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临床试验/NCT03889418
NCT03889418已完成不适用

Opioid Treatment and Recovery Through a Safe Pain Management Program

Ochsner Health System2 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
490
试验地点
2
主要终点
Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg

研究概览

简要总结

Opioid prescription drug abuse has become a major public health concern in the United States with mortality rates from fatal overdoses reaching epidemic proportions. This opioid crisis coincides with national efforts to improve management of chronic non-cancer pain. The net result, however, has been ever-growing increases in medical expenditures related to prescription costs and increased healthcare service utilization among opioid abusers. Healthcare provider prescribing pattern, especially among non-pain management specialists such as primary care, is a major factor. Louisiana is a major contributor to the epidemic with the 7th highest opioid prescribing rates accompanied by a 12% increase in fatal overdoses.

Providers are overdue for implementing safe opioid management strategies in primary care to combat the opioid crisis. Recent practice guidelines provide recommendations on what to do for safe prescribing of opioids, but they do not provide guidance on how to translate them into practice. Health systems must find ways to accelerate guideline adoption in primary care in the face of an overdose crisis. Research that examines a combination workflow- and provider-focused strategies are needed. Given the high prevalence of psychiatric disorders among patients with chronic non-cancer pain, care team expansion with integration of collaborative mental/behavioral health services may be the solution. Collaborative care can extend opioid management beyond standardized monitoring of risk factors for opioid misuse or abuse and set clear protocols for next steps in management.

This study is aligned with the National Institute on Drug Abuse's interest in health systems research that examines approaches to screening, assessment, prevention, diagnosis and treatment for prescription drug abuse. It will examine the primary care practice redesign of managing chronic non-cancer pain within a large health system whose 40+ Accountable Care Network-affiliated, adult primary care clinics may serve as an example for transforming opioid management in primary care practices across the country. This four-year type 2 effectiveness-implementation hybrid stepped wedge cluster randomized control trial is designed to compare the clinical and cost effectiveness of electronic medical record-based clinical decision support guided care versus additional integrated, stepped collaborative care for opioid management of primary care patients with chronic non-cancer pain (clinical pharmacist for medication management; licensed clinical social worker for cognitive behavioral therapy and community health worker care coordination); and to examine facilitators and barriers to implementing this multi-component intervention. Investigators anticipate that our study results will elucidate the role of technology versus care team optimization in changing provider opioid prescribing behaviors. Investigators further anticipate that results of our study will demonstrate that integrated mental/behavioral health care for opioid management of chronic non-cancer pain increases value-based care and leads to greater efficiencies in the way that care is delivered.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (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

入选标准

  • Age 18 and older
  • Have a primary care provider at any of the study clinics
  • Receiving chronic opioid prescriptions (3 of the prior 4 months) for chronic non-cancer pain
  • Have a diagnosis of depression or anxiety

排除标准

  • Age less than 18 years
  • Active cancer or undergoing cancer treatment
  • Chronic cancer-related pain
  • Having a terminal illness
  • Receiving hospice care

研究组 & 干预措施

Electronic medical recorded clinical decision support

Active Comparator

Usual care only

干预措施: Electronic medical recorded clinical decision support [EMR CDS] (Behavioral)

stepped opioid collaborative care model

Active Comparator

Usual care AND collaborative care with behavioral health integration

干预措施: Electronic medical recorded clinical decision support [EMR CDS] (Behavioral)

stepped opioid collaborative care model

Active Comparator

Usual care AND collaborative care with behavioral health integration

干预措施: Stepped opioid collaborative care model [CCM] (Behavioral)

结局指标

主要结局

Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg

时间窗: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)

Participants' opioid medication orders were monitored for 12 months prior to and following entry into study (index event). This outcome represents the odds of having an average MEDD ≥ 50 mg in the pre-index and post-index periods for the collaborative care and usual care groups. Odds of an event is defined as the ratio of the probability that the event will happen (prescribed high dose opioid) to the probability that the event will not happen (not prescribed high dose opioid)

次要结局

  • Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety(12 months following index event (post-index period))
  • Inpatient Hospital Admission Per 1000 Participants(12 months prior to index event (pre-index period) and 12 months following index event (post-index period))
  • Change in the Average Pain Score Among Participants Exposed to Collaborative Care(12 months following index event (post-index period))
  • New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service(12 months following index event (post-index period))
  • New Post-index Orders for Antidepressant Medications(12 months following index event (post-index period))
  • Provider Experience With Managing Depression/Anxiety/Pain(Baseline)
  • Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods(12 months prior to index event (pre-index period) and 12 months following index event (post-index period))
  • Emergency Department Visits Per 1000 Participants(12 months prior to index event (pre-index period) and 12 months following index event (post-index period))
  • Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression(12 months following index event (post-index period))
  • New Post-index Documentation for Signed Pain Management Agreement (Pain Contract)(12 months following index event (post-index period))
  • New Post-index Order for Urine Drug Screen (UDS)(12 months following index event (post-index period))
  • New Post-index Naloxone Prescription Order(12 months following index event (post-index period))
  • Change in Rate of Patient Report of Opioid Misuse(Baseline, 12 months following index event (post-index period))
  • Change in Patient Rating of Quality of Life(Baseline, 12-months following index event (post-index period))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eboni Price-Haywood

Medical Director

Ochsner Health System

研究点 (2)

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