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Completed

NCT Number: NCT03725774

The SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System

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)

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Key information

Conditions

Age Problem Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

GRIP (Getting Research into Practice) model

Other

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.

Primary outcomes

  1. Urinary incontinence

    Time frame: 15 month

    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

  2. Detection of pain, at admission

    Time frame: 15 month

    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)

  3. Risk of falls

    Time frame: 15 month

    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.

Secondary outcomes

  1. Type of institution

    Time frame: 15 month

    hospital unit, primary care unit or socio-healthcare unit

  2. Size of primary care unit

    Time frame: 15 month

    Population coverage will describe the size of primary care center.Number of patient assigned to the nurse

  3. Size of socio-healthcare centres

    Time frame: 15 month

    The number of the beds assigned to the socio-healthcare

  4. Size of hospital unit

    Time frame: 15 month

    number of beds assigned to the unit

  5. nurse/patient ratio

    Time frame: 15 month

    number of patients per nurse

  6. Age

    Time frame: 15 month

    Age of patients

  7. Sex

    Time frame: 15 month

    Sex of patients

  8. Reason for admission/consultation

    Time frame: 15 month

    Reason for admission/consultation of the patients. Reason for the patient to be admitted to the Hospital or to attend the consultation

  9. Days of stay

    Time frame: 15month

    days of stay in the case of admissions

  10. Impact of urinary incontinence

    Time frame: 15 month

    Impact of urinary incontinence.[Total number of patients with different urinary-incontinence impact levels 24 hours prior to assessment / Total number of patients attended during the data-collection period] * 100

  11. Severity of incontinence

    Time frame: 15 month

    Patient education, urinary Incontinence management.[Total number of patients with different levels of severity of urinary incontinence 24 hours prior to assessment/ Total number of patients attended during the data-collection period] * 100

  12. Type of urinary incontinence

    Time frame: 15 month

    Assessment of type of urinary incontinence. (Total number of incontinent patients with identification of type of incontinence, who are registered / Total number of incontinent patients) * 100

  13. Patient education, urinary incontinence management.

    Time frame: 15 month

    (Number of patients with incontinence who receive (patients, family members or carers) incontinence management education at least once during the care process, and who are registered / Total number of patients with incontinence)*100

  14. Urinary incontinence management

    Time frame: 15 month

    To establish and implement a comprehensive care plan to manage incontinence that includes: evaluation of results, believes, knowledge and level of comprehension of the patient, personal characteristics and incontinence characteristics. (Total number of incontinent patients that have a registered, multifactorial urinary incontinence management plan / Total number of incontinent patients) * 100

  15. Pain at admission in paediatric patient

    Time frame: 15 month

    Detection of pain, at admission. (Total number of paediatric 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 the FLACC scale tool (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

  16. Pain at admission in patient with dementia

    Time frame: 15 month

    Detection of pain, at admission. (Total number of patients with dementia 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 the PAINAD scale (pain assesment in advanded dementia): 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)

  17. Pain at admission in patient with mechanic ventilation

    Time frame: 15 month

    Detection of pain, at admission. (Total number of patients with mechanic ventilation 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 the ESCID scale (Scale of Behavior Indicators of Pain). Mesaure: Facial expression, tranquility (movements), muscle tone, comfort and adaptation to mechanic ventilation. Each item is scored from 0 to 2; being 0 the minimum score and 10 the maximum.

  18. Pain after a change in clinical status in adult patientfor pain

    Time frame: 15 month

    Detection of pain, after a change in clinical status. (Total number of adult patients who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of adults patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with 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).

  19. Pain after a change in clinical status in paediatric patient

    Time frame: 15 month

    Detection of pain, after a change in clinical status. (Total number of paediatric patients who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a FLACC scale (Face, Leg, Activity, Cry, Consolability): tool for paediatric patient. 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

  20. Pain after a change in clinical status in patient with dementia

    Time frame: 15 month

    Detection of pain, after a change in clinical status. (Total number of patients with dementia who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a PAINAD scale (pain assesment in advanded dementia): 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)

  21. Pain after a change in clinical status in patient with mechanic ventilation

    Time frame: 15 month

    Detection of pain, after a change in clinical status. (Total number of patients with dementia who have been assessed for the presence of pain after change of clinical situation and is registered / Total number of patients discharged during the measurement period) * 100 The assessment of the presence of pain after a change in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of pain assessment with a ESCID scale (Scale of Behavior Indicators of Pain). Tool for patient with mechanic ventilation. Mesaure: Facial expression, tranquility (movements), muscle tone, comfort and adaptation to mechanic ventilation. Each item is scored from 0 to 2; being 0 the minimum score and 10 the maximum.

  22. Pain assessment

    Time frame: 15 month

    Pain assessment is defined as overall pain assessment in persons in whom the presence of pain has been detected, and identification of the type of pain (acute, chronic, nociceptive or neuropathic). (Total number of patients with identification of the type of pain and is registered / Total number of patients with pain) * 100 The assessment of the pain in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of the type of pain (acute, chronic, nociceptive or neuropathic)

  23. Pain management

    Time frame: 15 month

    Establishing and implementing an overall pain management care plan for the patient which would include: evaluation of his/her outcomes, beliefs, knowledge, level of understanding and personal characteristics, and characteristics of the pain.(Total number of patients with pain who have a registered and multifactorial plan for pain management / Total number of patients with pain) * 100 The Pain management in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of evaluation of his/her outcomes, beliefs, knowledge, level of understanding and personal characteristics, and characteristics of the pain.

  24. Patient education in pain

    Time frame: 15 month

    Patient education: collaborating with the patient in the identification of pain-control targets and appropriate strategies for an integrated approach to the care plan. (Number of patients with pain they receive (they, their family or caregivers) education about pain management at least once during the care process, and is registered / Total number of patients with pain) * 100

  25. Intensity of Pain

    Time frame: 15 month

    ntensity of Pain assessment using a validated tool, for record-keeping purposes. [Total number of patients with pain intensity measurement / (Total number of patients attended during the data collection period] * 100

    The assessment of the intensity of pain in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of of the intensity of pain.

    The intensity of pain will be measured with different validated tools, according to whether the patient is an adult or paediatric, if he is conscious or not and if he has difficulty communicating.The tools are : Visual Analogic Scale (VAS), Numerical rating scale (NRS),FLACC Scale (Face, Leg, Activity, Cry, Consolability), PAINAD scale ( pain assesment in advanded dementia), ESCID scale (Scale of Behavior Indicators of PAin)

  26. Maximum pain

    Time frame: 15 month

    Maximum score reported by a patient after pain-intensity assessment using a validated tool.

    The intensity of pain will be measured with different validated tools, according to whether the patient is an adult or paediatric, if he is conscious or not and if he has difficulty communicating.The tools are : Visual Analogic Scale (VAS), Numerical rating scale (NRS),FLACC Scale (Face, Leg, Activity, Cry, Consolability), PAINAD scale ( pain assesment in advanded dementia), ESCID scale (Scale of Behavior Indicators of PAin)

  27. Risk after a fall

    Time frame: 15 month

    Assessment of fall risk with validated tool, after a fall. (Total number of patients who have been assessed the risk of falls with a validated tool after a fall and is registered / Total number of patients discharged in the measurement period) * 100 The assessment of fall risk after a fall in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of fall risk after a fall 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:0-12. Patient without risk (0), low risk (1-2) and high risk (> 3 points). Morse Falls Scale, score: 0-150. 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.

  28. Prevention of falls

    Time frame: 15 month

    Percentage of patients who are detected to be at risk using a fall-prevention plan or fall-injury reduction programme, based on a multifactorial approach, and are registered.

    The prevention of falls in clinical status will be measured in a dichotomous variable: Yes/No. For Yes, there must be registered evidence of are detected to be at risk using a fall-prevention plan or fall-injury reduction programme, based on a multifactorial approach, and are registered.

  29. Use of restraints

    Time frame: 15 month

    Percentage of patients who are used restraints are physical, chemical or environmental measures used to control a person's physical or behavioural activity or a part of his/her body

  30. Incidence of falls

    Time frame: 15 month

    Number of falls with or without injury among patients, per 1000 patients/day (acute care/rehabilitation/long stay) Total number of falls with or without injury, per 1000 patients (primary care)

  31. Falls that cause injury

    Time frame: 15 month

    Percentage of falls resulting in mild, moderate, severe injury or death, according to the WHO classification.

    Injury is defined as bodily harm suffered as a consequence of a fall.

Sponsors and collaborators

Lead sponsor

Teresa Moreno Casbas

Other Gov

Collaborators

  • Fondo de Investigacion Sanitaria

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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