Care Management for the Effective Use of Opioids - Full Text View

Purpose

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: 1) to compare the interventions' (PHARM vs. BEH) effects on pain intensity, function, and other pain relevant outcomes at 6 months (primary end point) and 12 months (sustained effect); and 2) to compare the cost-effectiveness of the interventions

Condition	Intervention
Low Back Pain Pain	Drug: Analgesic and co-analgesic therapy Behavioral: Pain self-management/coping skills treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Care Management for the Effective Use of Opioids (CAMEO)

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Brief Pain Inventory (BPI), includes BPI pain intensity score, BPI pain interference score and Roland Disability Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychological distress (PHQ-9, GAD-7 Anxiety, VA PTSD Screener, AUDIT-C [ Time Frame: at baseline, 3, 6, 6 9 and 12 months ] [ Designated as safety issue: No ]
Opioid Misuse - Current Opioid Misuse Measure (COMM) [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Generic HRQL (SF-12) measure of health status [ Time Frame: at baseline, 6 and 12 months ] [ Designated as safety issue: No ]
Pain Beliefs (Pain Catastrophizing Scale) [ Time Frame: at baseline, 6 and 12 months ] [ Designated as safety issue: No ]
Patient Global Rating of Change (PGIC) [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Opioid Dose [ Time Frame: at baseline, 6 and 12 months ] [ Designated as safety issue: No ]
Back Function (Functional Improvement) [ Time Frame: at baseline, 6 and 12 months ] [ Designated as safety issue: No ]
Social Support Questionnaire (SSQ6) [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	December 2011
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 Subjects in the Pharmacological (PHARM) 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: Analgesic and co-analgesic therapy 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 PHARM arm will be asked to sign an opioid treatment agreement at enrollment.
Experimental: Arm 2 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. 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: Pain self-management/coping skills treatment There will be 8 sessions that will last a maximum of 45-minutes to optimize participants' attentiveness and performance required by the cognitive demands of pain coping skills training. Each session will adhere to a common structure organized into three parts: 1) check-in; 2) intervention, and 3) wrap-up. Prior to each session participants will be asked to rate the strength and perceived impact for up to four pain beliefs that participants and the psychologist identified together. The sessions will occur during the scheduled clinical contacts (by telephone or face-to-face depending on patient preferences) at: with one week of baseline, 2 and 4 weeks, and months 2, 3, and 4 and skills reinforced at months 6 and 9. The content of these sessions are designed to modify coping strategies found to be related to pain and disability. Briefly, patients will be trained in a variety of evidence-based skills found to help reduce pain and improve function.

Arms

Assigned Interventions

Active Comparator: Arm 1

Subjects in the Pharmacological (PHARM) 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: Analgesic and co-analgesic therapy

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 PHARM arm will be asked to sign an opioid treatment agreement at enrollment.

Experimental: Arm 2

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. 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: Pain self-management/coping skills treatment

There will be 8 sessions that will last a maximum of 45-minutes to optimize participants' attentiveness and performance required by the cognitive demands of pain coping skills training. Each session will adhere to a common structure organized into three parts: 1) check-in; 2) intervention, and 3) wrap-up. Prior to each session participants will be asked to rate the strength and perceived impact for up to four pain beliefs that participants and the psychologist identified together. The sessions will occur during the scheduled clinical contacts (by telephone or face-to-face depending on patient preferences) at: with one week of baseline, 2 and 4 weeks, and months 2, 3, and 4 and skills reinforced at months 6 and 9. The content of these sessions are designed to modify coping strategies found to be related to pain and disability. Briefly, patients will be trained in a variety of evidence-based skills found to help reduce pain and improve function.

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.

Our study sample will include 450 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 (PHARM). Patients in the behavioral arm (BEH) 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' (PHARM vs. BEH) effects on pain intensity and function at 6 months (primary end point) and 12 months (sustained effect)
To compare the interventions' effects (PHARM vs. BEH) on other relevant outcomes
- Patient global impression of change
- Health-related quality of life
- Opioid dose
To compare the cost-effectiveness of the interventions

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236521

Contacts

Contact: Christy Sargent, BA CRA	(317) 988-3838	Christy.Sargent@va.gov
Contact: Katie Allen, BS CRA	(317) 988-4799	Katie.Allen@va.gov

Locations

United States, Indiana
Richard Roudebush VA Medical Center	Recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Dennis Benge, BA MBA 317-988-2604 Dennis.Benge@va.gov
Contact: Katie Allen, BS CRA (317) 988-4799 Katie.Allen@va.gov
Principal Investigator: Matthew J. Bair, MD MS
Sub-Investigator: Teresa M. Damush, PhD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Matthew J. Bair, MD MS

Richard Roudebush VA Medical Center

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT01236521 History of Changes
Other Study ID Numbers:	IIR 10-128
Study First Received:	November 5, 2010
Last Updated:	January 15, 2013
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Back pain
Care Management
Pain

Patient outcomes
Patient-center Care
Primary care

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Analgesics, Opioid

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 21, 2013

Care Management for the Effective Use of Opioids (CAMEO)