Strategies for Prescribing Analgesics Comparative Effectiveness Trial
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Back Pain, Osteoarthritis (OA) |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | June 1, 2013 |
| End Date: | May 31, 2017 |
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.
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, the investigators
will examine effects of the two prescribing strategies on health-related quality of life,
pain sensitivity, and aberrant drug-related behaviors. The investigators 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.
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, the investigators
will examine effects of the two prescribing strategies on health-related quality of life,
pain sensitivity, and aberrant drug-related behaviors. The investigators 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.
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.
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