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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1: Pharmacological (PHARM)

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.

Arm 2: Behavioral Treatment (BEH) 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.

Participant Flow:   Overall Study
    Arm 1: Pharmacological (PHARM)   Arm 2: Behavioral Treatment (BEH)
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 
Withdrawal by Subject                12                17 
Death                2                1 
Lost to Follow-up                7                7 



  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.
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Reporting Groups
  Description
Arm 1: Pharmacological (PHARM) 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.
Arm 2: Behavioral Treatment (BEH) 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 Total of all reporting groups

Baseline Measures
   Arm 1: Pharmacological (PHARM)   Arm 2: Behavioral Treatment (BEH)   Total 
Overall Participants Analyzed 
[Units: Participants]
 131   130   261 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (9.8)   58.2  (9.2)   57.9  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7   5.3%      13  10.0%      20   7.7% 
Male      124  94.7%      117  90.0%      241  92.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months   [ Time Frame: Baseline and 3, 6, 9, and 12 months ]

2.  Primary:   Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point   [ Time Frame: Baseline and 3, 6, 9, and 12 months ]

3.  Primary:   Brief Pain Inventory Pain Interference Scale Score   [ Time Frame: Baseline and 3, 6, 9, and 12 months ]

4.  Secondary:   Pain Catastrophizing Scale   [ Time Frame: baseline ]

5.  Secondary:   Roland Morris Disability Scale   [ Time Frame: Baseline ]

6.  Secondary:   Patient Health Questionnaire-9   [ Time Frame: Baseline ]

7.  Secondary:   Generalized Anxiety Disorder 7-item (GAD-7) Scale   [ Time Frame: Baseline ]

8.  Secondary:   AUDIT-C   [ Time Frame: Baseline ]

9.  Secondary:   Current Opioid Misuse Measure (COMM)   [ Time Frame: baseline ]

10.  Secondary:   SF-36 General Health Perception   [ Time Frame: baseline ]

11.  Secondary:   SF-36 Vitality Scale   [ Time Frame: baseline ]

12.  Secondary:   SF-36 Social Functioning Scale   [ Time Frame: Baseline ]


  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
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  More Information

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
e-mail: mbair@iupui.edu; Matthew.Bair@va.gov


Publications of Results:

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