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Care Management for the Effective Use of Opioids (CAMEO)

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ClinicalTrials.gov Identifier: NCT01236521
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : June 8, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Low Back Pain
Pain
Interventions Drug: Pharmacological (PHARM)
Behavioral: Behavioral treatment (BEH)
Enrollment 261
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description

Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants had an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment was assessed.

Analgesic and co-analgesic therapy: During the baseline assessment, the nurse care managers determined current and past treatments for chronic lower back pain.

Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Period Title: Overall Study
Started 131 130
3-month Completed 122 119
6-month Completed 122 116
9-month Completed 115 101
12-moth Completed 110 105
Completed 110 105
Not Completed 21 25
Reason Not Completed
Withdrawal by Subject             12             17
Death             2             1
Lost to Follow-up             7             7
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH) Total
Hide Arm/Group Description Subjects in the Pharmacological (PHARM) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. During the baseline assessment, the nurse care managers will determine current and past treatments for chronic lower back pain and establish whether or not patients have had an adequate trial (i.e., were analgesics sufficiently dosed). If not, the nurse care manager in conjunction with study doctors will recommend an adjustment of the patients' opioid or initiate treatment with a co-analgesic with appropriate dosing and scheduling. Veterans randomized to behavioral treatment arm (BEH) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. Total of all reporting groups
Overall Number of Baseline Participants 131 130 261
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 130 participants 261 participants
57.6  (9.8) 58.2  (9.2) 57.9  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 130 participants 261 participants
Female
7
   5.3%
13
  10.0%
20
   7.7%
Male
124
  94.7%
117
  90.0%
241
  92.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 130 participants 261 participants
American Indian or Alaska Native
3
   2.3%
1
   0.8%
4
   1.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
29
  22.1%
25
  19.2%
54
  20.7%
White
91
  69.5%
100
  76.9%
191
  73.2%
More than one race
2
   1.5%
0
   0.0%
2
   0.8%
Unknown or Not Reported
6
   4.6%
4
   3.1%
10
   3.8%
1.Primary Outcome
Title Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months
Hide Description The Brief Pain Inventory Total Score combines scores from the BPI Pain Intensity subscale and the BPI Pain Interference subscale. This scale provides a total score from 0 (no pain/no pain interference) to 10 (worst pain imaginable/completely interferes). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.
Time Frame Baseline and 3, 6, 9, and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 131 participants 130 participants
6.45  (1.79) 6.49  (1.67)
3 months Number Analyzed 121 participants 118 participants
-0.88  (0.16) -0.50  (0.17)
6 months Number Analyzed 121 participants 114 participants
-0.91  (0.16) -0.51  (0.17)
9 months Number Analyzed 105 participants 98 participants
-1.00  (0.17) -0.69  (0.18)
12 months Number Analyzed 108 participants 105 participants
-0.97  (0.17) -0.50  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Pharmacological (PHARM), Arm 2: Behavioral Treatment (BEH)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0385
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Parameter Dispersion
Type: Standard Deviation
Value: 0.13
Estimation Comments [Not Specified]
2.Primary Outcome
Title Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point
Hide Description The Brief Pain Inventory pain intensity score is scored from 0 (no pain) to 10 (worst pain imaginable). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.
Time Frame Baseline and 3, 6, 9, and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 131 participants 130 participants
6.78  (1.65) 6.76  (1.47)
3 months Number Analyzed 121 participants 118 participants
-0.67  (0.14) -0.37  (0.15)
6 months Number Analyzed 121 participants 114 participants
-0.68  (0.14) -0.17  (0.15)
9 months Number Analyzed 105 participants 98 participants
-0.79  (0.15) -0.44  (0.16)
12 months Number Analyzed 108 participants 105 participants
-0.86  (0.15) -0.25  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Pharmacological (PHARM), Arm 2: Behavioral Treatment (BEH)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.44
Parameter Dispersion
Type: Standard Deviation
Value: 0.11
Estimation Comments [Not Specified]
3.Primary Outcome
Title Brief Pain Inventory Pain Interference Scale Score
Hide Description The Brief Pain Inventory Pain Interference Scale score assesses if pain interferes with 7 common activities. This scale is score 0 (no interference) to 10 (high interference). The 7-items are averaged to give a score.
Time Frame Baseline and 3, 6, 9, and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 131 participants 130 participants
6.34  (2.07) 6.39  (1.99)
3 months Number Analyzed 121 participants 118 participants
-1.00  (0.19) -0.68  (0.25)
6 months Number Analyzed 121 participants 114 participants
-1.02  (0.19) -0.65  (0.19)
9 months Number Analyzed 105 participants 98 participants
-1.10  (0.20) -0.80  (0.20)
12 months Number Analyzed 108 participants 105 participants
-1.03  (0.20) -0.58  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Pharmacological (PHARM), Arm 2: Behavioral Treatment (BEH)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0740
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.39
Parameter Dispersion
Type: Standard Deviation
Value: 0.15
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pain Catastrophizing Scale
Hide Description The Pain Catastrophizing Scale a 13-item scale that assesses catastrophizing - a pain belief that have been found to be strong predictor of poor treatment response. It is scored from 0 (no catastrophizing) to 52 (severe catastrophizing)
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
23.95  (12.77) 24.44  (11.27)
5.Secondary Outcome
Title Roland Morris Disability Scale
Hide Description The Roland Morris Disability Scale is a 24-item pain-specific measure of physical disability. It provides a score from 0 (no disability) to 24 (high disability)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
16.59  (4.70) 16.72  (4.15)
6.Secondary Outcome
Title Patient Health Questionnaire-9
Hide Description The Patient Health Questionnaire-9 is used to assess depression severity. It's 9-items that are scored from 0 (no depression) to 27 (severe depression)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
11.18  (6.40) 11.19  (5.82)
7.Secondary Outcome
Title Generalized Anxiety Disorder 7-item (GAD-7) Scale
Hide Description The GAD-7 is a measure of anxiety. The GAD-7 consists of 7 items that are scored from 0 (no anxiety) to 21 (severe anxiety)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
6.68  (5.13) 6.81  (4.63)
8.Secondary Outcome
Title AUDIT-C
Hide Description The AUDIT-C is validated as an effective screening test and diagnostic tool for alcohol misuse in primary care samples. It is scored on 0 to 10 score with higher scores representing alcohol misuse
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5.65  (5.51) 5.87  (5.71)
9.Secondary Outcome
Title Current Opioid Misuse Measure (COMM)
Hide Description The COMM (Current Opioid Misuse Measure) is a 17-item instrument designed to monitor misuse and aberrant behaviors in patients prescribed opioids. The scale is scored from 0 (no evidence of opioid misuse or aberrant behaviors) to 64 (strong evidence for opioid misuse and aberrant behaviors)
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8.73  (6.81) 8.87  (6.54)
10.Secondary Outcome
Title SF-36 General Health Perception
Hide Description The SF-36 is a subscale that assesses the self-reported general health. It is scored on a 0 to 100 scale with higher scores representing greater perceived general health
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
43.66  (20.92) 45.39  (18.64)
11.Secondary Outcome
Title SF-36 Vitality Scale
Hide Description The SF-36 vital score is a subscale that assesses participants' vitality/energy. It is scored on a 0 to 100 scale with higher scores representing greater vitality/energy.
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
38.64  (16.98) 35.08  (16.17)
12.Secondary Outcome
Title SF-36 Social Functioning Scale
Hide Description The SF-36 social functioning scale is a subscale that assesses the self-reported social functioning. It is scored on a 0 to 100 scale with higher scores representing better social functioning.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description:
Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Number of Participants Analyzed 131 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
48.47  (27.21) 49.81  (29.32)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
 
Arm/Group Title Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Hide Arm/Group Description Nurse care managers followed an analgesic algorithm; supervised by study physicians Clinical psychologist delivered pain self-management/pain coping skills to Veterans
All-Cause Mortality
Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/131 (1.53%)      1/130 (0.77%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/131 (4.58%)      1/130 (0.77%)    
Cardiac disorders     
Atrial Fibrillation  [1]  1/131 (0.76%)  1 0/130 (0.00%)  0
Gastrointestinal disorders     
Small Bowel Obstruction  [2]  2/131 (1.53%)  6 0/130 (0.00%)  0
Infections and infestations     
Urinary Tract Infection and Sepsis  [3]  2/131 (1.53%)  2 0/130 (0.00%)  0
Surgical and medical procedures     
Knee Replacement Surgery  [4]  1/131 (0.76%)  1 1/130 (0.77%)  1
Indicates events were collected by systematic assessment
[1]
Participant admitted for atrial fibrillation with rapid ventricular rate
[2]
Participant was admitted to hospital for small bowel obstruction Another participant was admitted for dehydration due to high output ileostomy
[3]
Participant was admitted for urinary tract infection and sepsis Another participant was admitted with fever and cough. Discharge diagnosis was viral illness
[4]
Patient was admitted for knee replacement surgery
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Pharmacological (PHARM) Arm 2: Behavioral Treatment (BEH)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/131 (7.63%)      2/130 (1.54%)    
Cardiac disorders     
other adverse event   1/131 (0.76%)  2 0/130 (0.00%)  0
Gastrointestinal disorders     
other adverse event   2/131 (1.53%)  4 0/130 (0.00%)  0
Infections and infestations     
other adverse event   6/131 (4.58%)  6 0/130 (0.00%)  0
Musculoskeletal and connective tissue disorders     
other adverse event *  0/131 (0.00%)  0 2/130 (1.54%)  2
Renal and urinary disorders     
other adverse event   1/131 (0.76%)  1 0/130 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Matthew J. Bair
Organization: VA Center for Health Information and Communication
Phone: 317-988-2058
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01236521     History of Changes
Other Study ID Numbers: IIR 10-128
First Submitted: November 5, 2010
First Posted: November 8, 2010
Results First Submitted: March 8, 2017
Results First Posted: June 8, 2018
Last Update Posted: July 11, 2018