Elders Preferences in Care Decisions (EPIC-D)

Improving Appropriate Colorectal Cancer Screening in Elderly Patients

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.

Study Overview

• Status: Completed
• Conditions: Colon Cancer; Decision Making; Patient-Centered Care; Early Detection of Cancer
• Intervention / Treatment: Behavioral: Making A Decision About CRC Screening; Behavioral: Drivers 65 Plus

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.

• Study Type: Interventional
• Enrollment (Actual): 424
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Practiced Based Research Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 84 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Making A Decision About CRC Screening; A decision support intervention that is a literacy sensitive paper based tool with educational information targeted to the patient's age and gender.	Behavioral: Making A Decision About CRC Screening; Targeted by age and gender with 3 components.; Educational component; Values clarification exercise; Individualized decision making worksheet The intervention or control condition is administered before the index visit with the patient's provider.; Other Names: Making A Decision About Colon Cancer Screening Woman 70; Making A Decision About Colon Cancer Screening Woman 75; Making A Decision About Colon Cancer Screening Woman 80; Making A Decision About Colon Cancer Screening Men 70; Making A Decision About Colon Cancer Screening Men 75; Making A Decision About Colon Cancer Screening Men 80
Placebo Comparator: Drivers 65 Plus; The placebo comparator is an attention control with information about driving tips for drivers age 65 and older.	Behavioral: Drivers 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.; Other Names: Control condition; Attention control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate colorectal cancer screening	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.	Six months after intervention or control was adminstered

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate colorectal cancer screening decisions	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.	At baseline (after intervention or control was administered)
Appropriate screening and mediators	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.	Six months after intervention or control was adminstered
Appropriate screening for health strata	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.	Six months after intervention or control was adminstered
Appropriate screening for stool cards	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.	Six months after intervention or control was adminstered

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Carmen L Lewis, MD, MPH, University of North Carolina; Study Director: Rowena J Dolor, MD, MHS, Duke University

Publications and helpful links

General Publications

• Lewis CL, Kistler CE, Dalton AF, Morris C, Ferrari R, Barclay C, Brewer NT, Dolor R, Harris R, Vu M, Golin CE. A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial. Med Decis Making. 2018 Jul;38(5):614-624. doi: 10.1177/0272989X18773713.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Age; Colon cancer screening; Patient-centered care; Health status; Double blind; UNC; Decision support interventions
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 11-1638; P01HS021133-01 (U.S. AHRQ Grant/Contract)