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Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.
SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity, and randomize them to either the stepped care intervention or usual care control group. The intervention will be based upon the empirically-validated Three-Component Model which in SCOPE will involve collaboration between the primary care physician, a nurse pain care manager, and a supervising physician pain specialist. SCOPE will involve a telemedicine approach coupling automated home-based symptom monitoring with telephone-based nurse care management. The intervention will consist of optimized analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. Our principal aim is to test whether SCOPE is more effective than usual care in reducing pain as measured by the Brief Pain Inventory. Secondarily, we will test the impact on other pain outcomes (e.g., severity, self-efficacy, use of self-management strategies), emotional functioning, health-related quality of life, and treatment satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped Care | Experimental | Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used. |
|
| Usual Care | No Intervention | Patients receive usual care for pain from their primary care physician |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped care | Drug | Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (Pain) | The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain). | 1 year |
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Inclusion Criteria:
SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomize them to either the stepped care intervention or usual care control group.
Exclusion Criteria:
Individuals who:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Kroenke, MD | 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 |
|---|---|---|---|
| 23228858 | Result | Kroenke K, Krebs E, Wu J, Bair MJ, Damush T, Chumbler N, York T, Weitlauf S, McCalley S, Evans E, Barnd J, Yu Z. Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics. Contemp Clin Trials. 2013 Mar;34(2):270-81. doi: 10.1016/j.cct.2012.11.008. Epub 2012 Dec 8. | |
| 23639186 | Result |
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Participants were recruited from June 2010 through May 2012. Patients and physicians in 5 primary care clinics in the Roudebush Veterans Administration Medical Center in Indianapolis participated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stepped Care | Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used. Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study. |
| FG001 | Usual Care | Patients receive usual care for pain from their primary care physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stepped Care | Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used. Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 (Pain) | The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain). | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
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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 | Stepped Care | Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used. Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization unrelated to research study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kurt Kroenke | VA HSRD | 317-988-3476 | kkroenke@regenstrief.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Kroenke K, Outcalt S, Krebs E, Bair MJ, Wu J, Chumbler N, Yu Z. Association between anxiety, health-related quality of life and functional impairment in primary care patients with chronic pain. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):359-65. doi: 10.1016/j.genhosppsych.2013.03.020. Epub 2013 Apr 29. |
| 24369044 | Result | Chumbler NR, Kroenke K, Outcalt S, Bair MJ, Krebs E, Wu J, Yu Z. Association between sense of coherence and health-related quality of life among primary care patients with chronic musculoskeletal pain. Health Qual Life Outcomes. 2013 Dec 26;11:216. doi: 10.1186/1477-7525-11-216. |
| 25027139 | Result | Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689. |
| 41436014 | Derived | He A, Kroenke K, Stump T, Monahan PO, Connors J, Chernyak Y, Musey P. The patient health questionnaire somatization-anxiety-depression scale: Validation of the PHQ-SAD in 4 clinical trials. J Affect Disord. 2026 Apr 1;398:120906. doi: 10.1016/j.jad.2025.120906. Epub 2025 Dec 21. |
| 27187854 | Derived | Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322. |
| 25786741 | Derived | Outcalt SD, Kroenke K, Krebs EE, Chumbler NR, Wu J, Yu Z, Bair MJ. Chronic pain and comorbid mental health conditions: independent associations of posttraumatic stress disorder and depression with pain, disability, and quality of life. J Behav Med. 2015 Jun;38(3):535-43. doi: 10.1007/s10865-015-9628-3. Epub 2015 Mar 19. |
| 25138978 | Derived | Kroenke K, Yu Z, Wu J, Kean J, Monahan PO. Operating characteristics of PROMIS four-item depression and anxiety scales in primary care patients with chronic pain. Pain Med. 2014 Nov;15(11):1892-901. doi: 10.1111/pme.12537. Epub 2014 Aug 19. |
| BG001 | Usual Care | Patients receive usual care for pain from their primary care physician |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Patients receive usual care for pain from their primary care physician |
|
|
| 22 |
| 124 |
| 0 |
| 124 |
| EG001 | Usual Care | Patients receive usual care for pain from their primary care physician | 8 | 126 | 0 | 126 |
|
| Gall bladder removal surgery | Gastrointestinal disorders | Non-systematic Assessment | Surgery unrelated to participation in study. |
|
| Cardiac hospitalization | Cardiac disorders | Non-systematic Assessment | Cardiac hospitalization unrelated to participation in study. |
|
| Hospitalization due to infection | Infections and infestations | Non-systematic Assessment | Hospitalization not related to participation in study. |
|
| TIA hospitalization | Nervous system disorders | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Stress center hospitalization | Psychiatric disorders | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Sinus surgery hospitalization | Surgical and medical procedures | Non-systematic Assessment | Subject admitted to hospital for planned sinus surgery. |
|
| Hospitalization due to renal failure | Renal and urinary disorders | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Hospitalization due to knee replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Hospitalization and surgery unrelated to participation in study. |
|
| Hospitalization due to motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Bladder repair surgery and hospitalization | Renal and urinary disorders | Non-systematic Assessment | Surgery and hospitalization unrelated to participation in study. |
|
| Hospitalization due to removal of fibroids | Surgical and medical procedures | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Hospitalization due to planned hysterectomy | Reproductive system and breast disorders | Non-systematic Assessment | Surgery and hospitalization unrelated to participation in study. |
|
| Hospitalization due to appendicitis | Gastrointestinal disorders | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Hospitalization due to esophagogastrectomy | Gastrointestinal disorders | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Hospitalization due to hypotension, headache, muscle ache | General disorders | Non-systematic Assessment | Hospitalization unrelated to participation in study. |
|
| Mental Health referral due to suicidality | Psychiatric disorders | Non-systematic Assessment | Unrelated to participation in study. |
|
| Hospitalization due to coronary artery bypass surgery | Cardiac disorders | Non-systematic Assessment | Hospitalization unrelated to participation in research study. |
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| Subject suicidal ideation | Psychiatric disorders | Non-systematic Assessment | Subject revealed suicidal ideation during screening. Unrelated to participation in research study. |
|
| Death | General disorders | Non-systematic Assessment | Death unrelated to participation in study. |
|
| Hospitalization due to sepsis | Injury, poisoning and procedural complications | Non-systematic Assessment | Hospitalization unrelated to participation in research |
|
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