Shared decision making in primary care: Process evaluation of the intervention in the OPTIMAL study, a cluster randomised trial

Highlights

• Perceived level of SDM was high at baseline, shortly after the GPs’ training.

• At the end of the intervention, patients perceived lower levels of SDM.

• We recommend repeated SDM training to maintain high degrees of SDM.

Abstract

Aims

To analyse the performance of a Shared Decision Making (SDM) intervention, we assessed perceived and experienced SDM in General Practitioners (GPs) and patients with type 2 diabetes (T2DM).

Methods

Cluster-Randomised Controlled Trial (cRCT) testing the effect of a decision aid. Opinions and experienced role regarding SDM were assessed in 72 patients and 18 GPs with the SDM-Q-9 (range 0–45) and Control Preferences Scale (CPS, 0–5), and observed SDM with the OPTION5 (0–20). SDM at baseline was compared to 24 months’ follow-up using paired t-tests.

Results

At baseline, perceived levels of SDM did not significantly differ between GPs and patients with T2DM (difference of 2.3, p = 0.24). At follow-up, mean patients’ perceived level of SDM was 7.9 lower compared to baseline (p < 0.01), whereas GPs’ opinions had not changed significantly. After both visits, mean CPS scores differed significantly between patients and GPs. OPTION5 scores ranged between 6 and 20.

Conclusion

Patients and GPs perceived similar baseline levels of SDM. Two years later, patients perceived less SDM, while GPs did not change their opinion. SDM was appropriate immediately after training, but perhaps GPs fell back in old habits over time. We recommend repeated SDM training.

Introduction

The management of type 2 diabetes mellitus (T2DM) requires a multitude of decisions, each one entailing different combinations of possible therapeutic or adverse effects [1,2]. Therefore, T2DM patients need to be involved in determining the management strategy most consistent with their preferences and values [3]. Shared Decision Making (SDM) is a healthcare decision making model that promotes patient involvement, and has been identified as the crux of patient-centred care [4]. In SDM, both parties share information and expertise: the physician shares medical information about options and their benefits and risks, and T2DM patients share their preferences and values [5]. But how to implement SDM in daily practice? It has been demonstrated that general practitioners (GPs) can learn to deliver patient-centred care [6,7], and that options can be made clearer to patients using decision aids [8]. With regard to SDM, there is broad consensus about two core physician competencies that should be acquired during training. The first is relational competence, involving the creation of a favourable environment for communication, and an appropriate interaction during the clinical encounter. The second is risk communication competence, including discussion of uncertainty in treatment outcomes, and effective communication about benefits and risks of different treatment options [6,8,9]. Charles et al. [10] highlighted the need for bidirectional information exchange, participation of both parties in deliberation and agreement about the resulting treatment plan. They developed their framework in the acute setting in which typically one-time decisions are made. Their framework is one of the most-often cited basis for later frameworks [5]. In 2006, Montori et al. modified it to make it applicable to the care of people with chronic conditions [11]. This modification stressed the need for an ongoing partnership between GP and patients with T2DM and the recognition that decisions in chronic care can be revised.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) published a decision cycle to manage hyperglycaemia in T2DM patients, to be used during consultations. It integrates current lifestyle, comorbidities, clinical characteristics, and issues such as patient preferences, motivation, diabetes-related distress, depression, and financial resources. SDM is explicitly integrated in the cycle and the cycle requests smart goals to be set [12].

We conducted a Cluster-Randomised Controlled Trial (cRCT, the OPTIMAL study) with a follow-up of 24 months to assess to what extent the implementation of SDM, based on the framework by Montori et al., would affect the proportion of T2DM patients who achieve all their treatment targets (glucose, systolic blood pressure, and LDL-cholesterol) [13]. Furthermore, we were interested in the experienced SDM 24 months after training, to evaluate the sustainability of the effect of SDM training. SDM was introduced using two elements: a decision aid for T2DM patients, combined with a training of GPs. Here we evaluate the SDM-process during the trial, aiming to answer the following research questions:

• Did GPs and patients differ in their opinions regarding the extent to which SDM occurred during consultations at baseline and at 24 months follow-up?

• Which decisional role did GPs and patients experience in making the final decision at baseline and at 24 months follow-up?

• To what extent did the GPs adhere to the study protocol regarding the SDM elements?