ESPEffective Screening for Pain Study
NRS pain one week
+ PEG
+ DVPRS
Enfermedades del sistema nervioso+4
+ Manifestaciones Neurológicas
+ Trastornos Perceptuales
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 1 de junio de 2015
Fecha en la que se inscribió al primer participante.Background: In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS). The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products. Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference. The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered pain now. Objectives: 1) Qualitatively evaluate Veteran and multidisciplinary provider perspectives on pain screening and the use of the NRS vs. the PEG items, clinician-assessed vs. patient-reported pain 2a) Quantitatively assess, in a 3-arm randomized controlled primary care clinical team-based trial using tablets, the feasibility and completion rates, validity, and variability of pain information obtained comparing: Tablet-based vs. nurse-documented pain (e.g., 5th vital sign by tablet vs. clinician assessed) and the rate and severity of pain detected in tablet-based 'NRS one week' (Arm 1), tablet-based PEG (Arm 2), and DVPRS (Arm 3). Also pain, self-reported disability. 2b) Informed by Aims 1 and 2a, qualitatively evaluate provider perspectives on different pain reports to facilitate better pain management. Methods: The investigators are conducting a two phase mixed method study that will build on prior work to develop and test enhanced pain screening approaches for primary care and Patient Aligned Care Teams (PACTs). In the first (development) phase of the study, the investigators will conduct semi-structured qualitative interviews and focus groups with primary care clinicians, other primary care team members including non-provider staff, and primary care Veteran patients, to understand what patient-reported pain assessment data are most useful for clinical decision-making and how this pain information can best be integrated into primary care team processes, including the role of informatics to optimize primary care pain management and link pain screening to management. This will inform the development of the enhanced pain screening approaches used in the Aim 2 randomized controlled trial (RCT). The investigators will also submit the enhanced tablet-based pain screening approaches to usability testing by the University of California Office of Information Technology. The second (testing) phase of the study will include a multisite RCT to test the final enhanced pain screening approaches (Arm 1 PEG; Arm 2 NRS 'pain now', Arm 3 DVPRS) compared with the NRS one week (all Arms), on patient and primary care clinician outcomes. The investigators will assess whether the approaches improve detection of pain-related impairment, and also the feasibility, acceptability, and provider and patient experience with enhanced screening. Status: The investigators have completed data collection, coding, and analyses for all Aims. They have presented some findings as conference posters and presentations and published several manuscripts. Findings from Aim 1 were used to guide the development of a tablet-based pain screening survey that the investigators tested in Aim 2a as a randomized control trial. The investigators have have completed data collection, and are currently analyzing results.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 569 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: All Veterans are eligible to participate in the clinical trial when presenting for routine care in the primary care clinic at all sites (VA at Palo Alto, Minneapolis, and Portland). All are eligible who do not opt out of participation. All participants in the baseline tablet intervention will also be eligible for a one week follow up telephone interview - unless they are unable to complete a phone interview (see exclusions). For the qualitative Veteran component, all Veterans who can hear and respond in an interview are eligible. Providers/staff must be clinic and facility staff including administrative clerks, regular part time or full time employees in primary care who routinely participate in the care of Veterans who have painful conditions. Exclusion Criteria: Veterans who meet either of the following exclusion criteria that may interfere with outcome assessment will be ineligible for the follow up telephone interview: a) no working telephone (home, office, or mobile) b) hearing impaired and unable to complete a phone survey
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, United StatesAbrir VA Palo Alto Health Care System, Palo Alto, CA en Google MapsMinneapolis VA Health Care System, Minneapolis, MN
Minneapolis, United StatesVA Portland Health Care System, Portland, OR
Portland, United States