure treatment adherence (compliance) according to International Society for Pharmacoeconomics and Outcomes Research. Medication adherence will be calculated as a compliance rate over the entire study period. Compliance rate (CR) = number of doses taken/number of doses prescribed over the 180 day study period. This can be calculated overall and per medication prescribed. On the basis of self-report and pharmacy refills patients with non- ART medication adherence of 80% and ART medication adherence of >95% will be categorized as adherent. The investigators have chosen a cut-off percentage of >95% for ART medications because it has been shown that drug resistance is most common among patients with a medication adherence rate of <95%. Therefore, PLWH must adhere to their ART regimen at a rate of >95% to avert physiological deterioration due to HIV rebound. Moreover, the 80% cut-off percentage have been used widely in observational and randomized controlled studies on non-ART medication adherence (diabetes and cardiovascular drugs) and these definitions of sub-optimal adherence have been associated with moderate to severe adverse outcomes. Combination tablets will be counted as one medication. Only prescribed medication will be included in the medication adherence calculations. Vitamins and OTC will not be included, but they will be analyzed in secondary analyses (see below).
Secondary Endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Self-reported adherence to antiretroviral therapy (ART)
时间窗: baseline and 6 months
To measure medication adherence to ART the investigators will use the validated AIDS Clinical Trials Group (ACTG) Adherence Questionnaire. This assessment is considered one of the "gold-standard" ART self-reported adherence questionnaires. The questionnaire assesses the number of doses missed per medication per day over a recall period of the previous four days. Mean number of doses missed is calculated for all ART medications over the four days. A higher mean, indicates more doses missed.
次要结局
- Patients' illness-specific symptoms and medication-specific side effects(Change from patients' baseline illness-specific symptoms and medication-specific side effects at six months)
- Patients' beliefs about medication's(Change from patients' baseline beliefs about medication's at six months)
- Patients' pill burden perceptions(Baseline)
- CD4 (cluster of differentiation 4) T-cell counts(baseline and six months)
- Quality of Life (QoL)(Change from baseline QoL at six months)
- HIV viral load(baseline and six months)
- Patients' illness perception's(Change from patients' baseline illness perception's at six months)
- Hospitalization rates(change from 6 months prior to enrollment up to 6 months post enrollment)
- urgent care center rates(change from 6 months prior to enrollment up to 6 months post enrollment)
- Emergency Department visit rates(change from 6 months prior to enrollment up to 6 months post enrollment)
- Medication adherence using pharmacy refills to both ART and non-ART(Change from Medication adherence using pharmacy refills to both ART and non-ART at 6 months)