Effectivenness and Implementation of an Intervention to Improve Primary Care Patient Safety

NCT05958108 | Active Not Recruiting Phase 3

• 1 other identifier: G57326324
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Patient Safety

Keywords

Primary Health Care; randomized clinical trial; Patient Reported Outcome Measures; Surveys and Questionnaires; Patient safety

Outcome Measures

Primary Outcomes (1)

• Rate of avoidable hospitalizations

  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

  Baseline, and at 24 month follow-up

Secondary Outcomes (8)

• 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

• Burden of harm (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

Study Arms (2)

Control group

NO INTERVENTION

Primary care centers allocated to the Control Group will continue with healthcare as usual. They will receive the intervention at the end of the trial, once all post-intervention data has been collected (waitlist approach). Although audits will be conducted in this group, the centers in this group will not have access to the feedback reports or any other information with the results from the audits.

SinergiAPS intervention group

EXPERIMENTAL

SinergiAPS is an assessment and monitoring tool designed to support primary healthcare centers to identify potential problems and areas for improvement related to patient safety based on information provided by their own patients. This intervention consists of three main elements: 1. Patient safety audit of healthcare centers: Patient safety is evaluated from the perspective of patients using the validated PREOS-PC questionnaire. 2. Feedback of results to healthcare centers: SinergiAPS automatically generates a report with the audit results. This feedback report is specific to each healthcare center and includes a comparison with other participating centers to facilitate benchmarking. 3. Design of action plans: The centers design patient safety improvement plans based on the problems identified in their center's result report. For this purpose, the SinergiAPS web tool provides resources, training materials, and recommendations on how to improve patient safety in primary care.

Behavioral: SinergiAPS intervention

Interventions

SinergiAPS intervention BEHAVIORAL

Audit and feedback intervention, with the audit being based on patient-reported experiences and outcomes of patient safety.

SinergiAPS intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• professionals declining to complete the baseline questionnaires.
• professionals having been worked in the center for less than three months at the moment of recruitment

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Instituto de Investigación Biomédica de Salamanca: collaborator
• Avedis Donabedian Research Institute: collaborator
• Andalusian School of Public Health: collaborator
• INSTITUTO DE INVESTIGACIÓN SANITARIA GALICIA SUR: collaborator
• GERENCIA ASISTENCIAL DE ATENCION PRIMARIA, MADRID HEALTH SERVICE (SERMAS): collaborator
• Instituto de Investigación Sanitaria Aragón: collaborator
• Instituto Muciano de Investigación Sanitaria: collaborator

Study Sites (8)

Andalusian School of Public Health

Granada, Andalussia, 18011, Spain

Location

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, 07002, Spain

Location

Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)

Barcelona, Catalonia, 08007, Spain

Location

Gerencia Asistencial de Atención Primaria

Madrid, Madrid, 28035, Spain

Location

Instituto Muciano de Investigación Sanitaria

Murcia, Murcia, Spain

Location

Instituto de Investigación Biomédica de Salamanca (IBISAL)

Salamanca, Salamanca, 37007, Spain

Location

Instituto de Investigación Sanitaria Galicia Sur

Pontevedra, Vigo, 36312, Spain

Location

Instituto de Investigación Sanitaria de Aragón (IIS Aragón)

Zaragoza, Spain

Location

Related Publications (1)

• Fiol-deRoque MA, Mansilla GV, Maderuelo-Fernandez JA, Tamayo-Morales O, Martin-Lujan F, Astier-Pena P, Chacon-Docampo M, Orrego C, Gens-Barbera M, Andreu-Rodrigo P, Ricci-Cabello I; SinergiAPS team. Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial. Front Public Health. 2024 Mar 26;12:1324940. doi: 10.3389/fpubh.2024.1324940. eCollection 2024.

  PMID: 38596515 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 24, 2023
• Study Start: September 1, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (8)