Clinical trial NCT06522529: Sumamos Excelencia Project: Implementation of Best Practices in Clinical Practice (Thrid Edition)
Official title: SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (Thrid Edition)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Obesity, Childhood
Breast Feeding
Incontinence, Urinary
Smoking Cessation
Pressure Injury
Fall
Keywords: Implementation
Implementation science
Evidence-based practice
Nursing
Quality of Health Care
Lead sponsor: Instituto de Salud Carlos III
Sponsor class: OTHER_GOV
Collaborators: name: The Spanish Centre for Evidence Based Nursing and Healthcare
First posted: 2024-07-26
Enrollment: 400
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. Multifaceted implementation strategies are 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 multifaceted implementation strategy (training, audit, context analysis, local strategies design, feedback, facilitation). Data will be collected at baseline and, during the first year of follow up, at months (4,8,12)

Detailed description: Aim: To assess the effectiveness of implementing evidence-based recommendations using multifaceted implementation strategy 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 multifaceted implementation strategy (training, audit, context analysis, local strategies design, feedback, facilitation). 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, smoking cessation intervention, pressure injury prevention, fall prevention, 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 4, 8 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 2024-2025.

This project is a third edition of The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (NCT05466656), with an improved design and new recommendation topics.

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, Smoking Cessation, falls prevention, pressure injuries prevention. 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. Smoking Cessation:

      - ≥ 18 years of age
      * Smokers
   6. Pressure injury prevention:

      - Adults population (≥ 18 years).
      * Admitted to hospitals, nursing homes or included in home care programmes.
      * Patients at risk of developing pressure injuries.
   7. Falls prevention:

      * Adults aged 65 years or older, and adults aged 18 years or older who may potentially present problems in walking as a result of neurological or traumatic diseases, medication, or who suffer from loss of strength or drowsiness.
   8. Hand hygiene:

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

      Exclusion Criteria:

      -

Primary outcomes:
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 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
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: Quantification assessment in active smokers
timeFrame: 15 months
measure: Comprehensive assessment of active smokers
timeFrame: 15 months
measure: Comprehensive assessment of the non-active smoker
timeFrame: 15 months
measure: Brief interventions performed
timeFrame: 15 months
measure: Derivation of the active smoking patient
timeFrame: 15 months
measure: Expressed desire to quit smoking (active smokers)
timeFrame: 15 months
measure: Maintenance of willingness to remain smoke-free (non-active smokers)
timeFrame: 15 months
measure: Pressure injuries risk assessment at the initiation of care
timeFrame: 15 months
measure: Reassessment of the risk of pressure injuries
timeFrame: 15 months
measure: Nutritional screening of the person at risk of pressure injuries
timeFrame: 15 months
measure: Support surfaces for the prevention of pressure injuries
timeFrame: 15 months
measure: Pressure injury prevention care plan
timeFrame: 15 months
measure: Prevalence of pressure injuries
timeFrame: 15 months
measure: Pressure injuries associated with care
timeFrame: 15 months
measure: Healthcare-associated pressure injuries in persons at risk
timeFrame: 15 months
measure: Stage of most severe pressure injury:
timeFrame: 15 months
measure: Falls risk screening
timeFrame: 15 months
measure: Multifactorial falls risk assessment
timeFrame: 15 months
measure: Falls prevention care plan
timeFrame: 15 months
measure: Falls risk reassessment
timeFrame: 15 months
measure: Exercise interventions
timeFrame: 15 months
measure: Number of falls
timeFrame: 15 months
measure: Injuries resulting from falls
timeFrame: 15 months
measure: Urinary incontinence initial 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: Comprehensive assessment (obesity)
timeFrame: 15 months
measure: Promotion of healthy behaviours
timeFrame: 15 months
measure: Education and support
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: Daily physical activity
timeFrame: 15 months
measure: Sedentary behaviour
timeFrame: 15 months
measure: Fruit and vegetable intake
timeFrame: 15 months
measure: Assessment of mother's intention to breastfeed
timeFrame: 15 months
measure: Postpartum assessment of breastfeeding
timeFrame: 15 months
measure: Skin-to-skin contact
timeFrame: 15 months
measure: Information and education on breastfeeding, and support for the breastfeeding process (hospital).
timeFrame: 15 months
measure: Breastfeeding education and support for family members (hospital)
timeFrame: 15 months
measure: Breastfeeding at first feeding
timeFrame: 15 months
measure: Type of breastfeeding of the newborn during the hospital stay
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 (Primary care)
timeFrame: 15 months
measure: Breastfeeding education and support for family members
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
Secondary outcomes:
measure: Type of institution
timeFrame: 15 months
measure: Type of unit
timeFrame: 15 months
measure: Team Leader rol
timeFrame: 15 monthts
measure: Team members rol
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: Patients Age
timeFrame: 15 months
measure: Patients Sex
timeFrame: 15 months
measure: Type of incontinence
timeFrame: 15 months
measure: Incontinence triggering factors.
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: Child's height
timeFrame: 15 months
measure: Reason for admission/consultation
timeFrame: 15 months
measure: Previous history of pain
timeFrame: 15 months
measure: Type of smoker
timeFrame: 15 months
measure: Smoking relapses
timeFrame: 15 months
measure: Previous of pressure injuries
timeFrame: 15 months
measure: Stage of change
timeFrame: 15 months
measure: Tobacco use
timeFrame: 15 months
measure: Barriers
timeFrame: 15 months
measure: Strategies
timeFrame: 15 months
measure: Evidence Based Practice competencies
timeFrame: 15 months
measure: Clinical leadership skills
timeFrame: 15 months
measure: Empowerment
timeFrame: 15 months
measure: Evidence Based Practice (EBP) climate and leadership
timeFrame: 15 months
measure: Professional's sex
timeFrame: 15 months
measure: Professional's age
timeFrame: 15 months
measure: Professional's qualifications
timeFrame: 15 months
measure: Professional's experience
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, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Salud Carlos III
name: Esther González-María, PhD
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: Laura Albornos-Muñoz, PhD
role: STUDY_CHAIR
affiliation: Instituto de Salud Carlos III
name: Alba Ayala, PhD
role: STUDY_CHAIR
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