Evaluation of a leadership intervention for implementing recommendations for nursing care for people with diabetes and foot ulcers in community nursing practice

ISRCTN	ISRCTN06910890
DOI	https://doi.org/10.1186/ISRCTN06910890
Protocol serial number	N/A
Sponsor	Canadian Nurses Foundation (Canada) - Nursing Care Partnership Fund
Funder	Canadian Nurses Foundation (Canada) - September 2006

Submission date: 14/08/2008
Registration date: 12/09/2008
Last edited: 12/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Wendy Gifford
Scientific

1258 Portland Avenue
Ottawa
K1V 6E9
Canada

Phone	+1 613 260 8334
Email	wgifford@rogers.com

Study information

Primary study design	Interventional
Study design	A two phase mixed method design with matched pair cluster randomised controlled trial and qualitative methods
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	The University of Ottawa Health Sciences and Science Research Ethics Board on the 9th May 2007 (ref: H-03-07-09)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	01/12/2008

Locations

Countries of recruitment

Canada

Study participating centre

1258 Portland Avenue

Ottawa
K1V 6E9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes