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International Journal for Quality in Health Care Advance Access originally published online on November 16, 2007
International Journal for Quality in Health Care 2008 20(1):72-77; doi:10.1093/intqhc/mzm051
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© The Author 2007. Published by Oxford University Press on behalf of International Society for Quality in Health Care; all rights reserved

Implementing diabetes passports to focus practice reorganization on improving diabetes care

Rob Dijkstra, Joze Braspenning and Richard Grol

Centre for Quality of Care Research, University Medical Centre St Radboud Nijmegen, The Netherlands

Address reprint requests to: Rob Dijkstra, Centre for Quality of Care Research-114, UMC St Radboud, PO Box 9101, 6500 HB Nijmegen, The Netherlands. Tel: +31 24 3619640; Fax: +31 24 3540166; E-mail: r.dijkstra{at}kwazo.umcn.nl


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Funding
 References
 
Objective. Although an active role of the patient is often stressed in diabetes care, it is not easily implemented in daily practice. The aim of the study was to measure the effects of introducing a diabetes passport to patients after embedding the passport in the organization of care.

Design. Randomized controlled trial.

Setting. Forty general practice in The Netherlands.

Participants. Pre- and post-intervention data were obtained from 993 patients with type 2 diabetes mellitus. Patients treated in secondary care and patients over 80 years of age were excluded.

Intervention. The intervention consisted of clarifying the diabetes care tasks for all practice staff and embedding the diabetes passports in the structured care.

Main outcome measure. Self-reported use of the diabetes passport.

Results. Diabetes passports were issued to 87% of the patients. After 15 months, 76% of the patients reported that the passport was being used during clinic visits. The process indicators of care improved by 10% on average in the intervention group. However, there were no changes in the outcome measures.

Conclusion. Diabetes passports can be introduced successfully in structured primary care and they lead to improved effect measures for medical behaviour.

Keywords: delivery of health care, diabetes mellitus, guidelines, intervention studies, patient participation, physician–patient relations


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Funding
 References
 
Diabetes management is a core activity of many primary care practices and is generally regarded as an activity with a large clinical impact. Many evidence-based guidelines for diabetes care are available, but diabetes management is still not optimal [1–3]. Studies that try to explain the variation in diabetes care found that most of the variation occurs at the patient level, less at the physician level and least at the organizational level [4, 5]. Patients have to deal with many behaviour changes in lifestyle, pharmacological treatment (oral medication and insulin), regular visits to the physician and screening and treatment for complications (e.g. eye screening and foot care). The necessity of this active patient role accounts for the repeated call for more patient involvement [6–10]. There is indeed evidence that more patient involvement, in combination with structured care and involvement of nurses may raise the quality of diabetes care [11, 12]. An instrument that monitors important diabetes indicators and that is available to patients is necessary to plan and support further decisions and actions. Such a tool is the ‘diabetes passport’; a patient-held booklet with important personal information that can be used to track results, record treatment targets and give information. The passport also records the medications used, results of laboratory and physical examinations and patient education. Such a passport could facilitate the partnership between the patient and the health-care clinician in integrated care delivery systems. The patient can become involved and take responsibility for his or her own health behaviour. Regular discussions based on the available information may make the health professional more aware of the difficulties of making the many behaviour changes required.

Introduction of patient passports is not easy. In one general medicine clinic 69% of the patients were maintaining their records after 14 months [13], in psychiatric care only 44% were doing so [14] and studies in secondary diabetic care in The Netherlands showed even poorer results (36%) [15]. The effects of introducing diabetes passports on the quality of diabetes care gives mixed results [15–17]. The low dissemination rates in these studies might be explained by the fact that the passports were added to the existing care without any rearrangement of the structure of care. Not embedding the innovation may have led to negative attitudes of health-care professionals [18]. We expected that a personalized health programme with realistic, manageable goals for behavioural change could more easily be negotiated between patients and the diabetes staff of a primary care practice in an environment with structured working processes. Therefore, we conducted a study among practices aiming at improving the work process related to diabetes and we investigated the effects of introducing diabetes passports within such a setting on processes and outcomes of care.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Funding
 References
 
The study population
General practitioners in three regions in the middle and south of the Netherlands were invited by mail to participate in the study. Forty general practices were paired for stratification characteristics (urbanization level, presence of practice nurse and type of practice) and then randomly allocated to the intervention group or the control group. All patients in these practices who had diabetes, were younger than 80 years and were treated by the general practitioner were included. However, those with a life expectancy of less than 1 year were excluded, as were patients who received their diabetes treatment in secondary care (Fig. 1). In the Netherlands about 15% of the patients are treated in secondary care.


Figure 1
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  		Figure 1 Trial profile.

 
The intervention
A researcher visited all intervention practices at the beginning of the intervention period and discussed the current practice procedures for diabetes care with the staff. Situations in which various staff members shared tasks was a special topic of discussion. Then the diabetes passport was introduced, and the professionals discussed how the passport could best fitted into the practice routines and work processes. The researcher summarized the various responsibilities involved in diabetes care and the use of the diabetes passport on a desk-top card. The card was printed and distributed in each practice after the staff had reviewed it. A supply of diabetes passports were delivered to the practices on the first visit. To expedite a smooth start, all practices began recording the relevant patient data from the previous year in the passports, before giving them to the patients. Within the following 3 months, all passports were supposed to be issued to the patients at the next clinic visit. The patients were informed about the measurements that were entered in the passports, and they were requested to bring the diabetes passport to every clinic visit. Three months later, a researcher visited each practice again to discuss the progress of the project and to see whether the division of tasks was being maintained as planned. After 6 months, all patients completed a short questionnaire on the use of the diabetes passport, after which each practice received benchmarked feedback on its introduction and use. We discussed the feedback reports personally with the practice professionals. Nine months after the start of the intervention a follow-up telephone call was made.

Data collection
We mailed all patients questionnaires (pre- and post-measurement). Our main outcome measure was self-reported use of the passport. The patient questionnaire also addressed visits to various health professionals, medication usage, diabetes knowledge, quality of life [19], satisfaction [20], self-advocacy [21] and demographic variables. Trained medical students reviewed the medical records of all patients. The effect measures comprised the yearly measurements of weight, haemoglobin A1c (HbA1c), creatinine and cholesterol levels, examination of the feet and discussion of smoking behaviour. Glucose measurements for the previous 4 months and eye examinations during the previous 2 years were recorded as were the outcome measures HbA1c, blood pressure and cholesterol levels. Characteristics of the practice and health personnel were noted during our first visit.

Analysis
The power calculation was based on the success of introducing the diabetes passport. Assuming that 15% of the patients were already using the diabetes passport [4], the intervention was considered successful if an increase of 25% was achieved (alpha was set at 0.05 and beta at 0.10). We included a correction for clustering of patients in practices when we calculated that we would need 20 patients in each of 40 practices, which gave a total of 800 patients.

Because of the hierarchical structure of our study (patients nested within general practices) and the longitudinal design (repeated measures for the same patient after 1 year) we performed multilevel, mixed-model analyses. In these analyses, we included the variability associated with each level of nesting and the within-patient correlation. Our model had a random intercept, and all other variables were fixed. In the same model, we assumed a constant correlation between the repeated observations of the patient. We used SAS v8.2 for the analyses [proc mixed (normally distributed outcome measures) and Glimmix Macro (dichotomous outcome measures)]. On their own initiative, several practices implemented organizational interventions or revised professional roles, which are known to be potentially powerful intervention strategies [22]. Therefore, we did a post hoc analysis of the effect of these organizational interventions, or the revision of professional roles, taking these additional interventions as independent variables respectively. They were corrected for each other and the study intervention activities. The patients' opinions on the effect of the use of the passport on diabetes care were described in frequency tables.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Funding
 References
 
In the 40 practices, 2106 patients received the pre-intervention questionnaires. The response rate for the pre-intervention questionnaire was 68%, while it was 69% for the post-intervention questionnaire. This made it possible to analyse the data for 993 patients. Comparison of the baseline data from the intervention and control groups showed that there were some differences. The patients in the intervention group were more often women and fewer monitored glucose themselves than in the control group (Table 1).


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  		Table 1 Baseline data

 
During the 15-month intervention period, diabetes passports were issued to 87% of the 504 patients in the 20 intervention practices, while at the end of the intervention period, 76% of the patients reported that they had discussed the contents of the diabetes passport during clinic visits (Table 2). The most recent HbA1c data were entered into 67% of the passports and blood pressure data in 77%. Medication data were recorded in 71% of the passports. Personal target values for HbA1c were recorded in only 19% of the passports. Table 2 shows that, in addition to the research intervention activities, several control and intervention practices had initiated organizational interventions and revision of professional roles during the intervention period.


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  		Table 2 Number of intervention activities and additional activities initiated by the practices after the intervention started and the percentage of patients that received and used the diabetes passport

 
With regard to changes in effect measures, Table 3 shows that HbA1c, creatinine, eyes, cholesterol, weight and glucose were examined more often in intervention practices than in control practices, but there were no changes in blood pressure measurements, foot examination, smoking discussion or prescription rates of cholesterol inhibitors. The mean of the process indicators had increased by almost 10%. However, none of the clinical outcome measures changed significantly. Table 4 shows that the outcome measures of quality of life, satisfaction, self-advocacy and diabetes knowledge had not changed significantly, although the patients' knowledge of their own HbA1c levels had increased in the intervention group. Half of the general practitioners work in solo practices in the Netherlands, but it appeared that the type of practice did not influence the outcomes. Post hoc analyses on the effect of the additional activities performed in the practices on top of the intervention activities showed that both the organizational activities of the practices as well as revision of the professional roles, such as the employment of a practice nurse or delegating tasks, led to improved process – and outcome measures. However, these organizational activities in combination with the study intervention activities did not lead to better performance.


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  		Table 3 Pre- and post-intervention adherence rates (%) on process and outcome diabetes care indicators; the differences between intervention and control group are expressed in odds ratios [95% confidence interval (CI)]

 


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  		Table 4 Additional outcome measures on quality of life, satisfaction with care process, self-advocacy, knowledge on diabetes care and HbA1c level expressed in mean scores (standard deviation) on pre- and post-measurement separately for intervention and control group, and in odds ratios (95% CI) to describe the effect of the intervention

 
Many patients who used the diabetes passport perceived improvements in the diabetic care that they received and in their own roles in diabetes management (Table 5).


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  		Table 5 Patients' opinions (%) 18 months after intervention on the effect of diabetes passport in diabetes care, n = 384

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Funding
 References
 
Introduction of diabetes passports in primary care embedded in structured work processes in the practice led to high dissemination rates. Three quarter of the diabetes patients still used the passport during the clinic visits 15 months after the start of the intervention. Also, most process measures on diabetes care increased significantly, but there was no measurable effect on outcome indicators or on quality of life, patient-satisfaction or self-advocacy measures. Only the patients' knowledge of their own HbA1c levels increased. The fact that many patients were aware of positive effects of the passports on diabetes care contrasts with the lack of measured effects. One limitation of this multifaceted implementation study was the fact that it is difficult to point out the most influencing determinant of change. The diabetes passport was introduced as a catalytic agent for optimal diabetes care, but in the mean time, the whole staff had to work in a focussed environment of structured care. Our intervention was directed at the process of care, but we expected to see at least some effect on the clinical outcome measures. Perhaps, changes in outcome measures might not appear after such a short time.

Patients used diabetes passports more in this study than in a secondary care study on diabetes [15]. Maybe the fact that extensive attention was given to fitting the implementation of the passport into the existing working procedures and routines as well as the fact that patients received a personalized passport with their own names and the previous year's data already recorded increased the value of the passport for both patients and health professionals. Post hoc analyses showed that organizational activities in combination with the study intervention activities did not lead to better performances.

Although the passport was generally well accepted according to the self-reporting statements, the aims of the passport were not met for all patients. Some patients did not find it helpful in consultations, and some found that it did not improve their knowledge about diabetes. However, it is unclear whether this is a limitation of the passport itself or whether the needs had already been met. Earlier discussions with patient groups showed that many patients had a positive attitude towards the passport, but they expected lack of patient motivation in effective use of the passport [18].

In conclusion, diabetes passports can be introduced successfully in structured primary care, and they lead to improved effect measures regarding medical behaviour. Additional organizational activities do not potentiate the effect measures.


   Funding
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Funding
References
 
This study was funded by the Netherlands organisation for health research and development (ZONMW grant number 2300 0018).


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Funding
 References
 

  1. Konings GPJM, Wijkel D, Rutten GEHM. Lukt het werken volgens de NHG-standaard Diabetes mellitus type II? [Do general practitioners work according to Dutch diabetes guidelines?]. Huisarts Wet (1995) 38:10–4.

  2. Pellegrini F, Belfiglio M, De Berardis G, et al. Role of organizational factors in poor blood pressure control in patients with type 2 diabetes: the QuED Study Group–quality of care and outcomes in type 2 diabetes. Arch Intern Med (2003) 163:473–80.[Abstract/Free Full Text]

  3. Valk GD, Kriegsman DM, Nijpels G. Behandeling van diabetes mellitus type 2 in de huisartspraktijk. [Treatment of diabetes mellitus type 2 in general practice]. Ned Tijdschr Geneeskd (2001) 145:1536–40.[Medline]

  4. Dijkstra RF, Braspenning JCC, Huijsmans Z, et al. Patients and nurses determine variation in adherence to guidelines at Dutch hospitals more than internists or settings. Diabetic Med (2004) 21:586–91.[CrossRef][Web of Science][Medline]

  5. Pringle M, Stewart-Evans C, Coupland C, et al. Influences on control in diabetes mellitus: patient, doctor, practice or delivery of care. Br Med J (1993) 306:630–4.[Abstract/Free Full Text]

  6. Holman H, Lorig K. Patients as partners in managing chronic disease. BMJ (2000) 320:526–7.[Free Full Text]

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  8. Feste C, Anderson RM. Empowerment from philosophy to practice. Patient Educ Couns (1995) 26:139–44.[CrossRef][Web of Science][Medline]

  9. Wagner EH, Austin BT, Von Korff M. Improving outcomes in chronic illness. Manag Care Q (1996) 4:12–25.[Medline]

  10. Glasgow RE, Anderson RM. In diabetes care, moving from compliance to adherence is not enough. Diabetes Care (1999) 22:2090–2.[Free Full Text]

  11. Vermeire E, Wens J, Royen P van, et al. Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus. Cochrane Database Syst Rev (2005) (issue 2). CD003638.

  12. Renders CM, Valk GD, Griffin S, et al. Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings. Diabetes Care (2001) 24:1821–33.[Abstract/Free Full Text]

  13. Tobacman J, Nolan P. Utilization of a personal health record in a general medicine clinic. J Gen Int Med (1996) 11:370–2.[Web of Science][Medline]

  14. Warner J, King M, Blizard R, et al. Patient-held shared records for individuals with mental illness. Randomised controlled evaluation. Br J Psychiatry (2000) 177:319–24.[Abstract/Free Full Text]

  15. Dijkstra RF, Braspenning JCC, Huijsmans Z, et al. Introduction of diabetes passports involving both patients and professionals to improve hospital outpatient diabetes care. Diabetes Res Clin Pract (2005) 68:126–34.[CrossRef][Web of Science][Medline]

  16. Simmons D, Gamble GD, Foote S, et al. The New Zealand Diabetes Passport Study: a randomized controlled trial of the impact of a diabetes passport on risk factors for diabetes-related complications. Diabetes Med (2004) 21:214–7.[CrossRef][Web of Science][Medline]

  17. Chiou ST, Lin, HD, Yu NC, et al. An initial assessment of the feasibility and effectiveness of implementing diabetes shared care system in Taiwan-some experiences from I-Lan County. Diabetes Res Clin Pract (2001) 54:S67–73.[Web of Science][Medline]

  18. Dijkstra R, Braspenning J, Grol R. Empowering patients: how to implement a diabetes passport in hospital care. Patient Educ Couns (2002) 47:173–7.[CrossRef][Web of Science][Medline]

  19. Ware J, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care (1996) 34:220–33.[CrossRef][Web of Science][Medline]

  20. Wensing M, Grol R, Montfort P van, et al. Indicators of the quality of general practice care of patients with chronic illness: a step towards the real involvement of patients in the assessment of the quality of care. Qual Health Care (1996) 5:73–80.[Abstract/Free Full Text]

  21. Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun (1999) 11:97–121.[CrossRef][Web of Science][Medline]

  22. Grimshaw JM, Thomas RE, MacLennan G, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess (2004) 8:1–72.[Medline]

Accepted for publication October 9, 2007.


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