Care Management for the Effective Use of Opioids

NCT01236521 | Completed Results DMC

• 1 other identifier: IIR 10-128
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Pain

Keywords

Back pain; Care Management; Pain; Patient outcomes; Patient-center Care; Primary care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Pain Catastrophizing Scale

  Baseline, 6 months, and 12 months

• Roland Morris Disability Scale

  Baseline, 3 months, 6 months, 9 months, and 12 months

• Patient Health Questionnaire-9

  Baseline, 3 months, 6 months, 9 months, and 12 months

• Generalized Anxiety Disorder 7-item (GAD-7) Scale

  Baseline, 3 months, 6 months, 9 months, and 12 months

• AUDIT-C

  Baseline, 6 months, and 12 months

Study Arms (2)

Arm 1: Pharmacological (MED)

EXPERIMENTAL

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)

Arm 2: Behavioral treatment (CBT)

EXPERIMENTAL

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)

Interventions

Pharmacological (MED) DRUG

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.

Also known as: Co-analgesic algorithm

Arm 1: Pharmacological (MED)

Behavioral treatment (CBT) BEHAVIORAL

There will be 8 sessions of pain self-management and coping skills.

Also known as: Pain self-management/coping skills treatment

Arm 2: Behavioral treatment (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (10)

• 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.

  PMID: 29200181 RESULT

• 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.

  PMID: 30529442 RESULT

• 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.

  RESULT

• 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.

  PMID: 32056864 RESULT

• 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.

  PMID: 33541362 RESULT

• 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.

  PMID: 34052655 RESULT

• 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.

  PMID: 34048943 RESULT

• 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.

  PMID: 36394874 RESULT

• 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.

  PMID: 24073098 RESULT

• Koechlin H, Locher C, Barke A, Korwisi B. Retrospective identification of the diagnosis of chronic primary musculoskeletal pain: a pragmatic suggestion by The Pain Net. Pain. 2025 Feb 1;166(2):311-314. doi: 10.1097/j.pain.0000000000003380. Epub 2024 Sep 3. No abstract available.

  PMID: 39172815 DERIVED

MeSH Terms

Conditions

Low Back Pain; Pain; Back Pain

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Matthew J. Bair
• Organization: VA Center for Health Information and Communication

mbair@iupui.edu; Matthew.Bair@va.gov

317-988-2058

Study Officials

• Matthew J. Bair, MD MS

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: December 1, 2011
• Primary Completion: December 11, 2015
• Study Completion: December 31, 2015
• Last Updated: July 27, 2023
• Results First Posted: June 8, 2018

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)