Intervention Based on the Use of Patient Feedback Collected for Improving Patient Safety in Spanish Primary Care (PC) Centres
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,248
- 试验地点
- 2
- 主要终点
- Change in the Patient Safety Climate Synthetic Index
研究概览
简要总结
Background:
Patient safety has been defined as "the avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the processes of healthcare"[1]. It has been on the research agenda for more than two decades, but more prominently since the report 'To Err is Human'[2]. To date concern about the safety of patients in hospital settings has driven most research in the field, and the knowledge about patient safety in the primary care (PC) setting is still sparse.
More emphasis on research on PC patient safety is needed because many safety incidents identified in hospitals actually originate in PC centres[3], which is where the overwhelming majority of healthcare is delivered[4]. That is especially in Spain, country with the highest PC frequentation figures in Europe, (average of 9.5 PC consultations per person per year[5]).
The overall aim of this study is to develop and evaluate an intervention targeted at PC professionals to improve patient safety in PC centres by providing them with feedback on patient perceptions, experiences and outcomes of patient safety.
Specific objectives:
- To translate, cross-culturally adapt and validate the "Patient Reported Experiences and Outcomes of Safety in Primary Care" (PREOS-PC) instrument into the Spanish context.
- To develop a feasible, acceptable, low-cost and scalable theory-based intervention targeted at PC professionals to improve patient safety in PC centres by providing them with feedback on patient perceptions, experiences, and outcomes of patient safety collected through the Spanish version of PREOS-PC.
- To evaluate the acceptability and perceived utility of the intervention, and its effectiveness in improving safety climate, patient-reported patient safety, and reducing avoidable hospitalizations, when compared to usual care.
Method/design:
This study will involve 3 stages: Stage 1 (intervention development) will involve: a) qualitative study with end-users (PC providers) to explore the acceptability and utility of the proposed intervention, and potential implementation barriers; b) translation, cross-cultural adaptation and validation of the PREOS-PC survey for use in the Spanish context; c) development of the intervention components (feedback report and educational materials), and; d) development of an online tool to electronically administrate the PREOS-PC and to automatically generate and send feedback reports to PC centres. Stage 2 (piloting the intervention) will involve a feasibility study in 10 PC centres to inform refinement of the intervention and trial procedures. Stage 3 (evaluating the intervention) will involve: a) a cluster Randomized Controlled Trial to evaluate the impact of the intervention on patient safety culture, patient-reported safety experiences and outcomes, and avoidable hospital admissions, and; b) a qualitative study with PC providers to evaluate the acceptability and perceived utility of the intervention
详细描述
METHODS Description of the intervention The intervention will consist in gathering patient-reported experiences and outcomes of the safety of the healthcare patients received in their PC centres during the previous 12 months. This information will be processed and fed back to their PC professionals to help them identify potential problems, and then target improvements based on problematic areas.
The 3 stages of the intervention are:
- Measurement: Patients will be approached in the waiting room, the study explained, and informed consent taken. The PREOS-PC questionnaire will be completed using a tablet-computer. Patients will be given a choice of whether they would prefer to self-complete the questionnaire or have it facilitated by the researcher.
- Feedback: Using a bespoke online tool, the information for each PC centre will be collated and presented to the centres in the form of an automatically generated "Feedback Report", which will offer comparisons with other centres and also include a set of recommendations about how the problems identified could be addressed.
- Action planning and change: Participating PC centres will form an Action Planning Team. Each team will comprise around four people working in the centres. The team will be responsible for receiving the Feedback Report, considering which area(s) should be targeted, and developing, implementing and monitoring an action plan for safety improvement.
This intervention is based on the Feedback Intervention Theory (FIT), which states that behaviour is regulated through comparison with standards or goals, and that feedback can draw attention to existing gaps[6]. FIT further postulates that once the gap has been identified, different methods can be followed in order to decrease it and attain the standard, including increasing the effort currently done[6], and implementing new strategies to address the problems identified. This could result in improving proximal outcomes (such as safety climate), and potentially impact more distal outcomes (e.g. incidence of safety events or avoidable hospitalizations).
Development and evaluation of the intervention The methods described below are based on the Medical Research Council guidance for the development and evaluation of complex interventions[7]. The development and evaluation of the intervention described above will involve three stages. Stage 1 (intervention development) will involve: a) a qualitative study with end-users (PC providers) to explore the acceptability and utility of the proposed intervention, and potential implementation barriers; b) translation, cross-cultural adaptation and validation of the PREOS-PC survey for use in the Spanish context; c) development of the intervention components (feedback report and educational materials), and; d) development of an online tool to administrate the PREOS-PC and to automatically generate and send feedback reports to PC centres. Stage 2 (piloting the intervention) will involve a feasibility study in 10 PC centres (260 professionals and 500 patients). Stage 3 (evaluating the intervention) will involve: a) a cluster randomized controlled trial (48 PC centres, 1248 professionals and 3600 patients) to evaluate the impact of the intervention on patient safety culture, patient-reported safety experiences and outcomes, and avoidable hospital admissions, and; b) a qualitative study with PC providers to evaluate the acceptability and perceived utility of the intervention.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who to have visited their PC centre at least once in the previous 12 months.
- •have to be able to speak Spanish
排除标准
- •overt psychosis/critically ill/altered mental status
- •inability to provide written informed consent
结局指标
主要结局
Change in the Patient Safety Climate Synthetic Index
时间窗: At pre-intervention and after 12 months follow-up
Measured with the Spanish version of the Medical Office Survey on Patient Safety Culture (MOSPSC) at the PC professional level. This scale measures safety culture of the primary health centres.
次要结局
- Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Centre Activation(At pre-intervention and after 12 months follow-up)
- Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Overall rating of patient safety(At pre-intervention and after 12 months follow-up)
- Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Patient Activation(At pre-intervention and after 12 months follow-up)
- Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Harm(At pre-intervention and after 12 months follow-up)
- Rate of avoidable hospitalizations(At pre-intervention and after 12 months follow-up)
- Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Experiences of Safety Problems(At pre-intervention and after 12 months follow-up)