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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
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE March 29, 2012
First Posted Date  ICMJE April 12, 2012
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
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 measures 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • Appropriate colorectal cancer screening decisions [ Time Frame: Immediately after the patient/provider visit that occurred after the decision support intervention or control condition 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Elders Preferences in Care Decisions
Official Title  ICMJE Improving Appropriate Colorectal Cancer Screening in Elderly Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Early Detection of Cancer
  • Colon Cancer
  • Decision Making
  • Patient-Centered Care
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Making A Decision About CRC Screening
  • Placebo Comparator: Drivers 65 Plus
    The placebo comparator is an attention control with information about driving tips for drivers age 65 and older.
    Intervention: Behavioral: Drivers 65 Plus
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
424
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2012)
400
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 84 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575990
Other Study ID Numbers  ICMJE 11-1638
P01HS021133-01 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Duke University
  • Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Carmen L Lewis, MD, MPH University of North Carolina
Study Director: Rowena J Dolor, MD, MHS Duke University
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP