Evaluation of SINERGIAPS, an Intervention to Improve Patient Safety in Primary Care Centers in Spain Based on Patients' Perceptions and Experiences. Hybrid Type I Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 14
- 主要终点
- Rate of avoidable hospitalizations
研究概览
简要总结
Aims: To evaluate the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission, and; to explore the factors that may affect its implementation.
Design: 24-month, parallel, open-label, multicentre, pragmatic, hybrid type 1 randomized clinical trial.
Setting, sample, and randomization: 118 primary healthcare centers from multiple regions in Spain will be randomly assigned (ratio 1:1) to two groups (control and intervention). The intervention group will receive two audits (baseline and intermediate at 12 months). The audits will consist of the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a sample of around 100 patients per center. The intervention group will receive reports on the results of both audits, along with resources aimed at facilitating the design and implementation of safety improvement plans. The intervention will be deployed through the SinergiAPS web tool, developed and validated in previous projects. The control group will have access to the intervention after the end of the clinical trial (waitlist).
Outcomes: Primary outcome: rate of avoidable hospitalizations (electronic health records). Secondary outcomes: patient-reported patient safety (PREOS-PC questionnaire); patient safety culture perceived by professionals (MOSPC questionnaire); adverse events experienced by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions (ad hoc questionnaire). Outcome data will be collected at baseline and at 24 months follow-up.
Implementation evaluation: Drawing on the CFIR model, we will collect and analyze qualitative (30 individual interviews, implementation logbooks) and quantitative (questionnaires for professionals from intervention centers, level of use of the SinergiAPS web tool) data to examine the implementation of the intervention in the Spanish primary healthcare centers.
详细描述
GENERAL OBJECTIVE To evaluate the effectiveness and implementation of SinergiAPS, an intervention based on patient perceptions and experiences, aimed at improving patient safety in primary healthcare centers.
SPECIFIC OBJECTIVES
- To evaluate, through a hybrid type I randomized clinical trial with a 24-month follow-up, the effectiveness of the SinergiAPS intervention in improving patient safety in primary healthcare centers by reducing avoidable hospitalizations (primary outcome variable), as well as increasing the safety culture, increasing the number of patient safety improvement actions in the centers, and increasing patient-perceived safety (secondary outcome variables).
- To study the degree of usage of the SinergiAPS intervention in the primary healthcare centers allocated to the intervention group; as well as the contextual factors associated with its successful implementation.
METHODS Study design: Hybrid type 1 clinical trial, pragmatic, multicenter, open-label, with a 24-month follow-up. The primary healthcare centers will be randomly assigned to the intervention group (which will receive the SinergiAPS intervention - described below) and the control group (waitlist design: usual clinical practice during the 24-month follow-up, after which they will have access to the SinergiAPS intervention).
Description of SinergiAPS
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
- Double (Investigator, Outcomes Assessor)
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
- •In this study, we will apply specific criteria for 1) primary health care centers (unit of randomization and analysis), and 2) primary care professionals, as detailed below:
- •Inclusion Criteria for primary care CENTRES: We will include public primary healthcare centers from any autonomous community in Spain that willingly agree to participate through informed consent signed by the manager of the center.
排除标准
- •for primary care CENTRES:
- •Centers that exclusively provide specific services (such as pediatrics or women's health centers)
- •Centers that have been established for less than 12 months at the time of recruitment
- •Inclusion Criteria for primary care PROFESSIONALS: All professionals in primary care health centers meeting the criteria above described, including healthcare and non-healthcare professionals, who have been working at the center for at least 3 months will be invited to participate in the study.
- •Exclusion Criteria for primary care PROFESSIONALS:
- •professionals declining to complete the baseline questionnaires.
- •professionals having been worked in the center for less than three months at the moment of recruitment
结局指标
主要结局
Rate of avoidable hospitalizations
时间窗: Baseline, and at 24 month follow-up
The rate of avoidable hospitalizations will be assessed based on the definition provided by the Agency for Health Research and Quality. Data for this assessment will be extracted from the Minimum Basic Data Set (CMBD) using predefined CIE-9 codes. The rate of avoidable hospitalizations will be calculated specifically for conditions such as asthma, chronic obstructive pulmonary disease, congestive heart failure, angina, and diabetes. For each participating healthcare center, we will obtain the total number of registered patients and the total number of avoidable hospitalizations recorded during the previous twelve months
次要结局
- Activation of healthcare centers (patient-reported mesure)(Baseline, and at 24 month follow-up)
- Experiences of safety incidents (errors) (patient-reported mesure)(Baseline, and at 24 month follow-up)
- Experience of harm (severity) (patient-reported mesure)(Baseline, and at 24 month follow-up)
- Overall assessment of the center's safety level (patient-reported mesure)(Baseline, and at 24 month follow-up)
- Adverse events experienced by healthcare professionals (self-reported by professinals at primary health care centres)(Baseline, and at 24 month follow-up)
- Number of actions aimed at improving patient safety in the center in the last 12 months:(Baseline, and at 24 month follow-up)
- Burden of harm (patient-reported mesure)(Baseline, and at 24 month follow-up)
- Patient safety culture of healthcare professionals (self-reported by professinals at primary health care centres)(Baseline, and at 24 month follow-up)