STrengthening Ambulatory caRe for Non Communicable Diseases-STAR NCD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16,000
- 试验地点
- 4
- 主要终点
- Coverage, quality of service delivery, and equity
研究概览
简要总结
The National Program for Non-Communicable Diseases (NP-NCDs) in India has been implemented within the public health facilities since 2008. The introduction of several components ranging from prevention, screening, case finding and management of NCDs have been phased and sequentially implemented with presence of NCD digital platform for data entry and recording. Currently, there are implementation gaps in reach, retention, and quality of ambulatory NCD care services in the country. This project is an implementation research study planned to develop a model to strengthen the ambulatory care for common NCDs (hypertension, diabetes, chronic obstructive pulmonary disease, and secondary prevention of coronary artery disease).
The model developed will focus on improving coverage, quality, and equity within the scope of the national program for NCD (NP-NCD). The study will be done in four states with one district within each state namely Haryana (Jhajjar), Tripura (Gomati), Maharashtra (Nagpur), and Andhra Pradesh (Chittoor).
The provisional implementation strategies include strengthening of NCD governance at the district/state level, patient empowerment, supportive supervision to facilities and providers, use of evidence -based protocols for management and referrals (including use of clinical decision support systems), ensuring drug and diagnostic supplies, team based and coordinated care, and use of information technology. However, the implementation strategies are subject to change based on the findings emerged during formative phase assessment.
The study will have three phases-
Phase 1 Formative,
Phase 2 Co-design of implementation strategies, Iteration, and finalization
Phase 3 Implementation of model at scale in district, measure outcomes and cost
The total duration of the project will be three years.
The first phase of the project will be the formative phase, in the first six months. The primary objective of this phase is to understand the context and current situation of implementation of the NP-NCD program in the study districts. An understanding of the context is an imperative to enable assessment of readiness within the study facilities to adopt the proposed implementation strategies that will be rolled out. We propose using a mixed methods approach collecting both quantitative and qualitative data concurrently and triangulating the data during analysis.
Phase 2 will involve co-design of the implementation model. Stakeholders will be mapped and will be involved in shaping the model. Persons with NCDs are an important stakeholder often left out of delivery design. We will ensure the inclusion of patient groups in the co design process along with implementers and policymakers. Equity concerns will be embedded right from the beginning, keeping in mind inequalities that result from gender, age, location, and distance from health facilities that impedes access to care. Consultative workshops will be done with stakeholders block wise to co-create the 1st iteration of the model (Model 1). Additionally, we will also refine and develop treatment protocols engaging with experts and program officials. These protocols will be prepared as simple to follow algorithms for application at each level of health facility within the district health system, starting from sub center-HWC up to district hospital.
We will monitor the implementation in 2 blocks (pilot) for 3 months and will iterate this model with stakeholders through a process of co analysis with stakeholders. Model 2 will be implemented in 4 blocks including the pilot districts for the next 3 months. At the end of 6 months a similar stakeholder consultation will be held for co analysis and a final model to scale will be developed.
We will closely monitor processes and implementation through field level staff that will facilitate implementation and collect data once every month. We propose an interrupted time series design for the concurrent evaluation. The overarching design is a quasi-experimental design and includes a before and after cross-sectional community-based surveys (baseline and endline) and the interrupted time series for different outcome measurements. The survey design is used for assessment of change in the retention along the care cascade and impact of interventions on out-of-pocket expenditure and the interrupted time series for change in processes of care at facility level. We will use multiple methods to make inferences from triangulation of data -both qualitative and quantitative including routine reports, observations, exit interviews, prescription audits, observations, and qualitative interviews from various stakeholders.
We also propose to conduct a costing of implementing the intervention calculating, additional cost per patient by the level of healthcare facilities (activity-based costing). In addition, we will perform a budget impact analysis and estimate additional resources required for scale-up at district- or state-level. The findings and learnings through the study will be disseminated through multiple modalities. Some of these will include writing policy briefs for advocacy and meetings with policy makers, media briefs, and stakeholder and community meetings.
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
- 30.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Community survey : General population above 30 years Exit interview: Patients visiting public health facilities for Non communicable disease servicesFacility Assessment : Primary-Health and Wellness Centre,Primary Health Centre,Upgarded Primary Health Centre and Urban Health Centre, Secondary-Community Health Centre, Sub District Hospital,Tertiary-District Hospital Qualitative interviews and FGDs: All health care providers who are directly involved in NCD delivery Competency assessment: ANM,Mid Level Health Provider,Community Health Officer.
排除标准
- •Bedridden patients for exit interview.
结局指标
主要结局
Coverage, quality of service delivery, and equity
时间窗: 6 months formative phase | 2 iterations | One year and six months full scale implementation
次要结局
- Develop a model for improved delivery of NCD care at selected districts & iteratively implement the model & refine for scaling to the district(For iterative model 15 months & 18 months after the project initiation)
- Determine the incremental cost implication for the health care delivery system in the context of the national program for NCDs(Incremental cost at the end of three years project period)
研究者
Dr Roopa Shivashankar
Indian Council of Medical Research
