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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.
Study aims: This study will test which of two pain treatment strategies is better for managing pain and helping patients improve safety of opioid medication. For patients on high opioid doses who want to reduce, this study will also test whether offering an extra option for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine patients' and clinicians' experiences with the interventions.
Study description: The study will compare two treatment strategies among patients with pain who are taking long-term opioid pain medications prescribed by VA healthcare facilities across the country. Patients who wish to enter the study will be assigned by chance to telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a pharmacist and supervising physician working together to find the best medication options for each individual patient. In IPT, a team of clinicians focuses on non-medication pain management options, in addition to pain medication.
All participants will be asked to stay in the study for 12 months. Patients for whom it would be unsafe to participate will not be invited to join. With either treatment strategy, TCM or IPT, participants will have individualized pain care tailored to their needs and preferences. Participants on high opioid medication doses who want to reduce their opioid medication dose will be assigned by chance to get either a regular step-wise taper or a choice between a regular taper or switching to a different medication (buprenorphine-naloxone).
At the end of the study, the two treatment strategies will be compared to see which worked better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes important to patients will also be tracked. These include quality of life, sleep, fatigue, depression, anxiety, and side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telecare collaborative management (TCM) | Active Comparator | Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care. |
|
| Integrated pain team (IPT) | Active Comparator | Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options. |
|
| Standard taper options | Active Comparator | The standard taper options arm uses patient education and shared decision-making to guide opioid medication management. |
|
| Expanded taper options | Active Comparator | The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication management | Other | Individualized management of medications for pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Response | Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 50% Reduction in Opioid Daily Dose | Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline | 12 months |
| Composite Response | Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| VR-12 Physical Component Score | Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better) | 12 months |
| Symptom Checklist | Medication-related adverse symptoms count (0-19; higher is worse) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39960730 | Derived | Becker WC, Seal KH, Nelson DB, DeRonne BM, Kats AM, Morasco BJ, Frank JW, Makris UE, Painter JT, Allen KD, Mixon AS, Bohnert A, Reznik TE, Hagedorn HJ, Hammett P, Borsari B, Baxley C, Krebs EE; VOICE Study Group. Buprenorphine, Pain, and Opioid Use in Patients Taking High-Dose Long-Term Opioids: A Randomized Clinical Trial. JAMA Intern Med. 2025 Apr 1;185(4):372-381. doi: 10.1001/jamainternmed.2024.8361. | |
| 39652356 |
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Data sharing procedures have not been finalized. At a minimum, a complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses of the study will be created and made available within one year after the completion of the study, pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Depending on feasibility and guidance from VA Office of Research Oversight, a Limited Dataset (LDS) may be created and shared. We have not yet determined how to operationalize data sharing for this study. In the interim, contact the PI for questions or requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Telecare Collaborative Management (TCM) | Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care. |
| FG001 | Active Comparator: Integrated Pain Team (IPT) | Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Telecare Collaborative Management (TCM) | Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care. |
| BG001 | Active Comparator: Integrated Pain Team (IPT) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Pain Response | Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline | Posted | Count of Participants | Participants | 12 months |
|
12 months
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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 | Active Comparator: Telecare Collaborative Management (TCM) | Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency department visit | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Krebs | University of Minnesota | 612-629-7558 | Erin.Krebs@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2022 | Mar 31, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2020 | Mar 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
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| Non-pharmacological pain management | Other | Individualized management of non-medication pain treatment approaches |
|
| Buprenorphine-Naloxone | Drug | Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation |
|
| 12 months |
| Brief Pain Inventory (BPI) Total Score | Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse) | 12 months |
| 12 months |
| PODS Problems | Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse) | 12 months |
| PHQ-8 | Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse) | 12 months |
| GAD-7 | General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse) | 12 months |
| PROMIS Sleep Disturbance | Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean. | 12 months |
| PROMIS Fatigue | Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean. | 12 months |
| Headache Impact Test | Headache Impact Test score (range 36-78; higher is worse) | 12 months |
| VR-12 Mental Component Score | Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better) | 12 months |
| PODS Concerns | Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse) | 12 months |
| Derived |
| Krebs EE, Becker WC, Nelson DB, DeRonne BM, Jensen AC, Kats AM, Morasco BJ, Frank JW, Makris UE, Allen KD, Naylor JC, Mixon AS, Bohnert A, Reznik TE, Painter JT, Hudson TJ, Hagedorn HJ, Manuel JK, Borsari B, Purcell N, Hammett P, Amundson EC, Kerns RD, Barbosa MR, Garvey C, Jones EJ, Noh MY, Okere JB, Bhushan S, Pinsonnault J, Williams BE, Herbst E, Lagisetty P, Librodo S, Mapara PS, Son E, Tat C, Marraffa RA, Seys RL, Baxley C, Seal KH; VOICE Study Group. Care Models to Improve Pain and Reduce Opioids Among Patients Prescribed Long-Term Opioid Therapy: The VOICE Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):208-220. doi: 10.1001/jamainternmed.2024.6683. |
| 36384218 | Derived | Krebs EE, Becker WC, Nelson D, DeRonne BM, Nugent S, Jensen AC, Amundson EC, Manuel JK, Borsari B, Kats AM, Seal KH. Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study. Contemp Clin Trials. 2023 Jan;124:107001. doi: 10.1016/j.cct.2022.107001. Epub 2022 Nov 13. |
Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 50% Reduction in Opioid Daily Dose | Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline | All participants who were alive at 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Composite Response | Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline. | All participants who completed the measure at 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Brief Pain Inventory (BPI) Total Score | Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Other Pre-specified | VR-12 Physical Component Score | Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Other Pre-specified | Symptom Checklist | Medication-related adverse symptoms count (0-19; higher is worse) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | symptom count | 12 months |
|
|
|
| Other Pre-specified | PODS Problems | Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Other Pre-specified | PHQ-8 | Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Other Pre-specified | GAD-7 | General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Other Pre-specified | PROMIS Sleep Disturbance | Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean. | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| Other Pre-specified | PROMIS Fatigue | Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean. | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| Other Pre-specified | Headache Impact Test | Headache Impact Test score (range 36-78; higher is worse) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Other Pre-specified | VR-12 Mental Component Score | Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Other Pre-specified | PODS Concerns | Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse) | All participants who completed the measure at 12 months | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 7 |
| 358 |
| 109 |
| 358 |
| 207 |
| 358 |
| EG001 | Active Comparator: Integrated Pain Team (IPT) | Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options. | 9 | 363 | 109 | 363 | 178 | 363 |
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| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |