Clinical trial NCT05276089: GP Remote Consultation to Reduce Opioid Prescribing
Official title: Evaluating the Impact of an Evidence Informed, Digitally Deployed, GP Remote Consultation Video Intervention That Aims to Reduce Opioid Prescribing in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Teesside University
name: NIHR Applied Research Collaboration for North East and North Cumbria
name: North East Academic Health Science Network
First posted: 2022-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* if they are coded cancer or palliative care.

Primary outcomes:
measure: 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
timeFrame: Up to 7 months
Secondary outcomes:
measure: 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
timeFrame: Up to 7 months
measure: 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
timeFrame: Up to 7 months
measure: Change from baseline line high dose opioid items as percentage regular opioids
timeFrame: Up to 7 months
measure: 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.
timeFrame: Up to 7 months
measure: The percentage of the video watched by participants who were sent the video
timeFrame: Up to 7 months
measure: Intervention costs
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: LCRN
city: Newcastle
country: United Kingdom
facility: LCRN
Study officials:
References: