Testing Interventions to Motivate and Educate (TIME)
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|ClinicalTrials.gov Identifier: NCT01568151|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2012
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Clinic-directed intervention program Behavioral: Individual Patient-Directed Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||551 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Testing Interventions to Motivate and Educate|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 31, 2013|
|Estimated Study Completion Date :||December 31, 2018|
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.
- Number of participants who undergo colorectal screening because of interventions [ Time Frame: Up to 3 and a half years ]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.
- Number of problems associated with intervention program [ Time Frame: Up to 3 and half years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568151
|United States, Ohio|
|The Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43201|
|Principal Investigator:||Electra D. Paskett, PhD||The Ohio State University Comprehensive Cancer Center|