Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial

Trials

Victor M Montori²  Laurie J Pencille²  Kari L Ruud⁵  Holly Van Houten¹  Nilay D Shah⁵  Mark D Williams³  Jeph Herrin⁴  Kathleen J Yost⁵  Megan E Branda¹  Amy E Bodde⁵  Annie LeBlanc⁵ 

[1] Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA;Department of Medicine, Division of Endocrinology, Mayo Clinic, Rochester, MN, USA;Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA;Health Research & Educational Trust, Chicago, IL, USA;Center for the Science of Healthcare Delivery, Mayo Clinic, Rochester, MN, USA

关键词: Randomized controlled trial;    Implementation;    Decision aid;    Shared decision making;    Comparative effectiveness research;    Depression;   

Others  :  1094102
DOI  :  10.1186/1745-6215-14-127

 received in 2012-11-19, accepted in 2013-04-17,  发布年份 2013

【 摘 要 】

Background

Comparative effectiveness research (CER) documents important differences in antidepressants in terms of efficacy, safety, cost, and burden to the patient. Decision aids can adapt this evidence to help patients participate in making informed choices. In turn, antidepressant therapy will more likely reflect patients’ values and context, leading to improved adherence and mood outcomes.

Methods/Design

The objective of this study is to develop the Depression Medication Choice decision aid for use during primary care encounters, and to test its efficacy by conducting a clustered practical randomized trial comparing the decision aid to usual depression care in primary care practices.

We will use a novel practice-based, patient-centered approach based on participatory action research that involves a multidisciplinary team of designers, investigators, clinicians, patient representatives, and other stakeholders for the development of the decision aid. We will then conduct a clustered practical randomized trial enrolling clinicians and their patients (n = 300) with moderate to severe depression from rural, suburban and inner city primary care practices (n = 10). The intervention will consist of the use of the depression medication choice decision aid during the clinical encounter. This trial will generate preliminary evidence of the relative impact of the decision aid on patient involvement in decision making, decision making quality, patient knowledge, and 6-month measures of medication adherence and mental health compared to usual depression care.

Discussion

Upon completion of the proposed research, we will have developed and evaluated the efficacy of the decision aid depression medication choice as a novel translational tool for CER in depression treatment, engaged patients with depression in their care, and refined the process by which we conduct practice-based trials with limited research footprint.

Trial registration

Clinical Trials.gov: NCT01502891

【 授权许可】

   
2013 LeBlanc et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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