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

Jimbo M, Kelly-Blake K, Sen A, Hawley ST, Ruffin MT - Trials (2013)

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA. mjimbo@med.umich.edu.

ABSTRACT

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.

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Related in: MedlinePlus

Structural equation model.
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Figure 3: Structural equation model.

Mentions: After randomization, the participating patients will enter the introductory page for CW for those randomized to the intervention arm and SW for those randomized into the Control Arm. In the intervention arm, the patients will access and work through CW. On entering CW, the patient will be guided to Overview, then Personal Risk Assessment, where they will interactively answer questions about their personal and family health history. There will be immediate feedback on whether they are ‘Average Risk’, ‘Increased Risk’, or ‘Unknown Risk’ (this occurs if the patient, who is otherwise average risk, answers ‘I don’t know’ to any of the questions in the Personal Risk Assessment). Next, the patients will be guided to access the Comparison Table providing information on CRCS tests (see Figure 2) and a Preference Clarification Tool from which they may select the three most important issues of a CRCS test (see Figure 3). The test most closely matching the three selected issues will be provided. The patients may work on the tool for as long as they wish. Once they select the matched test, a Feedback Page reviewing their test of choice in the context of their risk will be provided: ‘Average Risk’, ‘Increased Risk’, or ‘Unknown Risk’. The combination of patient risk profile and preference will help the patients to understand the details of CRCS, how each test correlates with their preference, their risk for CRC, and how their preference may or may not match the recommended test based on their risk. They will be given a final opportunity to select a CRCS test based on their risk and preferences. Once they submit their choice, a Summary Page will appear that shows them: their risk, their three most important issues, CRCS test based on the three issues, and the test they ultimately selected. Participating patients in both intervention and control arms will undergo the intervention in a private room. For patients needing help using the computer, the research assistant will provide this support but will not counsel them on CRCS. These provisions will ensure privacy, standardization, and inclusion of patients without Internet access and low computer literacy and skills.


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

Jimbo M, Kelly-Blake K, Sen A, Hawley ST, Ruffin MT - Trials (2013)

Structural equation model.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3842677&req=5

Figure 3: Structural equation model.
Mentions: After randomization, the participating patients will enter the introductory page for CW for those randomized to the intervention arm and SW for those randomized into the Control Arm. In the intervention arm, the patients will access and work through CW. On entering CW, the patient will be guided to Overview, then Personal Risk Assessment, where they will interactively answer questions about their personal and family health history. There will be immediate feedback on whether they are ‘Average Risk’, ‘Increased Risk’, or ‘Unknown Risk’ (this occurs if the patient, who is otherwise average risk, answers ‘I don’t know’ to any of the questions in the Personal Risk Assessment). Next, the patients will be guided to access the Comparison Table providing information on CRCS tests (see Figure 2) and a Preference Clarification Tool from which they may select the three most important issues of a CRCS test (see Figure 3). The test most closely matching the three selected issues will be provided. The patients may work on the tool for as long as they wish. Once they select the matched test, a Feedback Page reviewing their test of choice in the context of their risk will be provided: ‘Average Risk’, ‘Increased Risk’, or ‘Unknown Risk’. The combination of patient risk profile and preference will help the patients to understand the details of CRCS, how each test correlates with their preference, their risk for CRC, and how their preference may or may not match the recommended test based on their risk. They will be given a final opportunity to select a CRCS test based on their risk and preferences. Once they submit their choice, a Summary Page will appear that shows them: their risk, their three most important issues, CRCS test based on the three issues, and the test they ultimately selected. Participating patients in both intervention and control arms will undergo the intervention in a private room. For patients needing help using the computer, the research assistant will provide this support but will not counsel them on CRCS. These provisions will ensure privacy, standardization, and inclusion of patients without Internet access and low computer literacy and skills.

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA. mjimbo@med.umich.edu.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus