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- Ensayo clínico NCT01583985
Strategies for Prescribing Analgesics Comparative Effectiveness Trial (SPACE)
Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Opioid-intensive
Opioid-intensive prescribing strategy
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The opioid-intensive arm emphasizes early use of strong opioid analgesics.
Medications will be individually adjusted according to patient preferences and responses.
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Comparador activo: Opioid-avoidant
Opioid-avoidant prescribing strategy
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The opioid-avoidant prescribing strategy emphasizes non-opioid medications from several drug classes.
Medications will be individually adjusted according to patient preferences and responses.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Brief Pain Inventory Interference Scale
Periodo de tiempo: 3 months, 6 months, 9 months, and 12 months
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Measure of pain-related functional interference (range 0-10; higher score is worse)
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3 months, 6 months, 9 months, and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Brief Pain Inventory Severity Scale
Periodo de tiempo: 3 months, 6 months, 9 months, and 12 months
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Measure of pain intensity (range 0-10; higher score is worse)
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3 months, 6 months, 9 months, and 12 months
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Medication-related Symptom Checklist
Periodo de tiempo: 3 months, 6 months, 9 months, and 12 months
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Checklist of bothersome medication-related symptoms (0-19, higher number = more symptoms)
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3 months, 6 months, 9 months, and 12 months
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Falls
Periodo de tiempo: 12 months
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Number of falls in 12 months after enrollment
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12 months
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Hospitalizations
Periodo de tiempo: 12 months
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All cause, EMR-confirmed hospitalizations
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Erin E. Krebs, MD MPH, Minneapolis VA Health Care System, Minneapolis, MN
Publicaciones y enlaces útiles
Publicaciones Generales
- Kroenke K, Stump TE, Kean J, Krebs EE, Damush TM, Bair MJ, Monahan PO. Diagnostic operating characteristics of PROMIS scales in screening for depression. J Psychosom Res. 2021 Aug;147:110532. doi: 10.1016/j.jpsychores.2021.110532. Epub 2021 May 25.
- Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health Qual Life Outcomes. 2021 Feb 4;19(1):41. doi: 10.1186/s12955-021-01674-3.
- Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. J Affect Disord. 2020 Apr 1;266:100-108. doi: 10.1016/j.jad.2020.01.101. Epub 2020 Jan 23.
- Krebs EE, Jensen AC, Nugent S, DeRonne B, Rutks I, Leverty D, Gravely A, Noorbaloochi S, Bair MJ, Kroenke K. Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. Contemp Clin Trials. 2017 Nov;62:130-139. doi: 10.1016/j.cct.2017.09.003. Epub 2017 Sep 8.
- Matthias MS, Donaldson MT, Jensen AC, Krebs EE. "I Was a Little Surprised": Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain. J Pain. 2018 Sep;19(9):1082-1090. doi: 10.1016/j.jpain.2018.04.008. Epub 2018 Apr 30.
- Koffel E, Kats AM, Kroenke K, Bair MJ, Gravely A, DeRonne B, Donaldson MT, Goldsmith ES, Noorbaloochi S, Krebs EE. Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial. Pain Med. 2020 Jun 1;21(6):1162-1167. doi: 10.1093/pm/pnz221.
- Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Artritis
- Osteoartritis
- Dolor de espalda
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Estupefacientes
- Analgésicos Opiáceos
Otros números de identificación del estudio
- IIR 11-125
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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