Testing Interventions to Motivate and Educate (TIME)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01568151
First received: March 19, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This study is being done to see if teaching physicians and people who are at least 50 years old and have not been screened within guidelines for colorectal cancer about the importance of colorectal cancer screening will increase screenings for colorectal cancer. The researchers want to understand what ways will work best to motivate and educate both patients and the doctors and nurses who care for them.


Condition Intervention Phase
Colorectal Cancer
Behavioral: Clinic-directed intervention program
Behavioral: Individual Patient-Directed Program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Testing Interventions to Motivate and Educate

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of participants who undergo colorectal screening because of interventions [ Time Frame: Up to 3 and a half years ] [ Designated as safety issue: No ]
    The effectiveness of clinic-directed interventions in encouraging subjects to undergo colorectal cancer screening in the 5 intervention clinics in the first 12 months will be assessed. The subjects who did not undergo colorectal cancer screening during that year will then undergo patient-directed intervention for up to a year. The effectiveness of both of these types of intervention will be compared to the control clinics where there is no intervention.


Secondary Outcome Measures:
  • Number of problems associated with intervention program [ Time Frame: Up to 3 and half years ] [ Designated as safety issue: No ]
    Conduct a process evaluation of the intervention program to identify problems experienced in implementing it. Process evaluation questions will be part of follow-up surveys that the participants complete. Responses will be analyzed by staff to determine intervention program concerns.


Enrollment: 551
Study Start Date: April 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention Clinics
Subjects recruited at the Intervention Clinics will first be provided with Clinic-directed interventions(Clinic-directed intervention program)including: 1)provider-directed interventions; 2)office-based systems; and 3) waiting room materials. If the subjects have not undergone colorectal cancer screening after 12 months, they will be provided with an individual patient-directed program consisting of the following stepped interventions: 1) tailored physician letter, easy-to-read educational materials, and an fecal occult blood test (FOBT)information sheet and card; 2) telephone counseling for those who do not respond to the letter; and 3) home visits by lay health advisors for those who do not respond to the letter or phone counseling.
Behavioral: Clinic-directed intervention program
Clinic-directed intervention program: Subjects recruited at the Intervention Clinics will first be provided with Clinic-directed interventions including: 1)provider-directed interventions (computerized case-based education, evidence-based guidelines, ask the expert; 2)office-based systems (risk assessment forms, procedure monitoring, follow-up protocol, audit with feedback, chart reminders); and 3) waiting room materials.
Behavioral: Individual Patient-Directed Program
If the subjects have not undergone colorectal cancer screening within 12 months of receiving the clinic-directed program, they will be provided with an individual patient-directed program consisting of the following stepped interventions: 1) tailored physician letter, easy-to-read educational materials, and an fecal occult blood test (FOBT)information sheet and card; 2) telephone counseling for those who do not respond to the letter; and 3) home visits by lay health advisors for those who do not respond to the letter or phone counseling.
No Intervention: Usual Care Clinics
Subjects recruited at the Usual Care Clinics (Control Clinics) will not receive any study intervention. The results of how many subjects undergo colorectal cancer screening at the Usual Care Clinics will be compared to the number that undergo colorectal cancer screening at the Intervention Clinics.

Detailed Description:

Colorectal cancer (CRC) is the third leading type of cancer and the third leading cause of cancer death in the United States. This study focuses on improving CRC screening in The Ohio State University Primary Care Network (OSUPCN). Ohio has higher than average rates of CRC mortality compared to the rest of the US. The study population for this study will also include minority and older individuals as these groups have higher CRC incidence and mortality rates.

The goal of this study is to test a program to improve CRC screening among male and female patients over the age of 50 in 10 primary care clinics. This study will use physician surveys, focus groups and a community advisory board to finalize the content of the interventions. Five theoretical models form the theoretical framework of the study - the health belief model, social networking, minority health communications model, PEN III, and the transtheoretical model. The interventions will be directed at the clinic and patient levels, and will be tested in a randomized design. Five clinics will receive the clinic plus patient-directed interventions and 5 clinics will be randomized to usual care. The clinic intervention will consist of provider, system and waiting room activities. The individual-directed intervention will include three stepped stages for patients who have not yet been screened: (1) a tailored physician letter, easy-to-read educational materials about CRC and an FOBT information sheet and card; (2) follow-up telephone barriers counseling for patients who do not complete CRC screening after receiving the letter; and (3) in person home visits by lay health advisors (LHA) for those who do not complete CRC screening after receiving the first two interventions. Research staff will conduct a process evaluation of the interventions to identify problems in implementing them and determine the extent to which each of the components is successfully carried out. They will also examine how components of the intervention relate to the theoretical frameworks used to motivate CRC screening completion. If successful, this program can easily be adapted for use by primary care practices and clinics to improve CRC screening.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 50 or older
  • No prior history of familial/hereditary cancer syndrome (e.g. hereditary non-polyposis colon cancer), polyps, or inflammatory bowel disease (e.g. Crohn's disease)
  • Have a current phone number
  • Have had 2 or more visits to the Family Practice or General Internal Medicine Clinics in the past 2 years
  • Have a current address in records and no definite plans to move within the next year
  • Be at average risk for colorectal cancer
  • Be in good health as judged by their primary care doctor
  • Not be over the age of 85

Exclusion Criteria:

  • Less than 50 years old
  • Greater than 85 years old
  • History of familial/hereditary cancer syndrome, polyps, or Crohn's disease
  • History of contraindications to colorectal cancer screening, such as congenital heart failure, renal failure, dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568151

Locations
United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43201
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Electra D. Paskett, PhD The Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by Ohio State University Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01568151     History of Changes
Other Study ID Numbers: TIME, RO1CA116487, OSU 08073
Study First Received: March 19, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Colorectal Cancer
Screening
Education
Testing

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 19, 2014