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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Veterans will be eligible if they have:
Exclusion Criteria:
Exclusion criteria includes:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Bair, MD MS | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29200181 | Result | 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. | |
| 30529442 | 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. |
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Upon request, we will share data with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Pharmacological (PHARM) | Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants had an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment was assessed. Analgesic and co-analgesic therapy: During the baseline assessment, the nurse care managers determined current and past treatments for chronic lower back pain. |
| FG001 | Arm 2: Behavioral Treatment (BEH) | Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Pharmacological (PHARM) | Subjects in the Pharmacological (PHARM) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 9, and 12 months |
|
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Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Pharmacological (PHARM) | Nurse care managers followed an analgesic algorithm; supervised by study physicians |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee Replacement Surgery | Surgical and medical procedures | Systematic Assessment | Patient was admitted for knee replacement surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| other adverse event | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew J. Bair | VA Center for Health Information and Communication | 317-988-2058 | mbair@iupui.edu; Matthew.Bair@va.gov |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral treatment (CBT) | Behavioral | There will be 8 sessions of pain self-management and coping skills. |
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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 |
| 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. |
| 32056864 | 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. |
| 33541362 | 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. |
| 34052655 | 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. |
| 34048943 | 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. |
| 36394874 | 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. |
| 24073098 | 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. |
| 39172815 | Derived | 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. |
| Lost to Follow-up |
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| BG001 | Arm 2: Behavioral Treatment (BEH) | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period. |
| OG001 | Arm 2: Behavioral Treatment (BEH) | Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. |
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| 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. | We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 9, and 12 months |
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| 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. | We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3, 6, 9, and 12 months |
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| 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) | Posted | Mean | Standard Deviation | scores on a scale | 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) | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 3 months, 6 months, 9 months, and 12 months |
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| 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) | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 3 months, 6 months, 9 months, and 12 months |
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| 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) | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 3 months, 6 months, 9 months, and 12 months |
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| 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 | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months, and 12 months |
|
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| 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) | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months, and 12 months |
|
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|
| 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 | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months, and 12 months |
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months, and 12 months |
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months, and 12 months |
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| 2 |
| 131 |
| 6 |
| 131 |
| 10 |
| 131 |
| EG001 | Arm 2: Behavioral Treatment (BEH) | Clinical psychologist delivered pain self-management/pain coping skills to Veterans | 1 | 130 | 1 | 130 | 2 | 130 |
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| Small Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment | Participant was admitted to hospital for small bowel obstruction Another participant was admitted for dehydration due to high output ileostomy |
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| Urinary Tract Infection and Sepsis | Infections and infestations | Systematic Assessment | Participant was admitted for urinary tract infection and sepsis Another participant was admitted with fever and cough. Discharge diagnosis was viral illness |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | Participant admitted for atrial fibrillation with rapid ventricular rate |
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| other adverse event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| other adverse event | Cardiac disorders | Systematic Assessment |
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| other adverse event | Gastrointestinal disorders | Systematic Assessment |
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| other adverse event | Renal and urinary disorders | Systematic Assessment |
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