Elders Preferences in Care Decisions (EPIC-D)

• ClinicalTrials.gov Identifier: NCT01575990
• Recruitment Status: Completed
• First Posted: April 12, 2012
• Last Update Posted: May 28, 2015
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Early Detection of Cancer; Colon Cancer; Decision Making; Patient-Centered Care	Behavioral: Making A Decision About CRC Screening; Behavioral: Drivers 65 Plus	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 424 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Improving Appropriate Colorectal Cancer Screening in Elderly Patients
• Study Start Date: March 2012
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

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: Attention control; Control condition

Outcome Measures

Primary Outcome Measures :

1. Appropriate colorectal cancer screening [ Time Frame: 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 Outcome Measures :

1. Appropriate colorectal cancer screening decisions [ Time Frame: 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.
2. Appropriate screening and mediators [ Time Frame: 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.
3. Appropriate screening for health strata [ Time Frame: 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.
4. Appropriate screening for stool cards [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

Duke Practiced Based Research Network

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

University of North Carolina, Chapel Hill

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01575990
• Other Study ID Numbers: 11-1638; P01HS021133-01 ( U.S. AHRQ Grant/Contract )
• First Posted: April 12, 2012
• Last Update Posted: May 28, 2015
• Last Verified: May 2015

Keywords provided by Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill:

Colon cancer screening; Decision support interventions; Health status; Patient-centered care; Age; Randomized controlled trial; Double blind; UNC

Additional relevant MeSH terms:

Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases