Development and Evaluation of Methodological Strategies for Implementation of Antimicrobial Stewardship in Secondary Care Hospitals in Indian Setting: A Design Science Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Reduction in inappropriate antimicrobial use, measured by compliance with Antimicrobial Stewardship (AMS) program recommendations and hospital-specific prescribing guidelines.
研究概览
简要总结
The project, titled Development and Evaluation of Methodological Strategies for Implementation of Antimicrobial Stewardship in Secondary Care Hospitals in the Indian Setting: A Design Science Approach, aims to improve antimicrobial stewardship (AMS) practices in secondary care hospitals across India. Its primary objective is to design, implement, and evaluate a comprehensive quality improvement plan (QIP) to address barriers to effective AMS, optimize antimicrobial usage, and enhance infection control practices. This project focuses on real-world applicability, especially in resource-constrained healthcare settings.
In Phase 1, the preparatory phase, a scoping review will identify barriers, facilitators, prescriber perceptions, and gaps in existing AMS programs in secondary care hospitals. Comprehensive data collection will assess the infrastructure, staffing, and key performance indicators of hospitals. A point prevalence survey (PPS) will analyze patterns of antimicrobial consumption and prescribing practices, supported by pilot testing and training for hospital coordinators. Stakeholder interviews will further explore the challenges in implementing AMS programs, assess prescriber awareness, and evaluate institutional support. Hospitals will then be categorized using stratified random sampling and simple randomization to ensure regional representation. The data collected will guide the subsequent development of the QIP.
In Phase 2, a tailored QIP will be designed based on stakeholder needs and expert recommendations. This plan will include forming dedicated AMS teams, appointing AMS champions, establishing prescribing guidelines, enhancing infection control measures, and integrating point-of-care testing. Robust documentation protocols, continuous audits, and feedback mechanisms will also be implemented. The QIP will undergo rigorous validation through expert panel reviews, focus group discussions, and iterative refinement using the Delphi methodology. Its content validity will be assessed using the Content Validity Index (CVI), and qualitative analysis will generate actionable themes to improve reliability and applicability.
In Phase 3, the validated QIP will be piloted and implemented in selected hospitals. Secondary care stakeholders will participate in discussions to refine the final plan and address potential implementation challenges. Structured mentorship and comprehensive training will be provided to AMS teams to facilitate effective execution. Baseline data collection and interim evaluations will help optimize the intervention throughout the implementation period. Over an 8-month follow-up, the effectiveness of AMS interventions will be assessed through primary and secondary outcomes, including reduced antimicrobial consumption (measured as DDD per 1,000 patient-days), improved compliance with AMS recommendations, enhanced healthcare professional knowledge, reduced inappropriate prescriptions, and improved infection control metrics.
This project has significant implications for addressing antimicrobial resistance (AMR) in India. By developing an evidence-based, scalable QIP, it aims to improve prescribing practices, enhance infection control, and reduce AMR in secondary care hospitals. The findings could serve as a model for AMS implementation in similar resource-limited settings globally, contributing to improved public health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Phase 1 Identification and selection of secondary care hospitals i.
- •Hospitals having bed capacity typically ranging from 50-500 beds, and willing to participate in the study and collaborate with the research team ii.
- •Hospitals located within the district to ensure accessibility for site visits and ongoing support iii.
- •Hospitals having basic infrastructure and resources to support data collection and without a pre-existing AMS program iv.
- •Availability of key stakeholders (e.g., hospital administration, medical staff) who are willing to engage in the study and provide necessary information v.
- •Hospitals that agree to participate in the study following ethical approval from relevant ethics committees or institutional review board Point Prevalence survey i.
- •Patients more than 18 years of age admitted in the clinical settings before 8 am on the study day ii.
- •Patients prescribed with at least one systemic/oral antibiotic Phase 2 Qualitative Interview with the physician i.
- •Physicians who are currently practicing in the selected clinical settings with more than 3 years of experience ii.
- •Physicians with consent to participate in the study and willing to share their experiences and perspectives iii.
- •Physicians available for the duration of the study and able to commit the necessary time for the interview.
排除标准
- •Phase 1 Identification and selection of secondary care hospitals i.
- •Hospitals that do not consent to participate or show lack of interest in the study ii.
- •Hospitals with fewer than 50 beds or more than 500 beds, thus not fitting the secondary care designation based on bed capacity iii.
- •Hospitals with a well-established AMS program that do not require support or improvement in this area Point Prevalence survey i.
- •Patients admitted after 8 am in the morning on data collection day ii.
- •Patient in outpatient and emergency departments iii.
- •Patients intended to be discharged on the day of survey iv.
- •Patients posted for surgery on the day of the survey Phase 2 Qualitative interview with the physicians i.
- •Physicians with fewer than the required minimum years of clinical practice (less than 3 years) ii.
- •Physicians who do not consent to participate in the study or are unwilling to share their experiences and perspectives iii.
结局指标
主要结局
Reduction in inappropriate antimicrobial use, measured by compliance with Antimicrobial Stewardship (AMS) program recommendations and hospital-specific prescribing guidelines.
时间窗: Baseline, mid-implementation (4 months), and end of follow-up (8 months).
次要结局
- 1. Percentage adherence to local antibiotic prescribing guidelines.(2. Improvement in AMS knowledge scores from pre-training to post-training.)
研究者
Rajalakshmi R
Manipal College of Pharmaceutical Sciences