NCT03725774

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
Last Updated

October 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

April 18, 2018

Last Update Submit

October 29, 2018

Conditions

Keywords

painaccidental fallsurinary incontinenceclinical audit

Outcome Measures

Primary Outcomes (3)

  • Urinary incontinence

    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 discharged in the assessment period) \* 100

    15 month

  • Detection of pain, at admission

    Total number of patients who have been assessed for the presence of pain and is registered / Total number of patients discharged during the measurement period) \* 100 The assessment of the presence of pain will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a Visual Analogic Scale (VAS; 10 cm, 0=no pain, 10=maximum pain) or Numerical rating scale (NRS; 0=no pain, 10 =worse pain), or the FLACC scale tool or paediatric patients,(Face, Leg, Activity, Cry, Consolability). Categories is scored from 0-2. Total scale: 0 is relaxed and comfortable, 1-2 Moderate discomfort, 3-6 Moderate pain and 7-10 Severe pain/discomfort f or PAINAD scale tool for patient with dementia. Measure breathing, negative vocalization, facial expression, body language and capacity for relief. Each item can get a maximum score of 2. The total scores can be from 0 (no pain) to 10 (maximum pain)

    15 month

  • Risk of falls

    Assessment of fall risk with a validated tool, at admission or onset of care.(Total number of patients to whom the risk of falls with a validated tool was initially assessed and registered / Total number of patients discharged during the measurement period) \* 100 The assessment of fall risk in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of fall risk with a validated tools.Tools: Hendrich II Fall Risk Model, score: 0-16. Patient without risk (0), risk (1-4 points) and high risk (\>5 points). H. Downton scale, score from 0 to 12. Patient without risk (0), low risk (1-2) and high risk (\> 3 points). Morse Falls Scale, score from 0 to 150. Patient without risk (0-25), low risk (25-50) and high risk (\> 50 points). Stratify or Stratify modified scale assesment includes five questions with dichotomous answer; obtaining two or more positive answer would classify the individual as a high risk patient to suffer a fall.

    15 month

Secondary Outcomes (31)

  • Type of institution

    15 month

  • Size of primary care unit

    15 month

  • Size of socio-healthcare centres

    15 month

  • Size of hospital unit

    15 month

  • nurse/patient ratio

    15 month

  • +26 more secondary outcomes

Study Arms (1)

Quasi-experimental uncontrolled, before-and-after

EXPERIMENTAL

The intervention will consist of the use of the GRIP (Getting Research into Practice) model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action

Other: GRIP (Getting Research into Practice) model

Interventions

The intervention will consist of the use of the GRIP (Getting Research into Practice) model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action. The GRIP model is a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying the obstacles to improvements in clinical practice, and drawing up and implementing a plan of action for the purpose of improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the obstacles 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

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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: 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (36)

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    BACKGROUND
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MeSH Terms

Conditions

PainUrinary Incontinence

Interventions

Hand StrengthModels, Biological

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological Manifestations

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaModels, TheoreticalInvestigative Techniques

Study Officials

  • TERESA MORENO CASBAS, DOCTOR

    Instituto de Salud Carlos III

    STUDY DIRECTOR
  • ESTHER GONZALEZ MARIA, DOCTOR

    Instituto de Salud Carlos III

    STUDY CHAIR
  • ISABEL ORTS CORTÉS, DOCTOR

    UNIVERSIDAD DE ALICANTE

    STUDY CHAIR
  • CLARA SANCHEZ PABLO, RN

    Instituto de Salud Carlos III

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Uncontrolled before-and-after study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Of Nursing Research Unit

Study Record Dates

First Submitted

April 18, 2018

First Posted

October 31, 2018

Study Start

June 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

October 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share