TIA: a feasibility study of telemedicine in addictions
| ISRCTN | ISRCTN36756455 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36756455 |
| IRAS number | 259335 |
| Secondary identifying numbers | V1130619 |
- Submission date
- 14/11/2019
- Registration date
- 02/12/2019
- Last edited
- 07/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
East Riding Partnership - Humber NHS Foundation Trust
7 Baker Street
Hull
HU2 8HP
United Kingdom
 ORCID ID |
0000-0002-5701-9568 |
|---|---|
| Phone | +44 (0)1482336675 |
| smayet@nhs.net |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Telemedicine in Addictions Randomised Controlled Trial |
| Study 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 |
| 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 |
Eligibility
| 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 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 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
Hull
HU2 8HP
United Kingdom
Sponsor information
Hospital/treatment centre
Trust HQ
Willerby Hill
Beverley Road
Willerby
HU10 6ED
England
United Kingdom
| Phone | +44 (0)1482 301723 |
|---|---|
| hnf-tr.ResearchTeam@nhs.net | |
| Website | https://www.humber.nhs.uk/ |
"ROR" |
https://ror.org/016bnqk64 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 01/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request, Published as a supplement to the results publication |
| 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. |
| 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. |
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
Editorial Notes
07/06/2023: Internal review.
06/12/2021: The following changes have been made:
1. Publication reference added.
2. The IRAS number has been added from the reference.
3. The intention to publish date has been changed from 01/02/2021 to 01/05/2022.
4. The IPD sharing summary has been changed from "Stored in repository" to "Available on request, Published as a supplement to the results publication, Stored in non-publicly available repository".
06/09/2021: Abstracts added.
03/06/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/05/2020 to 10/06/2020.
2. The intention to publish date was changed from 01/12/2020 to 01/02/2021.
30/04/2020: The intention to publish date was changed from 30/09/2019 to 01/12/2020.
05/12/2019: Uploaded protocol 13 Jun 2019 (not peer reviewed)
19/11/2019: Trial’s existence confirmed by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee.
