Transforming Opioid Prescribing in Primary Care (TOPCARE)
2 de marzo de 2016 actualizado por: Karen Lasser, Boston Medical Center
Implementing Opioid Risk Reduction Strategies Into Primary Care Practice
Prescription opioid misuse is a significant public health problem as well as a patient safety concern. Primary care providers are the leading prescribers of opioids for chronic pain, yet few providers follow standard practice guidelines regarding assessment and monitoring. The investigators propose a novel system change in delivery of primary care services to decrease misuse of and addiction to prescription opioids for patients with chronic pain.
The proposed intervention for the overall project includes a nurse-managed registry for planning individual patient care and conducting population-based care for a population of patients receiving opioids for chronic pain. Academic detailing to clinicians is another effective way to improve care. Finally, the researchers will create a knowledge management tool to facilitate guideline adherence. This tool will be accessible via an internet link, and will include validated instruments to assess patient status and also to facilitate physician adherence to suggested monitoring.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This project will implement interventions in the primary care setting to improve management of patients prescribed opioid therapy for chronic non-cancer pain.
Prescription opioid misuse is a significant current public health problem as well as a patient safety concern. Primary care providers are the leading prescribers of opioids for chronic pain, yet few providers follow standard practice guidelines regarding assessment and monitoring. The investigators propose a novel system change in delivery of primary care services to decrease misuse of and addiction to prescription opioids for patients with chronic pain.
The researchers will conduct a cluster randomized controlled trial, randomizing 50 primary care providers and their estimated 500 patients to the intervention condition (nurse care management, registry, electronic decision support tools, and academic detailing) or control condition (electronic decision support tools and educational outreach only). The primary outcomes, measured at twelve months, are PCP adherence to chronic opioid therapy guidelines and opioid misuse.
Tipo de estudio
Intervencionista
Inscripción (Actual)
53
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- All PCPs (physicians, doctors of osteopathy, nurse practitioners, and physicians' assistants) at participating sites with 4 patients prescribed opioid treatment along with their patients greater than or equal to age 18 who have 1) 3 or more completed visits to the primary care practice; 2) long-term opioid treatment defined by 3 or more opioid prescriptions written at least 21 days apart within 6 months; and 3) an inpatient or outpatient ICD9CM diagnosis for musculoskeletal or neuropathic pain. In addition, non-PCP staff at the health centers and at the Massachusetts State PMP who agree to be included in the qualitative assessments will be included and will be considered subjects. Note that the investigators have limited inclusion in the study to PCPs with at least 4 patients on chronic opioid therapy because it was determined that for PCPs with fewer than 4 patients the time burden associated with the study (meeting with nurse care manager, receiving academic detailing etc) would not be justified.
Exclusion Criteria:
- Patients currently receiving care for cancer, except non-melanoma skin cancer. Patients with remote (>5 years) histories being disease-free from other cancers (e.g. breast, colon, prostate) will not be excluded due to the low risk of current cancer related pain. PCPs and staff who do not consent to the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Control PCPs and their patients
PCPs randomized to the control condition will receive electronic decision support tools.
Patients of control PCPs will receive education materials that will be developed and made available to both control and intervention patients.
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Electronic decision support tools available to both control and intervention PCPs include patient pain assessments, (Brief Pain Inventory, Pain/Enjoyment/General Function "PEG"), substance abuse (DAST, AUDIT) depression (PHQ9), PTSD (PTSD ChecklistCivilian), and risk of prescription drug misuse (SOAPP and COMM).
The tools calculate scores with recommendation for specific action for each tool, when appropriate.
Patient education materials will be developed and made available to both control and intervention patients.
The investigators will design the materials for patients with low literacy, using pictures and simple graphics to augment written language.
The research staff will make PDFs of the materials available on the study website during and after the project.
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Experimental: Intervention PCPs and patients
The Intervention Condition has three main components: access to nurse care management, access to the patient registry, and academic detailing for intervention PCPs.
Intervention PCPs will also receive the control intervention of electronic decision support tools, and patients of intervention PCPs will receive the same patient education materials as patients of control PCPs.
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Electronic decision support tools available to both control and intervention PCPs include patient pain assessments, (Brief Pain Inventory, Pain/Enjoyment/General Function "PEG"), substance abuse (DAST, AUDIT) depression (PHQ9), PTSD (PTSD ChecklistCivilian), and risk of prescription drug misuse (SOAPP and COMM).
The tools calculate scores with recommendation for specific action for each tool, when appropriate.
Patient education materials will be developed and made available to both control and intervention patients.
The investigators will design the materials for patients with low literacy, using pictures and simple graphics to augment written language.
The research staff will make PDFs of the materials available on the study website during and after the project.
The nurse/care management intervention will be modeled on BMC's successful collaborative care office-based opioid treatment (OBOT) program.
One fulltime nurse care manager will work with PCPs assigned to the intervention condition.
The care manager will be based centrally, in the Section of General Internal Medicine, and will divide his/her time between the 3 health centers.
The main focus of the nurse care manager is to assure that patients are receiving guideline-adherent care, which involves appropriate clinical assessments, opioid treatment agreements, refill management, administering monitoring tools according to risk level (urine toxicology screen, pill counts, PMP data extraction) and timely physician visits to assess pain (minimum every 6 months).
The registry will be a freestanding centralized disease management application and built using standard database technology.
This system will communicate with the electronic medical record (EMR) at each community health center and with the Massachusetts State Prescription Monitoring Program (PMP) system.
Data that will feed into the registry include clinical data recorded from the EMR (documentation from other clinicians and labs), data from clinical users entered into the registry via pain and opioid management forms, and the PMP.
The nurse care manager will use a custom registry interface to monitor key practice activities across the entire practice at each site.
The nurse care manager will use population management tools to provide aggregate measures for quality monitoring and workforce management.
All quality metrics can be downloaded in aggregate form for further analysis.
All PCPs in the intervention group will receive one 30 minute individual visit 23 months after project implementation at the PCP's practice site.
The visits will be conducted with at least one of the study experts in pain medication management.
Visit content will combine elements of audit and feedback (e.g.
review registry of individual PCP compared with that of peers and goals) as well as traditional educational outreach.
Specifically, experts will review each aspect of guideline concordant care (assessment of risk and appropriateness for opioid medication, medication dosing, monitoring for harm/adherence, and pain outcomes) to solicit barriers to implementation or lack of knowledge on the underlying evidence for each aspect of care.
The experts will work with the individual PCPs to address barriers identified using motivational interviewing as needed to facilitate behavioral change in applying guideline concordant care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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PCP adherence to chronic opioid therapy guidelines
Periodo de tiempo: up to 12 months.
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The primary outcomes is PCP adherence to chronic opioid therapy guidelines and is defined as whether a PCP's patient has
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up to 12 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient opioid misuse, as measured by number of early refills
Periodo de tiempo: Each PCP's patient list will be assessed at baseline and at 12 months.
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The secondary outcome measures patient opioid misuse, defined as having multiple (>2) early refills in the past year.
To identify early refills of opioid prescriptions, the researchers will calculate the duration of a prescription based on the number dispensed and the directions, conservatively assuming that the patient took the medication at the maximal prescribed rate.
The investigators define an early refill as being written at least 7 days before the previous prescription for the same medication should have been finished.
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Each PCP's patient list will be assessed at baseline and at 12 months.
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Patient opioid and illicit substance misuse and/or abuse, as measured by urine toxicology results
Periodo de tiempo: Each PCP's patient list will be assessed at baseline and at 12 months.
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Patient substance abuse will be measured as urine drug tests where an illicit substance is present, the prescribed opioid is absent, and/or the patient has missed the urine drug screen.
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Each PCP's patient list will be assessed at baseline and at 12 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karen Lasser, MD, MPH, Boston Medical Center
- Investigador principal: Jane E Liebschutz, MD, MPH, Boston Medical Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Liebschutz JM, Xuan Z, Shanahan CW, LaRochelle M, Keosaian J, Beers D, Guara G, O'Connor K, Alford DP, Parker V, Weiss RD, Samet JH, Crosson J, Cushman PA, Lasser KE. Improving Adherence to Long-term Opioid Therapy Guidelines to Reduce Opioid Misuse in Primary Care: A Cluster-Randomized Clinical Trial. JAMA Intern Med. 2017 Sep 1;177(9):1265-1272. doi: 10.1001/jamainternmed.2017.2468.
- Lasser KE, Shanahan C, Parker V, Beers D, Xuan Z, Heymann O, Lange A, Liebschutz JM. A Multicomponent Intervention to Improve Primary Care Provider Adherence to Chronic Opioid Therapy Guidelines and Reduce Opioid Misuse: A Cluster Randomized Controlled Trial Protocol. J Subst Abuse Treat. 2016 Jan;60:101-9. doi: 10.1016/j.jsat.2015.06.018. Epub 2015 Jul 15.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2014
Finalización primaria (Actual)
1 de marzo de 2016
Finalización del estudio (Actual)
1 de marzo de 2016
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2013
Primero enviado que cumplió con los criterios de control de calidad
25 de julio de 2013
Publicado por primera vez (Estimar)
26 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
3 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
2 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01DA034252-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Electronic decision support tools
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