Elders Preferences in Care Decisions (EPIC-D)
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|ClinicalTrials.gov Identifier: NCT01575990|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : May 28, 2015
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||424 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
The intervention or control condition is administered before the index visit with the patient's provider.
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.
- 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.
- 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.
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
|United States, North Carolina|
|Duke Practiced Based Research Network|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Carmen L Lewis, MD, MPH||University of North Carolina|
|Study Director:||Rowena J Dolor, MD, MHS||Duke University|