PainPhase 3SCOPENCT00926588
Stepped Care to Optimize Pain Care Effectiveness
A Phase 3 study testing Stepped care in people with Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Stepped care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who:
- have filed a pain-related disability claim in the last 6 months;
- do not speak English;
- have moderately severe cognitive impairment;
- have schizophrenia, bipolar disorder, or other psychosis;
- are actively suicidal;
- have current illicit drug use; or
- have an anticipated life expectancy of less than 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- Stepped care
- Keywords
- Pain, Telecare, Collaborative care
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped careDrug
Also called Optimized analgesics with collaborative care management
Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Stepped care |
| Usual Care | No intervention | Patients receive usual care for pain from their primary care physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kurt Kroenke, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926588
- Sponsor's protocol ID
- IIR 07-119
- Acronym
- SCOPE
- Status last verified
- Jul 2015
- First submitted
- 18 Jun 2009
- Last updated
- 7 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23228858Kroenke 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.
PubMed 23639186Chumbler 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.
PubMed 24369044Kroenke 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.
PubMed 25027139He 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.
PubMed 41436014Kroenke 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.
PubMed 27187854Outcalt 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.
PubMed 25786741Kroenke 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.
PubMed 25138978
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
- ClinicalTrials.gov ID
- NCT00926588
- Acronym / sponsor ID
- SCOPE / IIR 07-119
- Conditions
- Pain
- Keywords
- Pain, Telecare, Collaborative care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Posted 19 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care | Experimental | Drug: Stepped carePatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- have filed a pain-related disability claim in the last 6 months;
- do not speak English;
- have moderately severe cognitive impairment;
- have schizophrenia, bipolar disorder, or other psychosis;
- are actively suicidal;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped careAlso: Optimized analgesics with collaborative care managementStructured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study. | Drug | Stepped Care |
Primary outcome
Brief Pain Inventory (Pain)
Time frame: 1 year
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23228858Kroenke 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.
- Results publication: PubMed 23639186Kroenke 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.
- Results publication: PubMed 24369044Chumbler 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.
- Results publication: PubMed 25027139Kroenke 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.
- Derived from this study: PubMed 41436014He 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.
- Derived from this study: PubMed 27187854Kroenke 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.
- Derived from this study: PubMed 25786741Outcalt 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.
- Derived from this study: PubMed 25138978Kroenke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Kroenke, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stepped care in people with Pain, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (Pain) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926588, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.