Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/08/2008
Date assigned
12/09/2008
Last edited
12/09/2008
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

Ms Wendy Gifford

ORCID ID

Contact details

1258 Portland Avenue
Ottawa
K1V 6E9
Canada
+1 613 260 8334
wgifford@rogers.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The impact of a tailored leadership intervention on the nursing assessments and management of foot ulcers for people with diabetes in community nursing practice

Acronym

Study hypothesis

H1: Nurses working in centres that receive the intervention will obtain significantly higher scores for practicing in accordance with guideline recommendations than the control group.
H0: No change in group means will occur following the intervention.

Ethics approval

The University of Ottawa Health Sciences and Science Research Ethics Board on the 9th May 2007 (ref: H-03-07-09)

Study design

A two phase mixed method design with matched pair cluster randomised controlled trial and qualitative methods

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes/foot ulcers/knowledge translation

Intervention

In addition to ‘usual’ implementation strategy, a 12 week strategy will be offered to mangers, supervisors, resource nurses, and two preceptor staff from each centre consisting of:
1. Mailed package of printed materials: study purpose; summary of recommendations, models of leadership and planned change; literature article; four questions related to assessing barriers to practice change. Review time: approx 15 - 30 minutes.
2. Interactive workshop (7.5 hours) at SEHC Corporate Office. Content and structure will be tailored to results of phase one, tentatively planned to include:
2.1. Evidence and theory on leadership and implementing practice change
2.2. Focus group discussions about barriers to implementing change based on recommendations
2.3. Case study discussions
2.4. Role playing exercises
2.5. Games
2.6. Development of implementation plan for each centre tailored to identified barriers.
Workshop will be facilitated by Co-PI (WG); SEHC senior administrator (NL); and administrative/clinical staff from SEHC to be determined.
3. Post-workshop teleconferences: (2, 6, and 10 weeks after workshop) to provide a forum for questions, discussions and networking amongst participants

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Nursing Assessments of Client Risk Factors Scores (NACRF), a composite score of 8 items based on recommendations from the Diabetes/Foot Ulcer guidelines.

Timepoints for primary and secondary outcomes: 12 weeks following completion of the intervention, chart audits will be conducted on all patients being treated for diabetic foot ulcers. To understand the leadership and management behaviours that influenced nursing practice, semi structured qualitative interviews will be conducted 12 weeks following intervention strategy with managers, supervisors, resource nurses and staff nurses at control and experimental centres.

Secondary outcome measures

1. Proportion of people with healed ulcers at 12 weeks (defined as complete wound closure)
2. Healing time, in number of weeks
3. Types of treatments used (e.g., hydrogel dressings, sharp debridement, offloading devices)
4. Referral rates to specialists services
5. Documented patient education
6. Proportion clients assessed for all items in the NACRF scale (all-or-none measure)
7. Nursing participant satisfaction and perceived utility of elements of the intervention

Timepoints for primary and secondary outcomes: 12 weeks following completion of the intervention, chart audits will be conducted on all patients being treated for diabetic foot ulcers. To understand the leadership and management behaviours that influenced nursing practice, semi structured qualitative interviews will be conducted 12 weeks following intervention strategy with managers, supervisors, resource nurses and staff nurses at control and experimental centres.

Overall trial start date

01/09/2007

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Service delivery centres with minimum number of clients with diabetes being treated for foot ulcers to satisfy sample size calculations
2. Chart audit: all adult clients (18 years or older) diagnosed with type 1 or type 2 diabetes that have been treated for a first or recurring foot ulcer(s) in the previous 6 months
3. Intervention: managers, supervisors, resource nurses and two staff nurses from each intervention site

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4 centres/60 clients

Participant exclusion criteria

1. Service delivery centres that did not have the minimum number of clients on service for diabetic foot ulcers to meet sample size calculations (i.e. 15 clients per centre in 6 months)
2. Clients that do not meet inclusion criteria:
2.1. Under 18 years of age
2.2. Do not have type 1 or type 2 diabetes
2.3. Not receiving home care service for a diabetic foot ulcer

Recruitment start date

01/09/2007

Recruitment end date

01/12/2008

Locations

Countries of recruitment

Canada

Trial participating centre

1258 Portland Avenue
Ottawa
K1V 6E9
Canada

Sponsor information

Organisation

Canadian Nurses Foundation (Canada) - Nursing Care Partnership Fund

Sponsor details

50 Driveway
Ottawa
K2P 1E2
Canada
+1 613 237 2159
jsolis@cna-aiic.ca

Sponsor type

Research organisation

Website

http://www.cnf-fiic.ca/Home/tabid/36/language/en-US/Default.aspx

Funders

Funder type

Research organisation

Funder name

Canadian Nurses Foundation (Canada) - September 2006

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes