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Completed

NCT Number: NCT01575990

Elders Preferences in Care Decisions

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.

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Key information

Conditions

Early Detection of Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Decision Making Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient-centered Care

Age range

70 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Practiced Based Research Network

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Making A Decision About CRC Screening

Behavioral

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

Drivers 65 Plus

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Duke University

Registry information

Official study title

Improving Appropriate Colorectal Cancer Screening in Elderly Patients

Acronym: EPIC-D

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 12, 2012
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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