Clinical trial NCT05466656: Sumamos Excelencia 2022
Official title: SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (Second Edition)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain
Incontinence, Urinary
Obesity, Childhood
Breastfeeding
Keywords: Implementation Science
Evidence-Based Practice
Evidence-Based Nursing
Nursing Care
Quality of Health Care
Clinical Audit
Lead sponsor: Instituto de Salud Carlos III
Sponsor class: OTHER_GOV
Collaborators: name: The Spanish Centre for Evidence Based Nursing and Healthcare
First posted: 2022-07-20
Enrollment: 115
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental, uncontrolled, before-and-after study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is a gap between research and clinical practice, leading to variability in decision-making. Clinical audits are an effective strategy for improving implementation of best practices. Quasi-experimental, multicentre, before and after. Primary care, hospital units and nursing homes, and the patients attended at both. Implementation of evidence-based recommendations by application of a continuous quality improvement cycle model (process of improvement by reference to a prior baseline clinical audit. Data will be collected at baseline and, during the first year of follow up, at months (3, 6, 12)

Detailed description: Aim: To assess the effectiveness of implementing evidence-based recommendations using a continuous quality improvement cycle model on patient outcomes and healthcare quality. Design: Quasi-experimental, multicentre, before-and-after. Methods: NHS units and Nursing Homes, patients attended by them and professionals implementing the recommendations. Intervention: implementation of evidence-based recommendation with a continuous quality improvement cycle's model (process of improvement by reference to a prior baseline clinical audit). Variables: Process and outcome criteria with respect to assessment and management of pain, management of urinary incontinence, prevention of child obesity, promotion of breastfeeding, promotion of hand hygiene, competencies in evidence-based practice, barriers to the implementation and strategies for overcoming them. Data will be collected at baseline and, during the first year of follow-up, at months 3, 6 and 12, with data on patients and indicators being drawn from clinical histories and records. Descriptive analysis and comparison of the effectiveness of the intervention by means of inferential analysis and analysis of trends across follow-up. 95% confidence level. This project is partially funded by The Spanish Centre for Evidence Based Nursing and Healthcare. Project duration 2022-2024.

This project is a second edition of The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (NCT03725774), with a similar design but with changes in some of the themes.

Eligibility criteria: Inclusion Criteria:

1. Unit inclusion criteria:

   * NHS units and nursing homes which voluntary adhere to the project.
   * NHS units and nursing homes providing direct patient care and commit to implement evidence-based recommendations on hand hygiene and one of the following topics: pain assessment and management, urinary incontinence management, obesity prevention and breastfeeding promotion. For the purposes of this study, a "unit" is defined as any service, centre or institution that delivers health services to a homogeneous group of patients who share similar characteristics.
2. Patient inclusion criteria: The study will include all patients attended in the units participating in the study, who meet the following criteria, depending on the recommendations to be implemented in each unit:

   1. Pain:

      * People susceptible to suffering some type of pain regardless of age.
      * Patients treated in acute or chronic health institutions (Hospitals, Nursing Homes or Primary Care).
   2. Urinary incontinence:

      * Patients 18 years or older.
      * Patients with uncomplicated stress, urge or mixed urinary incontinence
      * At least 7 days of admission or possibility of continuity of care preferably up to 6 weeks.
   3. Obesity:

      * Babies and preschool children up to 12 years old.
      * For ages 2 to 12 years (inclusive), children must not be overweight or obese 1 year prior to baseline measurement (in February 2021 or at the closest review to February 2021 at which BMI is recorded).
      * Good general health.
   4. Breastfeeding:

      * Lactating people.
      * Healthy neonates of gestational age greater than 36 weeks, with birth weight greater than or equal to 2500 gr.
      * Couples and relatives within the support network.
      * Postpartum period and up to 6 months of life of the baby (183 days of life, included).
      * In primary care, only non-urgent care will be included.
   5. Hand hygiene:

      * All health professionals who care for patients in the units participating in the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Urinary incontinence assessment
timeFrame: 15 months
measure: Voiding diary
timeFrame: 15 months
measure: Scheduled urination
timeFrame: 15 months
measure: Bladder training
timeFrame: 15 months
measure: Pelvic floor exercises
timeFrame: 15 months
measure: Severity
timeFrame: 15 months
measure: Impact
timeFrame: 15 months
measure: Improvement
timeFrame: 15 months
measure: Detection of pain at admission
timeFrame: 15 months
measure: Pain related to a procedure likely to cause pain
timeFrame: 15 months
measure: Pain after a change in the patient's clinical situation
timeFrame: 15 months
measure: Pain intensity assessment
timeFrame: 15 months
measure: Comprehensive pain assessment
timeFrame: 15 months
measure: Pain management care plan
timeFrame: 15 months
measure: Patient or/and caregiver education on pain
timeFrame: 15 months
measure: Intensity of pain on admission or in the first 24 hours after surgery or at the start of care
timeFrame: 15 months
measure: Maximum pain
timeFrame: 15 months
measure: Skin-to-skin contact
timeFrame: 15 months
measure: Postpartum assessment of breastfeeding
timeFrame: 15 months
measure: Assessment of breastfeeding after the first 24 hours and before discharge
timeFrame: 15 months
measure: Early assessment of breastfeeding in primary care
timeFrame: 15 months
measure: Follow-up assessment of breastfeeding in primary care (from 9 days of life to 6 months)
timeFrame: 15 months
measure: Breastfeeding education for the breastfeeding person
timeFrame: 15 months
measure: Breastfeeding education and support for family members
timeFrame: 15 months
measure: Type of breastfeeding of the newborn during the hospital stay
timeFrame: 15 months
measure: Type of breastfeeding of the newborn in early stage
timeFrame: 15 months
measure: Type of breastfeeding of the newborn in follow-up 1
timeFrame: 15 months
measure: Type of breastfeeding of the newborn in follow-up 2
timeFrame: 15 months
measure: Exclusive breastfeeding at 6 months
timeFrame: 15 months
measure: Training of health professionals
timeFrame: 15 months
measure: Assessment to prevent obesity
timeFrame: 15 months
measure: Education and support for parents/primary caregivers
timeFrame: 15 months
measure: Exclusive breastfeeding, children from birth to 6 months of age
timeFrame: 15 months
measure: Breastfeeding, children from 6 months of age up to 2 years
timeFrame: 15 months
measure: Sedentary behaviour
timeFrame: 15 months
measure: Daily physical activity
timeFrame: 15 months
measure: Incidence of childhood obesity
timeFrame: 15 months
measure: ICU beds with alcohol-based preparations at the point of care
timeFrame: 15 months
measure: Hospital beds with alcohol-based preparations at the point of care
timeFrame: 15 months
measure: Consumption of alcohol-based preparations in hospitalization
timeFrame: 15 months
measure: Consumption of alcohol-based preparations in Primary Care centers
timeFrame: 15 months
measure: Consumption of alcohol-based preparations in hospital units without admission
timeFrame: 15 months
measure: Consumption of alcohol-based preparations in Nursing Homes.
timeFrame: 15 months
Secondary outcomes:
measure: Type of institution
timeFrame: 15 months
measure: Size of hospital unit
timeFrame: 15 months
measure: Size of Nursing home
timeFrame: 15 months
measure: Size of primary care unit
timeFrame: 15 months
measure: No. Nurses
timeFrame: 15 months
measure: No. Healthcare assistants
timeFrame: 15 months
measure: Type of unit
timeFrame: 15 months
measure: Date of discharge
timeFrame: 15 months
measure: Date of attention
timeFrame: 15 months
measure: Date of residence
timeFrame: 15 months
measure: Age
timeFrame: 15 months
measure: Sex
timeFrame: 15 months
measure: Mother´s age
timeFrame: 15 months
measure: Breastfeeding for the first time
timeFrame: 15 months
measure: Type of birth
timeFrame: 15 months
measure: Weeks of gestation
timeFrame: 15 months
measure: Weight at birth
timeFrame: 15 months
measure: Child weight
timeFrame: 15 months
measure: Size
timeFrame: 15 months
measure: Reason for admission/consultation
timeFrame: 15 months
measure: Past-medical history
timeFrame: 15 months
measure: Barriers
timeFrame: 15 months
measure: EBP competencies
timeFrame: 15 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto de Salud Carlos III - Unidad de Investigación en Cuidados y Servicios de Salud
Study officials:
affiliation: Instituto de Salud Carlos III
name: María Teresa Moreno-Casbas, Doctor
role: STUDY_DIRECTOR
affiliation: Instituto de Salud Carlos III
name: Esther González-María, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Salud Carlos III
name: Leticia Bernués-Caudillo, PhD Candidate
role: STUDY_CHAIR
affiliation: Instituto de Salud Carlos III
name: Candela Cameselle-Lago, PhD Candidate
role: STUDY_CHAIR
affiliation: Instituto de Salud Carlos III
name: Laura Albornos-Muñoz, PhD Candidate
role: STUDY_CHAIR
References:
citation: Kreindler SA. What if implementation is not the problem? Exploring the missing links between knowledge and action. Int J Health Plann Manage. 2016 Apr;31(2):208-26. doi: 10.1002/hpm.2277. Epub 2014 Nov 25.
citation: Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
citation: Squires JE, Estabrooks CA, Gustavsson P, Wallin L. Individual determinants of research utilization by nurses: a systematic review update. Implement Sci. 2011 Jan 5;6:1. doi: 10.1186/1748-5908-6-1.
citation: Meijers JM, Janssen MA, Cummings GG, Wallin L, Estabrooks CA, Y G Halfens R. Assessing the relationships between contextual factors and research utilization in nursing: systematic literature review. J Adv Nurs. 2006 Sep;55(5):622-35. doi: 10.1111/j.1365-2648.2006.03954.x.
citation: Ortuno-Soriano I, Munoz-Jimenez D, Moreno-Casbas T, Albornos-Munoz L, Gonzalez-Maria E; en nombre del Grupo de Trabajo del Programa de implantacion de buenas practicas en Centros Comprometidos con la Excelencia en Cuidados(R). Evaluation of implementation strategies of the Best Practices Spotlight Organisations (BPSO) Project in Spain. Enferm Clin (Engl Ed). 2020 May-Jun;30(3):222-230. doi: 10.1016/j.enfcli.2019.10.027. Epub 2020 May 7. English, Spanish.
citation: Powell BJ, Fernandez ME, Williams NJ, Aarons GA, Beidas RS, Lewis CC, McHugh SM, Weiner BJ. Enhancing the Impact of Implementation Strategies in Healthcare: A Research Agenda. Front Public Health. 2019 Jan 22;7:3. doi: 10.3389/fpubh.2019.00003. eCollection 2019.
citation: Lewis CC, Boyd MR, Walsh-Bailey C, Lyon AR, Beidas R, Mittman B, Aarons GA, Weiner BJ, Chambers DA. A systematic review of empirical studies examining mechanisms of implementation in health. Implement Sci. 2020 Apr 16;15(1):21. doi: 10.1186/s13012-020-00983-3.
citation: Allen P, Pilar M, Walsh-Bailey C, Hooley C, Mazzucca S, Lewis CC, Mettert KD, Dorsey CN, Purtle J, Kepper MM, Baumann AA, Brownson RC. Quantitative measures of health policy implementation determinants and outcomes: a systematic review. Implement Sci. 2020 Jun 19;15(1):47. doi: 10.1186/s13012-020-01007-w.
citation: Moreno-Casbas T. Perspectives: Implementation strategies to adopt and integrate evidence-based nursing. What are we doing? J. Res. Nurs. 2015;20:729-33.
citation: Lau R, Stevenson F, Ong BN, Dziedzic K, Treweek S, Eldridge S, Everitt H, Kennedy A, Qureshi N, Rogers A, Peacock R, Murray E. Achieving change in primary care--causes of the evidence to practice gap: systematic reviews of reviews. Implement Sci. 2016 Mar 22;11:40. doi: 10.1186/s13012-016-0396-4.
citation: Almazrou SH, Alfaifi SI, Alfaifi SH, Hakami LE, Al-Aqeel SA. Barriers to and Facilitators of Adherence to Clinical Practice Guidelines in the Middle East and North Africa Region: A Systematic Review. Healthcare (Basel). 2020 Dec 15;8(4):564. doi: 10.3390/healthcare8040564.
citation: Davies B, Edwards N, Ploeg J, Virani T. Insights about the process and impact of implementing nursing guidelines on delivery of care in hospitals and community settings. BMC Health Serv Res. 2008 Feb 2;8:29. doi: 10.1186/1472-6963-8-29.
citation: Ploeg J, Davies B, Edwards N, Gifford W, Miller PE. Factors influencing best-practice guideline implementation: lessons learned from administrators, nursing staff, and project leaders. Worldviews Evid Based Nurs. 2007;4(4):210-9. doi: 10.1111/j.1741-6787.2007.00106.x.
citation: Mickan S, Burls A, Glasziou P. Patterns of 'leakage' in the utilisation of clinical guidelines: a systematic review. Postgrad Med J. 2011 Oct;87(1032):670-9. doi: 10.1136/pgmj.2010.116012. Epub 2011 Jun 29.
citation: Fleiszer AR, Semenic SE, Ritchie JA, Richer MC, Denis JL. A unit-level perspective on the long-term sustainability of a nursing best practice guidelines program: An embedded multiple case study. Int J Nurs Stud. 2016 Jan;53:204-18. doi: 10.1016/j.ijnurstu.2015.09.004. Epub 2015 Sep 8.
citation: Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD005470. doi: 10.1002/14651858.CD005470.pub2.
citation: Flodgren G, Deane K, Dickinson HO, Kirk S, Alberti H, Beyer FR, Brown JG, Penney TL, Summerbell CD, Eccles MP. Interventions to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese people. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD000984. doi: 10.1002/14651858.CD000984.pub2.
citation: Esposito P, Dal Canton A. Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology. World J Nephrol. 2014 Nov 6;3(4):249-55. doi: 10.5527/wjn.v3.i4.249.
citation: Wentland BA, Hinderer KA. A Nursing Research and Evidence-Based Practice Fellowship Program in a Magnet(R)-designated pediatric medical center. Appl Nurs Res. 2020 Oct;55:151287. doi: 10.1016/j.apnr.2020.151287. Epub 2020 May 15.
citation: Holmes BJ, Best A, Davies H, Hunter D, Kelly MP, Marshall M, Rycroft-Malone J. Mobilising knowledge in complex health systems: A call to action. Evid. Policy 2017;13:539-60.
citation: Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, Glass JE, York JL. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012 Apr;69(2):123-57. doi: 10.1177/1077558711430690. Epub 2011 Dec 26.
citation: Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3.
citation: Sinuff T, Muscedere J, Rozmovits L, Dale CM, Scales DC. A qualitative study of the variable effects of audit and feedback in the ICU. BMJ Qual Saf. 2015 Jun;24(6):393-9. doi: 10.1136/bmjqs-2015-003978. Epub 2015 Apr 27.
citation: Munoz Jimenez D. From evidence-based nursing to healthcare practice: The evaluation of results as an integrating element. Enferm Clin (Engl Ed). 2018 May-Jun;28(3):149-153. doi: 10.1016/j.enfcli.2018.04.004. No abstract available. English, Spanish.
citation: Christina V, Baldwin K, Biron A, Emed J, Lepage K. Factors influencing the effectiveness of audit and feedback: nurses' perceptions. J Nurs Manag. 2016 Nov;24(8):1080-1087. doi: 10.1111/jonm.12409. Epub 2016 Jun 16.
citation: GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
citation: Duenas M, Salazar A, Ojeda B, Fernandez-Palacin F, Mico JA, Torres LM, Failde I. A nationwide study of chronic pain prevalence in the general spanish population: identifying clinical subgroups through cluster analysis. Pain Med. 2015 Apr;16(4):811-22. doi: 10.1111/pme.12640. Epub 2014 Dec 19.
citation: García FJ, Salinas J, Madurga B, Cózar JM, Esteban M. Guía de atención a personas con incontinencia urinaria [internet]. Madrid: Asociación Española de Urología; Enero 2020 [consultado abril de 2021]. Available in: https://www.consejogeneralenfermeria.org/documentos-de-interes/guias-clinicas/send/67-guias-clinicas/908-guia-de-atencion-a-personas-con-incontinencia-urinaria
citation: Dufour S, Wu M. No. 397 - Conservative Care of Urinary Incontinence in Women. J Obstet Gynaecol Can. 2020 Apr;42(4):510-522. doi: 10.1016/j.jogc.2019.04.009.
citation: Estudio ALADINO 2019: Estudio sobre Alimentación, Actividad Física, Desarrollo Infantil y Obesidad en España 2019. Agencia Española de Seguridad Alimentaria y Nutrición. Ministerio de Consumo. Madrid, 2020
citation: Departamento de Salud del Gobierno Vasco. Estrategia de prevención de la obesidad infantil en Euskadi. PLAN SANO. 2019. Editado por Servicio Central de publicaciones del Gobierno Vasco. Disponible en: https://www.euskadi.eus/estrategia/prevencion-de-la-obesidad-infantil-en-euskadi/web01-a2osabiz/es/
citation: World Health Organization. Infant and young child feeding. Ginebra: WHO; 2021 [acceso12/11/2021]. Disponible en: https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding.
citation: Encuesta Nacional de Salud de España 2017. Instituto nacional de estadística. [acceso 25/08/2019]. Disponible en https://www.mscbs.gob.es/estadEstudios/estadisticas/encuestaNacional/encuesta2017.htm
citation: OMS, Ministerio de Sanidad. La higiene de las manos en la asistencia ambulatoria y domiciliaria y en los cuidados de larga duración. Guía de aplicación de la estrategia multimodal de la OMS para la mejora de la higiene de las manos y del modelo "Los cinco momentos para la higiene de las manos". Ginebra: Organización Mundial de la Salud. 2013
citation: Agencia Española del Medicamento y Producto Sanitarios. Programa Higiene de manos del SNS. Informe de indicadores 2019. Madrid. 2020
citation: Estudio nacional de vigilancia de infección nosocomial en servicios de medicina intensiva. Vall d'hebron. Barcelona; 2019. Disponible en: https://hws.vhebron.net/envin-helics/
citation: Estudio APEAS. Estudio sobre la seguridad de los pacientes en atención primaria de salud. Madrid: Ministerio de Sanidad y Consumo; 2008.
citation: Flottorp SA, Oxman AD, Krause J, Musila NR, Wensing M, Godycki-Cwirko M, Baker R, Eccles MP. A checklist for identifying determinants of practice: a systematic review and synthesis of frameworks and taxonomies of factors that prevent or enable improvements in healthcare professional practice. Implement Sci. 2013 Mar 23;8:35. doi: 10.1186/1748-5908-8-35.
citation: Escobar-Aguilar G, Moreno-Casbas MT, Gonzalez-Maria E, Martinez-Gimeno ML, Sanchez-Pablo C, Orts-Cortes I. The SUMAMOS EXCELENCIA Project. J Adv Nurs. 2019 Jul;75(7):1575-1584. doi: 10.1111/jan.13988. Epub 2019 Apr 2.
citation: Martinez-Gimeno ML, Fernandez-Martinez N, Escobar-Aguilar G, Moreno-Casbas MT, Brito-Brito PR, Caperos JM. SUMAMOS EXCELENCIA(R) Project: Results of the Implementation of Best Practice in a Spanish National Health System (NHS). Healthcare (Basel). 2021 Mar 28;9(4):374. doi: 10.3390/healthcare9040374.