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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
Enrollment 250

Recruitment Details 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  
Arm/Group Title Stepped Care Usual Care
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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.

Patients receive usual care for pain from their primary care physician
Period Title: Overall Study
Started 124 126
Completed 116 122
Not Completed 8 4
Arm/Group Title Stepped Care Usual Care Total
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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.

Patients receive usual care for pain from their primary care physician Total of all reporting groups
Overall Number of Baseline Participants 124 126 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 126 participants 250 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
124
 100.0%
126
 100.0%
250
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 126 participants 250 participants
Female
15
  12.1%
28
  22.2%
43
  17.2%
Male
109
  87.9%
98
  77.8%
207
  82.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 126 participants 250 participants
American Indian or Alaska Native
1
   0.8%
3
   2.4%
4
   1.6%
Asian
0
   0.0%
1
   0.8%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
31
  25.0%
17
  13.5%
48
  19.2%
White
89
  71.8%
103
  81.7%
192
  76.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.4%
2
   1.6%
5
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 124 participants 126 participants 250 participants
124 126 250
1.Primary Outcome
Title Brief Pain Inventory (Pain)
Hide Description The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain).
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepped Care Usual Care
Hide Arm/Group Description:

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.

Patients receive usual care for pain from their primary care physician
Overall Number of Participants Analyzed 124 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.57  (2.22) 4.59  (2.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stepped Care Usual Care
Hide Arm/Group Description

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.

Patients receive usual care for pain from their primary care physician
All-Cause Mortality
Stepped Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stepped Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   22/124 (17.74%)   8/126 (6.35%) 
Cardiac disorders     
Cardiac hospitalization * [1]  5/124 (4.03%)  1/126 (0.79%) 
Hospitalization due to coronary artery bypass surgery * [2]  2/124 (1.61%)  0/126 (0.00%) 
Gastrointestinal disorders     
Gall bladder removal surgery * [3]  0/124 (0.00%)  1/126 (0.79%) 
Hospitalization due to appendicitis * [4]  1/124 (0.81%)  0/126 (0.00%) 
Hospitalization due to esophagogastrectomy * [4]  1/124 (0.81%)  0/126 (0.00%) 
General disorders     
Hospitalization due to hypotension, headache, muscle ache * [4]  1/124 (0.81%)  0/126 (0.00%) 
Death * [5]  1/124 (0.81%)  0/126 (0.00%) 
Infections and infestations     
Hospitalization due to infection * [6]  2/124 (1.61%)  0/126 (0.00%) 
Injury, poisoning and procedural complications     
Hospitalization due to motor vehicle accident * [4]  1/124 (0.81%)  0/126 (0.00%) 
Hospitalization due to sepsis * [7]  1/124 (0.81%)  0/126 (0.00%) 
Musculoskeletal and connective tissue disorders     
Hospitalization due to knee replacement * [8]  3/124 (2.42%)  0/126 (0.00%) 
Nervous system disorders     
TIA hospitalization * [4]  0/124 (0.00%)  1/126 (0.79%) 
Psychiatric disorders     
Stress center hospitalization * [4]  0/124 (0.00%)  1/126 (0.79%) 
Mental Health referral due to suicidality * [9]  0/124 (0.00%)  1/126 (0.79%) 
Subject suicidal ideation * [10]  0/124 (0.00%)  1/126 (0.79%) 
Renal and urinary disorders     
Hospitalization due to renal failure * [4]  1/124 (0.81%)  0/126 (0.00%) 
Bladder repair surgery and hospitalization * [11]  1/124 (0.81%)  0/126 (0.00%) 
Reproductive system and breast disorders     
Hospitalization due to planned hysterectomy * [11]  1/124 (0.81%)  0/126 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia hospitalization * [12]  0/124 (0.00%)  1/126 (0.79%) 
Surgical and medical procedures     
Sinus surgery hospitalization * [13]  0/124 (0.00%)  1/126 (0.79%) 
Hospitalization due to removal of fibroids * [4]  1/124 (0.81%)  0/126 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Cardiac hospitalization unrelated to participation in study.
[2]
Hospitalization unrelated to participation in research study.
[3]
Surgery unrelated to participation in study.
[4]
Hospitalization unrelated to participation in study.
[5]
Death unrelated to participation in study.
[6]
Hospitalization not related to participation in study.
[7]
Hospitalization unrelated to participation in research
[8]
Hospitalization and surgery unrelated to participation in study.
[9]
Unrelated to participation in study.
[10]
Subject revealed suicidal ideation during screening. Unrelated to participation in research study.
[11]
Surgery and hospitalization unrelated to participation in study.
[12]
Hospitalization unrelated to research study.
[13]
Subject admitted to hospital for planned sinus surgery.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stepped Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/124 (0.00%)   0/126 (0.00%) 
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
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