Contact information
Type
Scientific
Primary contact
Prof Kate Seers
ORCID ID
Contact details
RCN Research Institute
School of Health and Social Studies
University of Warwick
Coventry
CV4 7AL
United Kingdom
-
kate.seers@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
223646
Study information
Scientific title
Facilitating Implementation of Research Evidence: a pragmatic randomised controlled trial with integral qualitative, quantitative and health economic evaluative components
Acronym
FIRE
Study hypothesis
This study aims to advance understanding about the contribution that facilitation and facilitators can make to translating the findings of research into practice and to study different facilitator models to identify whether it is possible to determine a 'good enough' model of facilitation that can address the complex range of factors that influence the uptake of research evidence within the time and resource constraints of day to day service delivery.
The objectives of the study are to:
1. Extend current knowledge of facilitation as a process for translating research evidence into practice
2. Evaluate the feasibility and effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence promotion
3. To advance current knowledge of guideline implementation in healthcare, with a particular focus on understanding the impact of contextual factors on the processes and outcomes of implementation
4. Implement a pro-active dissemination strategy that complements the design of the study and facilitates the diffusion of the study findings to a wide policy and practice community throughout Europe and beyond
Ethics approval
1. UK: South East Wales Research Ethics Committee - Panel D, 21/04/2010, ref: 10/WSE04/20; CSP No.: 33062)
2. Ireland: Local ethics committee, 02/03/2010, ref: ECM 4(u)
3. Netherlands: National ethical clearance not required for this study
4. Sweden: Local ethics committee, 11/01/2010, ref: 2009/180631/2; 2009/2:11
Study design
Pragmatic randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Long-term nursing care
Intervention
Arm 1: guidelines on continence care and an implementation guide (control)
Arm 2: guidelines on continence care and an implementation guide and type A facilitation (a 12-month development programme run by external facilitators using technical facilitation)
Arm 3: guidelines on continence care and an implementation guide and type B facilitation (a 24-month development programme run by external facilitators using enabling facilitation)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The extent to which the guidelines are implemented, using clear criteria linked to the guidelines. Follow up of outcome data is at 6, 12, 18 and 24 months after the interventions starts in all arms. Process data is also collected thoughout the study.
Secondary outcome measures
Clinical outcomes including:
1. Quality of life
2. Continence status
3. Pad use
4. Health economic analysis
Follow up of outcome data is at 6, 12, 18 and 24 months after the interventions starts in all arms. Process data is also collected thoughout the study.
Overall trial start date
01/03/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Long-term nursing care settings with at least 60 places
2. Publically funded places
3. Residents who are aged 60 years or older
4. Interested in taking part in the study
5. Residents with documented urinary incontinence
6. Participants within each site will include those who have consented to be involved as:
6.1. Facilitators engaged in intervention delivery
6.2. Staff at all levels working in sites delivering care
6.3. Key stakeholders related to sites (e.g. regional administrators, funding agencies)
6.4. Residents and carers
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Total number of patients, 50 per site = 300 per country = total 1,200
Total final enrolment
2313
Participant exclusion criteria
Patients with moderate or severe dementia
Recruitment start date
01/03/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Ireland, Netherlands, Sweden, United Kingdom
Trial participating centre
University of Warwick
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
Research Support Services
University House
Coventry
CV4 7AL
United Kingdom
-
dave.duncan@warwick.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Results and Publications
Publication and dissemination plan
Planned publication in the journal Implementation Science.
Intention to publish date
31/12/2018
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22453077
2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30442174
3. 2018 realist process evaluation results in https://www.ncbi.nlm.nih.gov/pubmed/30442165 (added 23/04/2019)