Sumamos Excelencia Project: Implementation of Best Practices in Clinical Practice (Thrid Edition) (SE24)

July 24, 2024 updated by: Teresa Moreno Casbas, Instituto de Salud Carlos III

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)

Study Overview

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Leticia Bernués-Caudillo, PhD Candidate
  • Phone Number: 644617184
  • Email: l.bernues@isciii.es

Study Contact Backup

Study Locations

      • Madrid, Spain, 28029
        • Recruiting
        • Instituto de Salud Carlos III - Unidad de Investigación en Cuidados y Servicios de Salud
        • Contact:
          • Leticia Bernués-Caudillo, PhD Candidate
          • Phone Number: 0034-918222539
          • Email: l.bernues@isciii.es
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Quasi-experimental uncontrolled, before-and-after.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scheduled urination
Time Frame: 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
15 months
Bladder training
Time Frame: 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
15 months
Pelvic floor exercises
Time Frame: 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
15 months
Severity
Time Frame: 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
15 months
Impact
Time Frame: 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
15 months
Improvement
Time Frame: 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
15 months
Detection of pain at admission
Time Frame: 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
15 months
Pain related to a procedure likely to cause pain
Time Frame: 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
15 months
Pain after a change in the patient's clinical situation
Time Frame: 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
15 months
Pain intensity assessment
Time Frame: 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
15 months
Comprehensive pain assessment
Time Frame: 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
15 months
Pain management care plan
Time Frame: 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
15 months
Patient or/and caregiver education on pain
Time Frame: 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
15 months
Intensity of pain on admission or in the first 24 hours after surgery or at the start of care
Time Frame: 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)
15 months
Maximum pain
Time Frame: 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)
15 months
Skin-to-skin contact
Time Frame: 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.
15 months
Follow-up assessment of breastfeeding in primary care (from 9 days of life to 6 months)
Time Frame: 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.
15 months
Type of breastfeeding of the newborn during the hospital stay
Time Frame: 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.

15 months
Type of breastfeeding of the newborn in early stage
Time Frame: 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.

15 months
Type of breastfeeding of the newborn in follow-up 1
Time Frame: 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.

15 months
Type of breastfeeding of the newborn in follow-up 2
Time Frame: 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.

15 months
Exclusive breastfeeding at 6 months
Time Frame: 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
15 months
Exclusive breastfeeding, children from birth to 6 months of age
Time Frame: 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
15 months
Breastfeeding, children from 6 months of age up to 2 years
Time Frame: 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
15 months
Sedentary behaviour
Time Frame: 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
15 months
ICU beds with alcohol-based preparations at the point of care
Time Frame: 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
15 months
Hospital beds with alcohol-based preparations at the point of care
Time Frame: 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
15 months
Consumption of alcohol-based preparations in Primary Care centers
Time Frame: 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
15 months
Consumption of alcohol-based preparations in hospital units without admission
Time Frame: 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
15 months
Consumption of alcohol-based preparations in Nursing Homes.
Time Frame: 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
15 months
Quantification assessment in active smokers
Time Frame: 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.

15 months
Comprehensive assessment of active smokers
Time Frame: 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.

15 months
Comprehensive assessment of the non-active smoker
Time Frame: 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.

15 months
Brief interventions performed
Time Frame: 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.

15 months
Derivation of the active smoking patient
Time Frame: 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.

15 months
Expressed desire to quit smoking (active smokers)
Time Frame: 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.

15 months
Maintenance of willingness to remain smoke-free (non-active smokers)
Time Frame: 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.

15 months
Pressure injuries risk assessment at the initiation of care
Time Frame: 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.
15 months
Reassessment of the risk of pressure injuries
Time Frame: 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.
15 months
Nutritional screening of the person at risk of pressure injuries
Time Frame: 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.
15 months
Support surfaces for the prevention of pressure injuries
Time Frame: 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
15 months
Pressure injury prevention care plan
Time Frame: 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
15 months
Prevalence of pressure injuries
Time Frame: 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
15 months
Pressure injuries associated with care
Time Frame: 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
15 months
Healthcare-associated pressure injuries in persons at risk
Time Frame: 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
15 months
Stage of most severe pressure injury:
Time Frame: 15 months
Stage of the most severe pressure injury developed by patients classified as at risk or not at risk of developing pressure injuries.
15 months
Falls risk screening
Time Frame: 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.
15 months
Multifactorial falls risk assessment
Time Frame: 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.
15 months
Falls prevention care plan
Time Frame: 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
15 months
Falls risk reassessment
Time Frame: 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
15 months
Exercise interventions
Time Frame: 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
15 months
Number of falls
Time Frame: 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
15 months
Injuries resulting from falls
Time Frame: 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
15 months
Urinary incontinence initial assessment
Time Frame: 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
15 months
Voiding diary
Time Frame: 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
15 months
Comprehensive assessment (obesity)
Time Frame: 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.
15 months
Promotion of healthy behaviours
Time Frame: 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
15 months
Education and support
Time Frame: 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
15 months
Daily physical activity
Time Frame: 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
15 months
Fruit and vegetable intake
Time Frame: 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
15 months
Assessment of mother's intention to breastfeed
Time Frame: 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
15 months
Postpartum assessment of breastfeeding
Time Frame: 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.
15 months
Information and education on breastfeeding, and support for the breastfeeding process (hospital).
Time Frame: 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.
15 months
Breastfeeding education and support for family members (hospital)
Time Frame: 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.
15 months
Breastfeeding at first feeding
Time Frame: 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
15 months
Early assessment of breastfeeding in primary care
Time Frame: 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.
15 months
Breastfeeding education for the breastfeeding person (Primary care)
Time Frame: 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.
15 months
Breastfeeding education and support for family members
Time Frame: 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.
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of institution
Time Frame: 15 months
Hospital unit, primary care unit or nursing home unit.
15 months
Type of unit
Time Frame: 15 months
Age, health problems and care required by the patients attended by the unit on a regular basis.
15 months
Date of discharge
Time Frame: 15 months
Patients discharge date in case of hospital admissions.
15 months
Date of attention
Time Frame: 15 months
Date when patients were attended in case of primary care.
15 months
Date of residence
Time Frame: 15 months
Date when patients were a resident in case of socio-healthcare centres.
15 months
Mother´s age
Time Frame: 15 months
Age of the mother.
15 months
Breastfeeding for the first time
Time Frame: 15 months
First time the mother is facing breastfeeding or not.
15 months
Type of birth
Time Frame: 15 months
Way in which the newborn was born: vaginal delivery, instrumental birth, caesarean section.
15 months
Weeks of gestation
Time Frame: 15 months
Number of weeks of pregnancy.
15 months
Weight at birth
Time Frame: 15 months
Weight of the newborn at birth, measured in grams.
15 months
Child weight
Time Frame: 15 months
Child's weight measured in kilograms.
15 months
Reason for admission/consultation
Time Frame: 15 months
Reason for admission/consultation of patients. Reason for the patient to be admitted to the Hospital or to attend the consultation.
15 months
Team Leader rol
Time Frame: 15 monthts
Supervisor, mid-level leader, high-level leader, clinical nurse, other rol in the institution
15 monthts
Team members rol
Time Frame: 15 months
Supervisor, mid-level leader, high-level leader, clinical nurse, other rol in the institution
15 months
Patients Age
Time Frame: 15 months
Age of patients.
15 months
Patients Sex
Time Frame: 15 months
Sex of patients.
15 months
Type of incontinence
Time Frame: 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.
15 months
Incontinence triggering factors.
Time Frame: 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.
15 months
Child's height
Time Frame: 15 months
Child's height measured in centimetres.
15 months
Previous history of pain
Time Frame: 15 months
History of previous painful experiences of the patient.
15 months
Type of smoker
Time Frame: 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.
15 months
Smoking relapses
Time Frame: 15 months
Number of relapses since patient stopped smoking
15 months
Previous of pressure injuries
Time Frame: 15 months
Numbers of pressure injuries that the patient had at the start of care
15 months
Stage of change
Time Frame: 15 months
Patient's stage of change according to Prochaska y Diclemente
15 months
Tobacco use
Time Frame: 15 months
Number of cigarettes or derivatives consumed by the patient per day and year
15 months
Barriers
Time Frame: 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.
15 months
Strategies
Time Frame: 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).
15 months
Evidence Based Practice competencies
Time Frame: 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©.
15 months
Clinical leadership skills
Time Frame: 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©.
15 months
Empowerment
Time Frame: 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 ©.
15 months
Evidence Based Practice (EBP) climate and leadership
Time Frame: 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 ©.
15 months
Professional's sex
Time Frame: 15 months
Sex of the professionals participating in the local implementation team
15 months
Professional's age
Time Frame: 15 months
Age of the professionals participating in the local implementation team
15 months
Professional's qualifications
Time Frame: 15 months
Professional's qualifications of the professionals participating in the local implementation team
15 months
Professional's experience
Time Frame: 15 months
Professional's experience of the professionals participating in the local implementation team
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Leticia Bernués-Caudillo, PhD Candidate, Instituto de Salud Carlos III
  • Study Director: María Teresa Moreno-Casbas, PhD, Instituto de Salud Carlos III
  • Principal Investigator: Esther González-María, PhD, Instituto de Salud Carlos III
  • Study Chair: Laura Albornos-Muñoz, PhD, Instituto de Salud Carlos III
  • Study Chair: Alba Ayala, PhD, Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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