Sumamos Excelencia 2022

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05466656
• Other study ID #: SE_CECBE_2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Instituto de Salud Carlos III
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Aim: To assess the effectiveness of implementing evidence-based recommendations using a continuous quality improvement cycle model 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 continuous quality improvement cycle's model (process of improvement by reference to a prior baseline clinical audit). 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, 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 3, 6 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 2022-2024.

This project is a second edition of The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (NCT03725774), with a similar design but with changes in some of the themes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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. 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. Hand hygiene:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Breastfeeding
• Enuresis
• Incontinence, Urinary
• Obesity, Childhood
• Pain
• Pediatric Obesity
• Urinary Incontinence

Intervention

Other:
• Continuous quality improvement cycle model
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.

Locations

Country	Name	City	State
Spain	Instituto de Salud Carlos III - Unidad de Investigación en Cuidados y Servicios de Salud	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Teresa Moreno Casbas	The Spanish Centre for Evidence Based Nursing and Healthcare

Country where clinical trial is conducted

Spain, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Type of institution	Hospital unit, primary care unit or nursing home unit.	15 months
Secondary	Size of hospital unit	Average number of admissions received per year.	15 months
Secondary	Size of Nursing home	Total number of beds in the nursing home unit.	15 months
Secondary	Size of primary care unit	Average number of appointments per day in the units.	15 months
Secondary	No. Nurses	Total number of nurses working in the unit by November 2021.	15 months
Secondary	No. Healthcare assistants	Total number of healthcare assistants working in the unit by November 2021.	15 months
Secondary	Type of unit	Age, health problems and care required by the patients attended by the unit on a regular basis.	15 months
Secondary	Date of discharge	Patients discharge date in case of hospital admissions.	15 months
Secondary	Date of attention	Date when patients were attended in case of primary care.	15 months
Secondary	Date of residence	Date when patients were a resident in case of socio-healthcare centres.	15 months
Secondary	Age	Age of patients.	15 months
Secondary	Sex	Sex of patients.	15 months
Secondary	Mother´s age	Age of the mother.	15 months
Secondary	Breastfeeding for the first time	First time the mother is facing breastfeeding or not.	15 months
Secondary	Type of birth	Way in which the newborn was born: vaginal delivery, instrumental birth, caesarean section.	15 months
Secondary	Weeks of gestation	Number of weeks of pregnancy.	15 months
Secondary	Weight at birth	Weight of the newborn at birth, measured in grams.	15 months
Secondary	Child weight	Child's weight measured in kilograms.	15 months
Secondary	Size	Height: child's height measured in centimetres.	15 months
Secondary	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.	15 months
Secondary	Past-medical history	History of previous illness, surgery or painful experiences of the patient.	15 months
Secondary	Barriers	Barriers for the implementation of evidence-based recommendations in the units assessed using a questionnaire adapted from the TICD checklist.	15 months
Secondary	EBP 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©.	15 months

External Links

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