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临床试验/NCT05276089
NCT05276089尚未招募不适用

Evaluating the Impact of an Evidence Informed, Digitally Deployed, GP Remote Consultation Video Intervention That Aims to Reduce Opioid Prescribing in Primary Care

Dr Yu Fu1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Change from baseline line opioids analgesics assessed as Average Daily Quantity (ADQ)/1000 Specific Therapeutic group Age-sex Related Prescribing Unit (STAR PU) at 6 months

研究概览

简要总结

Opioid prescribing rates are high in the North East and North Cumbria region of England. The COVID-19 pandemic has interrupted the existing regional programme that aims to reduce the use of opioid medications, and also prescribing is likely to have increased during the lockdown. Thus, it has become increasingly challenging for primary care to dedicate sustained clinical time to tackle this complex issue with patients, who may also be reluctant to seek help. A video messaging intervention based upon a GP consultation was developed to remotely explain the rationale for opioid reduction and facilitate self-initiation of support. The short video suitable for smartphone viewing is messaged using a two-way communication system. Patients can watch the video and request additional support by replying with a simple text or email response. This enables efficient delivery of a discrete offer of help to at risk individuals who often avoid service contact. The aim of this study is to evaluate the potential benefits, risks and economic consequences of 'at scale' implementation.

This study will be a mixed methods study comprising of a quasi-experimental non-randomised before-and-after study and qualitative interviews. In the first phase, the intervention arm will comprise 50 GP practices in the region using System 1 who will deliver the video to their patients. The control arm comprises 50 practices in the region using EMIS who will continue care as usual. The unit of analysis is the GP practice, with no individual-level quantitative data collected. Monthly practice level data will be accessed and followed up for 6 months. A general linear model will be used to estimate the association between the exposure (video message vs. control) and the outcome (opioid prescribing). In the second phase, semi-structured interviews will be undertaken remotely with purposively selected participants including patients who received the video and health professionals involved in sending out the videos. These interviews will be audio recorded with participants' consent, transcribed and analysed thematically.

As well as evidence and rapid insights to inform the potential accelerated implementation of the intervention within the Integrated Care System, this study will provide evidence that could underpin the future adoption of the intervention into wide scale clinical management that can be disseminated as a future national programme via the Academic Health Science Network.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults (aged 18 or over)
  • registered with a mobile phone number at practices
  • regularly taking opioids for more than 90 days or at a dose equivalent to > 100 mg of codeine a day (this varies for each opioid medication) using electronic records

排除标准

  • if they are coded cancer or palliative care.

结局指标

主要结局

Change from baseline line opioids analgesics assessed as Average Daily Quantity (ADQ)/1000 Specific Therapeutic group Age-sex Related Prescribing Unit (STAR PU) at 6 months

时间窗: Up to 7 months

This is a practice level data collected monthly by electronic Prescribing Analysis and Costs (ePACT2) by North of England Commissioning Support Unit (NECS). NECS has agreed to support data requests and access.

次要结局

  • Intervention costs(Up to 7 months)
  • Change from baseline line all opioids (adding in compound analgesics) Average Daily Quantity (ADQ)/1000 Specific Therapeutic group Age-sex Related Prescribing Unit (STAR PU)at 6 months(Up to 7 months)
  • Change from baseline line gabapentinoid (gabapentin&pregabalin) Average Daily Quantity (ADQ)/1000 Specific Therapeutic group Age-sex Related Prescribing Unit (STAR PU) at 6 months(Up to 7 months)
  • Change from baseline line high dose opioid items as percentage regular opioids(Up to 7 months)
  • The number (proportion) of individuals who were followed up by the practice within 1 month of choosing Options 1) and 3), will be quantified being sent the message.(Up to 7 months)
  • The percentage of the video watched by participants who were sent the video(Up to 7 months)

研究者

发起方
Dr Yu Fu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Yu Fu

Principal Investigator

Newcastle University

研究点 (1)

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