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Open Access Study protocol

The effect of a patient-oriented treatment decision aid for risk factor management in patients with diabetes (PORTDA-diab): study protocol for a randomised controlled trial

Petra Denig12*, Mathijs Dun12, Jan Schuling3, Flora M Haaijer-Ruskamp12 and Jaco Voorham12

Author Affiliations

1 Department of Clinical Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

2 Research Institute SHARE of the Graduate School of Medical Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

3 Department of General Practice, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

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Trials 2012, 13:219  doi:10.1186/1745-6215-13-219

Published: 21 November 2012

Abstract

Background

To improve risk factor management in diabetes, we need to support effective interactions between patients and healthcare providers. Our aim is to develop and evaluate a treatment decision aid that offers personalised information on treatment options and outcomes, and is intended to empower patients in taking a proactive role in their disease management. Important features are: (1) involving patients in setting goals together with their provider; (2) encourage them to prioritise on treatments that maximise relevant outcomes; and (3) integration of the decision aid in the practice setting and workflow. As secondary aim, we want to evaluate the impact of different presentation formats, and learn more from the experiences of the healthcare providers and patients with the decision aid.

Methods and design

We will conduct a randomised trial comparing four formats of the decision aid in a 2×2 factorial design with a control group. Patients with type 2 diabetes managed in 18 to 20 primary care practices in The Netherlands will be recruited. Excluded are patients with a recent myocardial infarction, stroke, heart failure, angina pectoris, terminal illness, cognitive deficits, >65 years at diagnosis, or not able to read Dutch. The decision aid is offered to the patients immediately before their quarterly practice consultation. The same decision information will be available to the healthcare provider for use during consultation. In addition, the providers receive a set of treatment cards, which they can use to discuss the benefits and risks of different options. Patients in the control group will receive care as usual. We will measure the effect of the intervention on patient empowerment, satisfaction with care, beliefs about medication, negative emotions, health status, prescribed medication, and predicted cardiovascular risk. Data will be collected with questionnaires and automated extraction from medical records in 6 months before and after the intervention.

Discussion

This decision aid is innovative in supporting patients and their healthcare providers to make shared decisions about multiple treatments, using the patient’s data from electronic medical records. The results can contribute to the further development and implementation of electronic decision support tools for the management of chronic diseases.

Trial registration

Dutch Trial register NTR1942.

Keywords:
Cardiovascular diseases; Diabetes mellitus; Type 2; Risk assessment; Decision-making; Electronic health records; Primary healthcare; Choice behaviour; Decision support systems; Patient participation; Research design