Elders Preferences in Care Decisions (EPIC-D)

University of North Carolina (UNC)

Status: Completed

Conditions: Early Detection of Cancer; Decision Making; Patient-Centered Care; Colon Cancer

Treatments: Behavioral: Making A Decision About CRC Screening; Behavioral: Drivers 65 Plus

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01575990

11-1638

P01HS021133-01 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 424 patients

Sex: All

Ages: 70 to 84 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

424 participants in 2 patient groups, including a placebo group

Making A Decision About CRC Screening

Experimental group

Description:

A decision support intervention that is a literacy sensitive paper based tool with educational information targeted to the patient's age and gender.

Treatment:

Behavioral: Making A Decision About CRC Screening

Drivers 65 Plus

Placebo Comparator group

Description:

The placebo comparator is an attention control with information about driving tips for drivers age 65 and older.

Treatment:

Behavioral: Drivers 65 Plus