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Improving Patient Safety in Spanish Primary Care (PC) Centres (SinergiAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837912
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Fundació d'investigació Sanitària de les Illes Balears

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


Condition or disease Intervention/treatment Phase
Patient Safety Behavioral: Patient reported safety experiences fed back to PC providers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-centre, 12 month, two-arm, two-level cluster randomized controls trial (Primary Care professionals within Primary Care centres, with randomization at the centre level in a 1:1 ratio)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Intervention Based on the Use of Patient Feedback Collected for Improving Patient Safety in Spanish Primary Care (PC) Centres
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Arm Intervention/treatment
Experimental: Patient reported safety experiences fed back to PC providers
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 healthcare professionals to help them identify potential safety problems, and then target improvements based on problematic areas.
Behavioral: Patient reported safety experiences fed back to PC providers
The intervention will involve three key stages: a) Measurement: Patients will be invited to complete the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire using a tablet-computer. b) Feedback: Using a bespoke online tool, the information will be processed and presented to each centre in the form of a Feedback Report, which will offer comparisons with other centres along with a set of recommendations for addressing the problems identified. c) Action planning and change: centres will form an Action Planning Team, which will be responsible for analyzing the report, considering which area(s) should be improved, and developing, implementing and monitoring an action plan to address the safety problems identified.

No Intervention: Patient reported safety experiences not fed back to providers
Waiting list: the practices allocated to the control group will receive the intervention (feedback report) after the trial finished (i.e., after post-intervention data collection has been completed).



Primary Outcome Measures :
  1. Change in the Patient Safety Climate Synthetic Index [ Time Frame: 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.


Secondary Outcome Measures :
  1. Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Centre Activation [ Time Frame: At pre-intervention and after 12 months follow-up ]

    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 α 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.


  2. Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Patient Activation [ Time Frame: At pre-intervention and after 12 months follow-up ]

    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; α=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.


  3. Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Experiences of Safety Problems [ Time Frame: At pre-intervention and after 12 months follow-up ]

    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; α= 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.


  4. Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Harm [ Time Frame: At pre-intervention and after 12 months follow-up ]

    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; α=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.


  5. Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Overall rating of patient safety [ Time Frame: At pre-intervention and after 12 months follow-up ]

    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.


  6. Rate of avoidable hospitalizations [ Time Frame: At pre-intervention and after 12 months follow-up ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837912


Contacts
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Contact: Ignacio Ricci-Cabello, PhD +34971175883 nacho.ricci.cabello@gmail.com
Contact: Maria J Serrano-Ripoll, PhD +34971175883 mariajesus.serranoripoll@ssib.es

Locations
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Spain
Ignacio Ricci-Cabello
Palma De Mallorca, Balearic Islands, Spain, 07002
Contact: Ignacio Ricci-Cabello, PhD    +34971175883    nacho.ricci.cabello@gmail.com   
Contact: Maria J Serrano-Ripoll, PhD    +34971175883    mariajesus.serranoripoll@ssib.es   
Sponsors and Collaborators
Fundació d'investigació Sanitària de les Illes Balears
Ministerio de Economía y Competitividad, Spain
Investigators
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Principal Investigator: Ignacio Ricci-Cabello, PhD Institut d'Investigació Sanitària de les Illes Balears

Additional Information:
Publications:
Kluger, A.N. and A. DeNisi, The effects of feedback interventions on performance: a historical review, a meta-analysis, and a preliminary feedback intervention theory. Psychological bulletin, 1996. 119(2): p. 254.
Someren, Maarten & Barnard, Yvonne & Sandberg, Jacobijn. (1994). The Think Aloud Method - A Practical Guide to Modelling Cognitive Processes.
Nunnally, J.C. and I.H. Bernstein, Psychometric theory. Vol. 226. 1967: McGraw-Hill New York.
Guest, G., K.M. MacQueen, and E.E. Namey, Applied thematic analysis. 2011: sage.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier: NCT03837912    
Other Study ID Numbers: CP17/00017
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació d'investigació Sanitària de les Illes Balears:
cluster randomized controlled trial
primary health care
patient safety
patient-centred care
patient-reported experiences and outcomes measures
audit and feedback interventions.