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Elders Preferences in Care Decisions (EPIC-D)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01575990
First Posted: April 12, 2012
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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 Intervention
Early Detection of Cancer Colon Cancer Decision Making Patient-Centered Care Behavioral: Making A Decision About CRC Screening Behavioral: Drivers 65 Plus

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 424
Study Start Date: March 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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.

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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years to 84 Years   (Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575990


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

Responsible Party: Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01575990     History of Changes
Other Study ID Numbers: 11-1638
P01HS021133-01 ( U.S. AHRQ Grant/Contract )
First Submitted: March 29, 2012
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