Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22,616
- 试验地点
- 2
- 主要终点
- Initial Opioid Prescription
研究概览
简要总结
The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain.
Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions (opioid justification and provider comparison), individually and in combination, on initial opioid prescription, initial use of non-opioid management, and patient-reported pain and function.
Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy.
Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral interventions.
Hypotheses:
Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of opioid prescription and increased proportion of non-opioid management at the initial outpatient visit for acute non-cancer pain.
Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with no difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months.
Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of patients receiving unsafe opioid therapy and a decreased proportion of patients transitioning to chronic opioid therapy.
Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics.
Study Population: The patient population will be 19,855 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache.
Primary and Secondary Outcomes: The primary outcome measures will be receipt of an initial opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain management, and, in 514 patients, patient-reported pain and function.
Analytic Plan: The investigators will test for differences in the primary and secondary outcomes among the 4 intervention groups.
Once completed, the project will provide evidence that health systems and other stakeholders need to implement interventions to prevent unsafe opioid prescribing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age 18 years or older; ii) index outpatient encounter with International Classification of Disease (ICD)-10 code for acute neck, back, or other musculoskeletal and headache diagnosis ("acute" defined as no similar diagnosis in past 3 months).
排除标准
- •Cancer diagnosis (other than non-melanoma skin cancer)
- •Receipt of opioid prescription within 12 months of index outpatient encounter
- •Inclusion Criteria:
- •Primary care provider (MD, Doctor of Osteopathy (DO), Physician Assistant (PA), Nurse Practitioner (NP)) at participating practice
- •Exclusion Criteria:
结局指标
主要结局
Initial Opioid Prescription
时间窗: 1 day (assessed on day of initial qualifying clinic visit
Initial opioid prescription (yes/no) (Primary) (Hypothesis 1a). Opioid prescription at qualifying clinic visit, measured via electronic health record (EHR).
次要结局
- Chronic opioid therapy at 6 months(6 months after initial qualifying clinic visit)
- Chronic opioid therapy at 12 months(12 months after initial qualifying clinic visit)
- Unsafe opioid prescribing at 3 months(3 months after initial qualifying clinic visit)
- Unsafe opioid prescribing at 6 months(6 months after initial qualifying clinic visit)
- Initial non-opioid management(1 day (assessed on day of initial qualifying clinic visit))
- Change in Patient Reported Pain and Function(Assessed at 1, 6, and 12 months after initial qualifying clinic visit)
- Unsafe opioid prescribing at 12 months(12 months after initial qualifying clinic visit)
- Chronic opioid therapy at 3 months(3 months after initial qualifying clinic visit)