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PainSE24NCT06522529

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

A study testing Multifaceted implementation strategy in people with Pain and Obesity, Childhood, run by Instituto de Salud Carlos III at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Pain, Obesity, Childhood, Breast Feeding
What is being tested?
Multifaceted implementation strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteSpain
Study dates
1 Sep 2024to 30 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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:
  • Pain:
  • People susceptible to suffering some type of pain regardless of age.
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  • Patients treated in acute or chronic health institutions (Hospitals, Nursing Homes or Primary Care).
  • 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.
  • 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.
  • 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.
  • Smoking Cessation:
  • ≥ 18 years of age
  • Smokers
  • 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.
  • 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.
  • Hand hygiene:
  • All health professionals who care for patients in the units participating in the study.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Leticia Bernués-Caudillo, PhD Candidate contact

644617184

l.bernues@isciii.es

Esther González-María, PhD contact

0034918222548

esthergomaria@isciii.es

Spain1 site, 1 recruiting

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

    Madrid, 28029

    Leticia Bernués-Caudillo, PhD Candidate, 0034-918222539, l.bernues@isciii.es

    Esther González-María, Doctor, 0034918222548, esthergomaria@isciii.es

    Recruiting

Other trials in Spain

About this study

Official title: SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (Thrid Edition)

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)

Read the 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.

Being tested
Multifaceted implementation strategy
Keywords
Implementation, Implementation science, Evidence-based practice, Nursing, Quality of Health Care
Medical subject headings
Pain, Pediatric Obesity, Breast Feeding, Urinary Incontinence, Smoking Cessation, Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multifaceted implementation strategyOther

    The multifaceted implementation strategy consist in a process of improvement by reference to a prior baseline clinical audit. It implies a local context analysis, identifying barriers to improvements in clinical practice, and developing 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.

Study groups in NCT06522529
Study groupRoleWhat they receive
Experimental: Quasi-experimental uncontrolled, before-and-after.ExperimentalThe 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.
Receives: Other: Multifaceted implementation strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICU beds with alcohol-based preparations at the point of care

    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

    Measured: 15 months

  2. Hospital beds with alcohol-based preparations at the point of care

    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

    Measured: 15 months

  3. Consumption of alcohol-based preparations in Primary Care centers

    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

    Measured: 15 months

  4. Consumption of alcohol-based preparations in hospital units without admission

    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

    Measured: 15 months

  5. Consumption of alcohol-based preparations in Nursing Homes.

    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

    Measured: 15 months

  6. Detection of pain at admission

    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

    Measured: 15 months

  7. Pain related to a procedure likely to cause pain

    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

    Measured: 15 months

  8. Pain after a change in the patient's clinical situation

    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

    Measured: 15 months

  9. Pain intensity assessment

    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

    Measured: 15 months

  10. Comprehensive pain assessment

    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

    Measured: 15 months

  11. Pain management care plan

    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

    Measured: 15 months

  12. Patient or/and caregiver education on pain

    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

    Measured: 15 months

  13. Intensity of pain on admission or in the first 24 hours after surgery or at the start of care

    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)

    Measured: 15 months

  14. Maximum pain

    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)

    Measured: 15 months

  15. Quantification assessment in active smokers

    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.

    Measured: 15 months

  16. Comprehensive assessment of active smokers

    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.

    Measured: 15 months

  17. Comprehensive assessment of the non-active smoker

    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.

    Measured: 15 months

  18. Brief interventions performed

    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.

    Measured: 15 months

  19. Derivation of the active smoking patient

    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.

    Measured: 15 months

  20. Expressed desire to quit smoking (active smokers)

    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.

    Measured: 15 months

  21. Maintenance of willingness to remain smoke-free (non-active smokers)

    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.

    Measured: 15 months

  22. Pressure injuries risk assessment at the initiation of care

    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.

    Measured: 15 months

  23. Reassessment of the risk of pressure injuries

    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.

    Measured: 15 months

  24. Nutritional screening of the person at risk of pressure injuries

    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.

    Measured: 15 months

  25. Support surfaces for the prevention of pressure injuries

    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

    Measured: 15 months

  26. Pressure injury prevention care plan

    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

    Measured: 15 months

  27. Prevalence of pressure injuries

    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

    Measured: 15 months

  28. Pressure injuries associated with care

    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

    Measured: 15 months

  29. Healthcare-associated pressure injuries in persons at risk

    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

    Measured: 15 months

  30. Stage of most severe pressure injury:

    Stage of the most severe pressure injury developed by patients classified as at risk or not at risk of developing pressure injuries.

    Measured: 15 months

  31. Falls risk screening

    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.

    Measured: 15 months

  32. Multifactorial falls risk assessment

    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.

    Measured: 15 months

  33. Falls prevention care plan

    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

    Measured: 15 months

  34. Falls risk reassessment

    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

    Measured: 15 months

  35. Exercise interventions

    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

    Measured: 15 months

  36. Number of falls

    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

    Measured: 15 months

  37. Injuries resulting from falls

    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

    Measured: 15 months

  38. Urinary incontinence initial assessment

    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

    Measured: 15 months

  39. Voiding diary

    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

    Measured: 15 months

  40. Scheduled urination

    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

    Measured: 15 months

  41. Bladder training

    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

    Measured: 15 months

  42. Pelvic floor exercises

    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

    Measured: 15 months

  43. Severity

    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

    Measured: 15 months

  44. Impact

    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

    Measured: 15 months

  45. Improvement

    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

    Measured: 15 months

  46. Comprehensive assessment (obesity)

    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.

    Measured: 15 months

  47. Promotion of healthy behaviours

    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

    Measured: 15 months

  48. Education and support

    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

    Measured: 15 months

  49. Exclusive breastfeeding, children from birth to 6 months of age

    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

    Measured: 15 months

  50. Breastfeeding, children from 6 months of age up to 2 years

    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

    Measured: 15 months

  51. Daily physical activity

    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

    Measured: 15 months

  52. Sedentary behaviour

    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

    Measured: 15 months

  53. Fruit and vegetable intake

    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

    Measured: 15 months

  54. Assessment of mother's intention to breastfeed

    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

    Measured: 15 months

  55. Postpartum assessment of breastfeeding

    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.

    Measured: 15 months

  56. Skin-to-skin contact

    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.

    Measured: 15 months

  57. Information and education on breastfeeding, and support for the breastfeeding process (hospital).

    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.

    Measured: 15 months

  58. Breastfeeding education and support for family members (hospital)

    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.

    Measured: 15 months

  59. Breastfeeding at first feeding

    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

    Measured: 15 months

  60. Type of breastfeeding of the newborn during the hospital stay

    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.

    Measured: 15 months

  61. Early assessment of breastfeeding in primary care

    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.

    Measured: 15 months

  62. Follow-up assessment of breastfeeding in primary care (from 9 days of life to 6 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.

    Measured: 15 months

  63. Breastfeeding education for the breastfeeding person (Primary care)

    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.

    Measured: 15 months

  64. Breastfeeding education and support for family members

    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.

    Measured: 15 months

  65. Type of breastfeeding of the newborn in early stage

    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.

    Measured: 15 months

  66. Type of breastfeeding of the newborn in follow-up 1

    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.

    Measured: 15 months

  67. Type of breastfeeding of the newborn in follow-up 2

    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.

    Measured: 15 months

  68. Exclusive breastfeeding at 6 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

    Measured: 15 months

Secondary outcomes (35)

  1. Type of institution

    Hospital unit, primary care unit or nursing home unit.

    Measured: 15 months

  2. Type of unit

    Age, health problems and care required by the patients attended by the unit on a regular basis.

    Measured: 15 months

  3. Team Leader rol

    Supervisor, mid-level leader, high-level leader, clinical nurse, other rol in the institution

    Measured: 15 monthts

  4. Team members rol

    Supervisor, mid-level leader, high-level leader, clinical nurse, other rol in the institution

    Measured: 15 months

  5. Date of discharge

    Patients discharge date in case of hospital admissions.

    Measured: 15 months

  6. Date of attention

    Date when patients were attended in case of primary care.

    Measured: 15 months

  7. Date of residence

    Date when patients were a resident in case of socio-healthcare centres.

    Measured: 15 months

  8. Patients Age

    Age of patients.

    Measured: 15 months

  9. Patients Sex

    Sex of patients.

    Measured: 15 months

  10. Type of incontinence

    Type of incontinence presented by the patient who has been assessed as an incontinent patient. It may be stress, urge or mixed incontinence.

    Measured: 15 months

  11. Incontinence triggering factors.

    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.

    Measured: 15 months

  12. Mother´s age

    Age of the mother.

    Measured: 15 months

  13. Breastfeeding for the first time

    First time the mother is facing breastfeeding or not.

    Measured: 15 months

  14. Type of birth

    Way in which the newborn was born: vaginal delivery, instrumental birth, caesarean section.

    Measured: 15 months

  15. Weeks of gestation

    Number of weeks of pregnancy.

    Measured: 15 months

  16. Weight at birth

    Weight of the newborn at birth, measured in grams.

    Measured: 15 months

  17. Child weight

    Child's weight measured in kilograms.

    Measured: 15 months

  18. Child's height

    Child's height measured in centimetres.

    Measured: 15 months

  19. Reason for admission/consultation

    Reason for admission/consultation of patients. Reason for the patient to be admitted to the Hospital or to attend the consultation.

    Measured: 15 months

  20. Previous history of pain

    History of previous painful experiences of the patient.

    Measured: 15 months

  21. Type of smoker

    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.

    Measured: 15 months

  22. Smoking relapses

    Number of relapses since patient stopped smoking

    Measured: 15 months

  23. Previous of pressure injuries

    Numbers of pressure injuries that the patient had at the start of care

    Measured: 15 months

  24. Stage of change

    Patient's stage of change according to Prochaska y Diclemente

    Measured: 15 months

  25. Tobacco use

    Number of cigarettes or derivatives consumed by the patient per day and year

    Measured: 15 months

  26. Barriers

    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.

    Measured: 15 months

  27. Strategies

    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).

    Measured: 15 months

  28. Evidence Based Practice competencies

    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©.

    Measured: 15 months

  29. Clinical leadership skills

    Clinical leadership skills of the healthcare professionals working in the units that are implementing evidence-based recommendations, assessed with the clinical leadership survey©.

    Measured: 15 months

  30. Empowerment

    Empowerment of the healthcare professionals working in the units that are implementing evidence-based recommendations, assessed with the Conditions for Work Effectiveness Questionnaire - II ©.

    Measured: 15 months

  31. Evidence Based Practice (EBP) climate and leadership

    EBP climate and leadership in the units participating in the project measured with the evidence-based practice nursing leadership and work environment scales ©.

    Measured: 15 months

  32. Professional's sex

    Sex of the professionals participating in the local implementation team

    Measured: 15 months

  33. Professional's age

    Age of the professionals participating in the local implementation team

    Measured: 15 months

  34. Professional's qualifications

    Professional's qualifications of the professionals participating in the local implementation team

    Measured: 15 months

  35. Professional's experience

    Professional's experience of the professionals participating in the local implementation team

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion15 Dec 2025 (estimated)
  4. Study completion30 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Quasi-experimental, uncontrolled, before-and-after study
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522529
Sponsor's protocol ID
SE_CECBE_2024
Acronym
SE24
Status last verified
Jul 2024
First submitted
19 Jul 2024
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25424863

  • 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.

    PubMed 22179294

  • 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.

    PubMed 21208425

  • 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.

    PubMed 16907795

  • 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.

    PubMed 32389600

  • 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.

    PubMed 30723713

  • 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.

    PubMed 32299461

  • 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.

    PubMed 32560661

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

  • 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.

    PubMed 27001107

  • 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.

    PubMed 33333843

  • 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.

    PubMed 18241349

  • 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.

    PubMed 18076464

  • 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.

    PubMed 21715571

  • 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.

    PubMed 26453418

Questions about this trial

What is this clinical trial studying?

A study testing Multifaceted implementation strategy in people with Pain and Obesity, Childhood, run by Instituto de Salud Carlos III at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leticia Bernués-Caudillo, PhD Candidate (644617184, l.bernues@isciii.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICU beds with alcohol-based preparations at the point of care (time frame: 15 months). The study lists 68 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06522529, which also lists 55 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.

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