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Decision Aid to Technologically Enhance Shared Decision Making

NCT ID: NCT01514786

Last Updated: 2017-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-04-30

Brief Summary

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Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.

Detailed Description

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This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention with Colorectal Website

Intervention website includes an interactive component including preferences and risk assessment.

Group Type ACTIVE_COMPARATOR

Colorectal Web

Intervention Type BEHAVIORAL

The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS

Interventions

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Colorectal Web

The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 50-75 years of age
* not current with colorectal cancer screening
* scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician
* able to read English
* current contact information

Exclusion Criteria

* history of colon cancer or adenomatous polyps
* history of dementia or psychosis
* contraindication to CRCS
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Masahito Jimbo, MD

Clinical Associate Professor, Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masahito Jimbo, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Children's and Family Medical Clinic

Allen Park, Michigan, United States

Site Status

Downriver Internists

Allen Park, Michigan, United States

Site Status

University of Michigan Family Medicine at Domino's

Ann Arbor, Michigan, United States

Site Status

University of Michigan Briarwood Family Medicine

Ann Arbor, Michigan, United States

Site Status

Dua Family Practice

Canton, Michigan, United States

Site Status

George C. Hawrot, MD

Dearborn, Michigan, United States

Site Status

Andrew Thomas, MD

Detroit, Michigan, United States

Site Status

Morang Chester Clinic

Detroit, Michigan, United States

Site Status

Rice Lanzilote & Egan

Detroit, Michigan, United States

Site Status

David Williams, MD

Detroit, Michigan, United States

Site Status

IPC - Livonia Internal Medicine

Livonia, Michigan, United States

Site Status

Lonnie Joe Jr. MD

Southfield, Michigan, United States

Site Status

Mark W. Sawka, MD

Woodhaven, Michigan, United States

Site Status

University of Michigan Family Medicine at Corner Health Center

Ypsilanti, Michigan, United States

Site Status

Countries

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United States

References

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Jimbo M, Sen A, Plegue MA, Hawley S, Kelly-Blake K, Rapai M, Zhang M, Zhang Y, Xie X, Ruffin MT 4th. Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. Am J Prev Med. 2019 Jul;57(1):77-86. doi: 10.1016/j.amepre.2019.03.004. Epub 2019 May 23.

Reference Type DERIVED
PMID: 31128959 (View on PubMed)

Jimbo M, Kelly-Blake K, Sen A, Hawley ST, Ruffin MT 4th. Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial. Trials. 2013 Nov 11;14:381. doi: 10.1186/1745-6215-14-381.

Reference Type DERIVED
PMID: 24216139 (View on PubMed)

Other Identifiers

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HUM00044733

Identifier Type: -

Identifier Source: org_study_id