Clinical Decision Support for Safety of Opioid Transitions

Обзор

The objective of this study is to evaluate the impact of clinical decision support (CDS) alert to notify providers when the opioid prescription being written will result in the patient transitioning into a new phase of opioid therapy. The 2022 CDC clinical practice guideline for prescribing opioids for pain recommends providers reassess patient pain as well as the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and when patients transition from subacute to chronic opioid treatment (3 months). This study will evaluate a clinical decision support tool identifying patients who will be transitioning between phases as a result of an opioid prescription and suggest a review of patient pain and goals. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will not be notified that the prescription transitions the patient to a new phase but will have access to the same patient pain scales and information. The intervention arm will receive a notification of the transition and suggest review of patient needs and encourage documentation. Opioid transition orders and outcomes of patients will be examined based on medical records data collected during routine care.

Вмешательства

• Другое Opioid Transitions Clinical Decision Support (CDS)
  Clinical decision support in the form of an electronic health record (EHR) integrated, provider-facing alert suggesting (a) the patient is transitioning to a new phase of opioid therapy and (b) the provider should review patient pain data and pain management goals as suggested by Center for Disease Control and Prevention (CDC) guidelines.

Первичные конечные точки

• Percentage of encounters with an opioid transitioning prescription [Срок оценки: 18 months]

Вторичные конечные точки (4)

• Clinical decision support (CDS) acceptance rate [Срок оценки: 18 months]
• Subsequent opioid overdose/poisoning rates [Срок оценки: Six months after an encounter where the opioid use disorder is identified]
• Opioid prescription abandonment [Срок оценки: 18 months]
• Number of patients with long term opioid use [Срок оценки: Six months after an encounter where the opioid use disorder is identified]

Критерии участия

Inclusion Criteria: Any primary care encounter where an opioid is prescribed that transitions the patient to a different stage of opioid therapy (acute to subacute after 1 month of opioids; subacute to chronic after 3 months of an opioid)

Критерии исключения

• Patients <12 and >89
• Patients with active cancer diagnosis in last 1 year
• Patients with hospice care/palliative care order
• Patients with sickle cell disease diagnosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06527040 · 24-1192 · R61DA057610

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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