Risk management in patients with diabetes mellitus: development and evaluation of a patient-oriented treatment decision aid (PTDA).

The implementation of various disease management programmes has resulted in
important improvements in processes of diabetes care but effects on patient
outcomes have been limited. Many patients with type 2 diabetes mellitus do not
achieve the recommended targets for cardiometabolic risk management, and are
undertreated or insufficiently adherent to treatment. Adequate management of
chronic diseases requires not only optimal performance from providers but also
sufficient understanding and motivation of patients to start and sustain
complicated medication and lifestyle regimens. Simple tools that can help to
structure and prioritize treatment goals and plans are needed. It is not clear,
however, what is the best way to inform patients regarding the benefits and
risks of treatment options, and engage them in setting treatment goals. Several
computer-based support systems have been developed to calculate patient
specific risks and recommendations but their value in daily practice is
limited. Most of these tools formulate treatment goals from the medical
perspective, while patients may have trouble with the quantitative scoring of
risk and the clinical focus on numerical treatment goals instead of functional
goals. As the tendency is to develop more computer and web-based decision aids,
there are also concerns that especially elderly patients may not be able to use
such tools.

The aim of this study is to develop and evaluate a patient-oriented treatment
decision aid (PTDA) focussing on shared goal-setting and decision making, which
is tailored to the needs and capacities of a heterogeneous group of patients
with type 2 diabetes. As part of the development process, the impact of
different presentation formats and methods will be evaluated. Research
questions are:
1. What is the impact of providing such personalized information on patient
empowerment, negative emotions, beliefs about treatment options, satisfaction
with care, and on treatment decisions and outcomes?
2. To what extent are effects at patient level modified by the presentation
format (using a clinical or patient perspective) and presentation medium (paper
or computer-based)?
3. What is the feasibility of implementing the decision support tool in daily
practice?

The newly developed PTDA will be evaluated in randomized pre-postintervention
study using a 2-by-2 factorial intervention design with a control group.

The PTDA offers personalized information on possible treatment options and
outcomes. The information is intended to empower the patients in taking a
proactive role in their disease management. It will be offered to the patients
before a scheduled year visit for diabetes management, and can then be used
during this visit and further follow-up visits with the general practitioner.

All participating patients will be asked to complete a structured questionnaire
consisting of 4 commonly used instruments (Diabetes Empowerment Scale (28
items), PEQ-D (14 items), BMQ (18 items), PAID (20 items) at home around 1
month before and 3-4 months after a routine annual visit to their own general
practitioner. A sample of 100 patients will get around 10 extra questions after
the intervention about their experience and use of the additional information
material. No discomfort is expected from filling in the questionnaire. Patients
in the intervention groups will receive additional educational information on
possible treatment options and outcomes. There will be no extra visits,
physical examinations or other tests being conducted for this study.