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)

Study Overview

• Status: Completed
• Conditions: Age Problem
• Intervention / Treatment: Other: GRIP (Getting Research into Practice) model

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Quasi-experimental uncontrolled, before-and-after; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of institution	hospital unit, primary care unit or socio-healthcare unit	15 month
Size of primary care unit	Population coverage will describe the size of primary care center.Number of patient assigned to the nurse	15 month
Size of socio-healthcare centres	The number of the beds assigned to the socio-healthcare	15 month
Size of hospital unit	number of beds assigned to the unit	15 month
nurse/patient ratio	number of patients per nurse	15 month
Age	Age of patients	15 month
Sex	Sex of patients	15 month
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
Days of stay	days of stay in the case of admissions	15month
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Teresa Moreno Casbas
• Collaborators: Fondo de Investigacion Sanitaria
• Investigators: Study Director: TERESA MORENO CASBAS, DOCTOR, Instituto de Salud Carlos III; Study Chair: 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

Publications and helpful links

General Publications

• Albornos-Muñoz, L., González-María, E., Moreno-Casbas, T. (2015). Implantación de Guías de Buenas Prácticas en España. Programa de Centros Comprometidos con la Excelencia en Cuidados® (Best Practice Guidelines Implementation in Spain. Best Practice Spotlight Organizations ® Programme). MedUNAB, 17(3), pp. 163-69.
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• Bauer MS, Damschroder L, Hagedorn H, Smith J, Kilbourne AM. An introduction to implementation science for the non-specialist. BMC Psychol. 2015 Sep 16;3(1):32. doi: 10.1186/s40359-015-0089-9.
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• Bornbaum CC, Kornas K, Peirson L, Rosella LC. Exploring the function and effectiveness of knowledge brokers as facilitators of knowledge translation in health-related settings: a systematic review and thematic analysis. Implement Sci. 2015 Nov 20;10:162. doi: 10.1186/s13012-015-0351-9. Erratum In: Implement Sci. 2015;10:171.
• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
• Davies B, Edwards N, Ploeg J, Virani T. Insights about the process and impact of implementing nursing guidelines on delivery of care in hospitals and community settings. BMC Health Serv Res. 2008 Feb 2;8:29. doi: 10.1186/1472-6963-8-29.
• Dobbins M, Cockerill R, Barnsley J, Ciliska D. Factors of the innovation, organization, environment, and individual that predict the influence five systematic reviews had on public health decisions. Int J Technol Assess Health Care. 2001 Fall;17(4):467-78.
• Estabrooks CA. The conceptual structure of research utilization. Res Nurs Health. 1999 Jun;22(3):203-16. doi: 10.1002/(sici)1098-240x(199906)22:33.0.co;2-9.
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• Mc Goldrick EL, Crawford T, Brown JA, Groom KM, Crowther CA. Identifying the barriers and enablers in the implementation of the New Zealand and Australian Antenatal Corticosteroid Clinical Practice Guidelines. BMC Health Serv Res. 2016 Oct 28;16(1):617. doi: 10.1186/s12913-016-1858-8.
• Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47.
• Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet. 1993 Nov 27;342(8883):1317-22. doi: 10.1016/0140-6736(93)92244-n.
• Grimshaw J, Eccles M, Thomas R, MacLennan G, Ramsay C, Fraser C, Vale L. Toward evidence-based quality improvement. Evidence (and its limitations) of the effectiveness of guideline dissemination and implementation strategies 1966-1998. J Gen Intern Med. 2006 Feb;21 Suppl 2(Suppl 2):S14-20. doi: 10.1111/j.1525-1497.2006.00357.x.
• Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012 May 31;7:50. doi: 10.1186/1748-5908-7-50.
• Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004 Feb;8(6):iii-iv, 1-72. doi: 10.3310/hta8060.
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• Squires JE, Estabrooks CA, Gustavsson P, Wallin L. Individual determinants of research utilization by nurses: a systematic review update. Implement Sci. 2011 Jan 5;6:1. doi: 10.1186/1748-5908-6-1.
• Stergiou-Kita M. Implementing Clinical Practice Guidelines in occupational therapy practice: recommendations from the research evidence. Aust Occup Ther J. 2010 Apr;57(2):76-87. doi: 10.1111/j.1440-1630.2009.00842.x.
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• Escobar-Aguilar G, Moreno-Casbas MT, Gonzalez-Maria E, Martinez-Gimeno ML, Sanchez-Pablo C, Orts-Cortes I. The SUMAMOS EXCELENCIA Project. J Adv Nurs. 2019 Jul;75(7):1575-1584. doi: 10.1111/jan.13988. Epub 2019 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pain; accidental falls; urinary incontinence; clinical audit
• Other Study ID Numbers: PI14CIII/00044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No