Improving Patient Safety in Spanish Primary Care (PC) Centres

NCT03837912 | Unknown

• 1 other identifier: CP17/00017
• Study Type: interventional
• Target: 1,248
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Patient Safety

Keywords

cluster randomized controlled trial; primary health care; patient safety; patient-centred care; patient-reported experiences and outcomes measures; audit and feedback interventions.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Centre Activation

  At pre-intervention and after 12 months follow-up

• Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Patient Activation

  At pre-intervention and after 12 months follow-up

• Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Experiences of Safety Problems

  At pre-intervention and after 12 months follow-up

• Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Harm

  At pre-intervention and after 12 months follow-up

• Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Overall rating of patient safety

  At pre-intervention and after 12 months follow-up

Study Arms (2)

Patient reported safety experiences fed back to PC providers

EXPERIMENTAL

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

Patient reported safety experiences not fed back to providers

NO INTERVENTION

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).

Interventions

Patient reported safety experiences fed back to PC providers BEHAVIORAL

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.

Patient reported safety experiences fed back to PC providers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who to have visited their PC centre at least once in the previous 12 months.
• have to be able to speak Spanish

You may not qualify if:

• overt psychosis/critically ill/altered mental status
• inability to provide written informed consent

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, 07002, Spain

Location

Related Publications (20)

• Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/

  PMID: 25077248 BACKGROUND

• Woods DM, Thomas EJ, Holl JL, Weiss KB, Brennan TA. Ambulatory care adverse events and preventable adverse events leading to a hospital admission. Qual Saf Health Care. 2007 Apr;16(2):127-31. doi: 10.1136/qshc.2006.021147.

  PMID: 17403759 BACKGROUND

• Green LA, Fryer GE Jr, Yawn BP, Lanier D, Dovey SM. The ecology of medical care revisited. N Engl J Med. 2001 Jun 28;344(26):2021-5. doi: 10.1056/NEJM200106283442611. No abstract available.

  PMID: 11430334 BACKGROUND

• Aranaz-Andres JM, Aibar C, Limon R, Mira JJ, Vitaller J, Agra Y, Terol E. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health. 2012 Dec;22(6):921-5. doi: 10.1093/eurpub/ckr168. Epub 2011 Nov 29.

  PMID: 23180803 BACKGROUND

• 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.

  BACKGROUND

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.

  PMID: 23159157 BACKGROUND

• Ricci-Cabello I, Avery AJ, Reeves D, Kadam UT, Valderas JM. Measuring Patient Safety in Primary Care: The Development and Validation of the "Patient Reported Experiences and Outcomes of Safety in Primary Care" (PREOS-PC). Ann Fam Med. 2016 May;14(3):253-61. doi: 10.1370/afm.1935.

  PMID: 27184996 BACKGROUND

• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

  PMID: 15804318 BACKGROUND

• Someren, Maarten & Barnard, Yvonne & Sandberg, Jacobijn. (1994). The Think Aloud Method - A Practical Guide to Modelling Cognitive Processes.

  BACKGROUND

• Boyce MB, Browne JP. Does providing feedback on patient-reported outcomes to healthcare professionals result in better outcomes for patients? A systematic review. Qual Life Res. 2013 Nov;22(9):2265-78. doi: 10.1007/s11136-013-0390-0. Epub 2013 Mar 17.

  PMID: 23504544 BACKGROUND

• Kasbauer S, Cooper R, Kelly L, King J. Barriers and facilitators of a near real-time feedback approach for measuring patient experiences of hospital care. Health Policy Technol. 2017 Mar;6(1):51-58. doi: 10.1016/j.hlpt.2016.09.003.

  PMID: 28367401 BACKGROUND

• Lawton R, O'Hara JK, Sheard L, Armitage G, Cocks K, Buckley H, Corbacho B, Reynolds C, Marsh C, Moore S, Watt I, Wright J. Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention. BMJ Qual Saf. 2017 Aug;26(8):622-631. doi: 10.1136/bmjqs-2016-005570. Epub 2017 Feb 3.

  PMID: 28159854 BACKGROUND

• Porter I, Goncalves-Bradley D, Ricci-Cabello I, Gibbons C, Gangannagaripalli J, Fitzpatrick R, Black N, Greenhalgh J, Valderas JM. Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities. J Comp Eff Res. 2016 Aug;5(5):507-19. doi: 10.2217/cer-2015-0014. Epub 2016 Jul 18.

  PMID: 27427277 BACKGROUND

• Greenhalgh J, Dalkin S, Gooding K, Gibbons E, Wright J, Meads D, Black N, Valderas JM, Pawson R. Functionality and feedback: a realist synthesis of the collation, interpretation and utilisation of patient-reported outcome measures data to improve patient care. Southampton (UK): NIHR Journals Library; 2017 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK409450/

  PMID: 28121094 BACKGROUND

• Nunnally, J.C. and I.H. Bernstein, Psychometric theory. Vol. 226. 1967: McGraw-Hill New York.

  BACKGROUND

• Silvestre-Busto C, Torijano-Casalengua ML, Olivera-Canadas G, Astier-Pena MP, Maderuelo-Fernandez JA, Rubio-Aguado EA. [Adaptation of the Medical Office Survey on Patient Safety Culture (MOSPSC) tool]. Rev Calid Asist. 2015 Jan-Feb;30(1):24-30. doi: 10.1016/j.cali.2014.12.006. Epub 2015 Feb 7. Spanish.

  PMID: 25659444 BACKGROUND

• Guest, G., K.M. MacQueen, and E.E. Namey, Applied thematic analysis. 2011: sage.

  BACKGROUND

• Ricci-Cabello I, Marsden KS, Avery AJ, Bell BG, Kadam UT, Reeves D, Slight SP, Perryman K, Barnett J, Litchfield I, Thomas S, Campbell SM, Doos L, Esmail A, Valderas JM. Patients' evaluations of patient safety in English general practices: a cross-sectional study. Br J Gen Pract. 2017 Jul;67(660):e474-e482. doi: 10.3399/bjgp17X691085. Epub 2017 Jun 5.

  PMID: 28583945 BACKGROUND

• Fiol-deRoque MA, Valderas JM, Serrano-Ripoll MJ, Gens-Barbara M, Martin-Lujan F, Sanchez-Freire E, Montano JJ, Mira-Martinez S, Pastor-Moreno G, Zamanillo-Campos R, Riera-Serra P, Ricci-Cabello I. Evaluating SinergiAPS, an intervention based on patient feedback to improve patient safety in primary care: a cluster randomized trial. BMC Med. 2025 Apr 7;23(1):202. doi: 10.1186/s12916-025-04029-7.

  PMID: 40189506 DERIVED

• Serrano-Ripoll MJ, Ripoll J, Llobera J, Valderas JM, Pastor-Moreno G, Olry de Labry Lima A, Ricci-Cabello I. Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol. BMJ Open. 2019 Dec 23;9(12):e031367. doi: 10.1136/bmjopen-2019-031367.

  PMID: 31874872 DERIVED

Related Links

• Related Info
• Agency for Healthcare Research and Quality
• Learning from International Networks about Errors and Understanding Safety in Primary Care

Study Officials

• Ignacio Ricci-Cabello, PhD

  Institut d'Investigació Sanitària de les Illes Balears

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: February 12, 2019
• Study Start: May 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: March 15, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)