A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing

1748-5908-3-51 1748-5908 Study protocol A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing Gifford A Wendy wgifford@rogers.com Davies Barbara bdavies@uottawa.ca Graham D Ian IGraham@cihr-irsc.gc.ca Lefebre Nancy knowledge@saintelizabeth.com Tourangeau Ann ann.tourangeau@utoronto.ca Woodend Kirsten kwoodend@uottawa.ca

University of Ottawa, Faculty of Health Sciences, School of Nursing, 451 Smyth Road, Ottawa, ON, K1H 8M5, Canada

Saint Elizabeth Health Care, 90 Allstate Parkway, Toronto, ON, Canada

Canadian Institute of Health Research, 160 Elgin Street, 9^thFloor, Ottawa, ON, Canada

University of Toronto, Faculty of Nursing, 155 College Street, Toronto, ON, Canada

Implementation Science 1748-5908 2008 3 1 51 http://www.implementationscience.com/content/3/1/51 19077199 10.1186/1748-5908-3-51 08 10 2008 10 12 2008 10 12 2008 2008 Gifford et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications) was not assessed at all.

Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing.

The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers.

Methods

Two phase mixed methods design is proposed (ISRCTN 12345678). Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers) will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations.

Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a) printed materials, b) one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c) three post-workshop teleconferences.

Discussion

This study will provide vital information on which leadership strategies are well received to facilitate and support guideline implementation. The anticipated outcomes will provide information to assist with effective management of foot ulcers for people with diabetes.

By tracking clinical outcomes associated with guideline implementation, health care administrators will be better informed to influence organizational and policy decision-making to support evidence-based quality care. Findings will be useful to inform the design of future multi-centered trials on various clinical topics to enhance knowledge translation for positive outcomes.

Trial Registration

Current Control Trials ISRCTN06910890

Background: diabetic foot ulcers

Diabetes mellitus, a complex, life-long metabolic disorder characterized by raised blood glucose concentrations, affects 4.2 percent of the world's population and over 1.5 million Canadians 12. Ulceration of the foot is a significant problem for people with diabetes, affecting 15 percent at some time in their life 34. Foot complications are a major reason for hospital admissions, accounting for approximately 20 percent of all diabetes-related admissions in North America 1. Foot ulcers precede 85 percent of lower limb amputations 45 and 30 percent of those undergoing amputation die within the following year 6. Diabetes pathology that increases risk of foot ulcerations and complications includes peripheral neuropathy (impairment of nerve function), peripheral vascular disease, limited joint mobility and deformity 1457. The triad of neuropathy, deformity, and trauma is present in almost two thirds of people with foot ulcers 5 with footwear being a major cause of traumatic ulcers 8.

Lack of awareness of risk factors associated with diabetic foot ulcer by health care professionals and patients adds to unnecessary morbidity such as prolonged healing, infections and gangrene that may result in amputations 459. Mills et al. (1991) reviewed records of 55 diabetic patients with localized gangrene or infection on a vascular surgical unit and found 29 percent were delayed in referral for definitive care due to a lack of recognition by practitioners of ischemia or an underestimation of the severity of infections 10.

Comprehensive assessments by health care professionals of risk factors are recommended in clinical practice guidelines for effective management and treatment of diabetic foot ulcers, and are supported by strong empirical evidence 14567111213141516. A recent Cochrane review showed managing ulcers with hydrogel dressings when compared to usual care (gauze dressings) improved healing rates by 23 percent at 12 to 20 weeks (95% CI 10–36%) 7. Assessments are recommended to include: peripheral neuropathy, vascular status, structural deformities, infection and ulcer size 15912131415. Referrals to multidisciplinary foot care specialists 51213 and patient education 417 are equally emphasized.

Problem: Implementing clinical guideline recommendations

Clinical practice guidelines synthesize and translate high quality research evidence into recommendations for practice, and provide an easy and accessible tool for bridging the evidence-practice gap 18192021. For practice change to occur however, guidelines must be utilized, and their timely and effective transfer into clinical practice remains fragmented and inconsistent 21222324. Implementation strategies directed at individuals, the environment and the organizational context are necessary for successful implementation and practice change to occur 20252627. In recent Cochrane reviews, tailored interventions that focus on individual and organizational barriers to change showed promise for implementing change and improving patient care 28, and interactive workshops were found to have moderately large effects on changing professional practice 29.

The importance of top managers' involvement and commitment in implementing innovations such as guidelines and change have been emphasized outside 30313233343536373839 and within healthcare settings 404142434445. Descriptive and qualitative evidence has identified leadership and management behaviours as having an important impact on nurses' work environments 424647484950 and their use of research evidence to inform practice 2751525354555657585960616263. Similarly, a systematic review of 30 studies identified the lack of support from managers, and 'other staff' to be one of the greatest barriers to nurses' use of research 60. Management behaviours such as support and commitment 5658646566676869, policy revisions 6670 and monitoring of clinical outcomes 6671 have been described as enablers to nurses' use of research 72. Limited experimental research exists however regarding which behaviours are most effective to facilitate guideline implementation in nursing. A recent mixed methods study of 37 organizations found leadership to be the only predictor of sustained use of clinical guideline recommendations two and three years post-implementation, accounting for 47 percent of the variance (p < .001) 73. Using grounded theory to analyze 9 of the 37 organizations, Gifford et al. found patterns of leadership and managerial behaviours in organizations that sustained practice change based on guideline recommendations (n = 4) at 2 and 3 years differed when compared to organizations that did not sustain practice change (n = 5) 63. A conceptual model was developed from the analysis that operationalizes leadership behaviours for implementing and sustaining practice change.

Study Aim

The aim of this pilot study is to evaluate the impact of a leadership intervention on implementing new recommendations from a clinical practice guideline on nursing assessments and management of foot ulcers for people with diabetes in community nursing practice. Specific objectives include:

1) To identify barriers and develop a tailored leadership intervention for home care nurse managers, supervisors, resource nurses and clinical staff to influence implementation of selected recommendations from the Registered Nurses Association of Ontario (RNAO) clinical practice guideline for care of foot ulcers for people with diabetes.

2) To determine the impact of the intervention on client, nurse and system outcomes.

3) To understand the feasibility of influencing leadership behaviours through the intervention.

4) To test and refine a model of leadership for implementing practice change.

We plan to test the following study hypotheses:

H₁: Nurses working in centers that receive the intervention will obtain significantly higher scores for practicing in accordance with guideline recommendations than control group.

H₀: No change in group means will occur following the intervention.

Design/Methods

A two phase mixed method design is proposed (Figure 1). A pilot study is planned because there is little information regarding effective leadership behaviours for implementing practice change in nursing, and there is a need to test the intervention strategies prior to launching a larger multi-centered trial. Phase one involves descriptive qualitative methods to understand barriers to implementing the guideline recommendations and to refine the intervention strategy to be useful and appealing to leaders. A cluster randomized controlled trial, considered the optimal design when evaluating strategies to change professional behaviour 2074, will evaluate differences in outcomes between the two implementation strategies. Randomization will occur at the unit level to minimize threats of experimental contamination 207576.

Figure 1

Design: Two phased mixed methods pilot study

Design: Two phased mixed methods pilot study.

Site

The research is being conducted in a home and community health-care service organization that provides nursing care through 23 centers in the province of Ontario Canada. The organization employs approximately 1500 nursing staff, 65 managers and supervisors, and 20 clinical resource nurses, and 7 clinical directors. Approximately 30 to 40 percent of clients receiving nursing services are diabetic, and clinical directors identified foot care for this population as a priority clinical topic, with a notable gap between current practices and guideline recommendations. For example no clients are currently being assessed for peripheral neuropathy the most significant predictor of ulcers, and recent chart audits indicated that co-morbidity, vascular status and wound size were not documented in at least 50 percent of charts for foot and leg ulcers. The organization has previously implemented clinical practice guidelines at an estimated cost of $60,000 per implementation. To date implementation strategies have had mixed success. Implementation of the RNAO guideline Assessing and Managing Foot Ulcers for People with Diabetes 13 is planned in 2008.

Primary outcome

Nursing assessments of client risk factors scores (NACRF), a composite score of 8 items based on recommendations from the Diabetes/Foot Ulcer guideline. The 8 items were chosen in consultation with clinical experts in diabetes and wound management, have a high level of research evidence for prediction of poor outcomes 13, and were reviewed for content validity by researchers and clinical experts in the field. Four of the eight items were previously used in a chart audit evaluation of another RNAO guideline related to the prevention of foot complications in people with diabetes 7778.

Secondary outcomes

1) proportion of people with healed ulcers at 12 weeks (defined as complete wound closure),

2) healing times in number of weeks,

3) types of treatments used (eg: 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) 79,

7) Nursing participant satisfaction and perceived utility of elements of the intervention.

Sample

All centers (approximately 10) with the minimum number of clients being treated for diabetic foot ulcers to satisfy sample size calculations will be invited to participate in the study. Two centers will be randomly assigned to participate in phase one and four will be randomly assigned for phase two. The four sites in phase two will be randomly allocated to control (n = 2) or experimental (n = 2) groups.

Sample size

Sample size calculations were determined, and are based on the use of an independent t-test on NACRF scores at the end of the study. The following assumptions have been made: alpha = .0.05 (two-tailed), Beta = 0.20 and an expected change in NACRF scores of 20 percent. Although all items within the NACRF have not been previously used, four were previously evaluated in a pre/post chart audit that showed a 26 percent absolute improvement in nursing documentation (range -3.6 to 57.1) 78. Thus, an estimate of 20 percent improvement will be used. In addition, standard deviations (SD) and intra-cluster correlation coefficients (ICCs = ρ) for NACRF are presently unknown. It is however, estimated that the effect size may be as small as 1.00 but to be conservative 0.83 (SD = 3) is assumed for this calculation. Based on these assumptions, 30 charts will be needed in both intervention and control groups (n = 60). While it is not known exactly how many clients with diabetes will be on service for foot ulcers during the study period, senior administrators have reassured investigators that a minimum of 30 clients per group is feasible.

Power estimates for secondary outcomes

The anticipated rate of healing in the control group is 24 percent in 12 weeks 16. For the proportion of ulcers healed and healing times, 30 charts in control and intervention groups would yield 80 percent power to detect an absolute increase in healing rates of 40 percent (alpha .05, two tailed). The study is also powered to detect an absolute increase of 40 percent in referral rates and patient education, also measured as a proportion.

Data Collection

Baseline

All adult clients (18 years or older) diagnosed with Type 1 or Type 2 diabetes being treated for a first or recurring foot ulcer(s) will be eligible for the study. Using data abstraction forms modified from a previous guideline evaluation project 77, chart audits will be performed at control and experimental sites prior to randomization until sample size is achieved or up to 12 weeks prior to the intervention. Chart audit data collectors will be trained and supervised by researchers with experience in conducting chart audits. Interrater and test-retest reliability will be assessed in a random review of 10 percent of charts.

PHASE I: Barriers Assessment and Intervention Development

Semi-structured interviews will be conducted at two centers with a sample of managers, supervisors, resource nurses and 2 'preceptor' staff nurses from each site (n = 10). Preceptor staff are experienced clinical nurses who volunteer to provide support to novice or newly hired nurses regarding clinical issues. The interview guide is based on previously published guides for assessing barriers and supports 80, and has been structured to understand components of an intervention strategy considered useful to managers and clinical leaders. Results of phase I will inform content and structure of the intervention strategy.

PHASE II: Intervention Strategy

Control Group

Staff at each center will receive the 'usual' guideline implementation strategy consisting of: 1) a formal guideline launch; 2) self-directed learning package, 3) educational sessions for staff related to the clinical application of practice recommendations. Senior administrators estimated that approximately 70 percent of staff typically attend 'usual' strategies.

Experimental Group

In addition to the 'usual' implementation strategy, a 12 week leadership strategy will be offered to mangers, supervisors, resource nurses, and 2 preceptor staff from each center to facilitate and support implementation, consisting of:

1) Mailed package of printed materials: to include study purpose; summary of recommendations, models of leadership and planned change; literature article; three questions to assess barriers to nurses assessing and managing foot ulcers in accordance to the guideline recommendations. Review time: approx 15–30 minutes.

2) Interactive workshop (one day): Content and activities will be tailored to results of phase one, planned to include: a) evidence and theory on leadership and implementing practice change; b) focus group discussions about barriers to implementing the recommendations; c) role playing exercises; and d) facilitated development of a team leadership implementation plan for each center, tailored to identified barriers.

3) Post-workshop teleconferences: (2, 6, and 10 weeks after workshop) to provide a forum for questions, discussions and networking amongst participants.

Guiding Theoretical Framework

The theoretical underpinnings of the proposed intervention are based on mechanisms of planned change as described in the Ottawa Model of Research Use (OMRU^©) 5281, effective leadership behaviours described by Yukl 82, and leadership for guideline implementation described by Gifford et al 63.

The OMRU is a planned change framework for knowledge transfer in health care delivery 52. Derived from evidence and theories of change, the OMRU recognizes that practice change is not a linear process, but involves simultaneous and interactive relationships between the nature of the innovation, the potential adopters, and the context within the practice environment. Three key processes involved are: 1) assessing barriers and supports; 2) developing and monitoring interventions tailored to barriers and supports; 3) evaluating outcomes. The underlying mechanism is that tailoring intervention strategies to address barriers and strengthen supports related to the innovation, potential adopters and practice environment will result in practice change.

The OMRU provides a template to assess barriers and supports for implementing change and will facilitate the selection of intervention strategies with the best probability of success. The relevance and pragmatic utility of the OMRU for guiding implementation of innovations (including nursing guidelines) has been demonstrated in previous research 8384858687.

Leadership is "the process of influencing others to understand and agree about what needs to be done and how to do it, and the process of facilitating individual and collective efforts to accomplish shared objectives" [82, p.8]. Three meta-categories of effective leadership behaviours described by Yukl and supported by decades of research 82828889, provide the foundation for this study: 1) relations-orientated, 2) change-orientated and 3) task-orientated. Relations-oriented behaviours include supporting, developing personal skills and job adjustments, and recognizing others and their contributions. Relations-oriented behaviours increase mutual trust, cooperation among members, and commitment to a unit and organization. Change-oriented behaviours are concerned with integrating a vision, developing strategies and building coalitions to support change, creating a sense of need and demonstrating commitment to change. Task-oriented behaviours include clarifying roles, monitoring operations and performance, and the efficient use of resources 82.

Three leadership themes emerged as central to implementing guidelines in the grounded theory study by Gifford et al., and these align closely with Yukl's 82 metacategories of effective leadership behaviours. Leaders were found to have: 1) facilitated staff through relations-oriented behaviours (e.g.: support, encouragement and recognition); 2) created a positive milieu within the clinical practice environment through change-related behaviours (e.g.: reinforced goals and philosophies of care); and 3) influenced organizational structures and processes through task-oriented behaviours (e.g.: providing resources, policies and monitoring). Together these behaviours influenced individuals, practice environments and infrastructures to enable nurses to practice based on guideline recommendations.

Drawing on the work of Van de Ven et al. (1999), effective leadership at different hierarchical levels is necessary for the adoption of new innovations in organizations 90. Successful implementation in healthcare is dependent on strong effective leadership to create a context which is receptive to change 262751638290919293949596. The organizational context exerts a particularly powerful set of influences on nurses' adoption of new innovations 819798. Extensive managerial involvement, commitment and attitude toward change, role clarity, and leadership styles are significantly associated with maintaining the momentum of innovation adoption in organizations 32339099100. A 'road map" that explains what leaders do is not however possible due to the inherent unpredictability and nonlinear processes of innovation adoption 90. "Management cannot ensure innovation success but can influence its odds" (p.11, 88). Leadership is an integral part of managerial roles, and is necessary for managers to influence change 348296101102103104. Individuals and organizational context must be influenced for practice change to occur based on new innovations 20. The proposed intervention aims to influence individuals, the practice environment and organizational context through leadership processes and behaviours that manage barriers and enable practice change to occur. (Figure 2)

Figure 2

Conceptual Framework

Conceptual Framework.

Post-intervention measures

Chart audits will be conducted on all patients being treated for diabetic foot ulcers up to 12 weeks following the intervention. To understand the leadership and management behaviours that influenced nursing practice, semi structured qualitative interviews will be conducted with managers, supervisors and resource nurses and staff nurses at control and experimental sites (n = 20). The experimental group interview guide will also ask for participants' opinions regarding the usefulness of the intervention. The interview guides are based on previously published guides for assessing barriers and supports 80, and previous research on implementing guidelines 105. To evaluate satisfaction and perceived utility of the one day workshop, an evaluation form, based on previously evaluations from RNAO guideline implementations, 106 will be administered at the end of the workshop.

Data Analysis

Pre/post univariate descriptive data will be computed for demographics of patients and staff.

Primary Outcome: Composite NACRF scores

Eeach item within the scale will be coded dichotomously (1 = yes; 0 = no), and a total score calculated out of 8. Bivariate analysis using independent groups t-tests will be conducted to assess the significance of differences pre/post intervention between control and experimental groups. The alpha level will be pre-set at .05, and 95 percent confidence intervals calculated. An 'intent to treat' analysis will be used 75.

Secondary Outcomes

The proportion of people with healed ulcer(s) at 12 weeks, and time to complete healing will be calculated. Types of treatments used (eg: hydrogel dressings, sharp debridement, offloading devices) will be calculated. Clients with documented patient education and referrals will be dichotomously coded (1 = yes; 0 = no/don't know). Independent groups t-tests for continuous variables, and chi squares for categorical variables will determine differences before and after the intervention within each center, and between control and experimental groups. Descriptive statistics will be used to evaluate nursing participants' satisfaction and perceived utility with the elements of the intervention.

Other Outcomes

ICCs (ρ) will be calculated on pre/post measures of composite NACRF scores, and demographic characteristics of clients (e.g.: age, gender) 107. Matching is expected to minimize between-unit variations, and previous research shows ICCs for the process of care to be high 2074108. ICCs from this study will be useful to inform future studies regarding sample size calculations 107109110.

Qualitative Findings

To understand how the intervention influenced leadership practices, data from qualitative interviews will be audio-taped, transcribed, entered into qualitative software (NVIVO) and analyzed using content analysis techniques involving an iterative process of data reduction, data display, conclusion drawing and verification 111.

Discussion

Limitations

An inherent limitation of collecting data through chart audit is the documented data obtained may potentially underestimate actual care 112. Other methods of data collection, such as direct observations are not feasible for this pilot study due to geographical distances and associated costs of observing home-care nurses provide care in patients' homes throughout the province. A second limitation of collecting data through chart audits involves reviewers accuracy, impartiality, attentiveness and consistency in extracting data 112. Having an experienced research manager overseeing the process, and pilot testing for interrater and test-retest reliability will assist with addressing this limitation. Additionally, this is a pilot study and not sufficiently powered to account for the effect of clustering.

Ethical Considerations

Prior to commencement, ethical approval will be obtained from University of Ottawa Research Ethics Board which follows Tri-council guidelines 113. Details of ethical considerations, including informed consent, anonymity and confidentiality are found in ethics submission form. Briefly, a numerical coding system will be used to track individual participant and chart audit data. Names of interview participants will be kept separated from data collection forms and locked at the University of Ottawa Nursing Best Practice Research Unit. Names from chart audits will be kept by the research manager at the participating organization in a secured place; only numerically coded data will be sent to investigators. Only aggregated data will be reported. Information consent forms will be available in English and French. Data will be securely stored for 5 years after study conclusion (e.g. December, 2014).

Feasibility

This study aligns with the participating organization's timeline to implement the Diabetes/Foot Ulcer BPG, and has been developed in consultations with senior administrators to ensure feasibility, support, and compatibility with organizational direction, initiatives and training strategies.

Potential Impact on Nursing Care

This pilot study will contribute to the development of leadership strategies to facilitate implementation of guideline recommendations on a priority clinical topic in community nursing. The anticipated outcome is information to assist with more effective management and faster healing of foot ulcers in community health nursing for people with diabetes. With the high cost of guideline implementation, this study will provide vital information on which strategies are well received when implementing practice change. By tracking clinical outcomes associated with guideline use, nursing administrators will be better informed to influence organizational and policy decisions to support high quality nursing care. Findings will be useful to inform the design of future multi-centered trials on various clinical topics, and to enhance the science of knowledge translation for evidence-informed practice change that impacts quality nursing care and client outcomes.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

WG and BD conceptualized the study. WG led the writing and application for funding. All other authors contributed to conceptualizing based on specific areas expertise: IG for knowledge translation framework and tool development; NL for organizational feasibility and data collection methods; AT for leadership development theory and leadership outcomes; KW for quantitative methodology and power analysis. All authors have read drafted versions of the manuscript, provided input and refinements, and agreed to the final manuscript.

Acknowledgements

Gifford is a doctoral student at the University of Ottawa, Ontario Canada through support from the University of Ottawa Excellence Scholarship and Registered Nurses Association of Ontario Doctoral Fellowship. This study is funded through a research grant from the Canadian Nurses' Foundation Nursing Care Partnership Fund and the Ministry of Health and Long Term Care of Ontario Nursing Research Fund.

Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada http://www.diabetes.ca/cpg2003/chapters.aspx?agrowinghealthcareproblem.htm Clinical practice guidelines for the management of diabetes in Canada Canadian Diabetes Association (CDA) Canadian Medical Association Journal 1998 159 S1 S29 1255890 9834731 Pressure relieving interventions for preventing and treating diabetic foot ulcers Spencer S Cochrane Database Syst Rev 2000 3 CD002302 10908550 Patient education for preventing diabetic foot ulceration Valk GD Kriegsman DM Assendelft WJ Cochrane Database Syst Rev 2005 1 CD001488 15674879 Neuropathic diabetic foot ulcers Boulton AJ Kirsner RS Vileikyte L New England Journal of Medicine 2004 351 48 55 10.1056/NEJMcp032966 15229307 Diabetes and peripheral vascular disease Chapter 6. In Diabetes in Ontario an ICES practice atlas http://www.ices.on.ca/file/DM_Chapter6.pdf Debridement of diabetic foot ulcers (Cochrane Review) Smith J Cochrane Database Syst Rev 2002 4 CD003556 12519603 Factors associated with ulceration and amputation in the neuropathic foot Birke JA Patout CA Jr Foto JG Journal of Orthopaedic and Sports Physical Therapy 2000 30 91 97 Diabetic foot ulcers: A framework for prevention and care Boulton AJ Meneses P Ennis WJ Wound Repair and Regeneration 1999 7 7 16 10.1046/j.1524-475X.1999.00007.x The diabetic foot: consequences of delayed treatment and referral Mills JL Beckett WC Taylor SM Southern Medical Journal 1991 84 970 974 1882274 Registered Nurses Association of Ontario Nursing Best Practice Guidelines Project Reducing foot complications for people with diabetes Toronto, Ontario, Canada: Registered Nurses Association of Ontario 2004 McIntosh A Peters J Young R Hutchinson A Chiverton R Clarkson S Prevention and management of foot problems in Type 2 diabetes: Clinical Guidelines and evidence Sheffield: University of Sheffield 2003 Registered Nurses Association of Ontario Assessment and management of foot ulcers for people with diabetes Toronto, Canada: Registered Nurses Association of Ontario 2005 Best practice recommendations for the prevention, diagnosis and treatment of diabetic foot ulcers: Update 2006 Orsted HL Searles G Trowell H Shapera L Miller P Rahman J Adv Skin Wound Care 2006 20 12 655 669 10.1097/01.ASW.0000284957.16567.3a Best Practice recommendations for preparing the wound bed: Update 2006 Sibbald RG Orsted HL Coutts P Keast D Adv Skin Wound Care 2006 20 7 390 405 10.1097/01.ASW.0000280200.65883.fd Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis Margolis DJ Kantor J Berlin JA Diabetes Care 1999 22 692 695 10.2337/diacare.22.5.692 10332667 Patient education for preventing diabetic foot ulceration. A systematic review. [Review] [44 refs] Valk GD Kriegsman DM Assendelft WJ Endocrinology & Metabolism Clinics of North America 2002 31 633 658 10.1016/S0889-8529(02)00021-X Resources to enhance evidence-based nursing practice Ciliska DK Pinelli J DiCenso A Cullum N AACN Clinical Issues 2001 12 520 528 11759424 Sources and models for moving research evidence into clinical practice Davies BL JOGNN – Journal of Obstetric, Gynecologic, & Neonatal Nursing 2002 31 558 562 10.1111/j.1552-6909.2002.tb00081.x Grol R Wensing M Eccles M Improving patient care The implementation of change in clinical practice Edinburgh: Elsevier Butterworth Heinemann 2005 Successes and failures in the implementation of evidence-based guidelines for clinical practice Grol R Medical Care 2001 39 II46 II54 10.1097/00005650-200108002-00003 11583121 Negotiating for change. The healthcare manager as catalyst for evidence-based practice: changing the healthcare environment and sharing experience Browman GP Snider A Ellis P Healthcarepapers 2003 3 10 22 12811083 Why don't physicians follow clinical practice guidelines?: A framework for improvement Cabana MD Rand CS Powe NR Wu AW Wilson MH Abboud PA Journal of the American Medical Association 1999 282 1458 1465 10.1001/jama.282.15.1458 10535437 Translating guidelines into practice: A systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines Davis DA Taylor-Vaisey A CMAJ 1997 157 408 416 1227916 9275952 Effectiveness and efficiency of guideline dissemination and implementation strategies Grimshaw JM Thomas RE MacLennan G Fraser C Ramsay CR Vale L Health Technol Assess 2004 8 6 iii-iv, 1-72 14960256 A framework for the dissemination and utilization of research for health-care policy and practice Dobbins M Ciliska D Cockerill R Barnsley J DiCenso A Online Journal of Knowledge Synthesis for Nursing 2002 9 7 12439759 Evidence-based practice and the role of nursing leadership Stetler CB Brunell M Giuliano KK Morsi D Prince L Newell-Stokes V Journal of Nursing Administration 1998 28 45 53 10.1097/00005110-199807000-00011 9709696 Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes (Review) Shaw B Cheater F Baker R Gillies C Hearnshaw H Flottorp S Cochrane Database Syst Rev 2005 3 CD005470 16034980 Continuing education meetings and workshops: effects on professional practice and health care outcomes (Review) Thomson O'Brien M Freemantle N Oxman A Wolf F Davis D Herrin J Cochrane Database Syst Rev 2001 2 CD003030 11406063 Leadership and innovation among teams The impact of empowerment Burpitt WJ Bigoness WJ Small group research 1997 28 414 423 10.1177/1046496497283005 Leadership and climate for innovation in teams Dackert I Loov LA Martensson M Economic and Industrial Democracy 2004 25 301 318 Organizational innovation: A meta-analysis of effects of determinants and moderators Damanpour F Academy of management journal 1991 34 555 588 10.2307/256406 Top management leadership and influence on innovation: The role of sociocultural context Elenkov DS Manev IM Journal of management 2005 31 381 402 10.1177/0149206304272151 Top management influence on innovations: Effects of executive characteristics and social culture Hoffman RC Hegarty WH Journal of management 1993 19 549 574 10.1016/0149-2063(93)90004-7 Transformational leadership, transactional leadership, locus of control, and support for innovation: Key predictors of consolidated-business-unit performance Howell JM Avolio BJ Journal of Applied Psychology 1993 78 891 902 10.1037/0021-9010.78.6.891 Leading for innovation: Conclusions, issues, and directions. [References] Mumford M Licuanan B Leadership Quarterly 2004 15 Feb04 171 Transformational leadership at different phases of the innovation process Waldman DA Bass BM The Journal of High Technology Management Research 1991 2 169 180 10.1016/1047-8310(91)90002-6 Leadership clarity and team innovation in health care West MA Borrill CS Dawson JF Brodbeck F Shapiro DA Haward B The Leadership Quarterly 2003 14 393 410 10.1016/S1048-9843(03)00044-4 Leadership research in business and health care Vance C Larson E Journal of Nursing Scholarship 2002 34 165 171 10.1111/j.1547-5069.2002.00165.x 12078542 Identifying and assessing competencies: A strategy to improve healthcare leadership Baker GR Healthcare Papers 2003 3 49 58 12811088 Where are the healthcare leaders? The need for investment in leadership development Leatt P Porter J Healthcare Papers 2003 4 14 31 14660891 Keeping patients safe: Transforming the work environment of nurses [retrieved April 9, 2005] Organizational change: A review for health care managers, professionals and researchers Iles V Sutherland K National Co-ordinating Centre for NHS Service Delivery and Organization R&D 2001 1 100 Executive development in healthcare during times of turbulence Top management perceptions and recommendations Hartman SJ Crow SM Journal of Management in Medicine 2002 16 359 370 10.1108/02689230210446535 12463650 Implications for practice: Challenges for healthcare leaders in fostering patient safety Weingart SN Page D Quality Safety Health Care 2004 13 52 56 10.1136/qhc.13.1.52 Shaping Systems to Promote Desired Outcomes: The Magnet Hospital Model Havens D Aiken L Journal of Nursing Administration 1999 29 14 20 10.1097/00005110-199902000-00006 10029797 Leader behavior impact on staff nurse empowerment, job tension, and work effectiveness Laschinger HKS Wong C McMahon L Kaufmann C Journal of Nursing Administration 1999 29 28 39 10.1097/00005110-199905000-00005 10333859 Review of magnet hospital research Findings and implications for professional nursing practice Gleason Scott J Sochalski J Aiken L Journal of Nursing Administration 1999 29 9 19 10.1097/00005110-199901000-00003 Evidence-based leadership: Nursing's new mandate De Groot HA Nurse Leader 2005 37 41 10.1016/j.mnl.2005.01.004 Supporting nurse managers in creating a culture of retention Manion J Nurse Leader 2005 3 52 56 10.1016/j.mnl.2005.01.006 Getting evidence into practice: the meaning of 'context' McCormack B Kitson A Harvey G Rycroft-Malone J Titchen A Seers K Journal of Advanced Nursing 2002 38 94 104 10.1046/j.1365-2648.2002.02150.x 11895535 Innovations in knowledge transfer and continuity of care Graham ID Logan J Canadian Journal of Nursing Research 2004 36 89 103 15369167 Enabling the implementation of evidence based practice: a conceptual framework Kitson A Harvey G McCormack B Quality in Health Care 1998 7 149 158 2483604 10185141 10.1136/qshc.7.3.149 Implementing evidence-based nursing practice: a tale of two intrapartum nursing units Angus J Hodnett E O'Brien-Pallas L Nursing Inquiry 2003 10 218 228 10.1046/j.1440-1800.2003.00193.x 14622368 Setting the climate for evidence-based nursing practice: what is the leader's role? Udod SA Care WD Canadian Journal of Nursing Leadership 2004 17 64 75 15656249 An exploration of the factors that influence the implementation of evidence into practice Rycroft-Malone J Harvey G Seers K Kitson A McCormack B Titchen A Journal of Clinical Nursing 2004 13 913 924 10.1111/j.1365-2702.2004.01007.x 15533097 BARRIERS: The Barriers to research utilization scale Funk SG Champagne MT Wiese RA Tornquist EM Applied Nursing Research 1991 4 39 45 10.1016/S0897-1897(05)80052-7 1741634 Barriers to, and facilitators of, research utilization among nurses in Northern Ireland Parahoo K Journal of Advanced Nursing 2000 31 89 98 10.1046/j.1365-2648.2000.01256.x 10632797 The accessibility of research-based knowledge for nurses in United Kingdom acute care settings Thompson C McCaughan D Cullum N Sheldon TA Mulhall A Thompson DR Journal of Advanced Nursing 2001 36 11 22 10.1046/j.1365-2648.2001.01938.x 11555045 Beyond the BARRIERS Scale Commonly reported barriers to research use Hutchinson AM Johnston L Journal of nursing administration 2006 30 189 199 10.1097/00005110-200604000-00008 The Yorkshire BARRIERS project: diagnostic analysis of barriers to research utilisation Bryar RM Closs SJ Baum G Cooke J Griffiths J Hostick T International Journal of Nursing Studies 2003 40 73 84 10.1016/S0020-7489(02)00039-1 12550152 Barriers to research use in the PACU Lapierre E Ritchey K Newhouse R J Perianesth Nurs 2004 19 2 78 83 10.1016/j.jopan.2004.01.001 15069646 Leadership strategies to influence the use of clinical practice guidelines Gifford WA Davies B Edwards N Graham ID Canadian Journal of Nursing Leadership 2006 19 72 87 17265675 Utilization of nursing research in practice and application strategies to raise research awareness amongst nurse practitioners: a model for success Camiah S Journal of Advanced Nursing 1997 26 1193 1202 10.1111/j.1365-2648.1997.tb00813.x 9429971 A survey of variables related to research utilization in nursing practice in the acute care setting Hatcher S Tranmer J Canadian Journal of Nursing Administration 1997 10 31 53 9355284 Building organizational capacity to engage in research utilization Rutledge D Donaldson N Journal of Nursing Administration 1995 25 12 16 10.1097/00005110-199510000-00004 7472612 Nurses' participation and utilization of research in the Republic of China Tsai SL International Journal of Nursing STudies 2000 3 435 444 10.1016/S0020-7489(00)00023-7 Evidence for nursing practice: A clarification of the issues Closs C Cheater FM Journal of Advanced Nursing 1999 30 10 17 10.1046/j.1365-2648.1999.01043.x 10403975 Nurses' experiences of research utilization within the framework of an educational programme Kajermo KN Nordstrom G Krusebrant A Lutzen K Journal of Clinical Nursing 2001 10 671 681 10.1046/j.1365-2702.2001.00526.x 11822518 Evidence and leadership: the tools for change Harrow D Foster J Greenwood J Contemporary Nurse 2001 11 9 17 11785869 National guidelines for Swedish neonatal nursing care: evaluation of clinical application Wallin L Bostrom A Harvey G Wikblad K Ewald U International Journal for Quality in Health Care 2000 12 465 474 10.1093/intqhc/12.6.465 11202600 Managerial leadership for nurses' use of research evidence: an integrative review of the literature. [Review] [79 refs] Gifford W Davies B Edwards N Griffin P Lybanon V Worldviews on Evidence-Based Nursing 2007 4 126 145 10.1111/j.1741-6787.2007.00095.x 17850494 Davies B Edwards N Ploeg J Virani T Skelly M Dobbins M Determinants of the Sustained Use of Research Evidence in Nursing Final Report Nursing Best Practice Research Unit, Funded by Canadian Health Services Research Foundation 2006 Research: Cluster randomised trials http://www.abdn.ac.uk/hsru/research/del_of_care/professionals_behaviour/cluster/ Shadish WR Cook TD Campbell DT Experimental and quasi-experimental designs for generalized causal inference Boston: Houghton Mifflin Company 2002 Donner A Klar N Design and analysis of cluster randomization trials in health research London: Arnold Publishers 2000 RNAO Evaluation Team – Nursing Best Practice Guidelines Project, Cycle 3: Reducing foot complications for people with diabetes Evaluation Tools http://www.rnao.org/Storage/12/635_BPG_foot_diabetes_eval.pdf Edwards N Davies B Dobbins M Griffin P Ploeg J Skelly J Evaluation Summary: Reducing Foot Complications for People with Diabetes 2003 All-or-none measurement raises the bar on performance Nolan T Berwick DM JAMA 1908 295 1168 1170 10.1001/jama.295.10.1168 Edwards N Davies B Griffin P Ploeg J Skelly J Danseco E Evaluation of nursing best practice guidelines: Interviewing nurses and administrators CHRU Publication No. M04-1 edn. Ottawa, ON: Community Health Research Unit, University of Ottawa 2004 http://www.rnao.org/Storage/13/778_CHRU_Monograph_Series_M04-1.pdf Toward a comprehensive interdisciplinary model of health care research use Logan J Graham ID Science Communication 1998 20 227 246 10.1177/1075547098020002004 Yukl GA Leadership in organizations Upper Saddle River, NJ: Pearson Prentice Hall 6 2006 Using the Ottawa Model of Research Use to implement a skin care program. [Review] [26 refs] Graham K Logan J Journal of Nursing Care Quality 2001 Evidence-based pressure-ulcer practice: The Ottawa Model of Research Use Logan J Harrison MB Graham I Dunn K Bissonnette J Canadian Journal of Nursing Research 1999 31 37 52 10455586 Barriers and facilitators influencing call center nurses' decision support for callers facing values-sensitive decisions: a mixed methods study Stacey D Graham ID O'Connor AM Pomey M Worldviews on Evidence-Based Nursing 2005 2 184 195 10.1111/j.1741-6787.2005.00035.x 17040526 The Ottawa Model of Research Use A guide to clinical innovation in the NICU Hogan DL Logan J Clinical Nurse Specialist 2004 18 255 261 10.1097/00002800-200409000-00010 15540068 Continuity through best practice: design and implementation of a nurse-led community leg-ulcer service Lorimer K Canadian Journal of Nursing Research 2004 36 105 112 15369168 An Evaluative Essay on Current Conceptions of Effective Leadership Yukl G European Journal of Work and Organizational Psychology 1999 8 33 48 10.1080/135943299398429 A hierarchical taxonomy of leadership behavior: Integrating a half century of behavior research Yukl G Gordon A Taber T Journal of Leadership & Organizational Studies 2002 19 15 32 10.1177/107179190200900102 Ven Van de AH Polley DE Garud R Venkataraman S The innovation journey New York: Oxford University Press 1999 Achieving change in health care practice Redfern S Christian S Journal of Evaluation in Clinical Practice 2003 9 225 238 10.1046/j.1365-2753.2003.00373.x 12787186 Setting the climate for evidence-based nursing practice: What is the leader's role? Udod SA Care WD Nursing Leadership 2004 17 64 75 15656249 No magic targets! Changing clinical practice to become more evidence based Dopson S Fitzgerald L Ferlie E Gabbay J Locock L Health Care Management Review 2002 27 35 47 12146782 Role of the organization in translating research into evidence-based practice Stetler CB Outcomes Management 2003 7 97 103 12881970 Iles V Sutherland K Organisational change. A review for health care managers, professionals and researchers London: National Co-ordinating Centre for NHS Service Delivery and Organisation R & D 2001 Swayne LE Duncan WJ Ginter PM Strategic management of health care organizations Malden, MA: Blackwell Publishing fifth 2006 The organizational environment and evidence-based nursing Royle J Blythe J Ciliska D Ing D Canadian Journal of Nursing Leadership 2000 13 31 37 11140046 Translating research into practice: Implications for organizations and administrators Estabrooks C Canadian Journal of Nursing Research 2003 35 53 68 14603570 Diffusion of innovations in service organizations: Systematic review and recommendations Greenhalgh T Robert G Macfarlane F Bate P Kyriakidou O The Millbank Quarterly 2004 82 581 629 10.1111/j.0887-378X.2004.00325.x Leadership clarity and team innovation in health care. [References] West M Borrill C Dawson J Brodbeck F Shapiro D Haward B Leadership Quarterly 2003 14 Hamlin RG Cooper DJ Identifying the criteria of managerial and leadership effectiveness within the Brimingham Women's Healthcare NHS Trust through HRD professional partnership research, WP101/04 edn University of Wolverhampton 2004 A study and comparative analysis of managerial and leadership effectiveness in the National Health Service: an empirical factor analytic study within an NHS Trust hospital Hamlin RG Health Services Management Research 2002 15 245 263 10.1258/095148402320589046 12396550 Leadership and climate for innovation in teams Dackert I Loov LA Martensson M Economic and Industrial Democracy 2004 25 301 318 Transformational leadership at different phases of the innovation process Waldman DA Bass BM The Journal of High Technology Management Research 1991 2 169 180 10.1016/1047-8310(91)90002-6 Davies B Edwards N Griffin P Dobbins M Ploeg J Skelly J Research Proposal: Determinants of the sustained use of research evidence in nursing Canadian Health Services Research Fund (CHSRF) 2002 Edwards N Davies B Danesco E Brosseau L Pharand D Ploeg J Evaluation of nursing best practice guidelines: perceived worth and educational/supportive processes, CHRU No. M04-3 edn Ottawa, Ontario: Community Health Research Unit University of Ottawa 2004 Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported Campbell MK Grimshaw JM Elbourne DR BMC Medical Research Methodology 2004 4 9 415547 15115554 10.1186/1471-2288-4-9 Intra-cluster correlation coefficients in adults with diabetes in primary care practices: the Vermont Diabetes Information System field survey Littenberg B MacLean CD BMC Med Res Methodol 2006 6 20 1513389 16672056 10.1186/1471-2288-6-20 Randomizing patients by family practice: sample size estimation, intracluster correlation and data analysis Cosby RH Howard M Kaczorowski J Willan AR Sellors JW Fam Pract 2001 20 1 77 82 2003 Feb 10.1093/fampra/20.1.77 What is an intracluster correlation coefficient? Crucial concepts for primary care researchers Killip S Mahfoud Z Pearce K Annals of Family Medicine 2004 2 204 208 1466680 15209195 10.1370/afm.141 Miles M Huberman A Qualitative Data Analysis: An expanded sourcebook Thousand Oaks, California: SAGE Publications Inc second 1994 Chart review. A need for reappraisal Wu L Ashton CM Eval Health Prof 1997 20 2 146 163 10.1177/016327879702000203 10183318 Canadian Institutes of Health Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research Council of Canada Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, (with 2000, 2002, 2005 amendments) edn 1998