Sumamos Excelencia 2022

NCT05466656 | Unknown DMC

• 1 other identifier: SE_CECBE_2022
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

There is a gap between research and clinical practice, leading to variability in decision-making. Clinical audits are an effective strategy for improving implementation of best practices. Quasi-experimental, multicentre, before and after. Primary care, hospital units and nursing homes, and the patients attended at both. Implementation of evidence-based recommendations by application of a continuous quality improvement cycle model (process of improvement by reference to a prior baseline clinical audit. Data will be collected at baseline and, during the first year of follow up, at months (3, 6, 12)

Conditions

Pain; Incontinence, Urinary; Obesity, Childhood; Breastfeeding

Keywords

Implementation Science; Evidence-Based Practice; Evidence-Based Nursing; Nursing Care; Quality of Health Care; Clinical Audit

Outcome Measures

Primary Outcomes (43)

• Urinary incontinence assessment

  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

  Record of all urination and leakage for 3 consecutive days. (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

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• 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)

  15 months

• 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)

  15 months

• 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.

  15 months

• Postpartum assessment of breastfeeding

  Assessment of breastfeeding completed within the first 24 hours of the newborn life. The objective is that in the first 24 hours the breastfeeding person is able to identify: proper position and grip, efficient breast milk transfer, support networks, breastfeeding self-efficacy, risks of mood disorders, assessment of the newborn in relation to 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

• Assessment of breastfeeding after the first 24 hours and before discharge

  Assessment of breastfeeding completed after first 24 hours of the newborn life and before hospital discharge. The objective is that before hospital discharge the breastfeeding person is able to identify: proper position and grip, efficient breast milk transfer, support networks, breastfeeding self-efficacy, risks of mood disorders, assessment of the newborn in relation to breastfeeding. To carry out the assessment, a breastfeeding assessment tool may be used. (Number of dyads assessed on the breastfeeding process after the first 24 hours and before hospital discharge / 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

• Early assessment of breastfeeding in primary care

  In Primary Care, early assessment is considered completed between birth 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 birth and 8 days of life / Total number of dyads between birth 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

• 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.

  15 months

• Breastfeeding education for the breastfeeding person

  In Hospital Care, it is considered completed if postpartum training has been carried out and resources have been provided to the mother by the interprofessional team in breastfeeding before hospital discharge. 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

  In hospital care, it is considered completed if education and support in breastfeeding has been carried out for family members before hospital discharge. 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

• 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.

  15 months

• 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.

  15 months

• 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.

  15 months

• 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.

  15 months

• 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

  15 months

• Training of health professionals

  Number of health professionals who have received advanced training and/or continuing education in breastfeeding. The training must have a minimum of 18 hours and include theoretical training and practical application of skills. (Number of health professionals who have received advanced training and/or continuing education in breastfeeding / Total number of health professionals) x100

  15 months

• Assessment to prevent obesity

  At least one comprehensive assessment including the assessment of nutrition, physical activity, sedentary behaviour, growth and family environment has been completed in infants from birth to 12 years of age. (Total number of children from birth to 12 years of age who have undergone a comprehensive assessment to prevent obesity, and are registered / Total number of children from birth to 12 years of age with one or more well-child follow-up visits in the previous year) x100

  15 months

• Education and support for parents/primary caregivers

  Parents or primary caregivers have received education and support including: breastfeeding, role modelling, children's eating practices, family physical activity, screen time, physical activity, healthy eating; and it is documented. (Total number of children from birth to 12 years of age whose parents or caregivers have received education to promote healthy eating or physical activity habits, by child's age, and is registered / Total number of children from birth to 12 years with one or more well-child follow-up visits in the previous year) x100

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

• Daily physical activity

  Number of children from birth 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

• Incidence of childhood obesity

  Incidence of childhood obesity. (Number of children between 2 and 12 years old (included) whose BMI for their age exceeds the percentile to be considered obese according to WHO standards, at the LAST follow-up VISIT of the infant/well-child, and is registered / Number of children between 2 and 12 years of age (included) with one or more well-child infant follow-up visits in the previous year, whose BMI has been assessed in the measurement period) x100

  15 months

• 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

  15 months

• 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

  15 months

• Consumption of alcohol-based preparations in hospitalization

  Litres of alcohol-based preparations consumed in hospitalization units with admission, including ICU (Number of litres of alcohol-based preparations delivered / Total number of stays in the evaluated period) x1000 Total number of stays in the evaluated period: It refers to the stays of hospitalized patients, where stay = Date of discharge - Date of admission, during the indicator calculation period.

  15 months

• 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

  15 months

• 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

  15 months

• 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

  15 months

Secondary Outcomes (23)

• Type of institution

  15 months

• Size of hospital unit

  15 months

• Size of Nursing home

  15 months

• Size of primary care unit

  15 months

• No. Nurses

  15 months

Study Arms (1)

Quasi-experimental uncontrolled, before-and-after.

EXPERIMENTAL

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

Other: Continuous quality improvement cycle model

Interventions

Continuous quality improvement cycle model OTHER

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

Quasi-experimental uncontrolled, before-and-after.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• NHS units and nursing homes which voluntary adhere to the project.
• NHS units and nursing homes providing direct patient care and commit to implement evidence-based recommendations on hand hygiene and one of the following topics: pain assessment and management, urinary incontinence management, obesity prevention and breastfeeding promotion. For the purposes of this study, a "unit" is defined as any service, centre or institution that delivers health services to a homogeneous group of patients who share similar characteristics.
• 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).
• 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.

Sponsors & Collaborators

• Teresa Moreno Casbas: lead
• The Spanish Centre for Evidence Based Nursing and Healthcare: collaborator

Study Sites (1)

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

Madrid, Spain

Location

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Related Links

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

MeSH Terms

Conditions

Pain; Urinary Incontinence; Pediatric Obesity; Breast Feeding

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Feeding Behavior; Behavior

Study Officials

• María Teresa Moreno-Casbas, Doctor

  Instituto de Salud Carlos III

  STUDY DIRECTOR

• Esther González-María, Doctor

  Instituto de Salud Carlos III

  PRINCIPAL INVESTIGATOR

• Leticia Bernués-Caudillo, PhD Candidate

  Instituto de Salud Carlos III

  STUDY CHAIR

• Candela Cameselle-Lago, PhD Candidate

  Instituto de Salud Carlos III

  STUDY CHAIR

• Laura Albornos-Muñoz, PhD Candidate

  Instituto de Salud Carlos III

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Nursing and helathcare research Unit (Investén-isciii)

Model Details: Quasi-experimental, uncontrolled, before-and-after study

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 20, 2022
• Study Start: November 25, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)