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Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596582
First Posted: May 11, 2012
Last Update Posted: March 21, 2017
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.
Information provided by (Responsible Party):
Paul C Schroy, MD, MPH, Boston Medical Center
Results First Submitted: January 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Colorectal Cancer
Intervention: Behavioral: Risk Assessment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Care Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
Risk Assessment

Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) and the ACNI risk assessment tool just prior to a scheduled office visit with their provider.

Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never).


Participant Flow:   Overall Study
    Standard Care   Risk Assessment
STARTED   172   180 
COMPLETED   168   173 
NOT COMPLETED   4   7 
Deemed ineligible after study visit                3                6 
Missing all outcome data                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Care Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
Risk Assessment

Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.

Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never).

Total Total of all reporting groups

Baseline Measures
   Standard Care   Risk Assessment   Total 
Overall Participants Analyzed 
[Units: Participants]
 168   173   341 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.0  (5.9)   56.8  (6.8)   56.4  (6.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      88  52.4%      92  53.2%      180  52.8% 
Male      80  47.6%      81  46.8%      161  47.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Ethnicity : Hispanic   13   10   23 
Ethnicity : Non-Hispanic   154   163   317 
Ethnicity : Refused   1   0   1 
Race : White   33   42   75 
Race : Black   104   104   208 
Race : Other   31   27   58 
Education 
[Units: Participants]
Count of Participants
     
High school or less      98  58.3%      114  65.9%      212  62.2% 
Greater than high school      70  41.7%      59  34.1%      129  37.8% 
Marital status 
[Units: Participants]
Count of Participants
     
Married/living with partner      49  29.2%      47  27.2%      96  28.2% 
Single/separated/divorced/widowed      119  70.8%      125  72.3%      244  71.6% 
Refused      0   0.0%      1   0.6%      1   0.3% 
Insurance 
[Units: Participants]
Count of Participants
     
Private/HMO      55  32.7%      38  22.0%      93  27.3% 
Medicare      46  27.4%      54  31.2%      100  29.3% 
Medicaid      37  22.0%      49  28.3%      86  25.2% 
Free care      21  12.5%      20  11.6%      41  12.0% 
Other      6   3.6%      11   6.4%      17   5.0% 
None      3   1.8%      1   0.6%      4   1.2% 
Desired role in decision-making 
[Units: Participants]
Count of Participants
     
Mostly patient      58  34.5%      53  30.6%      111  32.6% 
Shared      88  52.4%      88  50.9%      176  51.6% 
Mostly provider      22  13.1%      32  18.5%      54  15.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Concordance Between Patient Preference and Test Ordered   [ Time Frame: 3 months ]

2.  Secondary:   Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients   [ Time Frame: 3 months ]

3.  Secondary:   Satisfaction With Decision-making Process (SDMP)   [ Time Frame: One month ]

4.  Secondary:   Screening Intentions   [ Time Frame: 3 months ]

5.  Secondary:   Screening Test Completion   [ Time Frame: 6 months ]

6.  Secondary:   Provider Satisfaction   [ Time Frame: Two years ]

7.  Other Pre-specified:   Concordance Between Patient Preference for Colonoscopy and Test Ordered   [ Time Frame: 3 months ]

8.  Other Pre-specified:   Concordance Between Patient Preferences for Screening Tests Other Than Colonoscopy and Test Ordered   [ Time Frame: 3 months ]

9.  Other Pre-specified:   Concordance Between Patient Preference for Colonoscopy and Test Ordered for High Versus Low Risk Patients   [ Time Frame: 3 months ]

10.  Other Pre-specified:   Concordance Between Patient Preferences for a Screening Tests Other Than Colonoscopy and Test Ordered for High Versus Low Risk Patients   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Single institution setting; lack of provider education about the utility of risk stratification into their decision-making.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul C. Schroy III, MD, MPH
Organization: Boston Medical Center
phone: 671-638-8335
e-mail: paul.schroy@bmc.org


Publications of Results:
Other Publications:

Responsible Party: Paul C Schroy, MD, MPH, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01596582     History of Changes
Other Study ID Numbers: NCI-CA131197
First Submitted: May 7, 2012
First Posted: May 11, 2012
Results First Submitted: January 23, 2017
Results First Posted: March 21, 2017
Last Update Posted: March 21, 2017