Choice Architecture Based TB Preventive Therapy Prescribing: IMPAACT4TB Implementation Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Proportion of PWH initiating ART who are prescribed 3HP (or IPT)
研究概览
简要总结
Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what investigators know works and what is actually delivered at the clinic-level to patients, is known as the "science-to-service gap." In the realm of tuberculosis (TB) prevention, this gap is reflected in <20% of TB preventive therapy (TPT)-eligible persons living with HIV (PLWH) being offered or initiated on isoniazid preventive therapy (IPT) in many settings. Recent innovation in TPT have brought new pharmacological options allowing for shorter courses, intermittent dosing, or both. A 12-dose once-weekly rifapentine and isoniazid (3HP) regimen has been demonstrated to be effective and well tolerated. This regimen has several potential advantages over IPT; however, if patients are never assessed for 3HP eligibility and 3HP is not prescribed, TPT packets will remain on pharmacy shelves and the potential health benefits will not reach those who need it.
The overarching goal of this study is to identify a generalizable approach to overcome current barriers to delivery of TPT in order to achieve high levels of TPT delivery during routine care in public clinics. Investigators are proposing a choice architecture that makes prescribing TPT the "default" or standard option and that for TPT not to be prescribed will require a choice by a clinician to "opt-out" of TPT for a specific patient.
Methods: Investigators will use a cluster randomized design with the larger IMPAACT4TB (I4TB) program to deliver 3HP to countries in Africa, Asia, and Latin America. A subset of countries and clinics within these I4TB countries will be included with each clinic the unit of randomization. Clinics within study countries will be randomized to one of two strategies: (1) standard implementation within the UNITAID project (clinic training on TPT along with posters and other standard medication material) and (2) choice architecture default TPT.
Clinical process data will be used to assess the effectiveness of each strategy to determine the proportion of PLWH (1) screened for TB preventive therapy, (2) eligible for TPT, and (3) prescribed TPT.
Significance: Identifying a pragmatic approach will lead the way for improving TPT prescribing across the study sites. It will furthermore contribute to implementation science at large in describing implementation strategies that may be applied to clinic-level implementation of other innovations.
详细描述
BACKGROUND
Clinical guidelines and policies often fail to achieve high levels of delivery of the intended clinical intervention. The difference in what investigators know works and what is actually delivered at the clinic-level to patients, is known as the "science to service gap." In the realm of TB prevention, this "science to service" gap is reflected in <20% of isoniazid eligible PLWH actually receiving isoniazid in most settings. 3HP has several potential advantages over isoniazid for TB prevention; however, if patients are never assessed for 3HP eligibility and 3HP is not prescribed, packets of 3HP will remain on pharmacy shelves and the potential health benefits will not reach those who need it.
Failure of delivery of an innovation can occur for multiple reasons and at multiple levels: this includes an outer setting of national policy and funding and inner setting of providers embracing the innovation, feeling confident in prescribing it, and remembering to prescribe it. The failure with TB preventive therapy (TPT) delivery appears to be mostly due a failure of clinician having a realistic understanding in the benefits compared to risks of IPT, confidence in appropriate prescribing, and remembering to prescribe at the appropriate time.
Multiple approaches have been suggested and/or implemented to improve clinic-level delivery of recommended services. These include performance feedback, performance-based incentives, change agents, opt-out services, routinizing the service in normal care delivery, quality improvement officers or projects, clinic champions, electronic medical record "popups", etc. Not all of these approaches have been evaluated and of those that have been evaluated, success is uneven. Part of the reason for variable success is that some of these context specific approaches have failed in settings with variation in the context of the implementation and variation in the barriers to implementation.
Investigators are proposing to test an implementation strategy to achieve high levels of clinic-level delivery of TB preventive therapy. Investigators will conduct a cluster randomized trial of a clinician "optout" strategy, shifting clinician decision making from prescribing TPT to identifying individuals to whom not to prescribe TPT, and the standard implementation strategy for 3HP roll-out in the IMPAACT4TB project: training and visual aids (posters, etc.) in the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
The data identified by clinic allocation will be blinded to the PI and co-investigators and study statistician until completion of comparative analysis. There will be no other blinding.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •As this is a health system strategy with the intervention at the clinic level, all adult PWH receiving care at that clinic will be exposed to the strategy and included in the overall proportion of PWH seen at the clinic during the study period who receive 3HP
排除标准
- 未提供
研究组 & 干预措施
Standard of care study arm
Providers will receive training on benefits, indications, and contra-indications for TPT. Providers will use the standard approach of the "default" being to not prescribe. Only if providers specifically write for TPT will it be dispensed by a pharmacy or the provider.
Choice Architecture study arm
Clinic staff will be responsible for strategy delivery for all patient interactions. Research staff will provide training and guidance for the "choice architecture" arm. Research staff will also work with the clinics to develop appropriate clinical stationary, ink stamps, stickers, or EMR modifications for prescribing, and reminder systems (e.g. written by pharmacy in clinic file, post-it on clinic file, post-it on lab results). The goal of this approach is for TPT prescribing to occur routinely and as part of ART prescribing. This is in contrast to considering prescribing only at the end of a long algorithm that includes TB and other assessments. With this approach, a patient will "automatically" be prescribed TPT unless the clinician specifically decides patients are not candidates due to active TB treatment or other clinical reasons.
干预措施: Choice Architecture (Behavioral)
结局指标
主要结局
Proportion of PWH initiating ART who are prescribed 3HP (or IPT)
时间窗: Up to 12 months
Among those eligible/estimate of those eligible or the total ART initiator population
次要结局
- Proportion of all unique HIV patients during study period prescribed 3HP or IPT(Up to 12 months)
- Proportion of established ART patients who are prescribed 3HP or IPT(Up to 12 months)
- Clinician fidelity of choice architecture implementation as assessed by file review(Between 9-12 months after study initiation)
- Clinician fidelity of choice architecture implementation as assessed by provider discussions(Between 9-12 months after study initiation)
- Adverse events among TPT recipients and non-TPT recipients(Monthly or quarterly (dependent on country-level routine reporting) over a 12 month period)
- Proportion completing TPT among those initiating 3HP or IPT(Up to 12 months)
- Number of TB cases diagnosed among individuals on TPT(Up to 12 months)
- Clinician acceptability of choice architecture implementation as assessed by in-depth interviews with providers(Up to 52 weeks after study initiation)
- Clinician fidelity of choice architecture implementation as assessed by file review(Between 3-6 months after study initiation)
- Clinician fidelity of choice architecture implementation as assessed by provider discussions(Between 3-6 after study initiation)