Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,800
- 试验地点
- 6
- 主要终点
- Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
研究概览
简要总结
The purpose of this study is to assess whether the primary spine practitioner (PSP) model of care will lead to improvements in patient outcomes, as compared to usual care, based on change in patient-reported PROMIS Pain Interference and Physical Function from baseline to 3 months in patients aged 18 years and older with a primary complaint of low back pain (LBP).
详细描述
This study is a pragmatic, multi-site, two-arm cluster-randomized trial with the unit of randomization at the primary care clinic level. The overall goal is to evaluate implementation of the American College of Physicians (ACP) guideline for LBP by assessing the comparative effectiveness of the PSP model, which involves first contact care for LBP patients from either a physical therapist (PT) or a doctor of chiropractic (DC), versus usual care, which involves first contact care with primary care physicians. The study includes patients aged 18 years and older with a chief complaint of LBP.
Co-primary endpoints to be assessed are changes in Patient- Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Physical Function from baseline to 3 months. The Investigators have chosen to use these co-primary endpoints as they represent two domains that are important factors related to patient improvement.
Secondary endpoints collected at baseline, 3, 6 and 12 months include Pain Catastrophizing Scale - 4-item short form, PROMIS Global-10 (v1.2), opioid use, imaging and diagnostic testing, provider visits, and LBP-associated procedures and treatments: surgical procedures, medication prescriptions, hospital admissions and emergency room visits.
Additional exploratory analyses among enrolled patients will assess whether the PSP model leads to 1) long-term improvement compared to usual care using the PROMIS Pain Interference and Physical Function at 6, 12, and 24 months; and 2) lower healthcare utilization and costs for LBP at 12 and 24 months.
Patients enrolled within the first 12 months of the data collection phase will be included in the 24-month exploratory analyses. Additional analyses will evaluate LBP-related utilization within the academic healthcare systems among all patients seen in intervention versus control primary care clinics utilizing de-identified clinic level data extracted from the EHR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients, clinicians delivering care, LBP schedulers and site research coordinators will not be blinded to clinic intervention assignment in this pragmatic clinical trial. There will be both blinded and unblinded analysis teams.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years and older
- •initiating an outpatient visit for LBP at a participating PCP clinic
- •agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent)
排除标准
- •inability to provide consent or complete outcome questionnaires
- •positive screening for cauda equina symptoms (loss of total control of bowel/bladder associated with this episode of LBP )
研究组 & 干预措施
Usual Medical Care
This group will consist of patients who contact clinics that have been randomized to usual medical care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).
干预措施: Usual Care (Other)
Primary Spine Provider Model
This group will consist of patients who contact clinics that have been randomized to the primary spine provider (PSP) model (intervention clinics). Patients seeking care at intervention clinics will be given the option of seeing either a DC or a PT as their first contact clinician for an initial trial of PSP care.
干预措施: Primary Spine Provider Model (Other)
结局指标
主要结局
Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
时间窗: Baseline, 3 Months
The Investigators will compare the change in PROMIS Physical Function scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.
Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
时间窗: Baseline, 3 Months
The Investigators will compare the change in PROMIS Pain Interference scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.
次要结局
- NIH Low Back Pain Questions(Baseline, 12 Months)
- Patient Experience(3 Months)
- PROMIS Global 10 (v1.2) - Physical Health(Baseline, 3 Months, 6 Months, 12 Months)
- Number of Hospital Admissions(Up to approximately 12 Months)
- Number of Emergency Room Visits(Up to approximately 12 Months)
- Patient Satisfaction(3 Months)
- Perceived Improvement(3 Months)
- Number of LBP-related Provider Visits(Up to approximately 12 Months)
- Total Prescribed Opioid Dosage(Baseline, 3 Months, 6 Months, 12 Months)
- PROMIS Global 10 (v1.2) - Mental Health(Baseline, 3 Months, 6 Months, 12 Months)
- Number of LBP-related Surgical Procedures(Up to approximately 12 Months)
- Number of LBP-related Medical Prescriptions(Up to approximately 12 Months)
- Number of LBP-related Imaging and Diagnostic Tests(Up to approximately 12 Months)
- Number of LBP-related Injection Procedures(Up to approximately 12 Months)