The effects of a shared decision-making intervention in primary care of depression: A cluster-randomized controlled trial

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Abstract

Objective

Patient-centred depression care approaches should better address barriers of insufficient patient information and involvement in the treatment decision process. Additional research is needed to test the effect of increased patient participation on outcomes. The aim of this study was to assess, if patient participation in decision-making via a shared decision-making intervention leads to improved treatment adherence, satisfaction, and clinical outcome without increasing consultation time.

Methods

Cluster-randomized controlled intervention study based on physician training and patient-centered decision aid compared to usual care in primary care settings in Südbaden region of Germany. Twenty-three primary care physicians treating 405 patients with newly diagnosed depression were enrolled. Patient involvement was measured with the patient perceived involvement in care scale (PICS) and a patient participation scale (MSH-scale). Patient satisfaction was measured by the CSQ-8 questionnaire. Treatment adherence was evaluated by patient and provider self-report. Depression severity and remission outcomes were assessed with the Brief PHQ-D.

Results

Physician facilitation of patient participation improved significantly and to a greater extent in the intervention compared to the control group. There was no intervention effect for depression severity reduction. Doctor facilitation of patient participation, patient-rated involvement, and physician assessment of adherence improved only in the intervention group. Patient satisfaction at post-intervention was higher in the intervention group compared to the control group. The consultation time did not differ between groups.

Conclusion

A shared decision-making intervention was better than usual care for improving patient participation in treatment decision-making, and patient satisfaction without increasing consultation time. Additional research is needed to model causal linkages in the decision-making process in regard to outcomes.

Practice implications

The study results encourage the implementation of patient participation in primary care of depression.

Introduction

Depressive disorders are among the most common health problems seen by general practitioners. Unipolar depressive disorders are projected to be the second leading cause of the global burden of disease by the year 2030 [1]. Insufficiently treated depression is associated with a variety of adverse health, social, and occupational outcomes, resulting in substantially increased rates of morbidity, mortality, and other excess costs. Like most other Western countries, depression is prevalent in the German population (approximately 11.5% annual prevalence [2]), and depression care continues to be in need of quality improvement.

Most patients with clinically significant depression still do not receive adequate, guideline-concordant treatment [3], [4], especially in the general health care sector. Patient-related barriers to treatment are important but have been under-researched in the testing of depression care quality improvement interventions. A high percentage of patients are reluctant to consider taking antidepressant medication; e.g., Peveler et al. [5] documented a non-adherence rate of 34–58%. In a recent publication an antidepressant non-adherence rate of 57% was found [6]. In a review of patient depression treatment adherence, Pampallona et al. [7] included 14 studies and reported adherence rates between 35% and 97%.

Generally, effective physician–patient communication can increase the likelihood of favourable health outcomes [8], and encouraging patients to take an active role in their health care can influence treatment success [9]. Such positive effects of patient involvement are supported by Brody and colleagues who found an association between the patient's active role during medical visits and improvements in general medical condition [10]. Besides clinical outcome, there are other variables that are influenced by the quality of doctor–patient communication. Patient satisfaction and patient adherence measures are often used as outcome variables in physician–patient communication studies [11]. The association between doctor–patient interaction and patient satisfaction is better documented compared to the relationship between doctor–patient interaction and adherence. In addition, interventions to enhance patient involvement in medical care are identified as effective for increasing an active patient role in the clinical encounter (e.g. [12]).

In depression, factors that are associated with non-acceptance of treatment have been well-studied [13], [14], [15], [16], [17], [18], but less research has been done to test interventions to improve the quality of the patient-provider communication process regarding treatment options. This is a key gap in needed knowledge for improving usual clinical practice. For example, recent research has documented that lack of patient information [19], problems within the doctor–patient communication [20], and low patient participation in the medical decision-making process [21] are key predictors of patient reluctance to engage in treatment. Additional research is needed on effective ways to intervention with these barriers, especially patient involvement in the treatment decision-making process.

In our prior research, we have found that depressed patients are interested in more information and engagement in shared decision-making than has previously been assumed, even in context of moderate and severe major depression [22]. Patients with depressive disorders have been shown to be more likely to take an active role in the decision-making process compared to patients with mild forms of hypertension, heart disease, and severe diabetes [23]. Delegating solo responsibility to the patient for making a decision regarding type of treatment (e.g., drug therapy, psychotherapy, etc.) to the patient does not result in improved treatment outcomes [24]. However, incorporating patient-stated treatment preferences does result in a higher acceptance of preferred treatments and a greater likelihood of actually doing treatment [16]. It has also been shown that the number of patients who discontinue drug therapy prematurely can be lowered when patients are allowed to decide which treatment they prefer [25].

Emerging research on patient-provider shared decision-making approaches has promise for informing improvements to depression care, although only a few studies with inconsistent results have examined patient participation in context of depression treatment. For example, von Korff and colleagues [26], [27] have incorporated shared decision-making to enhance patient involvement in stepped collaborative care interventions for depression. However, the positive outcomes of the multi-faceted intervention programs cannot be ascribed solely to the effect of improved patient participation. In a newly published prospective cohort study, Clever and colleagues [28] showed that the involvement of depressed patients in primary care is associated with greater likelihood of guideline-concordant care and clinically significant improvement in depression over time. However, there was no specific intervention to enhance patients’ involvement in decision-making, and the association between patient-provider communication and patient satisfaction is assumed. Additional research is needed to identify which decision-making variables play the most central role in intervention outcomes. Byrne et al. [29] review the work and specific interventions in this area and conclude that strategies involving patients in the decision-making process have substantial potential for enhancing patient engagement with treatment decision-making and planning, which could result in improved clinical outcomes for depression care. Tests of improved interventions also need to evaluate feasibility issues against usual care for depression, such as length of consultation time. This is important because of the current emphasis on testing the effectiveness and feasibility of interventions for “real world” clinical care settings [30]. In summary, the results of recent research on patient involvement in depression treatment decision-making support the assumption that improved patient involvement in treatment decision-making can lead to higher likelihood of adherence, satisfaction, and improved clinical outcomes. Depressed patients have been shown to have an interest in improved information and involvement regarding treatment decisions. Additional research is needed to test the effects of patient involvement on these outcomes with intervention study designs.

The aim of this study was to evaluate the effect of a shared decision-making intervention compared to usual care on adherence, satisfaction, and clinical outcome for depression. The length of consultation time was also compared between the intervention and usual care in order to evaluate the feasibility of the intervention for usual care settings. Three research questions were adressed:

  • a.

    Are patient participation, treatment adherence, depression severity, and remission outcomes higher in a shared decision-making intervention group compared to a usual care control group?

  • b.

    Is consultation time longer in a shared decision-making intervention group compared to a usual care control group?

  • c.

    Is patient satisfaction with care higher in a shared decision-making intervention group compared to a usual care control group?

The evaluation of the shared decision-making intervention in depression care is embedded in a research consortium funded by the German Federal Ministry of health (www.shared-decision-making.org).

Section snippets

Sampling and research design

A randomized controlled trial was carried out with primary care physician as the unit of randomization. Thirty general practitioners from the German region of Südbaden were included in the study. Recruitment of the general practitioners was accomplished in co-operation with the Department of Primary Care of the University of Freiburg. All accredited general practitioners in Freiburg and all general practices that are associated as teaching practices with the Department of Primary Care at the

Physician sample

Five of the 20 (25%) physicians in the intervention group and two of the 10 (20%) control group physicians subsequently decided against participating in the study, resulting in 15 intervention group and eight control group physicians remaining in the study. The intervention physicians enrolled 263 patients and the control physicians 142 depressed patients (see flowchart of study participants by study condition in Fig. 1).

Two of the 10 physicians in the control group (20%) and five of 15 in the

Discussion

Even if the patient adherence results in our study are only moderately improved through the shared decision-making intervention, it indicates that patient participation strategies can foster adherence to drug treatment in primary care.

Since the treatment goal is primarily to achieve remission of depression, clinical outcomes are essential to evaluate. This study did not show statistically significant improvements in clinical outcome. Despite adequate adherence, a significant proportion of

Conclusion

This is the first randomised controlled trial to specifically examine the effects of a shared decision-making intervention for primary care of depression. A shared decision-making intervention was better than usual care for improving patient satisfaction and patient participation in treatment decision-making. There was no effect of the intervention on clinical outcome or consultation time. Clinical outcome and treatment adherence improved only in the intervention group, and may therefore not be

Acknowledgements

The study was funded by the German Ministry of Health (BMGS Grant 217-43794-5/6 www.shared-decision-making.org). In continuation the German Ministry of Health also supported a project concerning the methodological tasks of the research consortium (BMGS Grant 217-43794-5/11) and a project to transfer shared decision-making in medical education (BMGS Grant 217-43794-5/12, www.shared-decision-making.org). Celia E. Wills is a past recipient of a U.S. National Institute of Mental Health Mentored

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