Strategies for Prescribing Analgesics Comparative Effectiveness Trial (SPACE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01583985
First received: April 20, 2012
Last updated: January 7, 2014
Last verified: January 2014

April 20, 2012
January 7, 2014
June 2013
May 2016   (final data collection date for primary outcome measure)
Brief Pain Inventory Interference score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Measure of pain-related functional interference
Same as current
Complete list of historical versions of study NCT01583985 on ClinicalTrials.gov Archive Site
  • Brief Pain Inventory Severity score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure of pain intensity
  • Roland Disability Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Symptom checklist [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse effects checklist
  • Veterans RAND 12 Item Health Survey (VR-12) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health related quality of life measure
  • Global impression of change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient-reported rating of global impression of pain change
  • Multidimensional Fatigue Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Arizona Sexual Experience scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Falls [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Fall incidence
  • Hospitalizations and emergency/urgent visits [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Indiana University Telephone-Based Assessment of Neuropsychological Status (IU-TBANS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cognitive test battery that includes clinical instruments covering the following domains: attention, learning and recall, information processing speed, and verbal fluency
  • Fulleron advanced balance scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Gait speed test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Chair stand test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Brief Pain Inventory Severity score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure of pain intensity
  • Roland Disability Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Symptom checklist [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse effects checklist
  • Medical Outcomes Study Short Form-12 (SF-12) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health related quality of life measure
  • Global impression of change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient-reported rating of global impression of pain change
  • Multidimensional Fatigue Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Arizona Sexual Experience scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Athens Insomnia Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Headache impact test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Falls [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Fall incidence
  • Hospitalizations and emergency/urgent visits [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Indiana University Telephone-Based Assessment of Neuropsychological Status (IU-TBANS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cognitive test battery that includes clinical instruments covering the following domains: attention, learning and recall, information processing speed, and verbal fluency
  • Fulleron advanced balance scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Gait speed test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Chair stand test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cold pressor test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Strategies for Prescribing Analgesics Comparative Effectiveness Trial
Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial

Chronic musculoskeletal pain conditions are among the most prevalent conditions in VA primary care. Over the past two decades, improved clinical attention to pain has been associated with exponentially greater use of long-term opioid therapy for chronic non-cancer pain, both within and outside the VA system. Despite this change in practice, the proper place of opioids in chronic pain management continues to be controversial because research has not demonstrated the long-term safety and effectiveness of opioids for chronic musculoskeletal pain. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial will fill a critical gap in the evidence by comparing effectiveness and harms of two clinically relevant analgesic prescribing strategies-one that emphasizes early use of strong opioids and one that delays and minimizes opioid use-for Veterans with chronic back, hip, or knee pain. SPACE is designed to be highly relevant to clinical decision-making in VA primary care and to produce knowledge that will improve the lives of Veterans living with chronic pain.

Background: Chronic musculoskeletal pain conditions are among the most common problems seen in primary care. As the importance of these conditions for the health of individuals and society has been increasingly recognized, use of long-term opioid therapy for chronic musculoskeletal pain has grown exponentially. Unfortunately, research has not kept pace with this change in prescribing practice. Although evidence supports the ability of opioid analgesics to produce short-term reductions in pain intensity, long-term trials evaluating opioid effectiveness are not available. Evidence for effects of opioids on function and quality of life are limited, but observational data indicate that many patients treated with long-term opioids continue to experience severe pain and functional limitations. Furthermore, the long-term harms of opioids are poorly described in the literature. Preliminary investigations suggest a variety of potential harms related to opioid therapy, but the incidence and severity of these harms have not been well-quantified.

Objectives: The main objective of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial is to compare benefits and harms of two prescribing strategies: 1) an opioid-intensive strategy that uses strong opioids, such as morphine, early in treatment, and 2) an opioid-avoidant strategy that optimizes non-opioid medications while delaying and minimizing opioid use. SPACE will evaluate, over 12 months, 1) effects of opioid-intensive versus opioid-avoidant prescribing strategies on pain-related function and pain intensity and 2) adverse effects of opioid-intensive versus opioid-avoidant prescribing strategies, including adverse medication-related symptoms, clinically important adverse events, and changes in physical and cognitive performance. Secondarily, we will examine effects of the two prescribing strategies on health-related quality of life, pain sensitivity, and aberrant drug-related behaviors. We will also conduct a secondary qualitative analysis to better understand patients' perceptions of their response to the interventions and of the value of intervention components.

Methods: SPACE is a pragmatic randomized clinical trial designed to compare the benefits and harms over 12 months of two clinically-relevant prescribing strategies for chronic musculoskeletal pain. Eligible Veterans will be those seen in primary care for chronic back or lower-extremity (hip or knee) arthritis pain who have moderate-severe pain intensity and interference with function. Those currently receiving chronic daily opioid therapy will be excluded. Participants will be randomized to the opioid-intensive (n=138) or the opioid-avoidant (n=138) arm, with stratification by primary pain location (back or hip/knee). Medications in each arm will be adjusted to target improvement in pain, while considering individual patient preferences and responses. Interventions will be delivered in a care management model using the randomly assigned prescribing strategies, automated symptom monitoring, and a structured decision-making approach to guide medication adjustment. Outcome assessors masked to treatment assignment will conduct interviews to assess patient-reported outcomes at 0, 3, 6, 9, and 12 months and will assess physical performance and cognitive function at 0, 6, and 12 months. For the primary outcome, the Brief Pain Inventory (BPI) Interference scale, the study will have 80% power to detect a 1 point difference between groups, assuming 2-sided alpha=0.05 and 20% attrition. Analysis will use an intent-to-treat approach, including all participants in the arm to which they were originally assigned.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Back Pain
  • Osteoarthritis
  • Other: Opioid-intensive prescribing strategy
    The opioid-intensive arm emphasizes early use of strong opioid analgesics. Medications will be individually adjusted according to patient preferences and responses.
  • Other: Opioid-avoidant prescribing strategy
    The opioid-avoidant prescribing strategy emphasizes non-opioid medications from several drug classes. Medications will be individually adjusted according to patient preferences and responses.
  • Active Comparator: Opioid-intensive
    Opioid-intensive prescribing strategy
    Intervention: Other: Opioid-intensive prescribing strategy
  • Active Comparator: Opioid-avoidant
    Opioid-avoidant prescribing strategy
    Intervention: Other: Opioid-avoidant prescribing strategy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
276
August 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

Veterans with chronic back or lower extremity osteoarthritis pain with moderate-severe intensity and interference with function despite analgesic therapy.

Exclusion Criteria:

  • a) schizophrenia, bipolar disorder, or other psychosis;
  • b) moderately severe cognitive impairment;
  • c) anticipated back, knee, or hip surgery within 12 months;
  • d) anticipated life expectancy of less than 12 months;
  • e) current chronic daily opioid therapy;
  • f) absolute contraindications to either prescribing strategy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01583985
IIR 11-125
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Erin E. Krebs, MD MPH Minneapolis VA Health Care System
Department of Veterans Affairs
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP