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
smayet@nhs.net
Study website
Contact information
Type
Scientific
Contact name
Dr Soraya Mayet
ORCID ID
http://orcid.org/0000-0002-5701-9568
Contact details
East Riding Partnership - Humber NHS Foundation Trust
7 Baker Street
Hull
HU2 8HP
United Kingdom
+44 (0)1482336675
smayet@nhs.net
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
259335
ClinicalTrials.gov number
Nil known
Protocol/serial number
V1130619
Study information
Scientific title
Telemedicine in Addictions Randomised Controlled Trial
Acronym
TIA
Study hypothesis
Telemedicine consultations may improve attendance at addiction prescriber appointments
Ethics approval(s)
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; nrescommittee.yorkandhumber-bradfordleeds@nhs.net) ref: 19/YH/0237, IRAS project ID: 259335
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Community
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Opioid dependence
Intervention
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.
Intervention type
Behavioural
Primary outcome measure
Attendance at appointments measured using electronic care records
Feasibility outcomes:
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 study start date
14/12/2018
Overall study end date
10/06/2020
Reason abandoned (if study stopped)
Eligibility
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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
Both
Target number of participants
60
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
24/09/2019
Recruitment end date
28/02/2020
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
East Riding Partnership - Humber Teaching NHS Foundation Trust
7 Baker Street
Hull
HU2 8HP
United Kingdom
Sponsor information
Organisation
Humber Teaching NHS Foundation Trust
Sponsor details
Trust HQ
Willerby Hill
Beverley Road
Willerby
HU10 6ED
England
United Kingdom
+44 (0)1482 301723
hnf-tr.ResearchTeam@nhs.net
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
East Riding Clinical Commissioning Group
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Health Science Network
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published in scientific papers and made available to participants (through a 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.
Intention to publish date
01/05/2022
Individual participant data (IPD) sharing plan
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.
IPD sharing plan summary
Stored in non-publicly available repository, Available on request, Published as a supplement to the results publication
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/06/2019 | 05/12/2019 | No | No | |
| Abstract results | Participant and staff satisfaction results presented at the Royal College of Psychiatrists Virtual International Congress | 18/06/2021 | 06/09/2021 | No | No |
| Abstract results | Participant experience data presented at the Royal College of Psychiatrists Virtual International Congress | 18/06/2021 | 06/09/2021 | No | No |
| Other publications | Title: Patient Satisfaction with Telemedicine in Addictions | 01/08/2021 | 06/12/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN36756455_PROTOCOL_13Jun2019.pdf uploaded 05/12/2019