ISRCTN ISRCTN11598502
DOI https://doi.org/10.1186/ISRCTN11598502
Secondary identifying numbers 223646
Submission date
04/02/2010
Registration date
16/03/2010
Last edited
23/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kate Seers
Scientific

RCN Research Institute
School of Health and Social Studies
University of Warwick
Coventry
CV4 7AL
United Kingdom

Email kate.seers@warwick.ac.uk

Study information

Study designPragmatic randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleFacilitating Implementation of Research Evidence: a pragmatic randomised controlled trial with integral qualitative, quantitative and health economic evaluative components
Study acronymFIRE
Study objectivesThis 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(s)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
Health condition(s) or problem(s) studiedLong-term nursing care
InterventionArm 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 typeOther
Primary outcome measureThe 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 measuresClinical 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 study start date01/03/2010
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsTotal number of patients, 50 per site = 300 per country = total 1,200
Total final enrolment2313
Key inclusion criteria1. 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
Key exclusion criteriaPatients with moderate or severe dementia
Date of first enrolment01/03/2010
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • Ireland
  • Netherlands
  • Sweden
  • United Kingdom

Study participating centre

University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

Research Support Services
University House
Coventry
CV4 7AL
England
United Kingdom

Email dave.duncan@warwick.ac.uk
Website http://www2.warwick.ac.uk/
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

Government

Seventh Framework Programme
Government organisation / National government
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planPlanned publication in the journal Implementation Science.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 27/03/2012 Yes No
Results article results 16/11/2018 Yes No
Results article realist process evaluation results 16/11/2018 23/04/2019 Yes No

Editorial Notes

23/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added from the results publication.
19/11/2018: Publication reference added.
14/11/2018: The following changes were made:
1. The publication and dissemination plan was updated.
2. The intention to publish date was updated.