Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 May 7:14:127.
doi: 10.1186/1745-6215-14-127.

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

Annie LeBlanc  1 , Amy E Bodde, Megan E Branda, Kathleen J Yost, Jeph Herrin, Mark D Williams, Nilay D Shah, Holly Van Houten, Kari L Ruud, Laurie J Pencille, Victor M Montori
Affiliations
Randomized Controlled Trial

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

Annie LeBlanc et al. Trials. .

Abstract

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Development of a decision aid.
See this image and copyright information in PMC

References

    1. Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003;64(12):1465–1475. doi: 10.4088/JCP.v64n1211. - DOI - PubMed
    1. Blazer DG, Kessler RC, McGonagle KA, Swartz MS. The prevalence and distribution of major depression in a national community sample: the National Comorbidity Survey. Am J Psychiatry. 1994;151(7):979–986. - PubMed
    1. Jackson JL, Passamonti M, Kroenke K. Outcome and impact of mental disorders in primary care at 5 years. Psychosom Med. 2007;69(3):270–276. doi: 10.1097/PSY.0b013e3180314b59. - DOI - PubMed
    1. Hunot VM, Horne R, Leese MN, Churchill RC. A cohort study of adherence to antidepressants in primary care: the influence of antidepressant concerns and treatment preferences. Prim Care Companion J Clin Psychiatry. 2007;9(2):91–99. doi: 10.4088/PCC.v09n0202. - DOI - PMC - PubMed
    1. Akincigil A, Bowblis JR, Levin C, Walkup JT, Jan S, Crystal S. Adherence to antidepressant treatment among privately insured patients diagnosed with depression. Med Care. 2007;45(4):363–369. doi: 10.1097/01.mlr.0000254574.23418.f6. - DOI - PMC - PubMed

Publication types

Substances

Associated data