Developing a Theoretically Informed Implementation Model for Telemedicine-Delivered Medication for Opioid Use Disorder: Qualitative Study With Key Informants

Background Telemedicine-delivered medication for opioid use disorder (TMOUD) has become more prevalent during the COVID-19 pandemic, particularly in North America. This is considered a positive development as TMOUD has the potential to increase access to evidence-based treatment for a population heavily affected by the opioid crisis and consequent rising mortality and morbidity rates in relation to opioid use disorder. Despite the increase in the use of TMOUD, there are no established service- and process-focused models to guide the implementation of this intervention. Objective This study aims to develop a process- and service-focused implementation model in collaboration with key stakeholders and bring together peer-reviewed literature, practice-based knowledge, and expert opinions. Methods The simple rules for evidence translation in complex systems framework was applied to guide the development of a 6-step qualitative study. The steps were definition of the scope and objectives of the model, identification of evidence, stakeholder engagement, draft model development, key informant consultation, and final model specification. Results The final specification for the TMOUD implementation model incorporated key strategic priorities, service delivery prerequisites, service design elements, stakeholder identification and engagement, key process domains, and iterative cycles of evaluation and improvement. Conclusions Through stakeholder engagement and key informant consultation, we produced a process- and service-focused TMOUD implementation model. The model is modifiable to different contexts and settings while also in keeping with the current evidence base and national and international standards of high-quality opioid use disorder care.

A key DDTF priority has been to support service innovations which improve ease of access to and available options of Medication Assisted Treatment (MAT) for People Who Use Drugs (PWUD).
Innovative, flexible and responsive MAT has become even more important during the COVID-19 pandemic not least as people who use opioids and other drugs have heightened health and social risks increasing their vulnerability to poor outcomes.

Purpose of this guide
We see this guide as a resource for the implementation of TMAT in keeping with the proposed national MAT standards.This guide does not review the evidence for the MAT standards themselves which have been reported elsewhere (Johns et al., 2020).Figure 1.maps out the relationship between the MAT standards and the various aspects of TMAT delivery.The knowledge and literature around the implementation of specific healthcare interventions are not always readily accessible in the public domain.Specifically, when it comes to technology based interventions, or interventions in response to crises, the published literature becomes rapidly outdated (Mohr et al., 2015).We have therefore taken the Digital Design for Addiction Services (Colley & Marttila, 2017, p. 295-8) approach which is described in more detail below.
1,264 people tragically lost their lives to a preventable drug overdose in Scotland last year.The statistics, published by National Records of Scotland, show the toll is 6% higher than 2018, and the highest since records began in 1996.
Scotland's drug death rate is now 3.5 times higher than the rest of the UK and is higher than that reported for any other EU country.

Medication Assisted Treatment (MAT)
defined as 'the use of medication, such as opioids, together with psychological and social support, in the treatment and care of individuals who experience problems with their drug use'.
Aim: improve quality and consistency of care across the country.We have completed stage one, a seminar which capitalised on the wealth of experience gained by colleagues during the pandemic and earlier, in comparable international and national health systems with similar drug related death rates and service challenges.The seminar presentations and recordings are available on the digitAS website: http://med.standrews.ac.uk/digitas/.

Medication Assisted
Following on from the seminar which serves as a shared body of knowledge, we are launching this draft guidance.The guidance is intended to support the process of identifying the best point of patient contact to introduce telemedicine consultations.It also goes through the process of setting up Telemedicine Medication Assisted Treatment (TMAT) in existing systems of care, a guide to risk, safeguarding and ethical guidelines and a guide to the consultation process itself.In addition to the expertise derived from our panel, we have also conducted a rapid literature review and we refer extensively to the visual step-by-step guide for clinicians using video consultations in mental health services (Johns et al., 2020) and a series of toolkits produced by Technology Enabled Care (TEC) Cymru (TEC Cymru, 2021).Step-by-step guide This guide describes Telemedicine Medication Assisted Treatment (TMAT) delivery in three ways.The first section describes a set up process and considerations around TMAT delivery in an existing healthcare workflow.The second section discusses the ethical and legal principles to be considered in TMAT delivery.The final section discusses the actual TMAT consultation.We use tables and diagrams extensively to make this guide more easily adapted to local needs and to make information more readily available when required.
1. Setting up your TMAT service Mode 3. Triadic hub-spoke: Clinician in specialist 'hub' centre connects to patient in remote 'spoke' healthcare site (for example, a community pharmacy, GP practice) with another healthcare worker present (for example, nurse, pharmacist, healthcare support worker) Mode 4. Triadic hub-home: Clinician in specialist 'hub' centre connects to patient at home with another healthcare worker present (for example, nurse, GP, healthcare support worker).

Healthcare worker safety
Ensure that the lone worker and risk assessment guidance is adapted accordingly.

Who will conduct the TMAT consultation?
Will it be delivered by any independent prescriber?
Will it be piloted initially with a more senior clinician?
Will it be piloted by a senior clinician alongside another prescriber so that learning and experience is shared?
NHS Near Me is the agreed national platform in Scotland, and therefore all clinician to patient video calling should occur on Near Me.Other platforms do not necessarily have the information governance or security measures in place.
However, some services have used Skype for business, and some services in North America have used encrypted ZOOM calls.Some services also offer drop in video clinics.Additionally, some private companies in the UK have bespoke mobile platforms.

Identify how TMAT links and information will be sent to patient e.g. SMS, email, verbally
Appointment links and information may be sent via a Short Message Service (SMS), text or email, or the link may be embedded on a webpage that patient is directed to.

Identify how TMAT appointments will be booked and documented
Identify person(s) in charge of making the TMAT appointments.This person(s) should counter check that contact information such as email addresses or mobile numbers for SMS are correct to avoid the link for the appointment going to the wrong person.How much in advance can TMAT appointments be booked?This is particularly relevant in populations which may not have consistent mobile phone numbers or addresses.

Appointment system
How will appointment slots be offered, documented and given to the delivering clinician?Does the system being used to deliver TMAT integrate well with existing appointment systems?

Set up the clinical spaces
In all modes, will there be sufficient privacy for a clinical consultation to occur?Will there be appropriate lighting and bandwidth for example in kiosks or the pharmacy for mode 2 and 4.

Clinic templates and coding for TMAT
What adjustments need to be made to current clinical templates and coding?Do new codes need to be developed, for example to reflect mode of TMAT delivery?

Further information
Either the patient or the clinician may need further information.For example, it may not be possible on the first consultation for the clinician to be certain about withdrawal symptoms.Also, the patient may wish to have written information about MAT choices.In the case of sending information-this could be done by : (process 3) Please consider grouping related criteria together for example Clinical aspects (comorbidity, pregnancy, previous response etc.)/Social and Personal circumstances (remote location, poor transport access, Local Covid restrictions, access to technology, etc.) : How will TMAT incorporate Family Inclusive Practice (FIP).During lockdown families report to us a significant decrease in the involvement in the treatment and care of their loved one due to use of technology to engage with them.FIP should be embedded in TMAT from the outset and encouraged : (process 5) The names of the hub modes become very confusing for both patients and support professionals.
Specialist pharmacist in substance misuse: (process 5) Triadic Home -could a further option here be that the other worker is not actually at the home of the patient but joining the call between Prescriber and patient from another location or venue?This offers a different risk profile for alone working / visiting patients homes.
(process 8) Clinician to patient calling should be on Near Me.This is agreed national platform.Other platforms don't have the necessary information governance or security stuff in place.
(process 8) You can also consider drop in video clinics.
: (process 8) In Ayrshire addiction services, we have Near Me.We do a lot of review via telephone.
(process 9) also thinking about non NHS services (process 9) Links should be sent via SMS or email (sending by letter or verbally will lead to miss-typing and the patient ending up in the wrong place).Alternatively, the link may also be embedded on an easily accessible webpage that the patient is directed to.
(process 14) not just withdrawals though -may want to rephrase (process 14) drug testing?DBST?Venepuncture?Physical assessment?(process 15) Though Near Me is very stable -callers may run out of data/have a flat battery/get the link wrong so good contingency plan (usually reverting to phone consultation is required) : (process 15) access and privacy considerations : (process 15) better to rephrase as mental health or physical health emergencies which can includes lots of different scenarios.
(process 15) TMAT needs to be contactable by more than just phone.We have seen a considerable decrease in people accessing upport using the phone.Initial requests for support need to be able to be made via email, online, text (non voice based contacts) which are free and ease to enrole (process 15) signpost to reputable sources e.g.C&M website

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Family inclusive practice (FIP) should be encouraged in every interaction with a person who uses substances.This needs to be built into the process to ensure that families are included in the treatment and care of their loved one.-How are TMAT consultations going to take place to include family members.Families have told us during lockdown they have found it incredibly difficult to be part of their loved ones treatment and care due to the use of technology.They would normally attend appointments in person along with their loved one.During lockdown and the use of technology families have been excluded.This TMAT process does not promote FIP and actively excludes families.-How will family support be offered to those involved in their loved ones TMAT treatment and care?Rights Respect & Recovery states that families have the right to support in their own right not merely as part of their loved ones treatment and care.
2. Risk, safeguarding and ethical considerations Risk-assessment process.
Understanding the risks associated with each step in the provision of Telemedicine Medication Assisted Treatment (TMAT) and conducting an appropriate risk assessment is good practice and is advised across the development of healthcare services.This process, called Clinical Risk Management (CRM), adopts a number of risk management tools from other industries to use in clinical situations enabling a logical process to understand why critical incidents occur and create reasonable mitigation strategies (Rausand, 2013;Kaya, Ward & Clarkson, 2019).Risk management tools include Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (Senders, 2004).Most if not all NHS services have established processes and so this guide does not elaborate on this further.Nevertheless, one useful exercise to guide further risk assessment activities is to conduct process mapping.

Process Mapping
Process maps are a standard tool in business and engineering which attempts to visualise the workflow of a particular activity in order to improve efficiency (King, Ben-Tovim, Bassham, 2006).The flow of events in a process is mapped out such that we can delve into the mechanics of how intended and unintended outcomes happen.By identifying areas that have gone wrong or disrupted efficiency, we can introduce improvements.Process maps also enhances communications within a management structure by aligning understandings of the processes and standardises documentation (Mould, Bowers & Ghattas, 2010).
We have attempted in this section to breakdown each step in MAT to enable us to start thinking about how telemedicine may be used and what risk exposure may arise as a result.
Figures 3 & 4 can be adapted to suit your own services and potentially shorten the process of logically breaking down the important steps of Medication Assisted Treatment (MAT) delivery.
Comments nterim Senior Charge Nurse: How do patients of no fixed abode / no access to phone / internet etc access treatment and appointments?lies fected by alcohol & drugs: Accessing the service (how accessible is the service?):Services need to be contactable by non voice based contacts (online, email, webchat, text).Through lockdown we have seen an increase in non voice based contacts for people initially enquiring/looking to access support.Accessing the service (how inclusive and safe is the service?):Family Inclusive Practice needs to be included in this section.How will service users be pro actively encouraged to include family/friends in their treatment and care.Family involvement should be actively encouraged.Identification: Reference made to next of kin but no mention of family/friends network.Treatment planning: Again no mention of how families will be supported to be part of their loved ones treatment and care.How are we making sure that families are supported and have access to Naloxone?(Families are entitled to support in their own right.This is not the same as Family Inclusive Practice.Practitioners should be identifying appropriate supports for the families.Titration: If family are included in the care and treatment of their loved one this will be an avenue of enquiry if people miss appointments or the practitioner has concerns.Families can be a real wealth of knowledge regarding how a loved one is coping outwith appointment times.With appropriate family support families can ensure that their loved one attend their appointments.Issue of Naloxone for families should be a priority.When working through your own Medication Assisted Treatment (MAT) process map, consider the following.

Specialist pharmacist in substance misuse
• Will offering Telemedicine Medication Assisted Treatment (TMAT) in one or more of the 4 modes increase or decrease risk when compared to conventional services and also when compared to contextual factors such as delays in service provision due to capacity issues or the pandemic?• What steps can be taken to resolve the identified risk?In particular, would changing the mode or intake criteria alter this risk?• Is the risk of using TMAT greater than not seeing the patient at all? • Are TMAT risks any different to in person risks?What in reality is offered in-person which meaningfully reduces the risk in providing MAT? • What other types of risks (or new forms of risk) might there be -such as data protection or privacy?• If TMAT is used in only one particular group for example for patients undergoing 3monthly medication reviews, are there processes to use the increased appointment capacity to shorten waiting times for in-person evaluation and induction?
The outcome of the process mapping and initial risk assessments should be clear and easy to follow safeguarding contingency plans including a 'what to do if…' plan in the event of an emergency or concern during a virtual appointment.
A wide range of low to high probability risk scenarios with a range of impact levels should be considered.Staff will be able to relate more closely to scenarios which are applicable to their setting, and as close to real-life circumstances as possible and so make better use of the contingencies and processes.

Table 2 TMAT Risks and Actions
TMAT specific risk scenario

Actions to consider
Virtual settings should mirror in-person appointment settings.
With the pandemic, many healthcare workers have been working from home.It is important that the patient continues to feel that they are receiving a highly professional service which may involve the clinician ensuring that they have a home office which is appropriate.Also, most in person settings are private and the consultation should not be overhead.This will need to be mirrored in kiosk or virtual pod settings.Information governanceconsultation platform Patients may already be very familiar with FaceTime and WhatsApp and wonder why the service is making things seem complicated.Unfortunately, many of these platforms are not compliant with healthcare standards.In Scotland, NHS Near Me is often used.Information governancedata storage Patients may have concerns over whether recordings will be made and distributed and what the risks are to breaches in confidentiality.The clinician will need to be able to confirm endto end encryption robustness if asked for reassurance.Informed consent to a virtual consultation Informed consent is required from any person who is receiving a video consultation.Implied consent usually applies in in-person consultations-the person has attended in person indicating they wish a consultation with you.This is not quite as clear cut with virtual consultations.Explicit consent where the clinician states the activities involved in the consultation, ensures the person has the capacity to understand and has understood the explanation and agrees to proceed is recommended here.

Informed consent to Medication Assisted Treatment (MAT)
A further layer of difficulty may arise if the clinician cannot be certain that the patient has fully understood the implications of certain decisions or medication options-strategies to support these issues are detailed below.This final section describes some possible modes of TMAT delivery and how the video consultation may take place depending on the mode selected.Much has already been done to evaluate Near Me -need not to re-invent the wheel.Need to look at published reports on Scot Gov website (evaluation reports, pre and post covid written by U of Oxford, public engagement report and EQIA).

Conclusions
This draft document outlines a simple visual step-by-step guide to help addiction services to set up TMAT.Addiction services are among the most regulated systems of care largely due to the regular prescribing of controlled drugs.It is therefore no surprise that there is a lag in the adoption of technological solutions to address capacity issues in treatment delivery compared with other health services.The perceived need for telemedicine mediated treatment has increased in the pandemic context, with a greater willingness to test new ways of working.In our exploration of the telemedicine landscape in addiction services, we found several examples of accelerated adoption of TMAT in North America, Australia and Ireland.Further, we have seen successful outcomes from the first ever feasibility study of Telemedicine in Addiction Services in the UK (Mayet, 2019).With rising drug related deaths in Scotland, in keeping with rates in North America, it is critical that we find ways to bridge this telemedicine lag.We conclude this guidance with a final overarching infographic in Figure 9 illustrating what a TMAT service may look like.

Comments
: Conclusions could perhaps be a bit more tightly worded, with a few key points?
Figure 9 comments: Appropriateness and suitability box so that is basically all stages of the treatment pathway -so not sure about the need to mention this?
hmmm not sure about `safer' -more about is it suitable for managing associated risks or not perhaps amend aware of e.g.indemnity issues.Maybe rephrase about e.g.interventions can appropriately be implemented via TMAT, the person is unable to use/access/ Adequate support not available to enable?
Red flags box rephrase: distress is relative so maybe that this mode would cause otherwise avoidable distress, unable to adequately complete required physical assessments highest per capita Drug Related Death (DRD) rate in Europe, with opioids implicated in 86% of cases (Office for National Statistics, 2019).In July 2019, the Scottish Government set up the Drug Deaths Task Force (DDTF) (Drug Deaths Task Force, 2020) to stem this rising trend which has seen the DRD rate double since 2008.
Figure 1.The Medication Assisted Treatment (MAT) standards mapped against Telemedicine Medication Assisted Treatment (TMAT) delivery.

Commentss:
Would you want to highlight the global nature of this e.g.US, NZ etc.? : QI quality improvement (in reference to Figure 2) Figure 3: In-person MAT Service Process Mapping A (12-23) guide to conducting the TMAT consultation
Figure 9: A visual guide to TMAT.Diagram adapted from the Welsh National Video Consultation Service Toolkit (TEC Cymru, 2021)

. Define & agree clinical criteria for Telemedicine Medication Assisted Treatment (TMAT) use
Mode 2. Dyadic hub-spoke: Clinician in specialist hub centre connects to patient in remote spoke health spoke or care site without additional staff member present (e.g. in an unstaffed kiosk).
way of email.With regards to withdrawals -the clinician may need additional information or ask for a healthcare worker visit to carry out drug testing, Dry Blood Spot Testing (DBST) for blood borne viruses such as HCV, venepuncture or a physical assessment.This is less of a problem in modes 3 & 4.Your service will need to have a contingency plan for possible technical problems or clinical problems.Technical problems may include data or privacy breaches, software or hardware breakdown as well as access and privacy difficulties.Clinical problems can be categorised as either mental health emergencies (for example an unexpected safe-guarding incident where a patient is going through a psychotic episode or threatening self-harm) or physical health emergencies.For example, though NHS Near Me is very stable, callers may run out of data, have a flat batter or get the wrong link.In this situation a good contingency plan is usually to revert to a phone consultation.Worth adding any regulations to consider e.g.GDPR, CQC etc.
This project is specifically intended to empower and enable addiction services to develop Telemedicine Medication Assisted Treatment (TMAT) as a quality improvement endeavour.Implicit in this therefore is an iterative cycle of evaluation and improvement.There are several guides and frameworks to support this(Healthcare Improvement Scotland, 2018;  Backhouse & Ogunlayi, 2020; Jones, Vaux & Olsson-Brown, 2019; NHS Institute for Innovation & Improvement, 2005) and many NHS boards have a dedicated quality improvement resource.A recent review of questionnaires evaluating telemedicine services (Hajesmaeel-Gohari & Bahaadinbeigy, 2021) identified that in order to optimise future telemedicine interventions, it is essential to focus on service-user needs, end-user acceptance, implementation processes and service-users' satisfaction.Table3lists some of the more common questionnaires available to evaluate aspects of telemedicine.The DigitAS team are currently developing an implementation evaluation questionnaire based on Normalisation Process Theory(Gillespie et al., 2018)for telehealth and telemedicine interventions.