Clinical trial NCT03725774: The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System
Official title: The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Problem
Keywords: pain
accidental falls
urinary incontinence
clinical audit
Lead sponsor: Instituto de Salud Carlos III
Sponsor class: OTHER_GOV
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2018-10-31
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled before-and-after study
Primary purpose: PREVENTION

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 and hospital-care units and associated socio-healthcare structures, and the patients attended at both. Implementation of evidence-based recommendations by application of the Getting Research into Practice 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, 9,12)

Detailed description: Aim: To assess the effectiveness of a model of implementation of evidence-based recommendations, in terms of patient outcomes and healthcare quality. Desing: Quasi-experimental, multicentre, before-and-after. Methods Primary-care and hospital-care units and associated socio-healthcare structures, and the patients attended at both. Intervention: Implementation of evidence-based recommendations by application of the Getting Research into Practice model (process of improvement by reference to a prior baseline clinical audit). Variables: Process and outcome criteria with respect to pain, urinary incontinence and fall prevention. Data will be collected at baseline and, during the first year of follow up, at months (3, 6, 9,12), 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 funded by Spanish Strategic Health Action November 2014. Project duration 2015-2017.

Eligibility criteria: Inclusion Criteria:

* Unit-inclusion criteria. The study will cover all SNHS units and associated socio-healthcare structures which voluntarily adhere to the project and undertake to implement recommendations relating to pain, urinary incontinence and prevention falls.

For the purposes of this study, a "unit" is defined as any service, centre or institution that delivers health services to a homogeneous group of patients who share similar characteristics.

Patient-inclusion criteria. The study will include all patients attended at units participating in the study, who meet the following criteria, depending on the recommendations to be implemented at each unit:

* Pain: persons admitted to hospital centres who may potentially suffer from some type of pain. Patients will be classified according to whether they are adults or children (paediatric patients), and according to whether they experience chronic pain, acute postoperative pain, or acute pain due to other causes.
* Incontinence: community-dwelling or institutionalised persons prone to present with urinary incontinence. Patients will be classified according to whether they are 65 years of age or over.
* Falls: persons aged over 65 years who display one or more fall risk factors according to the assessment criteria established by the risk assessment instrument used.

Exclusion Criteria:

-

Primary outcomes:
measure: Urinary incontinence
timeFrame: 15 month
measure: Detection of pain, at admission
timeFrame: 15 month
measure: Risk of falls
timeFrame: 15 month
Secondary outcomes:
measure: Type of institution
timeFrame: 15 month
measure: Size of primary care unit
timeFrame: 15 month
measure: Size of socio-healthcare centres
timeFrame: 15 month
measure: Size of hospital unit
timeFrame: 15 month
measure: nurse/patient ratio
timeFrame: 15 month
measure: Age
timeFrame: 15 month
measure: Sex
timeFrame: 15 month
measure: Reason for admission/consultation
timeFrame: 15 month
measure: Days of stay
timeFrame: 15month
measure: Impact of urinary incontinence
timeFrame: 15 month
measure: Severity of incontinence
timeFrame: 15 month
measure: Type of urinary incontinence
timeFrame: 15 month
measure: Patient education, urinary incontinence management.
timeFrame: 15 month
measure: Urinary incontinence management
timeFrame: 15 month
measure: Pain at admission in paediatric patient
timeFrame: 15 month
measure: Pain at admission in patient with dementia
timeFrame: 15 month
measure: Pain at admission in patient with mechanic ventilation
timeFrame: 15 month
measure: Pain after a change in clinical status in adult patientfor pain
timeFrame: 15 month
measure: Pain after a change in clinical status in paediatric patient
timeFrame: 15 month
measure: Pain after a change in clinical status in patient with dementia
timeFrame: 15 month
measure: Pain after a change in clinical status in patient with mechanic ventilation
timeFrame: 15 month
measure: Pain assessment
timeFrame: 15 month
measure: Pain management
timeFrame: 15 month
measure: Patient education in pain
timeFrame: 15 month
measure: Intensity of Pain
timeFrame: 15 month
measure: Maximum pain
timeFrame: 15 month
measure: Risk after a fall
timeFrame: 15 month
measure: Prevention of falls
timeFrame: 15 month
measure: Use of restraints
timeFrame: 15 month
measure: Incidence of falls
timeFrame: 15 month
measure: Falls that cause injury
timeFrame: 15 month
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Salud Carlos III
name: TERESA MORENO CASBAS, DOCTOR
role: STUDY_DIRECTOR
affiliation: Instituto de Salud Carlos III
name: ESTHER GONZALEZ MARIA, DOCTOR
role: STUDY_CHAIR
affiliation: UNIVERSIDAD DE ALICANTE
name: ISABEL ORTS CORTÉS, DOCTOR
role: STUDY_CHAIR
affiliation: Instituto de Salud Carlos III
name: CLARA SANCHEZ PABLO, RN
role: STUDY_CHAIR
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