Trial Outcomes & Findings for Stepped Care to Optimize Pain Care Effectiveness (NCT NCT00926588)
NCT ID: NCT00926588
Last Updated: 2015-08-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
1 year
Results posted on
2015-08-07
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
126
|
|
Overall Study
COMPLETED
|
116
|
122
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stepped Care to Optimize Pain Care Effectiveness
Baseline characteristics by cohort
| Measure |
Stepped Care
n=124 Participants
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
n=126 Participants
Patients receive usual care for pain from their primary care physician
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
124 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
124 participants
n=5 Participants
|
126 participants
n=7 Participants
|
250 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe 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).
Outcome measures
| Measure |
Stepped Care
n=124 Participants
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
n=126 Participants
Patients receive usual care for pain from their primary care physician
|
|---|---|---|
|
Brief Pain Inventory (Pain)
|
3.57 units on a scale
Standard Deviation 2.22
|
4.59 units on a scale
Standard Deviation 2.13
|
Adverse Events
Stepped Care
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stepped Care
n=124 participants at risk
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
n=126 participants at risk
Patients receive usual care for pain from their primary care physician
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia hospitalization
|
0.00%
0/124
|
0.79%
1/126
|
|
Gastrointestinal disorders
Gall bladder removal surgery
|
0.00%
0/124
|
0.79%
1/126
|
|
Cardiac disorders
Cardiac hospitalization
|
4.0%
5/124
|
0.79%
1/126
|
|
Infections and infestations
Hospitalization due to infection
|
1.6%
2/124
|
0.00%
0/126
|
|
Nervous system disorders
TIA hospitalization
|
0.00%
0/124
|
0.79%
1/126
|
|
Psychiatric disorders
Stress center hospitalization
|
0.00%
0/124
|
0.79%
1/126
|
|
Surgical and medical procedures
Sinus surgery hospitalization
|
0.00%
0/124
|
0.79%
1/126
|
|
Renal and urinary disorders
Hospitalization due to renal failure
|
0.81%
1/124
|
0.00%
0/126
|
|
Musculoskeletal and connective tissue disorders
Hospitalization due to knee replacement
|
2.4%
3/124
|
0.00%
0/126
|
|
Injury, poisoning and procedural complications
Hospitalization due to motor vehicle accident
|
0.81%
1/124
|
0.00%
0/126
|
|
Renal and urinary disorders
Bladder repair surgery and hospitalization
|
0.81%
1/124
|
0.00%
0/126
|
|
Surgical and medical procedures
Hospitalization due to removal of fibroids
|
0.81%
1/124
|
0.00%
0/126
|
|
Reproductive system and breast disorders
Hospitalization due to planned hysterectomy
|
0.81%
1/124
|
0.00%
0/126
|
|
Gastrointestinal disorders
Hospitalization due to appendicitis
|
0.81%
1/124
|
0.00%
0/126
|
|
Gastrointestinal disorders
Hospitalization due to esophagogastrectomy
|
0.81%
1/124
|
0.00%
0/126
|
|
General disorders
Hospitalization due to hypotension, headache, muscle ache
|
0.81%
1/124
|
0.00%
0/126
|
|
Psychiatric disorders
Mental Health referral due to suicidality
|
0.00%
0/124
|
0.79%
1/126
|
|
Cardiac disorders
Hospitalization due to coronary artery bypass surgery
|
1.6%
2/124
|
0.00%
0/126
|
|
Psychiatric disorders
Subject suicidal ideation
|
0.00%
0/124
|
0.79%
1/126
|
|
General disorders
Death
|
0.81%
1/124
|
0.00%
0/126
|
|
Injury, poisoning and procedural complications
Hospitalization due to sepsis
|
0.81%
1/124
|
0.00%
0/126
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place