GP Remote Consultation to Reduce Opioid Prescribing

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use
• Intervention / Treatment: Behavioral: Video message

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Fu, PhD; Phone Number: 07809759652; Email: yu.fu@newcastle.ac.uk
• Study Contact Backup: Name: Julia Newton, PhD; Phone Number: 07732628443; Email: Julia.Newton@ahsn-nenc.org.uk

Study Locations

• United Kingdom
  • Newcastle, United Kingdom
    • LCRN
    • Contact: Laura Renwick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm; A total of 50 practices who use System 1 will be in the intervention arm to send out the video to their eligible patients.	Behavioral: Video message; The five-minute video will be sent to the patient's mobile phone, outlining reasons to reduce opioid use and highlighting the support available. It invites patients to consider 3 responses: I would like to reduce my opioid medication with support.; I understand this video but I want to continue my current dose.; I would like to speak to someone to understand more. Option 1) will enable the GP practice to initiate existing opioid reduction support, Option 2) will continue care and support as usual, and Option 3) will enable the team to offer more information.
NO_INTERVENTION: Control arm; 50 practices who use EMIS will be in the control arm to deliver care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	Up to 7 months
Change from baseline line high dose opioid items as percentage regular opioids	Information on high dose opioid items as percentage regular opioids will be collected from the publicly accessible dataset (OpenPrescribing.net), which records monthly data on opioid items with likely daily dose of ≥120mg morphine equivalence compared with prescribing of all items of these 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.	Intervention usage	Up to 7 months
The percentage of the video watched by participants who were sent the video	Fidelity	Up to 7 months
Intervention costs	Intervention costs will be estimated based on interviews with the developer of the videos and GP practice stakeholders to understand the licence costs and the opportunity costs of practice staff time in finding the appropriate population to whom the videos will be sent. If applicable, the investigators will estimate any additional resources needed by people receiving videos who decide to reduce or eliminate their opioid use, who may need GP practice visits to discuss this.	Up to 7 months

Collaborators and Investigators

• Sponsor: Dr Yu Fu
• Collaborators: Teesside University; NIHR Applied Research Collaboration for North East and North Cumbria; North East Academic Health Science Network

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (ACTUAL): March 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NU-010572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no IPD involved in this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No