Care Management for the Effective Use of Opioids

Study Overview
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Brief Summary
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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.

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

Official Title
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Care Management for the Effective Use of Opioids (CAMEO)

Conditions
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Low Back Pain, Pain

Intervention / Treatment
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* Drug: Pharmacological (MED)
* Behavioral: Behavioral treatment (CBT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Pharmacological (MED)<br>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)<br>* 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.<br>* Other names: Co-analgesic algorithm;|
| Experimental: Arm 2: Behavioral treatment (CBT)<br>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)<br>* There will be 8 sessions of pain self-management and coping skills.<br>* Other names: Pain self-management/coping skills treatment;|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back pain, Care Management, Pain, Patient outcomes, Patient-center Care, Primary care