NCT05276089

GP Remote Consultation to Reduce Opioid Prescribing

Status unknown NA Last updated 3 November 2022

What this trial tests

NA trial testing Video message in Opioid Use in 100 participants. Status unknown.

Timeline

1 February 2023

Primary endpoint
1 June 2023

1 June 2023

Quick facts

Lead sponsor	Dr Yu Fu
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	100
Start date	1 February 2023
Primary completion	1 June 2023
Estimated completion	1 June 2023
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Video message

Conditions studied

• Opioid Use — all drugs for Opioid Use →

Sponsor

Dr Yu Fu

Who can join

Adults 18 to 110, any sex, with Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Digitally deployed, GP remote consultation video intervention that aims to reduce opioid prescribing in primary care: protocol for a mixed-methods evaluation.
   Fu Y, Allen B, Batterham AM, Price C, et al · · 2023 · PMID 36746541 · DOI 10.1136/bmjopen-2022-066158