NCT01519999

Brief Summary

The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206,721

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

5.2 years

First QC Date

January 13, 2012

Last Update Submit

January 31, 2019

Conditions

Colorectal Cancer ScreeningShared Decision Making

Keywords

Shared decision makingAmbulatory CarePatient-Centered CareCommunity-wide interventionIntervention StudyLongitudinal Studies

Outcome Measures

Primary Outcomes (1)

  • Change in colorectal cancer screening adherence

    Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.

    Baseline up to 24 months post intervention initiation

Secondary Outcomes (5)

  • Decisional conflict

    Baseline up to 24 months post intervention initiation

  • Modality-specific colorectal cancer screening barriers

    Baseline up to 24 months post intervention initiation

  • Colorectal cancer screening-related confusion

    Baseline up to 24 months post intervention initiation

  • Patients' shared decision-making experience

    Baseline up to 12 months post intervention initiation

  • Providers'/staff shared decision-making experience

    Baseline up to 24 months post intervention initiation

Study Arms (2)

Shared Decision Making

EXPERIMENTAL
Behavioral: Shared Decision Making for Colorectal Cancer Screening

Comparison (control)

NO INTERVENTION

Interventions

Shared Decision Making for Colorectal Cancer ScreeningBEHAVIORAL

Age-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities.

Also known as: CRCS-WISDM
Shared Decision Making

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years of age
  • Lives in or receives care in the selected intervention or comparison (control) communities
  • Average-risk for colorectal cancer
  • Non-adherent to CRCS recommendation
  • English-speaking
  • People who consent to participate

You may not qualify if:

  • \<50 years of age or \>75 years of age
  • Not living in or receiving care in the selected intervention or comparison communities
  • High-risk for colorectal cancer
  • Adherent to CRCS recommendation
  • Non-English speaking
  • People who do not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allina Health Systems - Commons

Minneapolis, Minnesota, 55404, United States

Location

Study Officials

  • Resa M Jones, MPH, PhD

    Virginia Commonwealth University and Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 27, 2012

Study Start

May 1, 2012

Primary Completion

July 18, 2017

Study Completion

July 18, 2017

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

US(1)