Colon Cancer, Decision Making, Early Detection of Cancer, Patient-Centered Care
Conditions
Keywords
Colon cancer screening, Decision support interventions, Health status, Patient-centered care, Age, Randomized controlled trial, Double blind, UNC
Brief summary
The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.
Detailed description
The investigators propose a randomized controlled trial at the patient level to determine the efficacy of a colorectal cancer screening decision support intervention for patients ages 70 to 84 within a clinical setting. The investigators hypothesize that the use of the intervention will prepare patients for individualized decision making with their providers and result in an improvement in appropriate CRC screening decisions and screening outcomes. To assess appropriate CRC screening decisions and screening, the investigators will use a classification scheme derived from the literature based on age and the Charlson Comorbidity Index. Using this scheme, appropriate screening will include screening for those in the best health because they are likely to benefit, no screening for those in the worst health because they are unlikely to benefit, and evidence of a discussion about CRC screening for those in the intermediate health group because the benefit is unclear.
Interventions
BEHAVIORALMaking A Decision About CRC Screening
Targeted by age and gender with 3 components. 1. Educational component 2. Values clarification exercise 3. Individualized decision making worksheet The intervention or control condition is administered before the index visit with the patient's provider.
BEHAVIORALDrivers 65 Plus
This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.
Sponsors
Duke University
Agency for Healthcare Research and Quality (AHRQ)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women ages 70 to 84 * Not up to date with colon cancer screening or surveillance
Exclusion criteria
* Men and women younger than 70 years of age or older than 84 * History of Colorectal Cancer * Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appropriate colorectal cancer screening | Six months after intervention or control was adminstered | The proportion of participants classified as having appropriate colorectal cancer screening in the intervention group compared to the control group. Appropriate screening is a combined outcome measure using patient report of completion or non-completion of CRC screening tests and patient report of discussions about CRC screening with their provider at the index visit. The outcome will be measured six months after the index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appropriate colorectal cancer screening decisions | At baseline (after intervention or control was administered) | The proportion of participants classified as having appropriate colorectal cancer screening decisions in the intervention group will be compared to the control group. Appropriate screening decision making is a combined outcome measure using patient report of intent to complete or not complete CRC screening tests and discussions about CRC screening with their provider. This outcome will be measured immediately after the patient and provider index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered. |
| Appropriate screening and mediators | Six months after intervention or control was adminstered | For the mediation analysis covariates will be evaluated as potential mediators. The potential mediators to be examined include adequate preparation for individualized decision making (adequate knowledge+ clear values); knowledge scores, screening preference before the index visit, decisional balance, reported discussion during the index visit, gender, previous screening, functional status, and literacy level. |
| Appropriate screening for health strata | Six months after intervention or control was adminstered | Once we have tested our hypothesis for the main effects, we will also perform hypothesis-generating exploratory analyses to examine effect of the intervention in sub-groups of patients. We will examine the effect in the three strata (best, intermediate, worst health groups) defined by age and Charlson comorbidity score. |
| Appropriate screening for stool cards | Six months after intervention or control was adminstered | For this analysis, appropriate screening test completion will include stool cards for all age groups and health groups. Analyses described for the primary outcome will be performed using this classification of appropriate screening test completion. |
Countries
United States
Outcome results
None listed