Sumamos Excelencia 2022

NCT ID: NCT05466656

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-25

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Incontinence, Urinary Obesity, Childhood Breastfeeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Quasi-experimental, uncontrolled, before-and-after study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quasi-experimental uncontrolled, before-and-after.

The intervention will consist of the use of a continuous quality improvement cycle model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action.

Group Type EXPERIMENTAL

Continuous quality improvement cycle model

Intervention Type OTHER

The continuous quality improvement cycle model consist in a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying barriers to improvements in clinical practice, and drawing up and implementing a plan of action for improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the barriers that hinder the use of evidence in fostering best practices; and contribute to the development of implementation programmes for overcoming such obstacles.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Continuous quality improvement cycle model

The continuous quality improvement cycle model consist in a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying barriers to improvements in clinical practice, and drawing up and implementing a plan of action for improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the barriers that hinder the use of evidence in fostering best practices; and contribute to the development of implementation programmes for overcoming such obstacles.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Spanish Centre for Evidence Based Nursing and Healthcare

UNKNOWN

Sponsor Role collaborator

Teresa Moreno Casbas

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Teresa Moreno Casbas

Director of the Nursing and helathcare research Unit (Investén-isciii)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

María Teresa Moreno-Casbas, Doctor

Role: STUDY_DIRECTOR

Instituto de Salud Carlos III

Esther González-María, Doctor

Role: PRINCIPAL_INVESTIGATOR

Instituto de Salud Carlos III

Leticia Bernués-Caudillo, PhD Candidate

Role: STUDY_CHAIR

Instituto de Salud Carlos III

Candela Cameselle-Lago, PhD Candidate

Role: STUDY_CHAIR

Instituto de Salud Carlos III

Laura Albornos-Muñoz, PhD Candidate

Role: STUDY_CHAIR

Instituto de Salud Carlos III

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto de Salud Carlos III - Unidad de Investigación en Cuidados y Servicios de Salud

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25424863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22179294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21208425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16907795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32389600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30723713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32299461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32560661 (View on PubMed)

Moreno-Casbas T. Perspectives: Implementation strategies to adopt and integrate evidence-based nursing. What are we doing? J. Res. Nurs. 2015;20:729-33.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27001107 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33333843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18241349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18076464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21715571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26453418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20238340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20238311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25374819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32482374 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 22203646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22696318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25918432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29778244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27306646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27733282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25530229 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 32303295 (View on PubMed)

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

Reference Type BACKGROUND

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/

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Agencia Española del Medicamento y Producto Sanitarios. Programa Higiene de manos del SNS. Informe de indicadores 2019. Madrid. 2020

Reference Type BACKGROUND

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/

Reference Type BACKGROUND

Estudio APEAS. Estudio sobre la seguridad de los pacientes en atención primaria de salud. Madrid: Ministerio de Sanidad y Consumo; 2008.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23522377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30816569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33800670 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://evidenciaencuidados.es/

website fron the The Spanish Centre for Evidence Based Nursing and Healthcare with the project information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SE_CECBE_2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.