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

Abstract

BackgroundTo 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 designWe 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.DiscussionThis 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 registrationDutch Trial register NTR1942.

Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial

“…The rationale, goals, and a detailed description of the decision aid have been presented previously. 22 In short, the aid focuses on shared goal setting and decision making, particularly with respect to the drug treatment of risk factors. We followed a stepwise development process, including active involvement and testing with patients and providers.…”

“…We followed a stepwise development process, including active involvement and testing with patients and providers. 22 The decision aid shows several graphs using individually tailored information. Risks calculated with the United Kingdom Prospective Diabetes Study risk score were explained in positive and negative terms and expressing uncertainty.…”

“…Key features, identified as being relevant for productive patient-provider interaction, included a personal status report including test results and current drug treatment; the presentation of tailored information on achievable treatment goals and possible treatment options for specific risk factors; a combination of graphs and text using natural frequencies for outcome probabilities; the presentation of pros and cons of all treatment options; and asking patients to think about treatment options. 22 The aid retrieves clinical information directly from the electronic medical record. It should be used by patients before a regular quarterly check-up and discussed jointly with their healthcare provider during the consultation to help them prioritise on treatment that will maximise relevant outcomes.…”

Ethanolic Extract of Madhuhari Ameliorates Diabetes–Induced Oxidative Stress in Male Mice

“…It is also associated with an enhanced risk for developing premature atherosclerosis, cardiac abnormalities and causes damage to different body organs via enhanced free radical generation [2]. The augmented oxidative stress is also known to increase DM related complications [2,3]. As allopathic drugs, currently in use for treating DM are known to produce side effects, people are gradually turning towards ayurveda, a traditional Indian system of medicine [4].…”

“…The involvement of free radicals in DM and in lipid peroxidation (LPO) is well studied [3,5]. Increased blood glucose may also induce more free radical generation which damages membrane lipids and proteins, leading to disturbed cell functions.…”