Impact Study of the MSProgress Quality Approach Support Tool for Healthcare Centers Multiprofessionals (MSP) of the AUvergne-Rhône-Alpes Region Using a Mixed Method Evaluating the Evolution of Indicators Chosen by MSPs and Their Use in Multi-professional Teams
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of indicators selected at baseline, met at 12 months.
研究概览
简要总结
Since 2008, the Federation of Health Centers and Coordinated Practice in Auvergne Rhône-Alpes (FemasAURA&Co) has been supporting healthcare centers Multiprofessionals (MSPs) in their development in the Auvergne-Rhône-Alpes (AuRA) region. It aims to support and study the development of the quality approach in MSPs as part of the MSProgress project. The first phase of this project aimed to create a tool to support the quality approach in MSPs. In 2022, a qualitative study using semi-structured group interviews in 7 MSPs followed by a consensus method made it possible to develop a tool composed of quantitative indicators, identified by MSP professionals and queryable in the Health Insurance databases. In 2023, a pilot study was conducted to test the tool prototype with the seven MSPs that participated in its creation, as well as with five MSPs new to the project, in order to gather collective and individual opinions on the design, understanding, and use of this tool. This feedback enabled the finalization of the tool. The second phase of this project aims to evaluate the deployment of the MSProgress tool on a larger scale in MSPs in the AuRA region and to study the selection, monitoring, and analysis of three team indicators over time, with a view to improving their practices.
Our hypothesis is that the availability of this tool will encourage a process of improving practices and lead to improved results for the indicators chosen by the teams.
The main objective is to evaluate the impact of the MSProgress quality approach support tool on the evolution of the indicators chosen by the MSPs in comparison with standard care.
We will use a mixed quantitative and qualitative method.
To assess the impact of the provision of the MSProgress quality approach support tool on the evolution of the indicators selected by MSPs, we will conduct a stepped-wedge cluster randomized controlled trial in 60 MSPs in the AURA region, distributed as follows:
- "MSP Progress 2024" with the MSProgress tool in 2024-2025-2026 (n=20)
- "MSP Progress 2025" with the MSProgress tool in 2025-2026 (n=20)
- "MSP Progress 2026" with the tool in 2026 (n=20).
MSPs who already participated in the tool development phase and/or the MSProgress pilot study (n=12) will not be considered for randomization but will be followed in a parallel open-label arm.
The inclusion of MSPs in the study begins upon receipt of their MSProgress tool. One month later, they will be asked to choose three indicators from the list of 43 proposed by the MSProgress tool.
Statistical analyses will focus on the evolution of the three indicators selected by the MSPs between 2021 and 2027, with the years 2021 to 2023 allowing for monitoring the natural evolution of the results. These analyses will be performed at the patient level (resulting from an export of data queried from health insurance databases) (main analysis) and at the MSP level.
To assess the methods of choosing and using these indicators in teams and understand what the tool contributes to the quality approach in MSPs, we will conduct a qualitative study with the included MSPs selected by theoretical purposive sampling (these teams will be part of the MSProgress 2024 group of the randomized controlled trial, since the qualitative study will extend over the 3 years of the study). Data collection will be carried out during an annual semi-structured group interview for each MSP over the 3 years of the study by an observer/moderator pair from the research team following the established interview guides. Each interview will be transcribed and the data pseudonymized. The verbatim reports will be submitted for review to the team referent. The analysis will benefit from triangulation by comparing the results of two coders on the NVivo software, according to a grounded theory approach: open, axial and selective coding. Processing this data will enable us to conduct an integrative analysis and propose an explanatory model.
At the end of each interview, a questionnaire with an anonymized Likert scale will be distributed to each participant to gather their individual opinions on the format, understanding of the data and results, usage projections, and positioning on the quality approach (data triangulation).
详细描述
• Number of subjects required To assess the effectiveness of the MSProgress quality approach support tool on the evolution of the indicators selected by the MSPs, the estimation of the number of subjects required (NSR) will be based on the comparison between groups, with and without the MSProgress quality approach support tool, of the percentage of indicators selected at inclusion, satisfied at 12 months. For a criterion met at 20% at baseline, an absolute difference of 10% (i.e., 20% vs. 30%) could be demonstrated with 1,850 patients per group (with and without the MSProgress quality approach support tool), according to the stepped-wedge cluster randomization design described above (with 3 randomization sequences and 3 study periods (years), for a two-sided Type I error risk of 5%, a power greater than 90%, an intraclass correlation coefficient of 0.025 (to account for intra- and inter-cluster variability), and a mean number of 100 patients affected by the indicator, per MSP (steppedwedge command, Stata software, version 15, StataCorp, College Station).
If we consider 4,500 patients per MSP based on the data provided by the French National Health Insurance, the inclusion of 20 MSPs per group (with and without the MSProgress quality approach support tool) could involve 90,000 patients. With 2,000 patients per group (with and without the MSProgress quality approach support tool) (i.e., 20 MSPs with an average number of 100 patients affected per indicator for a calculated minimum population of around 1,850), the selected indicator should cover 2 to 3% of an MSP's patient base, which seems entirely consistent and realistic in terms of feasibility.
For a criterion met at 30% at inclusion, 800 patients are required per group (with and without the MSProgress quality approach support tool) under the assumptions described above; For a criterion met at 15%, 2,000 patients are required per group (with and without the MSProgress quality approach support tool), which is compatible with the inclusion of 20 MSPs and an average of 100 patients affected by each indicator.
• Statistical Methods Statistical analysis will be performed using Stata software (version 15, StataCorp, College Station).
All statistical tests will be performed at a 5% risk of Type I error (α). As discussed by Feise in 2002, adjustment for Type I error will not be proposed systematically, but rather based on clinical and not solely statistical considerations. No correction will be proposed for secondary objectives except for comparisons between the three sequences of the stepped-wedge cluster randomization design.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All MSPs in the Auvergne-Rhône-Alpes region that signed the Interprofessional Conventional Agreement (ICA) before October 31, 2023, granting the research team, through team consent, access to their data from the French National Health Insurance databases from 2021 to 2027, volunteer to participate in the MSProgress research project.
- •Additional specific criteria for the qualitative study:
- •After randomization of the 60 MSPs for the cluster randomized controlled trial, among the first established group named "MSProgress 2024," volunteer MSPs will be able to participate in the qualitative study. To do so, professionals agree to participate in three semi-structured group interviews (one per year over the three years of the study), by signing an individual consent form. We will ensure that the MSPs included are representative of the diversity of MSP profiles:
- •Territory and patient population: rural; peri-urban; urban; priority neighborhoods of the city policy;
- •Team size: "large MSP" defined as a team of > 15 healthcare professionals; "small MSP" defined as a team of < 15 healthcare professionals;
- •Site configuration: single-site; multi-site;
- •Length of time the ACI was signed: "old team" having signed the ACI more than 3 years ago; "young team" having signed the ACI less than 3 years ago.
排除标准
- •MSPs in the Auvergne-Rhône-Alpes region that have not signed the ICA before October 31, 2023.
结局指标
主要结局
Percentage of indicators selected at baseline, met at 12 months.
时间窗: 12 months
Binary criterion, treated and analyzed as such. Each MSP will choose 3 indicators at baseline from the 43 available. At 12 months of follow-up, the percentage of satisfied indicators (yes/no) will be compared between groups with and without the MSProgress quality approach support tool.
次要结局
- Percentage of indicators selected at baseline, met according to the number of years of use of the tool(12, 24 or 36 months according to the number of years of use of the tool)
- The indicator satisfies a yes/no question for each of the indicators in the cluster(12 months)
- Description and analysis of the tool's usage methods and the resources used to select the three indicators by teams during the first year of the study(12 months)
- Description and analysis of the corrective actions implemented by the teams on the three selected indicators during the second year of the study(18 months)
- Description and analysis of the evolution of previous or new corrective actions implemented during the third year of the study(30 months)
- Description and analysis of the obstacles and levers encountered in the use of the MSProgress tool after its deployment during the second and third year of the study(18 and 30 months)
- Analysis with the teams of the evolution of the results on the selected indicators after the implementation of their corrective actions during the second and third year of the study(18 and 30 months)