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Physician Coaching to Reduce Opioid-related Harms

3 de julho de 2018 atualizado por: University of Wisconsin, Madison
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.

The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.

Tipo de estudo

Observacional

Inscrição (Real)

53132

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

    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53705
        • University of Wisconsin - Madison

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

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Clinicians with prescribing authority at community-based primary care clinics

Descrição

Inclusion Criteria:

At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.

Exclusion Criteria:

  • Residents will be excluded.

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

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Physician coaching
This group includes 4 intervention primary care clinics that are part of the University of Wisconsin's Department of Family Medicine. These clinics will receive an organizational coaching intervention that includes in-person site visits and phone/email communication. Each participating clinic will designate one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit (during project month 13, July 2015), a follow-up site visit (month 15, October, 2015), and communicating with the coach throughout the 6-month follow-up period via phone and email.

The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.

The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice.

Control Group
This group includes 4 control primary care clinics that will not receive any intervention. A de-identified dataset will be created to examine differences in outcome variables between intervention and control clinics.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Rate of Opioid Prescribing
Prazo: Up to 3 years
The proportion of patients with a chronic pain diagnosis receiving daily opioids.
Up to 3 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Rate of Opioid / Benzodiazepine Co-prescribing
Prazo: Up to 3 years
Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
Up to 3 years
Urine Drug Screening Rate
Prazo: Up to 3 years
Proportion of opioid patients completing urine drug screens prior to and during the study intervention
Up to 3 years
Mental Health Screening Rate
Prazo: Up to 3 years
Proportion of opioid patients screened for mental health/substance use problems
Up to 3 years
Use of Pain Management Agreements
Prazo: Up to 3 years
Proportion of opioid patients signing pain management agreements
Up to 3 years
High-dose Patients
Prazo: Up to 3 years
Proportion of opioid prescriptions above 120 mg daily morphine equivalent
Up to 3 years
Provider Drop-out Rate
Prazo: 3 months
Number and percentage of providers who drop out of study at 3 months
3 months
Participating Patient Demographics
Prazo: Up to 3 years
Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
Up to 3 years
Participating Clinic Characteristics
Prazo: Up to 12 months
Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
Up to 12 months
Participating Staff Characteristics
Prazo: Up to 12 months
Characteristics of participating staff (profession)
Up to 12 months
Intervention Fidelity
Prazo: Up to 12 months
Total hours of coaching delivered/received among all clinics that received physician coaching.
Up to 12 months
Intervention Cost
Prazo: Up to 12 months
Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.
Up to 12 months
Proportion With MEDD >120 mg
Prazo: Up to 12 months
The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
Up to 12 months
Average Morphine Equivalent Daily Dose (MEDD)
Prazo: Up to 12 months
The average MEDD in milligrams for patients with consistent opioid Rx.
Up to 12 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Andrew R Quanbeck, PhD, Center for Health Enhancement Systems Studies

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

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

1 de julho de 2014

Conclusão Primária (Real)

30 de junho de 2017

Conclusão do estudo (Real)

30 de junho de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

20 de abril de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de abril de 2015

Primeira postagem (Estimativa)

5 de maio de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de julho de 2018

Última verificação

1 de julho de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 2015-0280
  • 1R34DA036720-01A1 (Concessão/Contrato do NIH dos EUA)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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