Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,817
- 试验地点
- 2
- 主要终点
- Change in Pain Interference Measure
研究概览
简要总结
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.
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
The only blinded members of the project include the VA research and Duke Clinical Research Institute (DCRI) research staff members administering the consent and follow up survey data collection processes. All other team members will be unblinded due to the pragmatic design.
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
- •Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
- •Provider determines LBP is appropriate for conservative management
- •Referred to integrated ICP pathway or CCP pathway by participating clinic provider
排除标准
- •Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
- •No documented phone number in the electronic health record.
结局指标
主要结局
Change in Pain Interference Measure
时间窗: Baseline, three months post baseline
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.
Change in Physical Function Measure
时间窗: Baseline, three months post baseline
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.
次要结局
- Change in Sleep Disturbance(Baseline, three months post baseline)
- Change in Patient Reported Outcomes--PROMIS Sleep Disturbance(Baseline, three, six, and twelve months)
- Number of Participants With Opioid Use--Chronic User(Baseline, twelve months post baseline)
- Change in Opioid Use - Morphine Dose(Baseline, twelve months post baseline)
- Change in Patient Reported Outcomes--PROMIS Pain Interference(Baseline, three, six, and twelve months)
- Change in Patient Reported Outcomes--PROMIS Physical Function(Baseline, three, six, and twelve months)