Table 1.
Data collection schedule for the SinergiAPS 2 trial.
| Source | Aggregation level | Data collection timing | |
|---|---|---|---|
| 1. Characteristics of the primary healthcare centers (all recruited centers) | |||
| Number of visits to the center in the last 12 months | Administrative data | Practice level | Baseline |
| List size (total number of registered patients at the center) | Administrative data | Practice level | Baseline |
| Average number of patients per physician in the center | Administrative data | Practice level | Baseline |
| Percentage of patients over 65 years old in the center | Administrative data | Practice level | Baseline |
| Percentage of female patients | Administrative data | Practice level | Baseline |
| Teaching center (yes/no) | Administrative data | Practice level | Baseline |
| Rurality index | Administrative data | Practice level | Baseline |
| Adjusted morbidity group (GMAs—percentage of patients in each of the five complexity groups) | Administrative data | Practice level | Baseline |
| 2. Effectiveness evaluation (all recruited centers) | |||
| Rate of avoidable hospitalizations during the previous 12 months (primary outcome measure) | Administrative data | Practice level (number hospitalizations/10000 registered patients) | Baseline and 24 months follow-up |
| Activation of healthcare centers: 4 items (Cronbach’s α = 0.70) that measure the proactivity of healthcare centers towards patient safety. | Patient-reported (PREOS-PC Compact) | Practice level (mean score—theoretical range: 0 to 100) | Baseline and 24 months follow-up |
| Experience of harm (severity): 3 items (Cronbach’s α = 0.85) that assess the level of harm suffered by patients as a result of the healthcare they received. | Patient-reported (PREOS-PC Compact) | Practice level (mean score—theoretical range: 0 to 100) | Baseline and 24 months follow-up |
| Burden of harm: 3 items (Cronbach’s α = 0.73) that evaluate the impact and consequences of the harm experienced by patients | Patient-reported (PREOS-PC Compact) | Practice level (mean score—theoretical range: 0 to 100) | Baseline and 24 months follow-up |
| Overall assessment of the center’s safety level (1 item). Visual analogue scale. | Patient-reported (PREOS-PC Compact) | Practice level (mean score—theoretical range: 0 to 100) | Baseline and 24 months follow-up |
| Patient safety culture | Healthcare provider-reported (MOSPSC questionnaire) | Practice level (mean score—theoretical range: 0 to 5) | Baseline and 24 months follow-up |
| Frequency of adverse events experienced by healthcare professionals in the last 12 months | Healthcare provider-reported (ad hoc questionnaire) | Practice level (mean score—theoretical range: 0 to 100) | Baseline and 24 months follow-up |
| Impact of adverse events on healthcare providers wellbeing | Healthcare provider-reported (ad hoc questionnaire) | Practice level (mean score—theoretical range: 0 to 100) | Baseline and 24 months follow-up |
| Number of actions aimed at improving patient safety in the center in the last 12 months | Reported by the practice responsible for patient safety | Practice level (total number) | 24 months follow-up |
| 3. Implementation and process evaluation (only centers allocated to the intervention group) | |||
| Number of accesses to the SinergiAPS tool | Metadata from SinergiAPS tool | Practice level (total number) | Monthly during the 24 months of follow up period |
| Time using the SinergiAPS tool | Metadata from SinergiAPS tool | Practice level (number of minutes) | Monthly during the 24 months of follow up period |
| Number of safety improvement actions registered in the SinergiAPS tool | Metadata from SinergiAPS tool | Practice level (total number) | Quarterly during the 24 months of follow up period |
| Usage of the SinergiAPS tool | Reported by the practice responsible for patient safety (ad hoc questionnaire) | Practice level (number of hours) | Quarterly during the 24 months of follow up period |
| Perceived utility and satisfaction with the SinergiAPS tool | Reported by the practice responsible for patient safety (ad hoc structured questionnaire) | Practice level (mean score—theoretical range: 0 to 100) | Quarterly during the 24 months of follow up period |
| Overall assessment of the SinergiAPS intervention, identification of aspects for improvement, and of suggestions to facilitate the large-scale implementation of SinergiAPS | In depth qualitative interviews with health-care professionals | Regional level (narrative experiences) | After the 24 months follow up |
| Implementation barriers | Researchers in from each region (implementation diary) | Regional level (narrative experiences) | Continuously during the 24 months follow up |
MOSPSC, Medical Office Survey on Patient Safety Culture.