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Completed

NCT Number: NCT00737646

Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics

This study is a three-arm randomized controlled trial to implement and evaluate the relative effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in primary care clinics. The study will also examine the relative effects of the intervention conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. The target population includes average-risk patients aged 50-75 years, clinicians, and clinical staff within the primary care setting. The intervention will be implemented within primary care clinics in two managed care organizations (MCOs). The intervention targets the following CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double contrast barium enema.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for the Patient-focused Intervention

  • Average risk
  • Male or female
  • 50-75 years
  • Scheduled for non-acute ambulatory care visit at one of the study sites
  • Due for CRC screening including no record of FOBT in the past year, no record of flexible sigmoidoscopy in the past 5 years, no record of colonoscopy in the past 10 years, and no record of double contrast barium enema in the past 5 years

Inclusion criteria

for the Clinic-focused Intervention

  • Primary care clinicians, to include the following specialties: Family Practice/General Practice Physicians, General Internal Medicine Physicians, Nurse Practitioners in Family/General Practice, Physician Assistants who conduct non-acute ambulatory medical exams in study clinics
  • Primary care clinical staff, to include nurses, medical assistants, and appointment schedulers

Exclusion criteria

(Patients):

  • Prior diagnosis of CRC
  • Prior diagnosis of colorectal polyps
  • Prior diagnosis of ulcerative colitis
  • Prior diagnosis of Crohn's Disease
  • Prior diagnosis of hereditary nonpolyposis or polyposis
  • Medical records contain an International Classification of Diseases (ICD-9) code for family history of CRC
  • Younger than 50 years of age
  • Older than 80 years of age.

Treatment and study plan

Usual Care

Behavioral

No intervention will be conducted in this arm of the study.

Clinic-focused intervention

Behavioral

The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff. The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based. The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.

Clinic- and patient-focused

Behavioral

This arm will combine the clinic-focused intervention and the patient-focused intervention. The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.

Primary outcomes

  1. Changes in colorectal cancer screening rates (4 modalities)

    Time frame: One year post initiation of intervention

Secondary outcomes

  1. Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)

    Time frame: One year post initiation in intervention

  2. Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.

    Time frame: One year post initiation of intervention

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 19, 2008
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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