Opioid UseNCT05276089
GP Remote Consultation to Reduce Opioid Prescribing
A study testing Video message in people with Opioid Use, run by Dr Yu Fu at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Opioid Use
- What is being tested?
- Video message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Feb 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- if they are coded cancer or palliative care.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Opioid Use
- Being tested
- Video message
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video messageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | A total of 50 practices who use System 1 will be in the intervention arm to send out the video to their eligible patients. Receives: Behavioral: Video message |
| Control arm | No intervention | 50 practices who use EMIS will be in the control arm to deliver care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 7 months
The percentage of the video watched by participants who were sent the video
Fidelity
Measured: 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.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Yu Fu
- Sponsor type
- University, hospital or other
- Collaborators
- Teesside University, NIHR Applied Research Collaboration for North East and North Cumbria, North East Academic Health Science Network
- Responsible party
- Sponsor-investigator, Dr Yu Fu, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276089
- Sponsor's protocol ID
- NU-010572
- Status last verified
- Oct 2022
- First submitted
- 21 Feb 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD involved in this trial.
Publications
Fu Y, Allen B, Batterham AM, Price C, Jones N, Martin D, Hex N, Maule E, Finch T, Newton JL, Ryan CG. Digitally deployed, GP remote consultation video intervention that aims to reduce opioid prescribing in primary care: protocol for a mixed-methods evaluation. BMJ Open. 2023 Feb 6;13(2):e066158. doi: 10.1136/bmjopen-2022-066158.
PubMed 36746541
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05276089
- Acronym / sponsor ID
- NU-010572
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr Yu FuUniversity, hospital or other
- Collaborators
- Teesside University, NIHR Applied Research Collaboration for North East and North Cumbria, North East Academic Health Science Network
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Video messageA total of 50 practices who use System 1 will be in the intervention arm to send out the video to their eligible patients. |
| Control arm | No intervention | –50 practices who use EMIS will be in the control arm to deliver care as usual |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- if they are coded cancer or palliative care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video messageThe 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: 1. I would like to reduce my opioid medication with support. 2. I understand this video but I want to continue my current dose. 3. 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. | Behavioural | Intervention arm |
Primary outcome
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
Time frame: 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.
6 secondary outcomes
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
Time frame: 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
Time frame: Up to 7 months
Change from baseline line high dose opioid items as percentage regular opioids
Time frame: 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.
Time frame: Up to 7 months
The percentage of the video watched by participants who were sent the video
Time frame: Up to 7 months
Intervention costs
Time frame: Up to 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 36746541Fu Y, Allen B, Batterham AM, Price C, Jones N, Martin D, Hex N, Maule E, Finch T, Newton JL, Ryan CG. Digitally deployed, GP remote consultation video intervention that aims to reduce opioid prescribing in primary care: protocol for a mixed-methods evaluation. BMJ Open. 2023 Feb 6;13(2):e066158. doi: 10.1136/bmjopen-2022-066158.
- Individual participant dataSharing planned: No. There is no IPD involved in this trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video message in people with Opioid Use, run by Dr Yu Fu at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Fu, PhD (07809759652, yu.fu@newcastle.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.