Patient Safety Clinical Trial
— SinergiAPSOfficial title:
Intervention Based on the Use of Patient Feedback Collected for Improving Patient Safety in Spanish Primary Care (PC) Centres
Verified date | March 2020 |
Source | Fundació d'investigació Sanitària de les Illes Balears |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 1248 |
Est. completion date | April 1, 2021 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - patients who to have visited their PC centre at least once in the previous 12 months. - have to be able to speak Spanish Exclusion Criteria: - overt psychosis/critically ill/altered mental status - inability to provide written informed consent |
Country | Name | City | State |
---|---|---|---|
Spain | Ignacio Ricci-Cabello | Palma De Mallorca | Balearic Islands |
Lead Sponsor | Collaborator |
---|---|
Fundació d'investigació Sanitària de les Illes Balears | Ministerio de Economía y Competitividad, Spain |
Spain,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Patient Safety Climate Synthetic Index | 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. | At pre-intervention and after 12 months follow-up | |
Secondary | Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Centre Activation | Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (the range is from 0 to 100. Higher scores indicate better results)
• Centre Activation (11 items; Cronbach's a of the original version=0.89). Average score of the scale. For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items. |
At pre-intervention and after 12 months follow-up | |
Secondary | Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Patient Activation | Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Patient Activation (2 items; a=0.80). Average score of the scale. For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items. |
At pre-intervention and after 12 months follow-up | |
Secondary | Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Experiences of Safety Problems | Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Experiences of Safety Problems (12 items; a= 0.75). Percentage of safety problems. For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items. |
At pre-intervention and after 12 months follow-up | |
Secondary | Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Harm | Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Harm (5 items; a=0.96). Average score of the scale. For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items. |
At pre-intervention and after 12 months follow-up | |
Secondary | Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Overall rating of patient safety | Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Overall rating of patient safety (1 item). Average score of the scale. For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items. |
At pre-intervention and after 12 months follow-up | |
Secondary | Rate of avoidable hospitalizations | Calculated as the number of avoidable hospitalizations per 1,000 patients in the last 12 months. Data on avoidable hospitalizations will be extracted from electronic medical records using available International Classification Diseases (CIE-9) codes | At pre-intervention and after 12 months follow-up |
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