NCT00324753

Brief Summary

The immediate objective of this proposal is to assess the effectiveness of a multi-faceted intervention to improve patient-provider communication about colorectal cancer screening in improving patient adherence with colorectal cancer screening recommendations. This intervention consists of: (1) guiding the communication process through patient activation to initiate a colorectal cancer screening discussion; (2) optimizing communication content through the use of a prompt sheet; and (3) cueing the provider to assess patient perception of the communication. The long-term objective of our research program is to maximize colorectal cancer screening rates throughout the VA through widespread adoption of clinically feasible approaches to enhance patient-provider communication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
454

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

3 active sites

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

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

November 29, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

May 9, 2006

Results QC Date

June 19, 2017

Last Update Submit

November 27, 2018

Conditions

Keywords

cancerscreeningcommunicationprevention

Outcome Measures

Primary Outcomes (3)

  • Completion of Colorectal Cancer Screening Tests

    A survey collected data on patient demographic characteristics, family history of colorectal cancer or polyp, and provider recommendation for colorectal cancer screening, if any. In addition, we asked patients whether colorectal cancer screening was discussed at the visit. If the response was yes, we then asked patients how satisfied they were with the PCP communication during the visit in general using a 5-point Likert scale to a number of items describing the communication. A medical record review was conducted to collect data on provider ordering and patient completion of the following colorectal cancer screening tests during the study period (i.e., 6 months from the time of the clinical encounter): fecal occult blood testing, sigmoidoscopy, or colonoscopy.

    6-12 months

  • Quality of Communication

    Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).

    immediate after the patient visit

  • Communication Content

    PCP Explains CRC screening to my satisfaction

    immediately after the patient visit

Study Arms (2)

Intervention

EXPERIMENTAL

Communication sheet

Behavioral: Communication

Control

OTHER

Standard of care brochures

Behavioral: Standard of care

Interventions

CommunicationBEHAVIORAL

Communication sheet

Intervention

Standard of care brochures

Control

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provider Eligibility:
  • Primary care providers (MD, Certified Registered Nurse Practitioner (CRNP), or PA) at the study sites who see patients in the primary care setting at least 1 day per week and had no involvement in the design of the study are eligible for enrollment in the study.
  • Patient Eligibility:
  • Primary care patients who are not "up-to-date" with colorectal cancer screening are the targeted population for study enrollment.
  • Up-to-date with colorectal cancer screening is defined as having completed one of the following:
  • fecal occult blood testing within the past year
  • sigmoidoscopy within the past 5 years
  • colonoscopy within the past 10 years
  • barium enema within the past 5 years.
  • Other patient eligibility criteria are:
  • Primary Care Provider (PCP) enrolled in the study
  • clinic visit scheduled with the enrolled PCP during the recruitment period
  • English speaking
  • no prior history of colorectal cancer or adenomatous polyps
  • no prior history of inflammatory bowel disease

You may not qualify if:

  • Patients who are deemed clinically not appropriate for colorectal cancer screening due to severe comorbidity and/or limited life expectancy as determined by the patient's primary care provider will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Ling BS, Trauth JM, Fine MJ, Mor MK, Resnick A, Braddock CH, Bereknyei S, Weissfeld JL, Schoen RE, Ricci EM, Whittle J. Informed decision-making and colorectal cancer screening: is it occurring in primary care? Med Care. 2008 Sep;46(9 Suppl 1):S23-9. doi: 10.1097/MLR.0b013e31817dc496.

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsCommunication

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Maria K. Mor
Organization
Center for Health Equity Research and Promotion (VAPHS)

Study Officials

  • Bruce S. Ling, MD MPH

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

April 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 29, 2018

Results First Posted

November 29, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations