减少共病慢性疼痛、抑郁和焦虑患者高剂量阿片类药物的决策支持和行为健康：阶梯式楔形集群随机试验。
Decision Support and Behavioral Health for Reducing High-Dose Opioids in Comorbid Chronic Pain, Depression and Anxiety: Stepped-Wedge Cluster Randomized Trial.
机构信息
Ochsner Xavier Institute for Health Equity and Research, Academic Center - 2nd Floor, 1401A Jefferson Highway, New Orleans, LA, 70121, USA.
Center for Outcomes Research, 1401A Jefferson Highway, New Orleans, LA, 70121, USA.
出版信息
J Gen Intern Med. 2024 Nov;39(15):2952-2960. doi: 10.1007/s11606-024-08965-7. Epub 2024 Aug 2.
BACKGROUND
High prevalence of depression or anxiety with opioid use for chronic pain complicates co-management and may influence prescribing behaviors.
OBJECTIVE
Compare clinical effectiveness of electronic medical record clinical decision support (EMR-CDS) versus additional behavioral health (BH) care management for reducing rates of high-dose opioid prescriptions.
DESIGN
Type 2 effectiveness-implementation hybrid stepped-wedge cluster randomized trial in 35 primary care clinics within a health system in LA, USA.
PARTICIPANTS
Patients aged 18+ receiving chronic opioid therapy for non-cancer pain with depression or anxiety and matched controls.
INTERVENTION
EMR-CDS included opioid risk mitigation procedures. BH care included cognitive behavioral therapy; depression or anxiety medication adjustments; and case management.
MAIN MEASURES
Outcomes of interest included difference-in-difference (DID) estimate of changes in probability for prescribing high-dose morphine equivalent daily dose (MEDD ≥50 mg/day and MEDD ≥90), average MEDD, and rates of hospitalization, emergency department use, and opioid risk mitigation.
KEY RESULTS
Most participants were female with 3+ pain syndromes. Data analysis included 632 patients. Absolute risk differences for MEDD≥50 and ≥90 decreased post-index compared to pre-index (DID of absolute risk difference [95%CI]: -0.036 [-0.089, 0.016] and -0.029 [-0.060, 0.002], respectively). However, these differences were not statistically significant. The average MEDD decreased at a higher rate for the BH group compared to EMR-CDS only (DID rate ratio [95%CI]: 0.85 [0.77, 0.93]). There were no changes in hospitalization and emergency department utilization. The BH group had higher probabilities of new specialty referrals and prescriptions for naloxone and antidepressants.
CONCLUSIONS
Incorporation of a multidisciplinary behavioral health care team into primary care did not decrease high-dose prescribing; however, it improved adherence to clinical guideline recommendations for managing chronic opioid therapy for non-cancer pain.
TRIAL REGISTRATION
ClinicalTrials.gov ID NCT03889418.
背景
慢性疼痛患者使用阿片类药物治疗时，抑郁或焦虑的高患病率使共同管理变得复杂，并可能影响处方行为。
目的
比较电子病历临床决策支持（EMR-CDS）与额外的行为健康（BH）护理管理对降低高剂量阿片类药物处方率的临床效果。
设计
在美国洛杉矶一家医疗系统的 35 家初级保健诊所中进行的 2 型有效性-实施混合式 2 期楔形集群随机试验。
参与者
年龄在 18 岁及以上、接受慢性阿片类药物治疗非癌症疼痛且伴有抑郁或焦虑的患者，以及匹配的对照者。
干预
EMR-CDS 包括阿片类药物风险缓解程序。BH 护理包括认知行为疗法、抑郁或焦虑药物调整以及病例管理。
主要观察指标
感兴趣的结局指标包括高剂量吗啡当量日剂量（MEDD≥50mg/天和 MEDD≥90）、平均 MEDD、住院率、急诊就诊率和阿片类药物风险缓解率的差异变化的差值（DID）估计值。
主要结果
大多数参与者为女性，有 3 种以上的疼痛综合征。数据分析纳入了 632 名患者。与基线前相比，索引后 MEDD≥50 和 MEDD≥90 的绝对风险差异降低（绝对风险差异的 DID [95%CI]：-0.036[-0.089，0.016]和-0.029[-0.060，0.002]）。然而，这些差异无统计学意义。与仅接受 EMR-CDS 的患者相比，BH 组的平均 MEDD 下降速度更快（DID 率比 [95%CI]：0.85[0.77，0.93]）。住院和急诊就诊率没有变化。BH 组的新专科转诊率和纳洛酮及抗抑郁药的处方率更高。
结论
将多学科行为健康护理团队纳入初级保健并未降低高剂量处方率；然而，它改善了对管理非癌症疼痛慢性阿片类药物治疗的临床指南建议的依从性。
试验注册
ClinicalTrials.gov 注册号 NCT03889418。
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