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

Age Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725774
• Other study ID #: PI14CIII/00044
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• 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 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Age Problem

Intervention

Other:
• GRIP (Getting Research into Practice) model
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Teresa Moreno Casbas	Fondo de Investigacion Sanitaria

References & Publications (35)

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Langley PC, Ruiz-Iban MA, Molina JT, De Andres J, Castellón JR. The prevalence, correlates and treatment of pain in Spain. J Med Econ. 2011;14(3):367-80. doi: 10.3111/13696998.2011.583303. Epub 2011 May 17. — View Citation

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Type of institution	hospital unit, primary care unit or socio-healthcare unit	15 month
Secondary	Size of primary care unit	Population coverage will describe the size of primary care center.Number of patient assigned to the nurse	15 month
Secondary	Size of socio-healthcare centres	The number of the beds assigned to the socio-healthcare	15 month
Secondary	Size of hospital unit	number of beds assigned to the unit	15 month
Secondary	nurse/patient ratio	number of patients per nurse	15 month
Secondary	Age	Age of patients	15 month
Secondary	Sex	Sex of patients	15 month
Secondary	Reason for admission/consultation	Reason for admission/consultation of the patients. Reason for the patient to be admitted to the Hospital or to attend the consultation	15 month
Secondary	Days of stay	days of stay in the case of admissions	15month
Secondary	Impact of urinary incontinence	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	15 month
Secondary	Severity of incontinence	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	15 month
Secondary	Type of urinary incontinence	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	15 month
Secondary	Patient education, urinary incontinence management.	(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	15 month
Secondary	Urinary incontinence management	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 month
Secondary	Pain at admission in paediatric patient	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	15 month
Secondary	Pain at admission in patient with dementia	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)	15 month
Secondary	Pain at admission in patient with mechanic ventilation	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.	15 month
Secondary	Pain after a change in clinical status in adult patientfor pain	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).	15 month
Secondary	Pain after a change in clinical status in paediatric patient	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	15 month
Secondary	Pain after a change in clinical status in patient with dementia	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)	15 month
Secondary	Pain after a change in clinical status in patient with mechanic ventilation	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.	15 month
Secondary	Pain assessment	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)	15 month
Secondary	Pain management	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.	15 month
Secondary	Patient education in pain	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	15 month
Secondary	Intensity of Pain	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)	15 month
Secondary	Maximum pain	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)	15 month
Secondary	Risk after a fall	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.	15 month
Secondary	Prevention of falls	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.	15 month
Secondary	Use of restraints	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	15 month
Secondary	Incidence of falls	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)	15 month
Secondary	Falls that cause injury	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.	15 month