Impact of knowledge of liver fibrosis on drinking behaviour
| ISRCTN | ISRCTN16922410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16922410 |
| IRAS number | 273765 |
| Secondary identifying numbers | CPMS 47834, IRAS 273765 |
- Submission date
- 21/01/2021
- Registration date
- 26/01/2021
- Last edited
- 12/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Heavy drinkers at risk of liver disease and in contact with alcohol services do not currently have access to testing to establish the severity of their liver disease. Fibroscan is a technology which can now provide this information. It is currently unknown if knowledge of the severity of liver disease in people who are at risk will affect their drinking behaviour. This study sets out to develop standardised fibroscan operator feedback of results and produce video patient stories to enhance feedback and then establish if the approach is feasible and deliverable via a feasibility randomised controlled trial.
Who can participate?
1. Participants who have successfully overcome their alcohol use disorder and had a fibroscan in the past
2. Participants self-presenting to any of the recruitment settings who have a history of alcohol misuse
What does the study involve?
Patients will be involved in the focus group to provide feedback on the prototype fibroscan script. The NRN alcohol keyworker in a focus group will give feedback on the final version. The researchers will record videos of alcohol recovery stories with participants who have successfully overcome their alcohol use disorder and had a fibroscan in the past.
Participants will be randomly allocated to the control group or the intervention group. Participants in the control group will continue with usual care which is provided as part of an alcohol management programme following national guidelines. Participants in the intervention group, in addition to usual care, will have a fibroscan and immediately after this will watch recovery video stories. All participants are followed up for 6 months
What are the possible benefits and risks of participating?
The researchers cannot guarantee that the study will benefit the participants. Participation in the study will contribute to improving knowledge in the field of alcohol misuse. It will provide an opportunity to test the effectiveness of new methods of helping and supporting people with a history of high-risk alcohol drinking behaviour.
Where is the study run from?
Nottinghamshire Healthcare NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2019 to February 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Mohsan Subhani
mohsan.subhani@nottingham.ac.uk
Contact information
Scientific
NDDC BRU E Floor West Block
Queen’s Medical Centre
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0001-8739-7263 |
|---|---|
| Phone | +44 (0)7572612429 |
| Mohsan.subhani@nottingham.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Prevention, Psychological & Behavioural, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): a feasibility randomised controlled trial |
| Study acronym | KLIFAD |
| Study hypothesis | The primary objective of this study is to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) in community specialist alcohol services settings to compare the clinical and cost-effectiveness of the KLIFAD intervention delivered in addition to usual care with usual care only for adults presenting with a problem of alcohol misuse. The objectives of this study are (all three work packages): 1. To establish a standardised script framework for fibroscan operators to deliver liver disease-specific advice to clients having fibroscan 2. To develop a collection of video stories describing how patients have responded to receiving a fibroscan score 3. To test the intervention (fibroscan plus feedback and video stories) in a feasibility randomised trial 4. To perform a qualitative evaluation of 1-3 above to inform a later, larger national randomised trial 5. Determine the feasibility of recruitment and randomisation to a large-scale RCT 6. Refine the eligibility criteria for a future definitive RCT 7. Determine the acceptability to patients/healthcare workers of randomisation 8. Determine the relevance and acceptability to patients/healthcare workers of the trial intervention 9. Determine the acceptability to patients/healthcare workers of the trial procedures 10. Assess the ability of community alcohol services to deliver the intervention 11. Assess training and support needs for community alcohol services keyworkers for delivering the intervention 12. Assess follow-up and outcome completion rates |
| Ethics approval(s) | Approved 20/01/2021, West of Scotland REC 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)1413140213; WoSREC5@ggc.scot.nhs.uk), REC ref: 20/WS/0179 |
| Condition | Alcohol misuse |
| Intervention | Trial Design The trial has the following work packages (WP): 1. WP1: Establish a standardised script framework for fibroscan operators to deliver liver disease-specific advice to eligible participants having fibroscan. 2. WP2: Develop and film patient video stories using fibroscan related information to aid recovery again using eligible participants. 3. WP3: Test the feasibility of the trial design including the script and video stories developed in WP1 and WP2 in a community based 1:1 feasibility randomised trial in alcohol treatment services. And to perform a qualitative evaluation of 1-3 above to inform a later, larger national randomised trial. Trial setting The feasibility RCT will be conducted at three community-based alcohol settings hosted by Framework and Nottingham Recovery Network and work in partnership with Nottinghamshire NHS Foundation Trust. The Framework housing association is a Registered Charity and Registered Social Landlord (regulated by the Regulator of Social Housing) which provides housing, health, employment and support services. Nottingham Recovery Network is the integrated drug and alcohol treatment pathway for Nottingham City, provided under contract from Nottingham City Council Crime and Drugs Partnership (CDP). 1. Primary care alcohol clinic run by NRN: The community clinics including Clifton and the potential to expand from one site to others depending on the level of recruitment 2. The Wellbeing hub A city-centre building where Framework provides Nottingham City’s alcohol services 3. Edwin House Edwin House is a 63-bed Care Quality Commission registered care home, proving residential care for people who have serious alcohol and drug-related health conditions Randomisation The participant in work package 3 will be individually allocated on a 1:1 ratio using minimisation with a probabilistic element. The minimisation variables will be age, gender, ethnicity and severity of alcohol misuse based on SADQ score. Control arm: Participants in the control arm will continue with usual care which is provided as part of an alcohol management programme at these centres following national guidelines as described above. Standard treatment at the Nottingham Recovery Network: As part of standard treatment, the NRN provide different types of interventions to clients in line with the National Drug Treatment Monitoring System Dataset (NDTMS) and Public Health England (PHE) guidelines. For adult Drug and alcohol services there are three main categories of standard interventions delivered by the NRN: 1. Psychological 2. Recovery Support 3. Pharmacological Psychological Interventions This involves the following sub interventions: 1. Motivational interventions 2. Family and social network interventions 3. Cognitive and behavioural based relapse prevention interventions (substance misuse specific) Recovery Support Interventions This involves the following sub interventions: 1. 12-step work 2. Counselling – British Association for Counselling and Psychotherapy (BACP) accredited Pharmacological Interventions This type of intervention involves prescribing medication for drug and/or alcohol relapse prevention support, such as naltrexone, acamprosate, disulfiram as part of alcohol or opioid relapse prevention therapy and chlordiazepoxide for acute alcohol withdrawal. Intervention arm: Participants in this arm, in addition to usual care, will have a fibroscan and immediately after this will watch recovery video stories. Fibroscan: Fibroscanning will be undertaken on the day of commencing the programme or detoxification regimen. Fibroscan is performed in a designated clinical area where the client lies on a clinical coach which is available in all the three locations involved in the study. Fibroscan takes 10-15 minutes to perform and does not involve the client undressing hence it is anticipated that it will have minimal impact on the clinical service. This impact will be explored in the qualitative component of the study. The key member had trial-specific training and will provide feedback on a standardised script developed as part of WP1. Video stories: In all centres, the video stories will be provided in a designated private waiting area. They will be available on a dedicated tablet computer. It is envisaged that the client will have a menu with a choice of the story with pictures of the storyteller and a brief description in the text. This will be part of WP2 and based on PPI group feedback on the stories to ensure diversity of person and liver disease stage. The client will be able to view all or select stories without restriction. Video stories will be made available for later viewing by the clients via a weblink. Impact and frequency of viewing will be explored in the qualitative interviews. Duration of follow up: Total duration of follow up: 6 months Health economics data taken from HES database at 12 months and 24 months |
| Intervention type | Mixed |
| Primary outcome measure | 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 12 months 2. Retention rate: number of participants who consent to participate that remain in the study until the end of follow up at 6 months 3. Acceptability of the intervention measured using qualitative interview at 6 months 4. Feasibility of outcome measures measured by analysing the feasibility of outcomes outlined as primary and secondary at baseline, 3 months and 6 months |
| Secondary outcome measures | 1. Weekly alcohol intake measured using self-reported alcohol intake at baseline, 3 months and 6 months 2. Alcohol misuse measured using AUDIT score at baseline, 3 months and 6 months 3. Severity of alcohol misuse measured using SADQ score at baseline, 3 months and 6 months |
| Overall study start date | 02/10/2019 |
| Overall study end date | 01/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Total final enrolment | 184 |
| Participant inclusion criteria | Work package 1 (WP1): 1. A person aged 18 years and over attending with a primary problem of alcohol misuse as defined by initial clinical assessment and had a fibroscan in past 2. Willing to participate in a focus group Work package 2 (WP2): 1. A person aged 18 years and over attending with a primary problem of alcohol misuse as defined by initial clinical assessment. 2. A person who previously had a fibroscan 3. A person with lived experience of alcohol problems, willing to consent to the recording and public use of video recording (identified via KLIFAD PPI group, existing NRN networks or research networks at Nottingham University Hospital) Participants from WP1 will also be invited to participate in WP2 Randomised feasibility trial (WP3): 1. A person aged 18 years and over attending with a primary problem of alcohol misuse as defined by initial clinical assessment |
| Participant exclusion criteria | Work package 1 (WP1): 1. Other primary substance misuses even where alcohol is a factor 2. Lacks the capacity to give confirmed consent Work package 2 (WP2): 1. Lacks the capacity to give confirmed consent Randomised feasibility trial (WP3): 1. Other primary substance misuses even where alcohol is a factor 2. Referrals from driving offences and student referrals as these individuals are essentially not self-presenting, may have different motivation and have lower overall levels of alcohol use and so are substantially lower risk of having liver disease 3. Out of area clients at Edwin house in whom we cannot obtain follow up data due to lack of follow up availability 4. Participants unable to comply with study procedures 5. Lacks the capacity to give confirmed consent |
| Recruitment start date | 01/04/2021 |
| Recruitment end date | 01/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
73 Hounds Gate
Nottingham
NG1 6BB
United Kingdom
House, 56, Edwin
57 Millers Ct
Nottingham
NG7 3DP
United Kingdom
Wellbeing Hub Nottingham
Nottingham
NG1 6BB
United Kingdom
Sponsor information
Hospital/treatment centre
The Resource, Trust HQ
Duncan Macmillan House
Porchester Road
Nottingham
NG3 6AA
England
United Kingdom
| Phone | +44 (0)7920454530 |
|---|---|
| mark.howells@nottshc.nhs.uk | |
| Website | http://www.nottinghamshirehealthcare.nhs.uk/ |
"ROR" |
https://ror.org/04ehjk122 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publications. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 03/11/2021 | 05/11/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 30/06/2023 | 17/07/2023 | Yes | No | |
| Other publications | Intervention development | 04/10/2023 | 05/10/2023 | Yes | No |
| Other publications | Application and Extension of the Alcohol Recovery Narratives Conceptual Framework | 08/09/2023 | 12/03/2025 | Yes | No |
Editorial Notes
12/03/2025: Publication reference added.
10/03/2025: The overall study end date was changed from 30/11/2022 to 01/02/2025.
05/10/2023: Publication reference added.
17/07/2023: Publication reference and total final enrolment added.
14/11/2022: The acronym was added.
05/11/2021: Publication reference added.
15/06/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2021 to 01/04/2021.
2. The recruitment end date was changed from 01/03/2022 to 01/07/2022.
21/01/2021: Trial's existence confirmed by the NIHR.
