Plain English Summary
Background and study aims
Opioids are very strong painkillers that are good for acute pain and pain at the end of life but there is little evidence that they are helpful for long-term pain. Despite this, they are widely prescribed for this reason in the UK. When opioids are used for long periods of time, they cause changes in the body which mean that to stop taking them is a very unpleasant mental and physical experience – this is known as dependence.
Opioid dependence is a chronic condition with high risks. Opioid substitution treatment with methadone or buprenorphine helps to improve outcomes. Department of Health UK guidelines recommended service users prescribed opioid substitution treatment have an addictions prescriber appointment every twelve weeks. This is to help improve health, wellbeing, recovery needs and ensure medication safety.
We have found that some service users do not attend appointments. This study will see if using telemedicine for appointments helps service users attend appointments.
Telemedicine is the use of Skype video calling. Service users would see their prescriber through their healthcare workers laptop. The prescriber would be at another location. This may help reduce travel, as service users could attend an appointment near to their home
Who can participate?
Service users with opioid dependence, prescribed opioid substitution treatment, and attending an outreach clinic are eligible for the study
What does the study involve?
Service users who accept to participate in the study will be randomly assigned to either telemedicine appointments or face-to-face appointments (treatment as usual). Service users will have their next two addiction prescriber appointments as either telemedicine appointments or face-to-face appointments.
Information will be collected on attendance rates, patient satisfaction and travel distance for service users, and also from staff on their experience of Telemedicine and the trial. Information from this smaller study will be used to inform a future larger study to help develop better access to addictions treatment
What are the possible benefits and risks of participating?
Benefits to trial participants may be that this intervention helps a participant attend appointments. This would also help the knowledge base on telemedicine in addictions.
Risks: none anticipated
Where is the study run from?
East Riding Partnership - Humber NHS Foundation Trust, UK
When is the study starting and how long is it expected to run for?
September 2019 to May 2020
Who is funding the study?
1. East Riding Clinical Commissioning Group, UK
2. Academic Health Science Network, UK
Who is the main contact?
Dr Soraya Mayet
Telemedicine in Addictions Randomised Controlled Trial
Telemedicine consultations may improve attendance at addiction prescriber appointments
Approved 27/08/2019, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (St Luke's Hospital, Extension Block, Little Horton Lane, Bradford, BD5 0NA, UK; +44 (0)207 104 8018; email@example.com) ref: 19/YH/0237, IRAS project ID: 259335
Interventional randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Service users who accept to participate in the study will be randomly assigned to either Telemedicine appointments or face-to-face appointments (treatment as usual). Service users will have their next two addiction prescriber appointments as either Telemedicine appointments or face-to-face appointments.
Information will be collected on attendance rates, patient satisfaction and travel distance for service users, and also from staff on their experience of Telemedicine and the trial. Information from this smaller study will be used to inform a future larger study to help develop better access to addictions treatment.
The first consultation will be offered within 4 weeks of consent, the second consultation will be within 12 weeks of the first consultation, follow up interviews within 4 weeks of the second consultation. The patients will be within the study for 20 weeks.
Randomisation will be carried out after consent has been gained and the initial baseline assessment has been conducted. This will be conducted via Red Cap Cloud to randomize 60 participants into two treatment groups with 1:1 ratio, using random permuted blocks. A remote randomisation procedure will be used through Red Cap data management to generate the treatment allocation, which will be initiated by a trained researcher. It is not possible for participants and the study team to be blind to treatment allocation due to the treatment intervention.
Primary outcome measure
Attendance at appointments measured using electronic care records
1. Recruitment rate measured using a count of consent forms at follow-up (20 weeks)
2. Retention rate measured using a count of completed questionnaires at follow-up (20 weeks)
3. Acceptability of the study - views and experiences of service users and staff measured using a research interview at follow-up (20 weeks)
Secondary outcome measures
1. Patient satisfaction measured using the Patient Satisfaction Questionnaire (PSQ) and the Telemedicine Satisfaction Questionnaire (TSQ) (Telemedicine arm only) at the end of the first and second consultations
2. Travel distance measured using electronic care records
3. Addiction changes that occur during treatment measured using the Treatment Outcome Profile (TOP) and urine tests at baseline and at follow-up (20 weeks)
4. Patient and staff evaluation of the process measured using a process evaluation interview at follow-up (20 weeks)
5. Addictions prescriber satisfaction measured using a non-validated questionnaire at follow-up (20 weeks)
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Diagnosis of opioid dependence
2. Prescribed opioid substitution treatment (OST) e.g. methadone or buprenorphine
3. Aged 18 years to 65 years
4. Willing and able to provide informed consent
5. Attending an outreach (spoke) clinic for keyworker appointments
Target number of participants
Participant exclusion criteria
1. Service users who cannot read English AND would require the service of an interpreter to understand a brief oral description of the study
2. Service users who have already entered the trial
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
East Riding Partnership - Humber NHS Foundation Trust
7 Baker Street
East Riding Clinical Commissioning Group
Funding Body Type
Funding Body Subtype
Academic Health Science Network
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Results will be published in scientific papers and made available to participants (through poster with summary results put up in participating site waiting areas).
A summary of the results will be presented at the Humber teaching NHS FT clinical network and Research and Development annual Conference.
The Protocol and findings will be published in an academic journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Hull Health Trials Unit, University of Hull, using two cloud based systems – REDCap Cloud and Box.
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
- ISRCTN36756455_PROTOCOL_13Jun2019.pdf uploaded 05/12/2019