Condition category
Not Applicable
Date applied
04/02/2010
Date assigned
16/03/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

http://www2.warwick.ac.uk/

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

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22453077

Publication citations

Additional files

Editorial Notes