Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention Based on the Use of Patient Feedback Collected for Improving Patient Safety in Spanish Primary Care (PC) Centres
Brief Summary: 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:

1. 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.
2. 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.
3. 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


Options:
A: Number of participants with self-reported outcome data at each time-point (6 months); Proportion of missing data in patient outcome questionnaires (6 months); Appropriateness of patient outcome questionnaires by assessing ceiling and floor effects ( quality of life questionnaire) (6 months)
B: Quality Of Life In Epilepsy (QOLIE)-31 global score (Month 18); Adverse Events Profiles (AEP) score (Month 18)
C: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)
D: Change in the Patient Safety Climate Synthetic Index (At pre-intervention and after 12 months follow-up)

Answer: D