Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
2021년 4월 26일 업데이트: Kevin Kraemer, University of Pittsburgh
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care
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.
연구 개요
상태
모집하지 않고 적극적으로
연구 유형
중재적
등록 (실제)
22566
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- UPMC Community Medicine Incorporated
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Patient Participants
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Cancer diagnosis (other than non-melanoma skin cancer)
- Receipt of opioid prescription within 12 months of index outpatient encounter
- Providers
Inclusion Criteria:
- Primary care provider (MD, Doctor of Osteopathy (DO), Physician Assistant (PA), Nurse Practitioner (NP)) at participating practice
Exclusion Criteria:
- None
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Usual Care/Guideline
The Usual Care group (also known as the Guideline group) follows the recent Center for Disease Control (CDC) guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy.
Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
|
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy.
Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
|
|
실험적: Guideline + Opioid Justification (OJ)
Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition.
The provider will be notified that the justification provided will be visible in the Epic EHR.
The provider has the option of entering a justification or not.
If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank).
The provider does not need to enter a justification if they choose to cancel the opioid prescription.
|
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy.
Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition.
The provider will be notified that the justification provided will be visible in the Epic EHR.
The provider has the option of entering a justification or not.
If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank).
The provider does not need to enter a justification if they choose to cancel the opioid prescription.
|
|
실험적: Guideline + Provider Comparison (PC)
Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids f or acute pain who transition to chronic opioid therapy (> 3 months).
Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions , unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain.
Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.
|
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy.
Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids or acute pain who transition to chronic opioid therapy (> 3 months).
Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions, unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain.
Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.
|
|
실험적: Guideline + OJ + PC
This arm will include the guideline, opioid justification, and provider comparison described above.
|
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy.
Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition.
The provider will be notified that the justification provided will be visible in the Epic EHR.
The provider has the option of entering a justification or not.
If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank).
The provider does not need to enter a justification if they choose to cancel the opioid prescription.
Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids or acute pain who transition to chronic opioid therapy (> 3 months).
Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions, unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain.
Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Initial Opioid Prescription
기간: 1 day (assessed on day of initial qualifying clinic visit
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Initial opioid prescription (yes/no) (Primary) (Hypothesis 1a).
Opioid prescription at qualifying clinic visit, measured via electronic health record (EHR).
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1 day (assessed on day of initial qualifying clinic visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Initial non-opioid management
기간: 1 day (assessed on day of initial qualifying clinic visit)
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Initial non-opioid management (yes/no) (Secondary) (Hypothesis 1a).
Defined as order for any non-opioid management strategy at baseline (e.g., non-opioid medication, physical therapy, behavioral therapy), measured via EHR.
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1 day (assessed on day of initial qualifying clinic visit)
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Change in Patient Reported Pain and Function
기간: Assessed at 1, 6, and 12 months after initial qualifying clinic visit
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Change in Patient Reported Pain and Function (Secondary) (Hypothesis 1b).
Measured by the 3-item Pain/Enjoyment/General Activities (PEG) instrument in clinic at baseline and via brief web survey or telephone interview
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Assessed at 1, 6, and 12 months after initial qualifying clinic visit
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Unsafe opioid prescribing at 3 months
기간: 3 months after initial qualifying clinic visit
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Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
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3 months after initial qualifying clinic visit
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Unsafe opioid prescribing at 6 months
기간: 6 months after initial qualifying clinic visit
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Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
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6 months after initial qualifying clinic visit
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Unsafe opioid prescribing at 12 months
기간: 12 months after initial qualifying clinic visit
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Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
|
12 months after initial qualifying clinic visit
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Chronic opioid therapy at 3 months
기간: 3 months after initial qualifying clinic visit
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Chronic opioid therapy (Secondary) (Hypothesis 2).
Ongoing, chronic opioid therapy will be measured via EHR
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3 months after initial qualifying clinic visit
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Chronic opioid therapy at 6 months
기간: 6 months after initial qualifying clinic visit
|
Chronic opioid therapy (Secondary) (Hypothesis 2).
Ongoing, chronic opioid therapy will be measured via EHR
|
6 months after initial qualifying clinic visit
|
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Chronic opioid therapy at 12 months
기간: 12 months after initial qualifying clinic visit
|
Chronic opioid therapy (Secondary) (Hypothesis 2).
Ongoing, chronic opioid therapy will be measured via EHR
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12 months after initial qualifying clinic visit
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kevin L Kraemer, MD, University of Pittsburgh
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 9월 23일
기본 완료 (실제)
2020년 1월 31일
연구 완료 (예상)
2022년 8월 31일
연구 등록 날짜
최초 제출
2018년 4월 29일
QC 기준을 충족하는 최초 제출
2018년 5월 14일
처음 게시됨 (실제)
2018년 5월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 26일
마지막으로 확인됨
2021년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UOP-1609-36881
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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