Clinical trial NCT01236521: Care Management for the Effective Use of Opioids
Official title: Care Management for the Effective Use of Opioids (CAMEO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Pain
Keywords: Back pain
Care Management
Pain
Patient outcomes
Patient-center Care
Primary care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-11-07
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility 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

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.

Primary outcomes:
measure: Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months
timeFrame: Baseline and 3, 6, 9, and 12 months
measure: Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point
timeFrame: Baseline and 3, 6, 9, and 12 months
measure: Brief Pain Inventory Pain Interference Scale Score
timeFrame: Baseline and 3, 6, 9, and 12 months
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 6 months, and 12 months
measure: Roland Morris Disability Scale
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: Patient Health Questionnaire-9
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: AUDIT-C
timeFrame: Baseline, 6 months, and 12 months
measure: Current Opioid Misuse Measure (COMM)
timeFrame: Baseline, 6 months, and 12 months
measure: SF-36 General Health Perception
timeFrame: Baseline, 6 months, and 12 months
measure: SF-36 Vitality Scale
timeFrame: Baseline, 6 months, and 12 months
measure: SF-36 Social Functioning Scale
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Matthew J. Bair, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen CX, Kroenke K, Stump TE, Kean J, Carpenter JS, Krebs EE, Bair MJ, Damush TM, Monahan PO. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018 Apr;159(4):775-782. doi: 10.1097/j.pain.0000000000001121.
citation: Chen CX, Kroenke K, Stump T, Kean J, Krebs EE, Bair MJ, Damush T, Monahan PO. Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials. J Pain. 2019 Jun;20(6):664-675. doi: 10.1016/j.jpain.2018.11.010. Epub 2018 Dec 6.
citation: Bair MJ, Outcalt SD, Slaven JE, Kroenke K, Kempf C, Zillich AJ, Damush TM, Saha C, French DD, Krebs EE. Care Management for the Effective Use of Opioids (CAMEO): A Randomized Trial. Abstracts of the 77th Annual Scientific Meeting, March 6-9, 2019. Vancouver, BC, Canada. Abstract 1734. [Abstract]. Psychosomatic medicine. 2019 May 1; 81(4):A-149.
citation: Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. J Affect Disord. 2020 Apr 1;266:100-108. doi: 10.1016/j.jad.2020.01.101. Epub 2020 Jan 23.
citation: Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health Qual Life Outcomes. 2021 Feb 4;19(1):41. doi: 10.1186/s12955-021-01674-3.
citation: Kroenke K, Stump TE, Kean J, Krebs EE, Damush TM, Bair MJ, Monahan PO. Diagnostic operating characteristics of PROMIS scales in screening for depression. J Psychosom Res. 2021 Aug;147:110532. doi: 10.1016/j.jpsychores.2021.110532. Epub 2021 May 25.
citation: Bushey MA, Slaven J, Outcalt SD, Kroenke K, Kempf C, Froman A, Sargent C, Baecher B, Zillich A, Damush TM, Saha C, French DD, Bair MJ. Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial. Contemp Clin Trials. 2021 Jul;106:106456. doi: 10.1016/j.cct.2021.106456. Epub 2021 May 25.
citation: Bushey MA, Slaven JE, Outcalt SD, Kroenke K, Kempf C, Froman A, Sargent C, Baecher B, Zillich AJ, Damush TM, Saha C, French DD, Bair MJ. Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242533. doi: 10.1001/jamanetworkopen.2022.42533.
citation: Midboe AM, Lewis ET, Paik MC, Gallagher RM, Rosenberg JM, Goodman F, Kerns RD, Becker WC, Trafton JA. Measurement of adherence to clinical practice guidelines for opioid therapy for chronic pain. Transl Behav Med. 2012 Mar;2(1):57-64. doi: 10.1007/s13142-011-0104-5.