Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial

Erin E. Krebs, Agnes C. Jensen, Sean Nugent, Beth DeRonne, Indulis Rutks, David Leverty, Amy Gravely, Siamak Noorbaloochi, Matthew J. Bair, Kurt Kroenke

Research output: Contribution to journalArticle

  • 4 Citations

Abstract

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12 months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31 months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21–80 years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care.

LanguageEnglish (US)
Pages130-139
Number of pages10
JournalContemporary Clinical Trials
Volume62
DOIs
StatePublished - Nov 1 2017

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Analgesics
Opioid Analgesics
Pain
Therapeutics
Hip Osteoarthritis
Knee Osteoarthritis
Back Pain
Post-Traumatic Stress Disorders
Random Allocation
Chronic Pain
Substance-Related Disorders
Primary Health Care
Mental Health
Anxiety
Alcohols
Depression
Delivery of Health Care

Keywords

  • Analgesics
  • Back pain
  • Chronic pain
  • Opioid analgesics
  • Osteoarthritis

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

Cite this

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. / Krebs, Erin E.; Jensen, Agnes C.; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J.; Kroenke, Kurt.

In: Contemporary Clinical Trials, Vol. 62, 01.11.2017, p. 130-139.

Research output: Contribution to journalArticle

Krebs, Erin E. ; Jensen, Agnes C. ; Nugent, Sean ; DeRonne, Beth ; Rutks, Indulis ; Leverty, David ; Gravely, Amy ; Noorbaloochi, Siamak ; Bair, Matthew J. ; Kroenke, Kurt. / Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. In: Contemporary Clinical Trials. 2017 ; Vol. 62. pp. 130-139
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