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EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use (EMC2)

23 de setembro de 2019 atualizado por: Danielle McCarthy, Northwestern University
The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge.

The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume >85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.

Tipo de estudo

Intervencional

Inscrição (Real)

652

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:

    1. Patient age 18 years and older
    2. English language speaking
    3. prescribed pill form of hydrocodone-acetaminophen opioid pain reliever
    4. own a cell phone with text messaging capabilities
    5. the patient is the person primarily responsible for administering medication

Exclusion Criteria:

  • Subjects will be excluded from the study if any of the following conditions are met:

    1. Aged <18
    2. non-English speaking
    3. clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician
    4. chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days
    5. admitted to hospital
    6. unable to complete follow up phone interviews
    7. pregnant

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Usual Care
Employ the standard of care, no intervention
Experimental: EMC2 strategy

Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.

  1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.
  2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.
  3. Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription.
Comportamental: EMC2 Strategy
Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
Experimental: EMC2 strategy + SMS Text Reminders
In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
Comportamental: EMC2 Strategy
Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
Comportamental: SMS Text Reminders
In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Safe Medication Dosing (Prescription Understanding)
Prazo: 7-14 days after enrollment
Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).
7-14 days after enrollment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Medication Knowledge
Prazo: 7-14 days after enrollment
The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire. Patients will be asked about each of the above via structured, open-ended items. Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included. The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10. A higher score on the scale represents better patient knowledge.
7-14 days after enrollment
Proper Medication Use (Medication Diary)
Prazo: 10 day medication diary
Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use.
10 day medication diary
Current Opioid Misuse Measure (COMM)
Prazo: 7-14 days after enrollment
Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.
7-14 days after enrollment
Pain Score
Prazo: 7-14 days after enrollment
Pain scores through structured questions about use in the past 24 hours were collected from participants. Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores.
7-14 days after enrollment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Northwestern University

Colaboradores

Agency for Healthcare Research and Quality (AHRQ)

Investigadores

  • Investigador principal: Danielle McCarthy, MD, Northwestern University Feinberg School of Medicine

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de julho de 2015

Conclusão Primária (Real)

1 de agosto de 2017

Conclusão do estudo (Real)

1 de setembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de abril de 2015

Primeira postagem (Estimativa)

1 de maio de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de setembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de setembro de 2019

Última verificação

1 de setembro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 1R18HS023459-01 (Concessão/Contrato da AHRQ dos EUA)

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