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: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Back Pain
Osteoarthritis
Other: Opioid-intensive prescribing strategy
Other: Opioid-avoidant prescribing strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Brief Pain Inventory Interference score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure of pain-related functional interference


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 276
Study Start Date: June 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Opioid-intensive
Opioid-intensive prescribing strategy
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.
Active Comparator: Opioid-avoidant
Opioid-avoidant prescribing strategy
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • schizophrenia, bipolar disorder, or other psychosis;
  • moderately severe cognitive impairment;
  • anticipated back, knee, or hip surgery within 12 months;
  • anticipated life expectancy of less than 12 months;
  • current chronic daily opioid therapy;
  • absolute contraindications to either prescribing strategy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583985

Locations
United States, Minnesota
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Investigators
Principal Investigator: Erin E. Krebs, MD MPH Minneapolis VA Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01583985     History of Changes
Other Study ID Numbers: IIR 11-125
Study First Received: April 20, 2012
Last Updated: June 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
opioid analgesics
chronic pain
musculoskeletal pain

Additional relevant MeSH terms:
Back Pain
Osteoarthritis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 22, 2014