Care Management for the Effective Use of Opioids (CAMEO)

July 19, 2023 updated by: VA Office of Research and Development

Care Management for the Effective Use of Opioids (CAMEO)

The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. The study aims are to compare the interventions' (PHARM vs. BEH) effects on pain intensity, pain interference, function, and other pain relevant outcomes over 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The general purpose of the CAre Management for the Effective use of Opioids (CAMEO) study is to develop, test, and implement novel treatments and care delivery models that address barriers to effective pain management and that can be practicably applied in VA primary care settings for chronic low back pain (CLBP). The CAMEO trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for CLBP.

The investigators' study sample will target 272 Veterans with moderate to severe CLBP despite long-term opioid therapy. Patients from five primary care clinics at the Roudebush VA Medical Center and two community based outpatient clinics will be recruited to participate in CAMEO and randomized to one of two treatment arms. The pharmacological arm will involve guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (MED). Patients in the behavioral arm (CBT) will receive pain self-management/coping skills training. The trial will last 12-months and all participants will undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months.

Study Aims: Among Veterans with chronic low back pain refractory to long-term opioid therapy

  1. To compare the interventions' (MED vs. CBT) effects on pain intensity and function over 12 months

  2. To compare the interventions' effects (MED vs. CBT) on other relevant outcomes

    • Health-related quality of life
    • Pain Catastrophizing
    • Depression
    • Anxiety
    • Disability
    • Opioid misuse and opioid dose

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Veterans will be eligible if they have:

  • chronic lower back pain of at least moderate intensity
  • pain for 6 months
  • on chronic opioid therapy
  • and access to a working telephone

Exclusion Criteria:

Exclusion criteria includes:

  • severe medical conditions
  • active psychosis
  • schizophrenia
  • active suicidal ideation
  • pending back surgery
  • moderately severe cognitive impairment
  • involvement in ongoing pain trials
  • and pregnant or trying to become pregnant

The investigators will exclude Veterans with an active substance use disorder (i.e., those currently in treatment), but to maximize generalizability the investigators will not exclude those with a past history of substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Pharmacological (MED)
Subjects in the Pharmacological (MED) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants will have an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. Patients' opioids will be adjusted and/or co-analgesics (or adjuvants) will be initiated. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. Follow-up NCM telephone contacts will occur at 2 and 4 weeks after baseline, and months 2, 3, 4, 6, and 9 months. On average, these calls last between 10 to 20 minutes. Detailed logs will be kept of the timing and content of patient contacts.
Drug: Pharmacological (MED)

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.

The Patients in the MED arm will be asked to sign an opioid treatment agreement at enrollment.

Other Names:
  • Co-analgesic algorithm
Experimental: Arm 2: Behavioral treatment (CBT)
Veterans randomized to behavioral treatment arm (CBT) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. Since optimal application of non-pharmacological interventions for pain involves tailoring to patient needs, participants will be introduced to a menu of self-management and coping skills rather than receive a prescribed program. Delivery of the behavioral intervention will employ a flexible approach that is easily adapted to individual preferences and perceived need for learning specific pain coping skills. Tailoring will include the selection of relevant content and skills and assessment of readiness to change behaviors.
Behavioral: Behavioral treatment (CBT)
There will be 8 sessions of pain self-management and coping skills.
Other Names:
  • Pain self-management/coping skills treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline and 3, 6, 9, and 12 months
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point
Time Frame: Baseline and 3, 6, 9, and 12 months
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.
Baseline and 3, 6, 9, and 12 months
Brief Pain Inventory Pain Interference Scale Score
Time Frame: Baseline and 3, 6, 9, and 12 months
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.
Baseline and 3, 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale
Time Frame: Baseline, 6 months, and 12 months
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)
Baseline, 6 months, and 12 months
Roland Morris Disability Scale
Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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)
Baseline, 3 months, 6 months, 9 months, and 12 months
Patient Health Questionnaire-9
Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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)
Baseline, 3 months, 6 months, 9 months, and 12 months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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)
Baseline, 3 months, 6 months, 9 months, and 12 months
AUDIT-C
Time Frame: Baseline, 6 months, and 12 months
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
Baseline, 6 months, and 12 months
Current Opioid Misuse Measure (COMM)
Time Frame: Baseline, 6 months, and 12 months
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)
Baseline, 6 months, and 12 months
SF-36 General Health Perception
Time Frame: Baseline, 6 months, and 12 months
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
Baseline, 6 months, and 12 months
SF-36 Vitality Scale
Time Frame: Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months
SF-36 Social Functioning Scale
Time Frame: Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Matthew J. Bair, MD MS, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

December 11, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimated)

November 7, 2010

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 10-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Upon request, we will share data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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