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Process evaluation of the Digital Alcohol Management on Demand -DIAMOND feasibility randomised controlled trial
Process evaluation of the Digital Alcohol Management on Demand (DIAMOND) feasibility randomised controlled trial
31 October 2016
01 October 2015
30 September 2016
Alcohol, Digital health intervention, Trial participation, Qualitative Study
- Dr Fiona Hamilton, Honorary Clinical lecturer, Faculty of Medicine, School of Public Health, Imperial College London
- Professor Elizabeth Murray, Research Department of Primary Care and Population Health, University College London
- Dr Fiona Stevens, Reader in Medical Sociology, Institute of Epidemiology & Health University College London
Dr Jo Hornby – DIAMOND Trial manager, Royal Free Hospital, University College London
Fiona Giles – Project Co-ordinator University College London
Ms Zoe Livingstone – patient representative
The main aim of the process study was to use qualitative methods to describe the experience of clients and alcohol counsellors taking part in a feasibility randomised controlled trial of an online alcohol intervention in community alcohol services in North London with a view to informing future trial design and conduct.
Specific objectives were:
- To explore participants’ thoughts and feelings about being directed to an online treatment when they were expecting to receive face-to-face treatment; their experience of the online data-collection and randomisation processes; their experience of accessing and using the intervention; the intervention content and its usefulness; what helped or hindered online data collection and use of the intervention; and what they thought about the engagement prompts
- To explore community alcohol service counsellors’ experiences of recruiting and randomising participants to the online alcohol intervention; what helped or hindered them in this; what would improve the process; and their thoughts and feelings about directing clients to the intervention rather than seeing them themselves, face-to-face.
Qualitative interviews were to be undertaken with 10-20 clients taking part in the DIAMOND feasibility RCT and 5-10 community alcohol counsellors from sites taking part in the DIAMOND feasibility RCT
Changes from Original Proposal
The feasibility RCT struggled to recruit participants. After the first phase of recruitment in community alcohol services (October 2014 to August 2015) recruited only 10 participants, we moved to a second phase recruiting from A&E departments and through online adverts (October 2015 to September 2016), and we recruited a further 19 participants. This meant we had a reduced pool of potential participants for the qualitative study.
In addition, due to the delay in getting ethical approval for the qualitative interviews with participants, the participants recruited from the first phase in community alcohol services did not respond to the email invitation to take part in the qualitative study, despite originally indicating they would be willing to take part. We were also not able to recruit people from the first phase of recruitment who had declined to take part in the RCT in the first place as the counsellors did not keep contact details for these people. An additional 11 people from phase 2 of recruitment logged on to the study portal, provided an email, were eligible to take part and consented to randomisation but did not complete baseline questionaires so could not be randomised. We emailed these people to take part in the qualitative study as their views on why they did not want to take part in the trial would have been valuable, and 1 person expressed an interest but has not yet confirmed a date to conduct the interview.
We have been able to conduct interviews with 5 alcohol counsellors and 3 participants from phase 2 of the RCT, and have expressions of interest from 3 more who are still in the trial but yet to complete their 3-month follow up measures, and 1 who did not take part in the trial but has not replied with availability.
We had intended to code using NVivo coding software but as there were so few it was possible to code themes by hand instead of using software.
Recruitment to the qualitative studies
The principal investigators (PI), alcohol counsellors at participating sites, had previously indicated they were willing to be interviewed about their experience of recruiting participants to the trial. After the first phase of recruitment to the feasibility RCT ended, the PIs were invited to take part in the qualitative interviews, and to ask other counsellors if they were willing to take part and pass their details to the research team. The counsellors who agree to participate were given a participant information sheet to read before deciding whether or not to take part. Counsellors took part in the study in their “own” time (e.g. lunch break / coffee break) and were offered a token of gratitude (a voucher for £25).
Service users who were recruited into the DIAMOND study from one of four community alcohol services in North London, and those who self-recruited online from A&E or online adverts on alcohol-support websites. If eligible (see criteria below), they were randomised to HeLP-Alcohol or face-to-face treatment. Inclusion criteria for taking part in the DIAMOND study are described below:
- Inclusion criteria: aged 18 or over; having a diagnosis of an alcohol use disorder using AUDIT criteria (score 8 or over); residing in a stable place of residence; providing informed consent for randomisation, treatment and follow-up, willing and able to use a computer to access an online alcohol treatment programme.
- Exclusion criteria: people undergoing treatment for substance use or primary drug dependence (excluding nicotine) in the past 90 days; already receiving help for an alcohol use disorder; having outstanding legal issues likely to lead to imprisonment; severe physical dependency on alcohol (Leeds Dependence Questionnaire >20) or severe and complex co-existing physical or mental health problems, or at risk of high risk of self-harm or suicide; unable to speak or read English; pregnancy; alcohol counsellor having concerns about child protection issues or domestic violence.
After completing the online follow up questionnaires at three months, participants were emailed a message thanking them for their participation and asking and inviting them to take part in further research to feedback their experience of the trial, asking them to provide an email contact if they were willing to take part. We emailed those participants who indicated they were willing to take part with further details of the qualitative study and an information sheet. If they were happy like to go ahead, we contacted them by email or phone to arrange a convenient time and place to conduct the interview. Participants were given a gift voucher for £10 after the interview to thank them for their time.
All participants were given a unique number to anonymise the interviews. Participants were given a participant information sheet describing the study and its aims, explaining that the interview was confidential and not attributable to the individual participant. A consent form was completed and signed just before starting each interview. Participants were told that if they were uncomfortable answering any questions they did not have to do so, and that they could terminate the interview at any time.
The interviews took up to 1 hour and with open questions based on a topic guide. Two pilot interviews were held prior to interviewing participants to finalise the questions and ensure smooth running of the study. The conversation was audio-recorded and field notes taken e.g. of participant’s body language, facial expressions, rapport, and interviewer’s impressions. When the interview ended the audio recorder was turned off and the participant thanked for their time and help with the study. Participants were asked if they would like to receive the findings of the study when the research was complete.
Security of trial processes
The recordings were stored digitally on university computers until professionally transcribed and were then securely deleted. Each participant was given an identification number to ensure anonymity. A transcript of the interview was emailed to each participant to check for accuracy. The participant had one week to respond and if they did not respond the transcript was assumed to be accurate and was then be used for the study. Transcripts may be kept for up to 20 years and may be used for subsequent research.
Transcripts were coded by hand, and thematic analysis was used to examine the transcripts. As these populations and subjects have not been researched previously, an iterative process was used to undertake the interviews, coding and theme generation. Thematic analysis enables new insights to inform the subject guide for subsequent interviews and earlier transcripts can be revisited throughout the process of coding and theme allocation. Themes were agreed by discussion among the research team, which includes experienced qualitative researchers.
Alcohol counsellors - main themes include:
- Enthusiasm and interest of community alcohol counsellors to take part in research for innovative treatments.
- A positive view for the role of online alcohol treatment for clients who did not want face-to-face treatment due to embarrassment/shame or who would not otherwise attend face-to-face treatment regularly due to e.g. work or child care commitments, and useful tools on the website such as drink diary. This was tempered by the impression that long-term drinkers may be unfamiliar with computers or did not have access.
- Need for senior management support for the trial, as lack of this impacted on the motivation of alcohol counsellors to recruit to the trial.
- Many service users were not eligible to take part (dependent drinkers; other complex problems or safeguarding issues (domestic violence, suicidality) which was frustrating for the counsellors when they were keen to recruit to the trial.
- Suggestions therefore that recruitment would be more successful from general practice. PIs also suggested recruitment from advertising in workplaces with high drinking culture such as law firms or bankers in the City of London.
- Some members of the alcohol counsellor team were unenthusiastic about the extra work the trial presented and struggled to adapt to the new task of recruitment, or were not confident about using computers themselves so were not confident when explaining the intervention to potential participants.
- Some members of the team were not at equipoise in recruiting – they thought some people would not manage online (without offering choice of being in the trial – paternalism) and if recruited to online would be ‘lost’ to the service.
- Some of the trial methods were confusing or onerous or introduced delays, so some participants did not receive the emails about the study, so it was difficult for them to know if someone had been randomised to the website or if had just dropped out of attending the service, required a lot of chasing up on the part of the counsellor.
- Lack of time for alcohol counsellors to undertake the data inputting and follow up of participants in addition to their every day work.
- The PIs were aware that potential participants declared strong preference to either face-to-face or website from the outset and were reluctant to take part in the study because they might not get their treatment of choice. Some said they would prefer to give participants the choice.
- The participants randomised to the website needed more input than was allowed in the trial, more email or text support, but phone calls were ignored due to call screening.
Trial participants - main themes include:
- High levels of motivation to seek help and interest in taking part in the trial in order to help other people get evidence-based treatment.
- Not at equipoise, had experienced face-to-face treatment and wanted to try website, disappointed to be randomised to face-to-face, did not turn up or only went for one session.
- Reasons for dropping out of the study included not accepting that they had a drink problem; life as a problem drinker interfered with ability to take part in a trial or access a service, with heavy drinking leading to forgetting appointments; alternatively, having a busy life and working but being randomised to face-to-face made it difficult to attend appointments and so led to drop out; or not being ready to give up drinking, so this led to disengagement with the trial.
- Data collection repetitive. Need for a drink diary for people in the face-to-face group as well as those in the website group.
- Trial processes were sometimes confusing and led to inefficiencies or delays, e.g. email with randomisation went to junk folder then they had to chase up the alcohol services themselves to find out what was happening.
- Positive response to prompts/reminders by email or text.
- Suggested recruitment from GP surgeries with poster or leaflets or invitation from GP; also from the Women’s Institute, political groups, gyms and online alcohol support groups, particularly for recruiting women.
Plain English summary
Treatment to help people cut down their intake of alcohol can be delivered online through a website, and make it easier for people can get help, but there have not been many studies to see if online treatment is as good as seeing an alcohol counsellor in a community alcohol service (usual treatment). We carried out a trial to compare usual treatment with an online alcohol treatment programme for people who drink above recommended levels but who are not physically dependent on alcohol. We recruited 19 people to the trial.
We wanted to explore people’s experiences of the trial, what helped and hindered recruitment and running the trial. 5 alcohol counsellors and 3 trial participants took part in an interview study. Everyone was given an identification number so their information was anonymous. The interviews were recorded and then typed up. The tape recordings were then deleted and the typed interviews were studied to look for themes.
The main themes from the interviews with alcohol counsellors:
Counsellors thought that online alcohol treatment is a good option for certain people, especially those who are working or too embarrassed to come for treatment. They thought that people strongly preferred one or other treatment so were not willing to take part in the trial. Most people attending their service were physically dependent on alcohol or had other problems, so they could not take part. Other members of the team were reluctant to recruit people if they thought they could not use a computer or that they might not come back to their service. They found it hard to fit in the extra work that the trial involved, and some of their managers were not very supportive. They suggested it would be better to recruit patients from general practice and from workplaces.
The main themes from the interviews with participants:
The participants were interested in testing new ways of providing alcohol treatment, in order to help other people. They were keen to see the website and were disappointed to be randomised to usual treatment. The process of being randomised was confusing and caused delays. All were randomised to usual treatment and found it difficult to attend appointments. They thought having access to an online drink diary for both groups would be good to collect data, and getting supportive text messages or emails was helpful. They also thought that it would be better to recruit in general practice, gyms or clubs.
DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use Fiona L. Hamilton, Jo Hornby, Jessica Sheringham, Stuart Linke, Charlotte Ashton, Kevin Moore, Fiona Stevenson and Elizabeth Murray, (2017), Pilot and Feasibility Studies, 34
The findings will be presented at the SPCR conference in November 2016 and writtn up for publication in a peer-reviewed journal.
Three service users were involved in refining the protocol for the DIAMOND feasibility randomised controlled trial and tested the website prior to recruitment starting, giving invaluable feedback on the look and usability of the website. Two service users sit on the DIAMOND Trial Steering Committee. They have been involved in developing the protocol for the qualitative study and gave feedback on the qualitative study information for participants, consent form and topic guide.
The research has informed the design of two subsequent studies for which we are applying for funding. The obvious preference potential participants had for either the website of face-to-face treatment has suggests a preference RCT design will improve recruitment. The trial procedures have been streamlined so that healthcare providers involved in recruitment do not have to input data themselves. Prompts (emails and text messages) to people randomised to the website have been modified in the light of the qualitative interviews and will be trialled in an entirely online effectiveness RCT prior to the preference study.
This project was funded by the National Institute for Health Research School for Primary Care Research (project number 279)
Department of Health Disclaimer
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR School for Primary Care Research, NIHR, NHS or the Department of Health.