Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial

Trials

Mack T Ruffin³  Sarah T Hawley²  Ananda Sen³  Karen Kelly-Blake¹  Masahito Jimbo³ 

[1] Center for Ethics and Humanities in the Life Sciences, Michigan State University, East Lansing, MI, USA;Departments of Internal Medicine and Health Management and Policy, University of Michigan, Ann Arbor, MI, USA;Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA

关键词: Health communication;    Shared;    Decision making;    Decision support techniques;    Decision aids;    Cancer screening;    Early detection of cancer;    Colorectal neoplasms;   

Others  :  807921
DOI  :  10.1186/1745-6215-14-381

 received in 2013-08-16, accepted in 2013-10-29,  发布年份 2013

【 摘 要 】

Background

Clinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient’s risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence.

Methods/Design

This is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician’s degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms.

Discussion

The central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient’s and clinician’s preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making ‘black box’ that currently exists between the delivery of decision aids to patients and subsequent patient behavior.

Trial Registration

ClinicalTrials.gov ID NCT01514786

【 授权许可】

   
2013 Jimbo et al.; licensee BioMed Central Ltd.

【 图 表 】

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