Aim: The aim of this paper is to present the development and evaluation of the Self-Efficacy Goal Achievement nursing intervention for type 2 diabetes.
Background: Systematic reviews support the clinical effectiveness of diabetes self-management programmes that are collaborative, involve biomedical feedback and are goal focussed.
Method: The self-efficacy goal achievement intervention comprises patient goal-setting consultations with practice nurses using the Diabetes Management Self-Efficacy Scale. The United Kingdom Medical Research Council framework for the evaluation of complex interventions by randomized controlled trial was used to develop and evaluate the intervention. The ‘preclinical’ study included literature analysis and findings from parallel studies. The ‘phase I’ study, carried out in spring 2003, was a small trial of the intervention, evaluation of its feasibility, identification of appropriate outcome measures for future trials and improvement of the components, with two nurses and eight patients.
Findings: The ‘preclinical’ study supported continued intervention development. The ‘phase I’ intervention resulted in a mean reduction in participants' glycosylated haemoglobin of 0.93% between baseline and 3-months postintervention. It showed an increase in patient self-efficacy and some decline in patient diabetes treatment satisfaction. Qualitative data recorded therapeutically desirable behavioural changes in all participants. Follow-up consultations and goal evaluation were found to be important to patients. Nurses reported (i) reservations about the repeated use of components of the intervention, which were felt to be repetitive and restrictive; and (ii) the time commitment required to deliver the educational sessions.
Conclusions: Most phase I components were effective in delivering a feasible nursing intervention. The intervention has been adjusted to remove the less effective components and enhance the more effective. The outcome measures were appropriate for the intervention. A phase II trial is being developed to further test both the intervention and research protocol for comparing the intervention to an alternative.
The emphasis in diabetes care has been shifting over the past decade towards providing a primary care diabetes service which has patient education and self-management at the forefront of policy initiatives. The International Diabetes Foundation (http://www.idf.org ) has both led and responded to this with their involvement at the outset in the St Vincent Declaration of 1989, leading in 2003 to their publication of international standards for diabetes education. These standards state ‘Implementation of diabetes education is learner-centred, facilitates cognitive learning, behaviour change and self-management’ and are powerful and challenging for national policymakers to uphold. Some commitment to facilitating these goals, through patient–healthcare professional partnerships is demonstrated in national policies. For example, shared decision-making is a standard promoted in Finland (http://www.diabetes.fi ), the UK (Department of Health 2002), the Americas (http://www.dota.org ) and the Netherlands (Rutten et al. 1999). This emphasis on active self-management and empowerment requires appropriate support for patients from healthcare professionals to enable them to engage confidently and competently in managing the complex metabolic condition of diabetes.
Systematic reviews of patient self-management training in asthma (Gibson et al. 2000) and type 2 diabetes (Norris et al. 2001) have both concluded that collaborative self-management interventions, where people respond to clinical information and goal setting, are the most effective self-management approaches for improving clinical outcomes. In these self-management interventions, patients are taught how to respond to biomedical feedback such as peak-flow rate or blood glucose levels, and they derive confidence to manage their condition through this process. Ismail et al. (2004) carried out a meta-analysis of 12 studies included in their systematic review of psychological interventions in type 2 diabetes. They found a 1% reduction in HbA1c after the delivery of psychological interventions by healthcare professionals. The interventions consisted mainly of motivational interviewing, relaxation training and cognitive behavioural therapy. Systematic reviews have, however, been subjected to some criticism (Rollnick 2001, Muhlhauser & Berger 2002, van Meijel et al. 2004), particularly in relation to the assessment of randomized controlled trials (RCTs) of complex interventions. A fundamental concern of Rollnick (2001) and Muhlhauser and Berger (2002) is the absence of detail about the intervention components in published trials. van Meijel et al. (2004) go further to suggest that, since the clinical situation rarely mimics a trial condition, the absence of detail limits clinicians' use of an intervention in a flexible way to meet the individual needs of presenting patients. This potentially leads clinicians to select intervention components with a weaker evidence base as a result of the lack of published findings about the intervention components. This often incomplete data set can also lead to the subsequent inclusion or exclusion of a trial from a review, based on descriptions of interventions that are neither fully understood nor justified. Criticisms such as these begin to cast doubt on the systematic review as the pinnacle in the hierarchy of evidence for the evaluation of the effectiveness of complex interventions.
The UK Medical Research Council (MRC) framework for the development and evaluation of complex interventions by RCT (MRC 2000) has been used to describe the accumulating evidence on the components of complex interventions (e.g. Bradley et al. 1999, Muhlhauser & Berger 2002, Walker et al. 2003). Within a complex intervention, the ‘active’ component may be difficult to describe, and the framework (Figure 1) provides a structure through which the components may be tested and compared, both theoretically (preclinical phase) and clinically (phase I/II). The framework proceeds towards the development of a phase III/IV trial in which the intervention is subjected to randomized controlled trial and long-term, pragmatic, studies. Muhlhauser and Berger (2002) have published a retrospective account of their diabetes patient education intervention development and evaluation work in Germany using the MRC framework. They suggest that it is essential to have these data in the public domain early to enable research teams to engage in critical analysis of the relative effectiveness of particular intervention components.
Figure 1 United Kingdom Medical Research Council framework of complex interventions.
The aim of the study was to develop and evaluate a Self-Efficacy Goal Achievement (SEGA) complex nursing intervention for type 2 diabetes.
This ongoing study uses the MRC (2000) framework for the development and evaluation of complex interventions by RCT. The preclinical and phase I studies have been completed and the findings used to develop and justify a phase II study.
The theoretical, also referred to as preclinical, basis for the assumed effectiveness of the SEGA intervention is Bandura's (1977) self-efficacy theory. Self-efficacy is recognized as one of the strongest predictors of health behaviour change (Gillis 1993, Conner & Norman 1998) and is defined as a person's level of confidence in their ability to perform a particular behaviour (efficacy expectations). Randomized trials of interventions incorporating the four specific efficacy-enhancing techniques of facilitating personal mastery, vicarious (observing others) experiences, identifying distress and providing verbal persuasion (e.g. Lewin et al. 1992, Lorig et al. 1999, Barlow et al. 2000) have demonstrated lower levels of health care consumption and improved psychosocial adjustment to a new health status. The majority of the literature found on Medline and CINAHL searches relating to type 2 diabetes self-efficacy refers to the theory in one of three ways: (i) the development and validation of self-efficacy outcome measures for aspects of diabetes management (e.g. van der Bijl et al. 1999, Samuel-Hodge et al. 2002); (ii) observational studies looking at associations between self-efficacy and other psychological or clinical outcomes (e.g. Plotnikoff et al. 2000, Rose et al. 2002, Ikeda et al. 2003); and (iii) as an outcome measure in a trial of an intervention where it is not possible to determine, from the papers, the conceptual or theoretical foundations of the intervention under scrutiny (e.g. Grey et al. 2004). Published examples of diabetes interventions based solely on self-efficacy theory were not found in the literature review. In a small number of trials, intervention components from differing theoretical frameworks are combined with self-efficacy theory, for example learning theory (e.g.Miller et al. 2002), social support and motivation (di Loreto et al. 2003). Self-efficacy intervention components have predominantly centred on the promotion of mastery and on vicarious experiences, and have largely been used in other clinical conditions. Lorig's (Lorig & Holman 1993, Lorig et al. 1999) arthritis and chronic disease group programmes in the USA have incorporated promotion of mastery experiences through small personal goal-setting opportunities. In these programmes, other group members and the lay leader, living with a chronic condition themselves, provided positive vicarious experiences. Vicarious experiences have also been provided through both written and audiorecorded patient vignettes in the UK Heart Manual programme (Lewin et al. 1992, Dalal & Evans 2003) for secondary prevention of coronary heart disease. di Loreto et al. (2003) have incorporated efficacy enhancement into a counselling strategy to promote physical activity in people with type 2 diabetes in Italy. Efficacy was enhanced through the negotiation of small, incremental, goals which patients felt confident to achieve. This counselling strategy demonstrated a statistically significant (P < class="fulltext-IT">P <>
Further evidence supporting the preclinical phase largely embodies what the MRC refers to as ‘accumulating wisdom from empirical evidence’ (MRC 2000, p. 6).
Three pieces of empirical and theoretical evidence were used to inform the preclinical phase of our work. Firstly, a needs analysis of patient diabetes educational needs (Sturt et al. 2005a, 2005b) concluded that people with diabetes want an educational syllabus to incorporate (i) the provision of information, (ii) training in personal monitoring, (iii) specific, and (iv) general behavioural goal-setting and evaluation. Secondly, self-efficacy measurement scales for particular health-related behaviours are widely available in the health and psychology literature for population or individual use. Re-validation of the Dutch 20-item type 2 Diabetes Management Self-Efficacy Scale (DMSES) (van der Bijl et al. 1999) in the UK (Sturt & Hearnshaw 2003) enabled measurement of diabetes self-management self-efficacy. This scale continues to undergo re-validation by the International Partnership of Self-Management and Empowerment (IPSE) research collaboration (Hearnshaw et al. 2002), of which two of us are founder members. This ongoing re-validation of the DMSES is taking place with majority populations in UK (Sturt & Hearnshaw 2003), USA, Belgium, Switzerland and Australia (McDowell et al. 2005) for majority populations. Further validation for minority populations in the UK, USA, Australia is underway. The scale comprises 20 self-management statements, for example, ‘I am able to correct my blood sugar when it is high’. The final piece of empirical evidence is provided by a study in which nurses demonstrated their ability to apply self-efficacy theory to their smoking cessation and sexual health patient consultations, both opportunistically and within structured sessions. (Sturt 1997, 1998). They were able to negotiate goal-setting with patients and develop successful strategies to achieve them. This work also identified extended consultation time as a result of opportunistic use of self-efficacy theory in practice as confounding the evaluation of the intervention.
Phase I studies use the theoretical and empirical evidence from the preclinical phase to start to build a complex intervention. An iterative relationship existed between the previous and the current phase of the SEGA study as we looked back and forth between the preceding evidence and the intervention components to hypothesise and test possible interactions, determinants and consequences. This iterative process in relation to the SEGA phase I study resulted in identifying the following aims:
Two practice nurses who had completed a diabetes education course were recruited to the study. We required extended-skill nurses because part of their role was to help us to define a feasible patient intervention, and they were required to focus on self-efficacy learning with a secure diabetes knowledge base already in place. The intervention began with a half-day training for the nurses focussing on measuring self-efficacy using the DMSES (Sturt & Hearnshaw 2003) and understanding personal mastery and vicarious experiences for people with type 2 diabetes. It also explored how the nurses could enhance patients' efficacy expectations. The nurse training was also based on self-efficacy theory and a training manual was given to them and they were encouraged to refer to this throughout the intervention delivery period to enhance their own mastery experiences of delivering the intervention. The nurses, who were previously unknown to each other, exchanged contact details to enable them to become positive role models for each other during the study period. They participated in one further session during the intervention phase to work with us and each other on areas of difficulty or success.
Four patients were recruited in Spring 2003 by each practice nurse from their diabetes clinics (n = 8) according to the following eligibility criteria: (i) adults with type 2 diabetes, (ii) aged 65 or over, (iii) last three HbA1c >7%, (iv) ability to communicate in English, and (v) attended last three GP/nurse appointments. Our inclusion criteria were developed in part to avoid attrition from our small sample, and potential patient participants were excluded if (i) their diabetes care was managed by someone else, e.g. nurse/carer, (ii) they had learning disabilities, and/or (iii) they recorded high scores on the DMSES at the first consultation, suggesting little room for improvement in self-efficacy. Five patients were aged 65–70 years, three were over 70 years old and four were women.
Outcome data consisting of (i) most recent glycosylated haemoglobin (HbA1c) level (recorded from the clinical records), (ii) diabetes psychosocial self-efficacy [measured by the Diabetes Empowerment Scale (DES) (Anderson et al. 2000)], and (iii) treatment satisfaction [using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) (Bradley 1994)] were collected at baseline and immediately postintervention. HbA1c and diabetes management self-efficacy using the DMSES were assessed again 3 months after the intervention. We collected the psychosocial data by postal questionnaire. Qualitative data were collected from nurse journals, four patient interviews and monthly 15-minute telephone interviews with the nurses. The nurses were asked to record critical incidents (Brookfield 1988) in their journals after consultations with participating patients. These incidents were determined as critical because they resulted in some degree of reflection as to whether and why the consultation had appeared to go well or badly from the nurse's perspective. These diary entries formed the basis of the monthly 15-minute telephone interviews, which were tape recorded and later transcribed and analysed. Four patients were invited to take part in interviews in their own homes. They were chosen to represent a gender and age mix, and two patients of each of the nurses.
Each nurse delivered the intervention to four patients (n = 8) during four consultations held at monthly intervals. The patient and practice nurse focused on goal setting and goal achievement informed by self-efficacy theory. Each consultation was designed to last 20–30 minutes, as follows:
Research ethics committee approval for the study was obtained. The nurses negotiated permission to participate in the study from their employers. A letter of invitation to take part, based on advice from the Warwick Diabetes Care Research User Group (http://www2.warwick.ac.uk/fac/med/healthcom/diabetes/ ), was sent from the GP practice to potential patient participants. Consent was sought at the time of invitation. All patient data leaving the practice were anonymized and names replaced with a research code. Confidentiality was assured throughout the conduct of the study and its dissemination.
The clinical and questionnaire data were analysed using SPSS. The qualitative interviews and nurse diaries were analysed thematically using NVIVO to identify key learning features for both patient and nurse, and identify any critical intervention points. The data were also analysed to assess the feasibility and applicability of the study method and effectiveness (MRC 2000). The data were triangulated to look for patterns where an intervention component might demonstrate strength or weakness within the whole.
All eight patients completing the monthly DMSES as part of the SEGA intervention (Figure 2) and seven of the eight completing the DES (Anderson et al. 2000) (Figure 3) demonstrated a modest increase in their diabetes self-efficacy. The qualitative data concurred with the quantitative data. The nurses reported that all eight patients engaged successfully in goal setting. The nurses referred repeatedly to increasing patient confidence and described specific areas in which the latter had been able to set, achieve and maintain their diabetes management goals.
Figure 2 Diabetes Management Self-Efficacy Scale (DMSES) (range 0–11) mean scores for all items over the study period.
Figure 3 Diabetes Empowerment Scale (DES) (range 1–5) scores pre- and postintervention.
Mean clinical HbA1c reduction of 0.93% occurred between preintervention and 3 months postintervention (Table 1). Six patients had reductions between 0.5% and 2.7%, one patient's HbA1c increased by 0.6%, and one had no change. This mean reduction was mirrored (0.96%) when the mean of the previous three preintervention clinical HbA1c results were compared with 3-months postintervention in each patient.
Table 1 Glycated haemoglobin (HbA1c) measures for study participants
The nurses reported reservations about aspects of the intervention involving the repeated use of the DMSES. This was felt to be repetitive and restrictive after the first two consultations. They also reported that considerable time was required to deliver basic knowledge about diabetes. Three patients showed a decline in treatment satisfaction on the DTSQ. Follow-up consultations and goal evaluation were found to be important to patients.
The phase I study was a very small uncontrolled trial and, as such, its findings should be treated with caution. These, whilst indicating improved diabetes management in this small group of patients and nurses, should be of more current interest to researchers rather than clinicians aiming to use evidence-based practice. The dissemination of findings from intervention development trials, such as this report, starts to address the concerns of Rollnick (2001) and Muhlhauser and Berger (2002) and may lead to more appropriate inclusion of complex intervention trials in systematic reviews. The few examples of self-efficacy-based interventions published in the literature suggest a further need to disseminate early phase data of working examples of intervention components.
The MRC (2000) framework suggests the need for phase I studies to identify the components of the intervention, mechanisms through which they influence the outcomes and interrelation between the components. In our study, the SEGA intervention component parts and the underlying mechanisms (Table 2) suggested some component redundancy and areas that required strengthening.
Table 2 Self-Efficacy Goal Achievement (SEGA) components and underlying influences
Redundant SEGA components appeared to be the repeated use of the DMSES over the 4-month period and the feasibility of maintaining lengthy consultations over and above the routine clinics and opportunistic consultations. Findings from the DMSES re-validation study in the UK (Sturt & Hearnshaw 2003) suggested the reduction of the Dutch 20-item DMSES to a 15-item scale. This addressed the concerns of our nurses using SEGA about the repetitive nature of some of the items in the 20-item DMSES.
There were additional nurses' concerns about meeting patient educational needs without the lengthy additional consultations provided in this phase I study. These findings led to a process of scenario testing, advocated within the MRC framework for phase I studies, to ascertain by actual or virtual means the implications of removing one component for those remaining. Within our SEGA Phase I study, we looked to the data to explore scenarios (Table 3) and establish the validity of any resulting changes to the intervention.
Table 3 Scenario testing
Following scenario testing, a number of changes were made to SEGA (Table 4) to strengthen it. The intervention is justified according to the findings of the preclinical phase, phase I, and the DMSES revalidation.
Table 4 Self-Efficacy Goal Achievement (SEGA) phase II justification
The SEGA phase II intervention has many similarities to the self-efficacy components of di Loreto et al.'s (2003) counselling strategy to increase physical exercise in people with diabetes. Small incremental goals were negotiated in both interventions, with SEGA using the structure of the DMSES to identify appropriate goal areas for broader diabetes self-management. di Loreto et al. (2003) did not assess self-efficacy as an outcome measure. Indeed, one of the limitations of self-efficacy-based interventions is that they are challenging to assess. Self-efficacy is highly behaviour-specific (Bandura 1977) and requires the use of behaviour-specific instruments in order to be certain of reliable outcomes. In di Loreto et al.'s (2003) study, this was the level of confidence for performing physical activity in a population with type 2 diabetes. For such outcomes to be reliably assessed, a great many outcome instruments need to be developed and validated across a wide range of diabetes self-management behaviours.
A phase I trial is concerned primarily with understanding the intervention and its possible effects (MRC 2000). The SEGA intervention delivered a mean 0.93% reduction in HbA1c levels. This compares well with the findings of Ismail et al.'s (2004) systematic review of psychological interventions. A modest increase in self-efficacy occurred when measured on two scales, the DMSES and the DES. The reduced treatment satisfaction expressed by three participants was not found to be reported elsewhere in the data set and may have resulted from improved understanding of the required treatment activities for diabetes, or a ceiling effect observed with the use of this scale (Witthaus et al. 2001). Our outcome measures have provided data which suggest these as the appropriate measures for a phase II trial.
Our results demonstrate the potential of the SEGA intervention, delivered by nurses, to influence diabetes related health behaviours. This, together with systematic review evidence (Gibson et al. 2000, Norris et al. 2001, Ismail et al. 2004) and the policy imperative on partnership with patients (e.g. http://www.idf.org ; http://www.diabetes.fi ; Department of Health 2002), indicates a need for clinical nurses to offer a behaviourally focussed intervention during diabetes consultations and that a phase II (exploratory) trial should be developed.
Our continuing study highlights a number of issues for nursing research. Nursing interventions are commonly complex, and the MRC framework (MRC 2000) enables researchers to describe and demonstrate the relevance of early nursing studies to the long-term development of nursing interventions. An alternative model for the development and evaluation of nursing interventions has been proposed by van Meijel et al. 2004. They suggest a list of questions that research teams should ask themselves in deciding whether an RCT is justified in further demonstrating the effectiveness of a nursing intervention. They assert that if the conditions of sound science, high perceived intervention value by patients and successful target outcomes have been demonstrated in qualitative work, then an RCT should not be the priority. We agree that trial patient eligibility is rarely replicated in a clinical context. The contextual considerations that clinicians are required to make when using RCT findings in their practice, however, are far less onerous than those that are required following evaluation by qualitative means. The size of the sample needed in a trial suggests that the chances of the findings applying to a larger population are greater. There is also an assumption in van Meijel et al.'s (2004) argument that qualitative studies have broader patient inclusion criteria and therefore represent a broader population base. Trials must adhere to strict guidelines in the publication of their eligibility criteria (Moher et al. 2001), and the presentation of this data ensures clarity for the clinician in implementing evidence-based practice. We suggest that nursing needs complex interventions to be developed, described and evaluated under controlled conditions. Our ongoing study shows that complexity does not restrict evaluation within a quantitative paradigm. The MRC framework provides one method of enabling the development and evaluation of complex interventions within such a quantitative approach.
Arguments in the literature surrounding the preclinical theoretical phase, strongly advocated by the MRC framework, variously describe theory as strengthening (McEvoy & Richards 2003, Walker et al. 2003), a source of misplaced loyalty (Dunn et al. 2001) and leading to oversimplification of ‘constantly shifting circumstances’ (Whitelaw et al. 2001 p. 348). Within the MRC framework, the theoretical justification undergoes the same levels of testing as the clinical phases I and II. We found the SEGA study theoretical phase to be appropriate and challenging. Self-efficacy is recognized as a component of the majority of psychological theories about behaviour (Nigg 2004). In this respect, the theoretical phase has provided a firm base upon which to build an intervention and interpret the findings. We have some sympathy with the views expressed in the literature, but the debate is an important one and research teams need to challenge themselves in the choice of theoretical perspectives and justify this against the intervention components.
In concordance with the International Diabetes Federation (http://www.idf.org ) recommendations, many national diabetes policies have introduced annual or bi-annual diabetes reviews. For example, the Netherlands operates a national policy standard published by the Dutch Royal College of General Practitioners (NHG) (Rutten et al. 1999) requiring annual review for people with diabetes. Both Australian and UK GPs have payments linked to annual and bi-annual minimum levels of care, e.g. HbA1c and blood pressure measurement (http://www.medicareaustralia.gov.au ; http://www.doh.gov.uk ). This more recent emphasis on achieving payment-linked targets for reductions in clinical measures associated with diabetes complications and cardiovascular disease risk factors has implications for the nature of the annual diabetes review. Where GPs have increasing access to nurses, it is they who carry out much of the diabetes review (Baan et al. 2003), and consequently the nursing role in relation to diabetes is increasingly focussed on clinical tasks rather than diabetes education. nurses' roles in providing diabetes education and care differ across healthcare systems, but across the globe access to nursing care is, for the majority, time-limited. A conflict is, therefore, being created as to whether the nursing resources available should be used to engage with patients in the broadly accepted (http://www.idf.org ) partnership approach to diabetes management or in the collection of payment-linked, target-oriented, clinical data. As a consequence of this conflict, the time available for nurses to focus on behavioural therapeutic goals with patients is compromised. We have adapted the SEGA intervention, based on both the findings of our phase I study and this diabetes care conflict, into a nursing intervention that will enable behaviourally focussed, goal-oriented work to occur within the demands of a healthcare system that must achieve clinical targets. These intervention differences may result in our earlier encouraging findings not being repeated in phase II. In this case, we may have to go back to the phase I study and look at the data alongside the phase II trial findings. Whilst this may seem a laborious and costly process, the resources required to undertake these early studies is minimal compared with the cost of multi-site RCTs. Full-scale trials may provide compelling evidence for the introduction of interventions in clinical practice. Ultimately, however, the interventions may prove to be inadequately prepared for exposure to the pragmatic world in which healthcare delivery takes place (van Meijel et al. 2004, Rowlands et al. 2005). Research teams and academic journals are unaccustomed to encouraging the publication of early phase, mixed method, studies. If the research community continues to depend on systematic reviews for the synthesis of reliable evidence, however, we concur with Muhlhauser and Berger (2002) that the publication of data to form a decisional trail for the inclusion, or rejection, of complex intervention components in trial development is increasingly important.
We would like to thank the British Council/NWO Partnership Programme in Science and Warwick-West Midlands Primary Care Research for funding the preclinical and phase I studies. The nurses and people with diabetes who participated are warmly thanked and we are indebted to members of the Warwick Diabetes Care Research User Group who provided a welcome perspective to this intervention development and evaluation. We are grateful to Prof. Jeremy Dale (Warwick Medical School) and the following IPSE collaborators for their challenging discussions and for reading earlier drafts of this paper, Prof Lillie Shortridge-Baggett (Pace University, New York, USA), Dr Jaap van der Bijl (University of Utrecht, Utrecht, The Netherlands) and Dr Jan McDowell (Queensland University of Technology, Australia).
JS, SW and HH contributed to the study conception and design. SW and JS contributed to data collection and analysis. JS, SW and HH contributed to the drafting of the manuscript and to critical revisions of the manuscript for important intellectual content. JS and SW obtained funding for the study.
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Keywords: behaviour therapy; diabetes; goal achievement; nursing; self-efficacy; self-management
1 comment:
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