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Stepped Care to Optimize Pain Care Effectiveness (SCOPE)

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ClinicalTrials.gov Identifier: NCT00926588
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : December 19, 2014
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: Stepped care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from June 2010 through May 2012. Patients and physicians in 5 primary care clinics in the Roudebush Veterans Administration Medical Center in Indianapolis participated.

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
Stepped Care

Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.

Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.

Usual Care Patients receive usual care for pain from their primary care physician

Participant Flow:   Overall Study
    Stepped Care   Usual Care
STARTED   124   126 
COMPLETED   116   122 
NOT COMPLETED   8   4 



  Baseline Characteristics

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
Stepped Care

Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.

Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.

Usual Care Patients receive usual care for pain from their primary care physician
Total Total of all reporting groups

Baseline Measures
   Stepped Care   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 124   126   250 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   124   126   250 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   15   28   43 
Male   109   98   207 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   3   4 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   31   17   48 
White   89   103   192 
More than one race   0   0   0 
Unknown or Not Reported   3   2   5 
Region of Enrollment 
[Units: Participants]
     
United States   124   126   250 


  Outcome Measures

1.  Primary:   Brief Pain Inventory (Pain)   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Kurt Kroenke
Organization: VA HSRD
phone: 317-988-3476
e-mail: kkroenke@regenstrief.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00926588     History of Changes
Other Study ID Numbers: IIR 07-119
First Submitted: June 18, 2009
First Posted: June 23, 2009
Results First Submitted: November 7, 2014
Results First Posted: December 19, 2014
Last Update Posted: August 7, 2015