Results Summary
What was the research about?
Colorectal cancer, or CRC, is cancer in the colon or rectum. Regular screening can detect CRC early. One way to screen for CRC is with a colonoscopy. With this test, a doctor inserts a long, flexible tube with a camera into the colon to check for signs of CRC. Another way to screen is with a fecal immunochemical test, or FIT, which checks the stool for signs of CRC.
Many people don’t get regular CRC screening. Some people don’t like the tests or preparing for them. Others lack time or transportation. In this study, the research team compared three ways to help patients who had been scheduled for a colonoscopy but then canceled or missed their appointment to complete CRC screening:
- DVD. Patients received a DVD with information about colonoscopy, FIT, and barriers to and benefits of completing each test.
- DVD plus nurse calls. Patients received the DVD plus a call from a trained nurse two weeks later. The nurse answered questions and helped solve transportation and scheduling problems. The nurse also called a few days before patients' screening appointments to help them prepare.
- Usual care. Patients were rescheduled for a colonoscopy and received information on how to prepare.
What were the results?
Compared with the usual care and DVD alone groups, the group receiving the DVD plus nurse calls had a higher percentage of patients who completed the CRC screening test within a year. About 49 percent of patients who received the DVD plus nurse calls and 30 percent of patients who received the DVD alone completed CRC screening versus 21 percent of patients who received usual care.
Compared with the usual care group, patients in the DVD plus nurse calls group had more CRC knowledge, more confidence, and less anxiety about screening. The groups didn’t differ in how well patients prepared for screening or in patient satisfaction.
Who was in the study?
The study included 371 patients who were ages 45–75 if they were Black or ages 50–75 if they were non-Black. Patients were at average risk for CRC. All received care from one of nine community health centers serving patients with low incomes in Indiana. Among patients, 66 percent were Black, 28 percent were White, and 6 percent were another race. The average age was 58, and 61 percent were women.
What did the research team do?
The research team assigned patients by chance to receive the DVD, the DVD plus nurse calls, or usual care. The team reviewed health records to see who got CRC screening. The team interviewed patients at the start of the study and six and nine months later.
Patients, caregivers, doctors, and insurers helped plan and conduct the study.
What were the limits of the study?
The research team didn’t know whether patients viewed the DVD, which limits what they can say about the effect of the DVD.
Future research could find other ways to increase CRC screening for patients who miss their colonoscopy appointment.
How can people use the results?
Doctors and clinics can use the results when considering ways to support CRC screening.
Professional Abstract
Objective
To compare the effectiveness of a tailored DVD, a tailored DVD plus patient navigation, and usual care in increasing colorectal cancer (CRC) screening among patients who were scheduled for a colonoscopy appointment but did not attend
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 371 patients ages 45–75 (if Black) or 50–75 (if non-Black) at average risk for CRC who had been referred and scheduled for colonoscopy in 1 of 9 community health centers in Indiana, but did not attend their appointment |
| Interventions/ Comparators |
|
| Outcomes |
Primary: completion of CRC screening (colonoscopy or FIT) Secondary: knowledge about CRC, anxiety about screening, colonoscopy self-efficacy, satisfaction with colonoscopy experience, quality of bowel preparation |
| Timeframe | 1-year follow-up for primary outcome |
This randomized controlled trial compared the effectiveness of two interventions—a tailored DVD alone and the tailored DVD plus patient navigation—versus usual care on improving CRC screening rates and other patient and clinician-reported outcomes.
Researchers assigned patients to one of three groups by chance. In the first group, patients received a DVD with information about CRC screening through colonoscopy or fecal immunochemical test (FIT), common barriers to screening, and ways to help overcome these barriers. It also had information to help the patient decide which type of screening test is best for them. In the second group, patients received the same DVD plus patient navigation support from a trained nurse. Two weeks after researchers mailed the DVD, nurses called patients to answer questions, counsel patients about reasons for not getting screened, and assist with scheduling a screening test. For patients who scheduled a screening test, the nurse called the patient before the appointment to help them prepare. In the third group, patients received usual care, which included automated scheduling of a colonoscopy and mailed preparation instructions.
The study included 371 patients ages 45–75 if Black or ages 50–75 if non-Black at average risk for CRC. Patients had been referred and scheduled for colonoscopy at one of nine public safety-net community health centers in Indiana but had canceled or missed their appointment. Of these patients, 66% were Black, 28% were White, and 6% were another race. The average age was 58, and 61% were female.
At one year, researchers looked at electronic health records to determine who had completed CRC screening. Patients completed interviews at baseline and again six and nine months later.
Patients, caregivers, clinicians, and insurers helped plan and conduct the study.
Results
Compared with the usual care and the DVD alone groups, the DVD plus patient navigation group had a higher percentage of patients who completed a CRC screening test (p<0.001). About 49% of patients who received the DVD plus patient navigation and 30% of patients who received the DVD alone completed a screening test compared with 21% of patients who received usual care.
Compared with the usual care group, patients in the DVD plus patient navigation group had increased CRC knowledge, increased colonoscopy self-efficacy, and decreased anxiety about screening (all p<0.05). The three groups did not differ significantly in other study outcomes.
Limitations
Researchers could not determine whether patients who received the DVD viewed it, which limits understanding of its effectiveness.
Conclusions and Relevance
In this study, a tailored DVD plus patient navigation increased CRC screening test rates compared with a tailored DVD alone and usual care.
Future Research Needs
Future research could look at other ways to increase CRC screening among patients who did not attend a colonoscopy appointment.
Final Research Report
This project's final research report is expected to be available by February 2023.
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted the high level of patient engagement and satisfaction described in the report and advised the researchers to discuss this more fully and how patient engagement could be related to intervention effectiveness. The researchers added information to the report about their community advisory board’s influence on the study, including intervention refinement and study implementation, which they believed contributed to the high patient satisfaction.
- The reviewers asked the researchers to address their questions about missing data analyses because there was not enough information provided in the report. The researchers expanded their discussion of missing data analyses for each aim. They explained their reasoning for using complete case analysis and added some sensitivity analyses controlling for baseline variables that appeared to be related to missingness. The researchers also stated that they had minimal loss of power given the low level of missing data and therefore chose not to conduct additional sensitivity analyses or multiple imputation, a more robust method for accounting for missing data.
Conflict of Interest Disclosures
Project Information
Patient / Caregiver Partners
- Sandra Bailey
- Beatrice Cork
- Thomas Griffin
- Juan Lagunes
- Ruth Lambert
- Sylvia Strom
Other Stakeholder Partners
- Hala Fatima, MBBS, Eskenazi Health
- Kimberly Mitchell, RN, Eskenazi Health