Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover
Chronic back pain is the world's leading cause of disability, with spine surgery being a common yet costly intervention. However, many patients experience suboptimal recovery, with persistent pain and functional limitations contributing to high healthcare utilization and costs. Traditional surgical pathways often overlook the role of mental well-being and patient engagement in recovery. However, research indicates that interventions promoting self-management and stress reduction can lead to improvements in pain, faster recovery, and reduced hospital readmissions.
Evidence shows that preoperative psychosocial factors, such as anxiety and depression, significantly predict post-surgical outcomes, yet structured perioperative support is lacking. To address this gap, Ready Set Recover (RSR), a mobile health (mHealth) intervention, provides education, behavioral strategies, and psychosocial support to enhance surgical preparedness and optimize post-surgical recovery. By addressing both psychological and behavioral factors, RSR has the potential to fill a critical gap in perioperative care. As a scalable digital platform, RSR offers an accessible, cost-effective solution that can be easily integrated into existing surgical care models, reducing the burden on healthcare providers while empowering patients to take an active role in their healing process.
RSR aims to accomplish this by integrating evidence-based components such as cognitive behavioral therapy, mindfulness, gratitude practices, and guided movement to foster patient empowerment and sustainable health practices in the pre- and post-surgical periods. The platform provides patients with a structured and flexible tool to improve self-efficacy, adherence to post-surgical recommendations, and the overall surgical recovery experience.
This study aims to evaluate the feasibility and acceptability of RSR through an explanatory mixed-methods pilot randomized controlled trial (RCT) in patients undergoing medium-to-long segment spinal fusion at Oregon Health & Science University.
Aim 1 assesses feasibility and acceptability by measuring patient engagement, intervention completion rates, and satisfaction.
Aim 2 qualitatively evaluate barriers and facilitators to implementation of RSR within the clinic setting via provider, patient, and clinic stakeholder semi-structured interviews.
Aim 3 establishes a patient community advisory board (CAB) to guide future research and the development of a Phase II Small Business Technology Transfer (STTR) efficacy trial.
Findings from this study will inform the refinement and scalability of RSR as a low-burden, cost-effective solution to improve surgical outcomes. Insights gained from this research may extend beyond spine surgery, informing the development of digital health interventions for other surgical populations, ultimately advancing patient-centered, technology-driven approaches to perioperative care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ryan Wexler Assistant Research Investigator, ND, MSRC
- Número de teléfono: 15034947377
- Correo electrónico: rwexler@nunm.edu
Copia de seguridad de contactos de estudio
- Nombre: Dana Dharmakaya Colgan Assistant Professor, PhD
- Número de teléfono: 5034947377
- Correo electrónico: dcolgan@nunm.edu
Ubicaciones de estudio
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Oregon
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Portland, Oregon, Estados Unidos, 97201
- Oregon Health & Science University
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Contacto:
- Dana Dharmakaya Colgan Assistant Professor, PhD
- Número de teléfono: 15034947377
- Correo electrónico: colgand@ohsu.edu
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Contacto:
- Ryan Wexler, ND, MSCR
- Número de teléfono: 5034947377
- Correo electrónico: rwexler@nunm.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients deemed candidates for medium-/long-segment spinal fusion
- Patients who score a > 4 on a 0-10 NRS for the question "How motivated are you to participate in this research study?"
- At least 18 years of age and not older than 80 at the time of study enrollment •Ability to read and understand English
- Daily access to the internet via cell phone, tablet, or computer
Exclusion Criteria:
- Have received epidural steroid injection for low back pain, lumbosacral radiculopathy, or scoliosis in the prior 3 months
- Have received a surgical intervention for low back pain, lumbosacral radiculopathy, or scoliosis in the previous 6 months
- Concurrent diagnosis of cancer
- Cognitive impairment
- Severe comorbidities (e.g., terminal illness, severe organ failure)
- Non-elective/emergency surgery in the past
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Surgery + Standard of Care
Surgery + Standard of care is defined as instrumented spinal fusion with routine perioperative care, including preoperative information, postoperative mobilization, and standard analgesia.
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Experimental: Surgery+RSR
Spinal Fusion + Ready Set Recover.
Ready Set Recover is a peri-operative mHealth platform designed to help patients prepare for and recover from surgery.
RSR empowers patients to be a self-advocate in their surgical journey, plan appropriately for surgery day, garner support from loved ones, and maintain healthy lifestyle practices including: spending time in nature, mindfulness practices and stress reduction, gratitude practice, and post-surgical mindful movement.
These activities encourage intrinsically motivated, sustainable behavior change that supports surgical recovery.
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Ready Set Recover is a peri-operative mHealth platform designed to help patients prepare for and recover from surgery.
RSR empowers patients to be a self-advocate in their surgical journey, plan appropriately for surgery day, garner support from loved ones, and maintain healthy lifestyle practices including: spending time in nature, mindfulness practices and stress reduction, gratitude practice, and post-surgical mindful movement.
These activities encourage intrinsically motivated, sustainable behavior change that supports surgical recovery.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of Retention
Periodo de tiempo: 30 days post-surgery
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Measured using a participant tracking spreadsheet
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30 days post-surgery
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Adverse Events (AEs)
Periodo de tiempo: Daily from baseline through end of intervention (30 days post surgery)
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The study team will regularly monitor for adverse events via the daily survey.
In addition to reporting adverse events to the IRB, the investigators will regularly review adverse events at each study meeting in order to rapidly address these events and to facilitate early recognition of any emerging patterns.
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Daily from baseline through end of intervention (30 days post surgery)
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Feasibility of enrollment
Periodo de tiempo: Data collected during screening and enrollment process
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Enrollment Rate: Measured using a participant tracking spreadsheet.
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Data collected during screening and enrollment process
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Feasibility of Adherence
Periodo de tiempo: Daily from baseline through end of intervention (30 days post surgery)
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Measured through completion with the RSR daily actions and educational materials.
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Daily from baseline through end of intervention (30 days post surgery)
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Acceptability and Accessibility
Periodo de tiempo: 30- days post surgery
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Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire.
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30- days post surgery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visual Analog Scale for Pain Back Pain Intensity
Periodo de tiempo: Daily from baseline through end of intervention (30 days post surgery)
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The NRS is a self-reported scale where participants will be asked to report their pain intensity on a scale from 0 to 10 (0 = "no pain", 10 = "worst pain").
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Daily from baseline through end of intervention (30 days post surgery)
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Modified Oswestry Disability Index (ODI)
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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Designed to assess the impact of pain on participants' ability to perform activities of daily living such as personal care, lifting, walking, and sitting.
0 to 100% (raw 0-50 points), with lower scores indicating better function.
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30 Days Pre-surgery and 30 Days Post-surgery
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Central Sensitization Inventory (CSI)
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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Participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization.
Scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom burden.
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30 Days Pre-surgery and 30 Days Post-surgery
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Tampa Scale of Kinesiophobia
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The TSK-11 is designed to assess for the presence of fear of movement.
Scores range from 11-44 (11 items, 4-point Likert 1 = strongly disagree to 4 = strongly agree).
Higher scores indicate greater fear of movement/(re)injury
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30 Days Pre-surgery and 30 Days Post-surgery
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Pain Catastrophizing Scale (PCS)
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The PCS is ubiquitously used to assess pain catastrophizing via its subscales: helplessness, rumination, and magnification.
Scores range from 0-52 (13 items, each 0 = not at all to 4 = all the time).
Higher = greater catastrophizing.
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30 Days Pre-surgery and 30 Days Post-surgery
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Pain Self-efficacy Questionnaire (PSEQ)
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The PSEQ is designed to assess participants perceived ability and confidence to manage their pain.
Scores range from 0-60 (10 items, 0 = not at all confident to 6 = completely confident).
Higher scores indicate greater pain self-efficacy.
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30 Days Pre-surgery and 30 Days Post-surgery
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PROMIS Ability to Participate in Social Roles
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The ability to participate in social roles questionnaire is a PROMIS measure designed to evaluate the impact of a condition on social engagement.
It uses a T-score metric, mean 50 ± 10 (US general population); practical range ~20-80 .
Higher scores indicate better social participation; <40 = moderate-severe impairment.
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30 Days Pre-surgery and 30 Days Post-surgery
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Brief Pain Inventory (BPI)
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The BPI has previously been used to assess pain interference in patients with chronic pain and is the most frequently used measure of pain interference in trials of MORE.
Scores range from 0-10 (mean of 7 items).
Higher scores indicate worse interference; MCID ≥1-point improvement.
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30 Days Pre-surgery and 30 Days Post-surgery
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Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB):
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The PEB is designed to assess patients' beliefs about the biopsychosocial model of chronic pain.
Includes 11 items, unidimensional.
Higher scores indicate greater endorsement of a biopsychosocial pain model, associated with greater readiness for/engagement in self-management.
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30 Days Pre-surgery and 30 Days Post-surgery
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Patient Reported Outcomes Measurement Information System (PROMIS)-29:
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The PROMIS- 29 assesses an individual's overall quality of life using self-reporting questions in domains such as physical function, anxiety, depression, fatigue, sleep disturbance. Each of 7 domains scored as a T-score, mean 50 ± 10; plus single 0-10 pain intensity item Direction is domain-dependent. Higher scores indicate better physical function and ability to participate in social roles and activities. Lower scores are better in anxiety, depression, fatigue, sleep disturbance, pain interference subscales. |
30 Days Pre-surgery and 30 Days Post-surgery
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Perioperative Anxiety Scale-7 (PAS-7)
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The peri-operative anxiety scale was developed in collaboration with psychiatrists, anesthesiologists, and surgeons to assess mental and somatic symptoms of pre-operative anxiety.
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30 Days Pre-surgery and 30 Days Post-surgery
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Generalized Anxiety Disorder (GAD)-7
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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The GAD-7 is a screening tool used for assessing symptoms of generalized anxiety disorder.
Scores range from 0-21 (7 items, 0 = not at all to 3 = nearly every day).
Higher indicates greater anxiety severity.
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30 Days Pre-surgery and 30 Days Post-surgery
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Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)
Periodo de tiempo: 30 Days Pre-surgery and 30 Days Post-surgery
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MAIA-2 is designed as a tool to assess interoceptive awareness.
It is made up of eight subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust.
Each subscale is totaled separately.
Subscales are scored 0-5 (mean of items).
Higher scores indicate greater interoceptive awareness.
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30 Days Pre-surgery and 30 Days Post-surgery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Primero enviado que cumplió con los criterios de control de calidad
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Actualizaciones de registros de estudio
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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
Otros números de identificación del estudio
- Ready Set Recovery DC90325
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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