Care Management for the Effective Use of Opioids

Pain Clinical Trial

— CAMEO  

Official title:

Care Management for the Effective Use of Opioids (CAMEO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236521
• Other study ID #: IIR 10-128
• Status: Completed
• Phase: N/A
• Start date: December 1, 2011
• Est. completion date: December 31, 2015

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: December 31, 2015
• Est. primary completion date: December 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

Intervention

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.

Behavioral:
• Behavioral treatment (CBT)
There will be 8 sessions of pain self-management and coping skills.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Vancouv

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; — View 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 Receivi — View 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. — View 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 — View 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;266:1 — View 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 — View 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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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