Sumamos Excelencia Project: Implementation of Best Practices in Clinical Practice (Thrid Edition)

Not Applicable

Recruiting

• Conditions: Pain; Obesity, Childhood; Breast Feeding; Fall; Incontinence, Urinary; Smoking Cessation; Pressure Injury
• Interventions: Other: Multifaceted implementation strategy

• Registration Number: NCT06522529
• Lead Sponsor: Instituto de Salud Carlos III

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Study Start: 2024-09-01
• Primary Completion: 2025-12-15
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Quasi-experimental uncontrolled, before-and-after.	Multifaceted implementation strategy	The intervention will consist of the use of a multifaceted implementation strategy based in the continuous quality improvement cycle model and in implementation science theories, model and frameworks to be developed in clinical practice according to the study unit in question and the scope of action.

Primary Outcome Measures

Name	Time	Method
Consumption of alcohol-based preparations in Nursing Homes.	15 months	Litres of alcohol-based preparations consumed in Nursing Homes (Number of liters of alcohol-based preparations delivered in Nursing Homes / Total number of residents in the evaluated period) x100
Pain management care plan	15 months	Establishing and implementing a pain management care plan for the patient based on the results of the person's assessment, which would include: pharmacological and non-pharmacological measures, the person's goals and appropriate and effective pain management strategies. (Total number of patients with a care plan for acute or chronic pain, and it is registered / Total number of patients with positive detection of pain or susceptible to have pain in the data collection period) x100
Patient or/and caregiver education on pain	15 months	Patient or/and caregiver education on the importance of communicating pain, pharmacological, physical and psychological pain management options, how to take the analgesic medication, manage the possible side effects and how the follow-up will be done and who can be consulted with possible doubts. (Total number of patients, family members or caregivers who have received education on pain management, at least once during the care process, and it is registered / Total number of patients with positive detection of pain or likely to have pain in the data collection period) x100
Intensity of pain on admission or in the first 24 hours after surgery or at the start of care	15 months	Intensity of pain on admission or in the first 24 hours after surgery or at the start of care measured in numerical format, with the value that corresponds to the scale used in the unit for the assessment of pain, units must indicate on the form the scale they have used. (Sum of pain intensity of patients with positive pain detection or likely to have pain / Total number of patients with assessed pain intensity in the data collection period)
Nutritional screening of the person at risk of pressure injuries	15 months	Nutritional screening of the person at risk of developing pressure injuries with a structured, validated and reliable tool. (Total number of persons at risk of pressure injuries who have been nutritionally screened)/(Total number of persons at risk of pressure injuries) x100.
Prevalence of pressure injuries	15 months	Number of patients presenting with a pressure injury at the start of care (Total number of people with one or more pressure injuries)/(Total number of people with health care provision) x100
Falls risk reassessment	15 months	Risk reassessments made after any significant change in health following a fall, at 30-90 days for people at high risk of falls or one year since the last reassessment for people at low risk. (Total number of people with falls risk reassessment recorded)/(Total number of people eligible for risk reassessment) x100
Hospital beds with alcohol-based preparations at the point of care	15 months	Availability of the alcohol-based preparations in the hospital units (excluding ICU beds) as close as possible to the place where an activity that requires contact with the patient and/or their immediate environment is going to be carried out and without having to leave the patient's area. Point of care is the place where the patient, the health professional and the care or treatment that involves contact with the patient coincide. (Number of hospitalization beds in the unit, with alcohol-based preparations at the point of care)/(Number of beds in the unit) x100
Consumption of alcohol-based preparations in hospital units without admission	15 months	Litres of alcohol-based preparations consumed in hospital units without admission (outpatient consultations, day hospital, etc.). (Number of liters of alcohol-based preparations@delivered in a hospital unit without admission / Total number of consultations in the evaluated period) x1000
Detection of pain at admission	15 months	Detection of pain at admission. (Total number of patients in whom pain detection was performed upon admission or at the start of care, and it is registered / Total number of patients discharged or attended in the collection period data) x100
Pain after a change in the patient's clinical situation	15 months	Detection of pain after a change in the patient's clinical situation (clinical situation: significant clinical change, in the general condition of the patient or in their pain, which requires the referral of the patient to a professional with the skills to resolve it). (Total number of patients in whom pain has been detected after a change in their clinical situation, and it is registered / Total number of patients with a change in their clinical situation in the data collection period) x100
Comprehensive assessment of the non-active smoker	15 months	Assessment carried out with a comprehensive and systematic approach, taking into account various factors related to smoking, such as: Existence or not of current nicotine withdrawal symptoms; Relapses; Current stage of change; Other symptoms. The criterion is fulfilled when at least 3 of the 5 criteria are fulfilled and recorded (Total number of patients who have undergone a 'comprehensive non-active smoking assessment' and are recorded) / (Total number of non-active smoking patients in the data collection period) x100; Active smoker: person who is currently smoking or has smoked in the last 30 days.; Non-active smoker: smoked the last cigarette or similar product more than 30 days but less than 183 days (6 months) ago.
Brief interventions performed	15 months	Number of brief interventions (BI) based on the 5 As and 5 Rs carried out in smoking patients. For a BI to be considered as having been carried out, the nurse must at least: convey the advice to 'stop smoking', advise the patient on smoking cessation, offer support and accompaniment and specific comments on the health risks related to smoking and the benefits related to smoking cessation. (Number of smoking patients who have undergone Brief Intervention)/(Total number of smoking patients seen in the data collection period) x100 Brief intervention (BI): Intervention in which there is a brief (less than five minutes) contact between the health care provider and the patient.; Active smoker: person who is currently smoking or has smoked in the last 30 days.; Non-active smoker: smoked the last cigarette or similar product more than 30 days but less than 183 days (6 months) ago.
Pressure injuries risk assessment at the initiation of care	15 months	Assessment of the risk of pressure injuries in the first 24 hours of admission, after the initiation of care or the first visit in primary care with a structured, validated and reliable tool, together with clinical judgement (Total number of people with complete assessment of pressure injuries at admission or initiation of care)/(Total number of people with health care provision) x100.
ICU beds with alcohol-based preparations at the point of care	15 months	Availability of the alcohol-based preparations in the Intensive Care Units (Hospital care) as close as possible to the place where an activity that requires contact with the patient and/or their immediate environment is going to be carried out and without having to leave the patient's area. Point of care is the place where the patient, the health professional and the care or treatment that involves contact with the patient coincide. (Number of ICU beds in the unit, with base alcoholic preparations at the point of care / Number of ICU beds in the unit) x100
Consumption of alcohol-based preparations in Primary Care centers	15 months	Litres of alcohol-based preparations consumed in primary care centres. (Number of liters of alcohol-based preparations delivered in primary care / Total number of consultations in the evaluated period) x10000
Pain related to a procedure likely to cause pain	15 months	Detection of pain related to a procedure likely to cause pain. This indicator evaluates whether the assessment of pain linked to the painful procedure is carried out before and after the procedure, it is also recommended to assess pain during the procedure in cases where it is possible. (Total number of patients in whom pain has been detected after a procedure likely to cause pain, and is registered / Total number of patients in whom a procedure likely to cause pain has been performed in the data collection period data) x100
Pain intensity assessment	15 months	Pain assessment measured with a pain intensity assessment tool. (Total number of patients who have an assessment of pain intensity, and it is recorded / Total number of patients with positive detection of pain in the data collection period) x100
Quantification assessment in active smokers	15 months	Quantitative assessment of the intensity of tobacco or tobacco products use measured with a validated tool (Total number of patients who have undergone a quantification assessment and it is recorded )/(Total number of patients with positive detection of active smoking @ in the period of data collection ) x100 Active smoker: person who is currently smoking or has smoked in the last 30 days.; Non-active smoker: smoked the last cigarette or similar product more than 30 days but less than 183 days (6 months) ago.
Healthcare-associated pressure injuries in persons at risk	15 months	Total number of persons who develop one or more pressure injuries during care and who had been assessed as being at risk of developing pressure injuries (Total number of persons developing one or more pressure injuries since admission or start of care)/(Total number of persons at risk of PBI with healthcare provision) x 100
Comprehensive pain assessment	15 months	Comprehensive pain assessment takes into account various factors related to pain, including: location of pain, circumstances related to the onset of pain, type of pain, pain intensity, associated symptoms, effect of pain on activities, effect of pain on patient rest and sleep, treatment, relevant medical history, factors that influence pain management. To be considered a comprehensive assessment, at least 60% of the 10 criteria must be performed and recorded. (Total number of patients who have done a comprehensive pain assessment, and it is registered / Total number of patients with positive pain detection in the data collection period) x100
Maximum pain	15 months	Maximum scored reported by patients and registered by nurses after pain intensity assessment using an assessment tool. Units must indicate on the form the assessment tool they have used. (Sum of the maximum intensity of pain during the stay or care of patients with positive detection of pain or likely to have pain / Total number of patients with pain intensity assessed in the data collection period)
Comprehensive assessment of active smokers	15 months	Assessment carried out with a comprehensive and systematic approach, taking into account various factors related to smoking, such as: Motivation to quit smoking (measured with the Richmond test); Degree of nicotine dependence (measured with the full Fagerström test); Current nicotine withdrawal symptoms; Previous quit attempts; Current need for smoking cessation treatments; Factors influencing patient behaviour change. The criterion is met when at least 50% of the 6 criteria (at least 3) are fulfilled and recorded (Total number of patients who have had a comprehensive smoking assessment performed and recorded)/(Total number of patients with positive screening for active smoking in the data collection period )/(Total number of patients with a positive screening for active smoking in the data collection period ) x100; Active smoker: person who is currently smoking or has smoked in the last 30 days.
Support surfaces for the prevention of pressure injuries	15 months	Recording whether a support surface that meets the person's needs has been used to prevent the occurrence of pressure injuries (Total number of persons at risk of pressure injuries who have a support surface applied)/(Total number of persons at risk of pressure injuries) x100
Pressure injuries associated with care	15 months	Total number of people who develop one or more pressure injuries during care (Total number of people who develop one or more pressure injuries since admission or start of care)/(Total number of people with health care provision ) x 100
Falls risk screening	15 months	Falls risk screening carried out on all patients aged 65 years and over to determine their risk of falling. (Total number of people with falls risk screening recorded)/(Total number of people) x100.
Multifactorial falls risk assessment	15 months	Multifactorial falls risk assessment carried out on patients at high risk of falls. This should include at least: mobility, activities of daily living and cognitive function (Total number of people with recorded falls risk assessment)/(Total number of people at risk of falls) x100.
Derivation of the active smoking patient	15 months	Referral to smoking cessation follow-up consultations is considered to be referral to primary care consultations and/or specific monographic smoking cessation consultations. If the unit is capable of carrying out the follow-up, the recommendation will be considered to have been made when the follow-up is planned in the same unit (Number of smoking patients referred for smoking follow-up after being seen/(Total number of smoking patients seen in the period of data collection) x100; Active smoker: person who is currently smoking or has smoked in the last 30 days.; Non-active smoker: smoked the last cigarette or similar product more than 30 days but less than 183 days (6 months) ago.
Expressed desire to quit smoking (active smokers)	15 months	Documented evidence of the patient's expressed desire to quit smoking after the brief intervention (Total number of patients who have expressed an expressed desire to quit smoking after the brief intervention)/(Total number of patients with positive smoking screening who have undergone a BI in the data collection period)/(Total number of patients with positive smoking screening who have undergone a BI in the data collection period)x100; Active smoker: person who is currently smoking or has smoked in the last 30 days.; Non-active smoker: smoked the last cigarette or similar product more than 30 days but less than 183 days (6 months) ago.; Brief intervention: Intervention in which there is a brief (less than five minutes) contact between the health care provider and the patient.
Maintenance of willingness to remain smoke-free (non-active smokers)	15 months	Documented evidence of the non-active smoker patient's expressed desire to maintain their willingness to remain smoke-free after the comprehensive assessment. (Total number of patients who maintain their willingness to quit smoking after comprehensive assessment of active smoking)/(Total number of non-active smoking patients who have undergone a comprehensive assessment in the data collection period)x100; Active smoker: person who is currently smoking or has smoked in the last 30 days.; Non-active smoker: smoked the last cigarette or similar product more than 30 days but less than 183 days (6 months) ago.
Reassessment of the risk of pressure injuries	15 months	Reassessment of the risk of PBI: reassessment of the risk of developing pressure sores upon a significant clinical change in the person's general condition, change of caregiver, change of setting or care unit and at discharge; with a structured, validated and reliable tool, together with clinical judgement. (Total number of people with reassessment of pressure sores)/(Total number of people with health care provision) x100.
Stage of most severe pressure injury:	15 months	Stage of the most severe pressure injury developed by patients classified as at risk or not at risk of developing pressure injuries.
Injuries resulting from falls	15 months	Injuries resulting from the fall, according to the following scale: None, slight injury, moderate injury, severe injury, fear of falling, death. (Total number of persons with fall/s that have had consequences)/(Total number of persons who have fallen) x100
Voiding diary	15 months	Record of all urination and leakage for 3 consecutive days before and after the intervention. (Total number of patients with a voiding diary of 3 days recorded / Total number of patients with urinary incontinence discharged or attended during the data collection period) \* 100
Bladder training	15 months	Program of education and programmed evacuation in which the intervals of micturition are gradually adjusted. (Total number of patients with a bladder training care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) \* 100
Comprehensive assessment (obesity)	15 months	Requires realization and documentation of a comprehensive assessment of children from birth to 12 years has been carried out considering all of the following elements: Growth; Feeding / breastfeeding (as appropriate); Physical activity; Sedentary behaviour / screen time; Family environment. (Number of children from birth to 12 years (and parents or carers) who have had a full assessment)/(Number of children from birth to 12 years ) x100.
Pressure injury prevention care plan	15 months	Establishing and implementing a pressure injury prevention care plan for the patient based on the results of the person's assessment, which would include: comprehensive skin and tissue assessment; preventive skin and tissue care; early mobilisation; use of pressure relief devices/support surfaces; health education. (Total number of people with a pressure injury prevention care plan)/(Total number of people at risk of pressure injuries) x100
Number of falls	15 months	Number of falls that have occurred during the hospital stay or duration of care.(Total number of people who have fallen)/(Total number of people) x100
Exclusive breastfeeding, children from birth to 6 months of age	15 months	Children from 0 to 183 days inclusive who have received exclusive breastfeeding, directly from the breast or stored. (Number of children 0-6 months (or-183 days) who received EXCLUSIVE breastfeeding in the previous 24 hours, and is registered / Total number of children 0-6 months with one or more visits well-infant-child follow-up in the previous year) x100
Sedentary behaviour	15 months	Number of children from birth to 12 years old who spent the recommended time for their age in front of a screen. (Number of children from birth to 12 years old, whose daily screen time is the recommended for their age, as of parents' declaration, and is registered / Total number of children from births up to 12 years of age with one or more follow-up visits to the well-child infant in the previous year, with assessment of screen time or comprehensive assessment) x100
Information and education on breastfeeding, and support for the breastfeeding process (hospital).	15 months	In Hospital Care, it is considered completed if postpartum training and resources have been provided to the mother by the interprofessional team on breastfeeding before hospital discharge. The specific components are: Latching/postpartum and latch-on; Milk transfer; Breastfeeding based on infant cues; Other. ((Number of mothers receiving information and education on breastfeeding and support for the breastfeeding process)/ Total number of dyads) x100 Dyad: Pair consisting of mother and breastfeeding infant who form a bond with each other.
Falls prevention care plan	15 months	Individualised falls and injury prevention plan for people at risk of falling, taking into account the scope of care and its possibilities, patient preferences and multifactorial assessment by professionals (Total number of people at high risk of falls with a recorded falls prevention care plan)/(Total number of people at high risk of falls) x100
Breastfeeding, children from 6 months of age up to 2 years	15 months	Children with more than 183 days of life who received breastfeeding directly from the breast or stored. (Number of children \>6 months and up to 2 years (more than 183 days-2 years) who received breastfeeding in the previous 24 hours, and is registered / Total number of children \>6 months - and up 2 years with one or more well-infant-child follow-up visits in the previous year) x100
Daily physical activity	15 months	Number of children from birth from 0 to 12 years of age who meet the recommendations on amount of daily physical activity. (Number of children from birth to 12 years of age who meet the recommendations on amount of daily exercise, and are registered / Total number of children from birth to 12 years of age with one or more follow-up visits of the healthy infant-child in the previous year, with assessment of physical activity or comprehensive assessment) x100
Fruit and vegetable intake	15 months	Number of children aged 2-12 consuming fruit and vegetables daily and up to 5 times a day, and recorded (Number of children aged 2-12 consuming fruit and vegetables daily or up to 5 times a day)/(Number of children aged 2-12 ) x100
Skin-to-skin contact	15 months	Skin-to-skin contact is the placement of a newborn, naked or with a diaper and cap, in a prone position on the bare chest of a person, covered with a previously heated blanket to prevent heat loss. It should be facilitated immediately (up to 1 hour) after birth or once the child and the nursing person are clinically stable. (Number of infants performing skin-to-skin immediately after birth or with clinically stable dyad /Total number of infants) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Breastfeeding at first feeding	15 months	Requires the infant to have been breastfed for the first feeding after birth (Number of infants who were breastfed for the first feeding)/(Total number of infants discharged) x100
Exercise interventions	15 months	Considers whether people at risk of falls have been referred to a specialist for exercise or whether exercise interventions have been implemented. (Number of people at high risk of falls who have participated in @exercise and physical training interventions)/(Total number of people at high risk of falls where the indicator applies) x100
Scheduled urination	15 months	Using verbal and physical prompts or signals to make people pay attention to their dry/wet situation and the need to go to the bathroom. (Total number of patients with a scheduled urination care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) \* 100
Pelvic floor exercises	15 months	The individualized education and training of pelvic floor exercises. (Total number of patients with a pelvic floor exercise care plan, and it is registered / Total number of patients with urinary incontinence and a 3-day voiding diary discharged or attended in the data collection period) \* 100
Severity	15 months	Severity of urinary incontinence. Total number of patients with different levels of urinary incontinence 24 hours prior to assessment / Total number of patients with urinary incontinence during the data collection period) x 100
Improvement	15 months	Perception of improvement in urinary incontinence. (Total number of patients who perceive an improvement 6 weeks after the intervention / Total number of patients with urinary incontinence before the start of the intervention) x100
Urinary incontinence initial assessment	15 months	Initial assessment of presence of urinary incontinence. Total number of patients in whom the presence of urinary incontinence has been initially assessed, and who are registered / Total number of patients with positive detection of urinary incontinence during the data collection period) \* 100
Impact	15 months	Impact of urinary incontinence. (Total number of patients whose urinary incontinence has an impact on their quality of life, in the 24 hours prior to the assessment / Total number of patients with urinary incontinence during the data collection period) x 100
Promotion of healthy behaviours	15 months	Delivery and documentation of age-appropriate healthy behaviour promotion recommendations (e.g.: Support for breastfeeding, exclusive or complementary feeding (if appropriate); Healthy behaviour promotion on feeding; Healthy behaviour promotion on physical activity; Healthy behaviour promotion on sedentary/ screen time. (Number of children from birth to 12 years (and parents/caregivers) who have received healthy behaviour promotion interventions)/(Number of children from birth to 12 years) x100
Postpartum assessment of breastfeeding	15 months	Assessment of breastfeeding completed within the first 24 hours of the newborn life. It should include all of the following components: knowledge and attitudes; level of self-efficacy or self-confidence regarding breastfeeding; concerns; support network; breastfeeding technique in relation to positioning, latch-on, effective milk transfer; assessment of the newborn/infant (regarding breastfeeding). To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process in the first 24 hours/Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Breastfeeding education for the breastfeeding person (Primary care)	15 months	In Primary Care, it is considered completed if training has been carried out and resources have been provided to the mother after hospital discharge by the interprofessional team in breastfeeding, at least once in the period after discharge to 8 days or in the period from 9 days to 6 months, in the same visit or in successive visits. (Number of lactating persons receiving education in breastfeeding / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Type of breastfeeding of the newborn in early stage	15 months	Type of breastfeeding of the newborn from birth to 8 days of life assessed in Primary care. (Number of newborns who were exclusively breastfed, received mixed breastfeeding or were not breastfed from birth to 8 days of life / Total number of newborns between 0 and 8 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.; Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.; Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Education and support	15 months	Requires documented evidence that parents/primary caregivers have received age-appropriate education on any of the following topics: breastfeeding, role modelling, child feeding practices, family physical activity; screen time, physical activity, healthy eating. (Number of parents or caregivers of children from birth to 12 years who have been provided with education and support to maintain healthy habits)/(Number of children from birth to 12 years ) x100
Assessment of mother's intention to breastfeed	15 months	Requires that mothers of newborns have been assessed for their intention to breastfeed during hospital admission for delivery (Number of mothers assessed for their intention to breastfeed)/(Total number of mothers) x100
Early assessment of breastfeeding in primary care	15 months	In Primary Care, early assessment is considered completed between hospital discharge and day 8 of the neonate's life (included). To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed early on the process of breastfeeding (between hospital discharge and 8 days of life / Total number of dyads between hospital discharge and 8 days of life of the newborn) x 100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Breastfeeding education and support for family members	15 months	In Primary Care, it is considered accomplished if breastfeeding education and support has been provided to family members, at least once in the period after discharge to 8 days or in the period from 9 days to 6 months, in the same visit or on successive visits. (Number of dyads whose family has received education and support in breastfeeding / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Type of breastfeeding of the newborn in follow-up 1	15 months	Type of breastfeeding of the newborn from 9 to 90 days of life, assessed in Primary Care. (Number of infants exclusively breastfed, receiving mixed breastfeeding or not breastfed from 9 days to 90 days of life / Total number of infants from 9 to 90 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.; Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.; Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Breastfeeding education and support for family members (hospital)	15 months	In hospital care, it is considered completed if education and support in breastfeeding has been carried out for family members before hospital discharge. (Number of dyads whose family has received education and support in breastfeeding / Total number of dyads) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Type of breastfeeding of the newborn during the hospital stay	15 months	Type of breastfeeding of the newborn during the hospital stay. (Number of infants exclusively breastfed, receiving mixed breastfeeding or not breastfed during hospital stay / Total number of infants discharged) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.; Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.; Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Follow-up assessment of breastfeeding in primary care (from 9 days of life to 6 months)	15 months	In Primary Care, the follow-up evaluation is carried out between 9 days of life and 6 months/183 days of life of the neonate (included). To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process from 9 days of life to 6 months / Total number of dyads from 9 days of life to 6 months of the newborn) x100 Dyad: A couple formed by the mother and the nursing baby who form a bond with each other.
Type of breastfeeding of the newborn in follow-up 2	15 months	Type of breastfeeding of the newborn from 91 to 182 days of life assessed in Primary care (Number of newborns who received exclusive breastfeeding, receiving mixed breastfeeding or not breastfed from 91 days to 182 days of life / Total number of newborns from 91 to 182 days of life) x100 Exclusive breastfeeding: The infant receives directly or indirectly breast milk. He does not receive any other type of solid or liquid food.; Mixed breastfeeding: The infant receives breast milk as well as other solid and liquid foods (including water), including non-human milk or formula.; Non-breastfeeding: The infant receives artificial milk and/or animal milk. The infant does not receive breast milk.
Exclusive breastfeeding at 6 months	15 months	Number of newborns who received exclusive breastfeeding on day 183 of life (Number of newborns who received exclusive breastfeeding on day 183 of life / Total number of newborns with 183 days completed) x100

Secondary Outcome Measures

Name	Time	Method
Team members rol	15 months	Supervisor, mid-level leader, high-level leader, clinical nurse, other rol in the institution
Date of attention	15 months	Date when patients were attended in case of primary care.
Patients Age	15 months	Age of patients.
Weight at birth	15 months	Weight of the newborn at birth, measured in grams.
Tobacco use	15 months	Number of cigarettes or derivatives consumed by the patient per day and year
Patients Sex	15 months	Sex of patients.
Type of institution	15 months	Hospital unit, primary care unit or nursing home unit.
Type of unit	15 months	Age, health problems and care required by the patients attended by the unit on a regular basis.
Mother´s age	15 months	Age of the mother.
Type of birth	15 months	Way in which the newborn was born: vaginal delivery, instrumental birth, caesarean section.
Clinical leadership skills	15 months	Clinical leadership skills of the healthcare professionals working in the units that are implementing evidence-based recommendations, assessed with the clinical leadership survey©.
Team Leader rol	15 monthts	Supervisor, mid-level leader, high-level leader, clinical nurse, other rol in the institution
Date of discharge	15 months	Patients discharge date in case of hospital admissions.
Breastfeeding for the first time	15 months	First time the mother is facing breastfeeding or not.
Weeks of gestation	15 months	Number of weeks of pregnancy.
Child weight	15 months	Child's weight measured in kilograms.
Child's height	15 months	Child's height measured in centimetres.
Reason for admission/consultation	15 months	Reason for admission/consultation of patients. Reason for the patient to be admitted to the Hospital or to attend the consultation.
Previous history of pain	15 months	History of previous painful experiences of the patient.
Stage of change	15 months	Patient's stage of change according to Prochaska y Diclemente
Date of residence	15 months	Date when patients were a resident in case of socio-healthcare centres.
Barriers	15 months	Barriers for the implementation of evidence-based recommendations in the units assessed using a questionnaire adapted from the The comprehensive, integrated checklist of determinants of practice (TICD checklist) and the Consolidated Framework for Implementation Research.
Evidence Based Practice competencies	15 months	Competencies in evidence-based practice of the healthcare professionals working in the units that are implementing evidence-based recommendations, assessed with the questionnaire EBP-COQ Prof©.
Professional's age	15 months	Age of the professionals participating in the local implementation team
Professional's experience	15 months	Professional's experience of the professionals participating in the local implementation team
Type of incontinence	15 months	Type of incontinence presented by the patient who has been assessed as an incontinent patient. It may be stress, urge or mixed incontinence.
Incontinence triggering factors.	15 months	Factors that cause the patient to experience episodes of incontinence. They may be: Multifactorial causes (cognitive, previous urinary problems, neurological causes, malignancy, surgery); Medication; Overweight/Obesity; Tobacco use; Lifestyle and fluid intake.
Previous of pressure injuries	15 months	Numbers of pressure injuries that the patient had at the start of care
Professional's qualifications	15 months	Professional's qualifications of the professionals participating in the local implementation team
Type of smoker	15 months	Currently smoking or have quit less than 1 month ago or non-active if quit more than 1 month ago but less than 6 months ago.
Smoking relapses	15 months	Number of relapses since patient stopped smoking
Evidence Based Practice (EBP) climate and leadership	15 months	EBP climate and leadership in the units participating in the project measured with the evidence-based practice nursing leadership and work environment scales ©.
Professional's sex	15 months	Sex of the professionals participating in the local implementation team
Strategies	15 months	Strategies designed for the implementation of evidence-based recommendations in the units assessed using a questionnaire adapted from the Expert Recommendations for Implementing Change (ERIC).
Empowerment	15 months	Empowerment of the healthcare professionals working in the units that are implementing evidence-based recommendations, assessed with the Conditions for Work Effectiveness Questionnaire - II ©.

Trial Locations

Locations (1)

Instituto de Salud Carlos III - Unidad de Investigación en Cuidados y Servicios de Salud; 🇪🇸 Madrid, Spain