GP Remote Consultation to Reduce Opioid Prescribing

Opioid Use Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05276089
• Other study ID #: NU-010572
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2022
• Source: Newcastle University
• Contact: Yu Fu, PhD
• Phone: 07809759652
• Email: yu.fu[@]newcastle.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	LCRN	Newcastle
United Kingdom	LCRN	Newcastle

Sponsors (4)

Lead Sponsor	Collaborator
Dr Yu Fu	NIHR Applied Research Collaboration for North East and North Cumbria, North East Academic Health Science Network, Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The percentage of the video watched by participants who were sent the video	Fidelity	Up to 7 months
Secondary	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