Family Practice Vol. 21, No. 1, 39-45
© Oxford University Press 2004, all rights reserved.
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The North Dublin randomized controlled trial of structured diabetes shared care
Department of General Practice and c Department of Public Health Medicine and Epidemiology, UCD, a Department of General Practice and b Department of Health Services Research, RCSI, and d Diabetes Centre, Beaumont Hospital, Dublin, Ireland
Correspondence to Dr SM Smith, Department of Community Health and General Practice, Trinity College Centre for Health Sciences, Adelaide and Meath Hospital, Incorporating the National Children's Hospital, Tallaght, Dublin 24, Ireland; E-mail: susmith{at}tcd.ie
Received 21 October 2002; Revised 15 July 2003; Accepted 8 September 2003.
Smith S, Bury G, O'Leary M, Shannon W, Tynan A, Staines A and Thompson C. The North Dublin randomized controlled trial of structured diabetes shared care. Family Practice 2004; 21: 39–45.
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Abstract |
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Background. A new diabetes shared care service was introduced in North Dublin. It was designed as a randomized controlled trial with a complex intervention comprising education of participating practitioners, the introduction of a community-based diabetes nurse specialist, local agreement on clinical protocols and structured communication across the primary–secondary care interface.
Objectives. Our aim was to assess the feasibility and effectiveness of a structured diabetes shared care service in a mixed health care system and to analyse the impact on total patient care.
Methods. A Cluster randomized controlled trial lasting 18 months was carried out in 183 patients with type 2 diabetes from 30 general practices in North Dublin. Biophysical outcomes (HbA1c, blood pressure, body mass index), psychosocial measures (smoking status and Diabetes Clinic Treatment Satisfaction and Diabetes Well-being scores) and process outcomes were collected.
Results. There were significant improvements in diabetes care delivery and in psychosocial outcomes, but no significant improvements in biomedical outcomes. Process data collection revealed a significant increase in diabetes care-related activity for participating patients with an increase in structured annual reviews and fewer patients defaulting from care. There were also significant improvements in information exchange between primary and secondary care.
Conclusion. Structured diabetes shared care, in a mixed health care system, can produce significant improvements in diabetes care delivery and in psychosocial outcomes for patients, with improved information exchange across the primary–secondary care interface.
Keywords. Diabetes mellitus, family practice, general practice, randomized controlled trial, shared care.
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Introduction |
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Diabetes is an important chronic condition with significant associated morbidity and mortality, which can be reduced by effective treatment and preventive measures.1 Diabetes care varies significantly between countries and is delivered in either primary care or specialist centres or in shared care systems involving both sectors. Earlier research into diabetes care in general practice focused on a comparison of general practice and specialist diabetes care delivery.2,3 The main conclusion was that care provided in structured general practice or shared care systems can be at least as effective as hospital-based care. However, if care provision is unstructured, outcomes in primary care are worse because of reduced monitoring and screening for complications and loss of patients to follow-up. More recent research has moved away from the specialist versus generalist debate which has been described as ‘sterile’4 to focus on different models of diabetes care within general practice.5,6 A recent Cochrane Review of interventions to improve the management of diabetes mellitus in primary care, out-patient and community settings concluded that multifaceted interventions can improve the management of people with diabetes, as can organizational interventions that improve the recall and tracking of patients.7 A recent randomized trial of diabetes care in general practice in Denmark looked at an intervention that fulfilled the Cochrane criteria and demonstrated the potential in general practice to achieve successful outcomes in diabetes management.8
In Ireland, diabetes care traditionally has been delivered in the hospital sector. This has been changing recently for a number of reasons, including the commitment of GP teams to become more involved in diabetes care and the increasing recognition that the diabetes epidemic makes specialist care for all impossible, even if it were desirable. This situation presented an opportunity to introduce a new structured diabetes shared care service in a setting where there was no pre-existing structured care for diabetes in general practice and to design a randomized controlled trial that aimed to assess its feasibility and effectiveness using current health service research methodology.
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Methods |
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The study was carried out in general practice in Ireland. Ireland has a mixed health care delivery system where only a third of the population (those with lowest income) are eligible for General Medical Services (GMS), i.e. free GP, hospital and community care, with the remaining two-thirds paying their GP for each visit but having an entitlement to free hospital care. In contrast, all patients are eligible to receive hospital out-patient care free of charge. Between 1998 and 1999, local GPs were invited to attend meetings on diabetes care in general practice (chaired by the local diabetes specialist, CT), during which they were asked to indicate their interest in participating in a diabetes shared care project. This database formed the basis for the project's contact with interested GPs.
The study design was a cluster randomized controlled trial evaluating a complex multifaceted intervention, i.e. the introduction of a structured diabetes shared care service, The nature of the intervention is outlined in Box 1.
| BOX 1 The diabetes shared care model in the DiSC project The intervention: diabetes shared care model Professional education: immediately prior to the service commencing, participating GPs and practice nurses undertook a 6-week distance learning course with three skills sessions relating to primary diabetes care Appointment of a community-based diabetes nurse specialist (DNS) Locally agreed clinical and referral guidelines: annual diabetes review, performed by specialist team in diabetes out-patient clinic, Beaumont Hospital, Dublin 3-monthly routine reviews, carried out by the GP and practice nurse Structured record cards and communication across primary–secondary care interface (facilitated by the community DNS) Fast track referral system initiated by primary care team as needed The control: usual care Prior to this new service, general practice diabetes care was underdeveloped and was provided opportunistically, with no practices running diabetes miniclinics and no formal liaison between primary and secondary care other than standard referral and discharge letters. Therefore, 24% of patients received no structured diabetes care at all, while the remainder attended hospital-based diabetes clinics and were seen on an annual basis only, due to limited resources. In addition, there was no publicly funded access to community-based dieticians for patients with diabetes and limited access to chiropody services depending on patients' income. These conditions continued for the control group for the duration of the study.
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Patients from 30 general practices in North Dublin were randomized, by practice, into intervention and control groups. Prior to randomization, practices were divided into groups according to the following criteria: number of full-time equivalent GPs in the practice, practice type (private practice only or mixed private and GMS) and presence of a practice nurse (PN). A restricted randomization procedure using a random number table was then carried out by an independent researcher to ensure equal numbers of practices in each group.10 Control group practices continued to provide care as previously (see Box 1). The trial lasted for 18 months and, on its completion, in April 2001, the control practices undertook the education course and commenced the shared care service.
The education course was an integral part of the intervention and involved a consideration of current treatment guidelines. Targets for HbA1c, blood pressure (BP) and cholesterol levels were agreed by all participating clinicians and were summarized on cards to be kept in the clinicians' consulting rooms. The targets for optimal control were HbA1c <7%, total cholesterol <5 mmol/l and BP <140/80 mmHg. The targets chosen were those recommended in the international literature,9 although clinicians decided to aim to achieve optimal glycaemic, BP and lipid control in stages by applying individualized management targets. These were agreed at annual reviews with patients, stated on the patient's individual record card and reinforced during routine reviews in general practice. The community diabetes nurse specialist (DNS) visited each practice for 1–2 half-days a month depending on practice size. Individual practices were encouraged to make their own arrangement with the DNS. Practices with a PN generally requested that the DNS train the PN and then step back and provide ongoing support as needed. In practices without a PN, she saw patients directly herself in the practice and liaised with their GP when indicated. There was no community-based dietician though patients could attend the dietician in the specialist centre if indicated. During the education course, the specialist dietician was involved in training the PNs to provide and reinforce dietary treatments during routine reviews. General exercise advice was also provided by the DNS and PNs. In addition, some patients attended private community dieticians, though these practitioners were not part of the structured shared care service.
Sample size was calculated using glycosylated haemoglobin (HbA1c) as the main outcome measure. The research aimed to demonstrate a 10%improvement in HbA1c levels among patients receiving the intervention. A sample size of 118 gave 90% power to detect a clinically significant difference in HbA1c (0.9%)1 given a standard deviation in HbA1c of 1.5%. This was then multiplied by a design effect size of 1.19 (based on an intraclass correlation coefficient of 0.0475) to take account of cluster randomization,14 thus giving a total sample size of 140 patients recruited from at least 28 practices. We recruited 183 patients from 30 practices to allow for a drop-out rate of 20%.
Patients were selected from practice diabetes registers that were compiled de novo in the 3-month period prior to the start of the trial.11 All patients identified were invited to participate in the service if they had type 2 diabetes and were not on insulin and were not attending the other specialist centre in North Dublin which was not participating in shared care. If eligible for the service, they were then asked to consent to participation in the research. Inclusion criteria for the research were age over 18 years, type 2 diabetes duration of at least 1 year and willingness to attend the GP surgery for diabetes care. Biophysical [HbA1c, total cholesterol, BP and body mass index (BMI)] and psychosocial outcome measures (smoking status, Diabetes Well-being scores and Diabetes Clinic Satisfaction scores12) were predefined and collected directly from patients at baseline and at 18 months. Patients also reported details of location of care, treatment and co-existing medical conditions. Data on the process of care were collected from GP and hospital records. All practices in the intervention group were visited at 1 year to provide an opportunity for practices to provide feedback on their experience of implementing and delivering the new service. A parallel qualitative research study examining the impact of a change in service delivery on patients has been published elsewhere.13
Biochemical tests were carried out in a single laboratory in Beaumont Hospital. HbA1c was assayed using low-pressure liquid chromotography (local reference range 3.7–5.7%). Serum total cholesterol was assayed using the Beckman Synchron CX7 Analyser (target range <5.2 mmol/l). It was not possible to measure subtypes of cholesterol as the patients were not fasting prior to data collection. Systolic and diastolic BP were measured with the patient sitting, using an Omron M4 portable sphygmomanometer. Weight was measured using the Seca 880 scales. Height was measured at baseline using the Seca Leicester portable stadiometer. All measurements were carried out by one individual (MOL), and intra-observer measurement errors were checked before the study commenced.
All results were analysed using Stata statistical software. Unpaired t-tests were used to compare means between groups, and chi-squared tests were used to compare proportions where appropriate. Analysis was by ‘intention to treat’ and was undertaken at cluster level using both a simple approach of calculating summary statistics for each cluster and a more complex patient level model using the svy procedures in Stata.
Ethical approval was granted by the Irish College of General Practitioners Research Ethics Committee.
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Results |
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A flow sheet of patient progress through the study is presented in Figure 1.
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Participating practices
In total, 38 general practices were approached; 30 practices (50 GPs) agreed to participate; eight declined citing pressure of other commitments or inadequate numbers of patients attending Beaumont Hospital. Therefore, 77% of those approached agreed to participate. Participating GPs were more likely to be single handed (36% compared with 51%, P = 0.04) and less likely to have a PN (14% compared with 31%, P = 0.01) than in a recent national profile.15
Baseline results
A baseline profile of participating patients is presented in Table 1 and indicates no significant differences at baseline between the control and intervention groups. The baseline results and an analysis of the feasibility of implementing a diabetes shared care service in a mixed health care system and of its acceptability to patients have been published previously.11 Interestingly, the baseline data indicated that only 21% of all patients had a HbA1c level >8%, although the majority had BP, total cholesterol and BMI levels above recommended guidelines.
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Patient outcomes
There were significant improvements in psychosocial outcomes, with a significantly higher Diabetes Well-being score and a significantly higher proportion of patients ‘very satisfied’ on the Diabetes Clinic Satisfaction Questionnaire (GP version) in the intervention group (see Table 2). There were no significant differences at study completion in biophysical outcomes, patient-reported attendance at dieticians and chiropodists, proportions taking aspirin/warfarin and use of lipid-lowering medication (see Table 2).
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Diabetes care: impact of the intervention on the process of care
There was evidence of increased diabetes care for intervention group patients both in the specialist centre and in participating general practices. There was a significant increase (from 65 to 85%, P < 0.0001) in the numbers attending for annual reviews in the specialist centre, while in general practice, diabetes registers grew by 120% during the period of the study. The proportion of patients defaulting from care (patient self-report) fell by 8% in the intervention group as compared with an increase of 7% in the control group (P = 0.008). There was no significant difference in process measures at baseline. At study completion, there was significant improvement in some of the measures of diabetes care delivery in the intervention group compared with the control group (see Table 3). There was also a trend towards improvement in the intervention group in recording of HbA1c, diabetes-related prescribing changes, other diabetes complications and the number of patients on insulin (6% versus 1%). There was evidence of an increase in prescribing for aspirin, antihypertensive medication and lipid-lowering medication in both the intervention and control group, with no statistically significant differences that could be attributed to the intervention at study completion.
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Information exchange across sectors
The fact that information regarding a given patient existed in both their GP and hospital record did not necessarily mean that this information was shared by the two sectors. We therefore assessed the proportion of information that was held exclusively in either sector and could definitely not be known to the other sector. As illustrated in Table 4, there were significant reductions in information held exclusively in one sector between baseline and study completion in the intervention group.
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Health professionals' perspective
Feedback from participating GPs and PNs was collected during semistructured interviews 1 year after the intervention commenced. GPs and PNs were generally very positive about the new service and expressed increased confidence in providing routine diabetes care within general practice. However, they identified several difficulties that related primarily to lack of additional funding for practices making it difficult, particularly for the GPs, to provide protected time for routine reviews unless problems were identified by the PNs or the community DNS. There were also frustrations at the absence of dedicated community-based dietetic and chiropody services. The feedback from the community DNS indicated problems with GPs having time to engage fully in routine reviews and tending only to become involved if asked specifically about individual patients.
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Discussion |
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This research involved a unique opportunity to analyse the introduction of a structured diabetes shared care service in a local area using the optimal research design of a cluster randomized controlled trial. All aspects of this complex and multifaceted intervention were evidence based, including the preparation and education of GPs and PNs,16 the design and implementation of the clinical guidelines,17 the information exchange systems and the use of a community-based DSN to support participating practices.3
The intervention produced significant improvements in diabetes care delivery, information exchange between sectors and psychosocial outcomes such as Diabetes Well-being scores and Diabetes Clinic Satisfaction scores. There was, however, no significant difference in glycaemic control or other biophysical outcomes between the intervention and control groups at study completion; this may not be surprising given the relatively good control described at baseline. The Danish study of structured personal diabetes care is the only published randomized trial to show an improvement in glycaemic control in a general practice setting (HbA1c 8.5 versus 9%, P = 0.0004).8 However, a difference of 0.5% in HbA1c is less than the 0.9% difference demonstrated by the UKPDS to be associated with a significant difference in microvascular outcomes.1 There was also no significant difference in BP at study completion, though there was a significant improvement in blood pressure recording in the preceding 6 months (see Table 3). In the Danish study, this improvement in BP recording was matched by a significant improvement in BP control.8 However, the Danish study lasted for 6 years, suggesting that improvements in BP outcomes may follow improvements in recording over time.
The fact that this study ran for the shorter duration of 18 months may have been a factor contributing to the lack of change in biophysical outcomes. However, as this study was designed around the introduction of a new service delivery, the study duration was limited by the need to accommodate service development in all the practices that had agreed to participate in the project. This highlights the tension in health services research in balancing optimal research methodology with service provider requirements.
Improvements in patient well-being and satisfaction rates are encouraging and have been documented previously in a randomized trial of patient-centred diabetes care in general practice by Kinmonth et al.5 As in our study, these psychosocial improvements did not translate into improvements in biophysical outcomes, leading Kinmonth to highlight the need for further research into the psychosocial correlates of health status in diabetes.
Potential limitations of this research include an emphasis on glycaemic control as the main outcome measure. Since this research was designed, the publication of the UKPDS has highlighted the importance of other cardiovascular risk factors in relation to diabetes outcomes.18 Though this study had sufficient power to detect changes in the proportions of patients with poor BP control, these changes were not attained. None of the previously published studies of diabetes care have specifically anticipated improvements in the control groups and made adjustments for this possibility in their power calculations. We found that improvements in diabetes care delivery for many variables also took place in the control practices, thus reducing the potential to detect the effectiveness of the intervention. A study of patient-centred diabetes care in Cardiff also detected improvements in the control group in relation to some psychosocial outcomes.6 Future studies need to anticipate these improvements in the control group when calculating sample sizes.
Feedback from participating GPs predominantly related to the difficulty they experienced in providing high quality diabetes care without any additional resources. This was also reflected by the patients in the qualitative arm of this research,13 with patients identifying GPs as being too busy to be involved in their diabetes care and identifying the shared care service as relating to the community DNS and the PNs. Patients not eligible for free GP care also reported considerable barriers to attending for preventive care when they feel well.
These difficulties lead to concerns regarding the sustainability of such a service without additional funding. Pill et al.6 found that only 20% of practices in their study maintained the intervention, which was a consultation approach designed to promote active patient participation in their own care. The intervention in our study primarily involved organizational change rather than a change in consulting approach, making it more likely to continue over time if appropriate resources are provided. The introduction of this new service and the parallel research project were carried out and funded independently from the local Health Board, who have now taken over its funding and future development, thus providing increased sustainability.
None of the previous randomized trials of diabetes shared care involved identifying patients within general practice, and therefore failed to include patients who had never received specialist care or had defaulted from care (27% of our patients fitted into this category). There have been several randomized trials looking at different systems of providing diabetes care within general practice. However, these studies did not assess the specialist care received simultaneously by a proportion of patients,5,6,8 an aspect of health services research potentially lacking in patient-centredness. The collection of data in general practice and the hospital sector coupled with the collection of data directly from patients enabled an evaluation of information exchange between sectors, which is a key feature of shared care.2 Previous studies have not specifically measured information exchange beyond the observation of use of patient-held record cards. We looked at data in both GP and hospital records in order to measure information that was held exclusively in either sector. There was a significant reduction in information held exclusively in either sector at study completion. This reflects the efforts that were taking place in transferring patient record cards and referral letters between sectors. This activity was co-ordinated by the community DNS and depended upon the support of the Diabetes Centre administrator. The collection of data in both sectors also enabled an assessment of the considerable impact of shared care on the specialist sector (CT, unpublished).
Conclusions
The introduction of structured diabetes shared care is feasible in a mixed health care system and leads to improvements in diabetes care delivery and psychosocial outcomes for patients. The disappointingly negative results in relation to biophysical outcomes may be explained by several factors such as inadequate study duration, lack of access to community dieticians and lack of additional resources to fund protected time with GPs in particular. This research indicates that larger, longer, more comprehensive studies may be necessary to detect potentially clinically significant changes in all outcomes, thus limiting the ability to assess the effectiveness of small-scale pilot introductions of new health services. Health care research needs to incorporate all aspects of the patients' experience, not just the general practice- or hospital-based components. We have moved on from the debate about specialist versus generalist diabetes care, but we have yet to determine which health service interventions have the capacity to improve both biophysical and psychosocial outcomes for people with diabetes.
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References |
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1 UKPDS. Intensive blood glucose control with sulphonlyureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837–854.[CrossRef][Web of Science][Medline]
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3 Greenhalgh PM. Shared Care for Diabetes: A Systematic Review. Occasional Paper. Report No. 67. London: The Royal College of General Practitioners; 1994.
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5 Kinmonth AL, Woodcock A, Griffin S, Spiegal N, Campbell MJ. Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future disease risk. The Diabetes Care From Diagnosis Research Team. Br Med J 1998; 317: 1202–1208.
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