NCT00926588

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3 pain

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 19, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

3.7 years

First QC Date

June 18, 2009

Results QC Date

November 7, 2014

Last Update Submit

July 17, 2015

Conditions

Pain

Keywords

PainTelecareCollaborative care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Drug: Stepped care

Usual Care

NO INTERVENTION

Patients receive usual care for pain from their primary care physician

Interventions

Stepped careDRUG

Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.

Also known as: Optimized analgesics with collaborative care management
Stepped Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (8)

  • 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.

    PMID: 23228858RESULT

  • 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.

    PMID: 23639186RESULT

  • 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.

    PMID: 24369044RESULT

  • 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.

    PMID: 25027139RESULT

  • 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.

    PMID: 41436014DERIVED

  • 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.

    PMID: 27187854DERIVED

  • 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.

    PMID: 25786741DERIVED

  • 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.

    PMID: 25138978DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Kurt Kroenke
Organization
VA HSRD
kkroenke@regenstrief.org
317-988-3476

Study Officials

  • Kurt Kroenke, MD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 23, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2015

Last Updated

August 7, 2015

Results First Posted

December 19, 2014

Record last verified: 2015-07

Locations

US(1)