Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 543
- 试验地点
- 6
- 主要终点
- Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12
研究概览
简要总结
Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help maintain or improve their function and quality of life.
This study compared two programs for helping people living with long-term pain who have been prescribed opioids for 3 or more months. This study was done at primary care and pain care clinics at 3 health systems in the Southeastern United States.
The study team assigned people by chance to one of two study programs: (1) individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) or (2) patient-clinician shared decision making. In the MI+CBT program, the patient learned strategies to better cope with chronic pain. In the SDM program, the patient and clinician worked together through enhanced communication to make decisions that aligned with values and preferences of the patient.
The study team compared the two programs by looking at changes in opioid dosage, physical functioning, and pain interference over time. They collected information about prescribed opioid dosage from electronic health records and patients completed surveys at the start of the study and 6 and 12 months later.
The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.
详细描述
Objective:
To compare the effectiveness of individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) versus patient-clinician shared decision making (SDM) on change in daily dosage of prescribed opioids, physical functioning, and pain interference for individuals with chronic non-cancer pain (CNCP).
Rationale:
About 24% of Americans suffer from CNCP and clinicians often prescribe opioids to treat it. Once on chronic opioid therapy (COT), individuals often continue with this class of medication for years. Evidence for the effectiveness of COT to treat CNCP is limited, exposing individuals to known risks. Modified or novel pharmacological and nonpharmacological strategies are needed to improve pain management and promote informed decision making regarding possible opioid dose reduction.
Study Design and Approach:
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 85 years
- •History of chronic non-cancer pain (CNCP)
- •Receiving chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily prescribed dosage of 20 milligrams of morphine equivalents
- •Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months.
排除标准
- •Not meeting the above inclusion criteria
- •Opioid use is for pain directly related to an active cancer diagnosis
- •Opioid use is for maintenance treatment of an opioid use disorder
- •Suicide attempt within the past 3 years
- •Active suicidal ideation
- •Currently receiving Cognitive-Behavioral Therapy (CBT)
- •Non-English speaking
- •Other reason at the discretion of the investigator
结局指标
主要结局
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12
时间窗: Month 12 (PRIMARY TIMEPOINT)
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 12 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3
时间窗: Month 3
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 3 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6
时间窗: Month 6
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 6 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9
时间窗: Month 9
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 9 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15
时间窗: Month 15
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 15 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18
时间窗: Month 18
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 18 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12
时间窗: Month 12
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3
时间窗: Month 3
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6
时间窗: Month 6
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9
时间窗: Month 9
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15
时间窗: Month 15
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18
时间窗: Month 18
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
次要结局
- Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6(Month 6)
- Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6(Month 6)
- Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12(Month 12)
- Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12(Month 12)
研究者
Lauren McCormack
Senior Vice President
RTI International