Clinical trial NCT01514786: Decision Aid to Technologically Enhance Shared Decision Making
Official title: Decision Aid to Technologically Enhance Shared Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Screening
Prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 570
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits
timeFrame: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed.
Secondary outcomes:
Other outcomes:
Locations:
city: Allen Park
country: United States
facility: Children's and Family Medical Clinic
state: Michigan
city: Allen Park
country: United States
facility: Downriver Internists
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Family Medicine at Domino's
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Briarwood Family Medicine
state: Michigan
city: Canton
country: United States
facility: Dua Family Practice
state: Michigan
city: Dearborn
country: United States
facility: George C. Hawrot, MD
state: Michigan
city: Detroit
country: United States
facility: Andrew Thomas, MD
state: Michigan
city: Detroit
country: United States
facility: Morang Chester Clinic
state: Michigan
city: Detroit
country: United States
facility: Rice Lanzilote & Egan
state: Michigan
city: Detroit
country: United States
facility: David Williams, MD
state: Michigan
city: Livonia
country: United States
facility: IPC - Livonia Internal Medicine
state: Michigan
city: Southfield
country: United States
facility: Lonnie Joe Jr. MD
state: Michigan
city: Woodhaven
country: United States
facility: Mark W. Sawka, MD
state: Michigan
city: Ypsilanti
country: United States
facility: University of Michigan Family Medicine at Corner Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Masahito Jimbo, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.