PUBLIC HEALTH RESEARCH

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1 PUBLIC HEALTH RESEARCH VOLUME 1 ISSUE 3 SEPTEMBER 2013 ISSN Reducing acoho-reated harm in disadvantaged men: deveopment and feasibiity assessment of a brief intervention deivered by mobie teephone IK Crombie, DW Faconer, L Irvine, B Wiiams, IW Ricketts, G Humphris, J Norrie, P Rice and PW Sane DOI /phr01030

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3 Reducing acoho-reated harm in disadvantaged men: deveopment and feasibiity assessment of a brief intervention deivered by mobie teephone IK Crombie, 1 * DW Faconer, 1 L Irvine, 1 B Wiiams, 2 IW Ricketts, 3 G Humphris, 4 J Norrie, 5 P Rice 6 and PW Sane 7 1 Schoo of Medicine, University of Dundee, Dundee, UK 2 Nursing, Midwifery and Aied Heath Professions (NMAHP) Research Unit, University of Stiring, Stiring, UK 3 Schoo of Computing, University of Dundee, Dundee, UK 4 Schoo of Medicine, University of St Andrews, St Andrews, UK 5 Centre for Heath Care Randomised Trias, University of Aberdeen, Aberdeen, UK 6 NHS Substance Abuse Services, Stracathro Hospita, Brechin, UK 7 The Erskine Practice, Arthurstone Medica Centre, Dundee, UK *Corresponding author Decared competing interests of authors: none Discaimers: This report contains transcripts of focus groups and interviews conducted in the course of the research. Quotes from the transcripts contain anguage that may offend some readers. Pubished September 2013 DOI: /phr01030 This report shoud be referenced as foows: Crombie IK, Faconer DW, Irvine L, Wiiams B, Ricketts IW, Humphris G, et a. Reducing acoho-reated harm in disadvantaged men: deveopment and feasibiity assessment of a brief intervention deivered by mobie teephone. Pubic Heath Res 2013;1(3).

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5 Pubic Heath Research ISSN (Print) ISSN X (Onine) This journa is a member of and subscribes to the principes of the Committee on Pubication Ethics (COPE) ( Editoria contact: nihredit@southampton.ac.uk The fu PHR archive is freey avaiabe to view onine at Print-on-demand copies can be purchased from the report pages of the NIHR Journas Library website: Criteria for incusion in the Pubic Heath Research journa Reports are pubished in Pubic Heath Research (PHR) if (1) they have resuted from work for the PHR programme, and (2) they are of a sufficienty high scientific quaity as assessed by the reviewers and editors. Reviews in Pubic Heath Research are termed systematic when the account of the search, appraisa and synthesis methods (to minimise biases and random errors) woud, in theory, permit the repication of the review by others. PHR programme The Pubic Heath Research (PHR) programme, part of the Nationa Institute for Heath Research (NIHR), evauates pubic heath interventions, providing new knowedge on the benefits, costs, acceptabiity and wider impacts of non-nhs interventions intended to improve the heath of the pubic and reduce inequaities in heath. The scope of the programme is muti-discipinary and broad, covering a range of interventions that improve pubic heath. The Pubic Heath Research programme aso compements the NIHR Heath Technoogy Assessment programme which has a growing portfoio evauating NHS pubic heath interventions. For more information about the PHR programme pease visit the website: This report The research reported in this issue of the journa was funded by the PHR programme as project number 09/3001/09. The contractua start date was in March The fina report began editoria review in January 2012 and was accepted for pubication in January The authors have been whoy responsibe for a data coection, anaysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors' report and woud ike to thank the reviewers for their constructive comments on the fina report document. However, they do not accept iabiity for damages or osses arising from materia pubished in this report. This report presents independent research funded by the Nationa Institute for Heath Research (NIHR). The views and opinions expressed by authors in this pubication are those of the authors and do not necessariy refect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Heath. If there are verbatim quotations incuded in this pubication the views and opinions expressed by the interviewees are those of the interviewees and do not necessariy refect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Heath. Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Pubished by the NIHR Journas Library ( produced by Prepress Projects Ltd, Perth, Scotand (

6 Pubic Heath Research Editor-in-Chief Professor Catherine Law Professor of Pubic Heath and Epidemioogy, Unit Head, Centre for Paediatric Epidemioogy and Biostatistics, UCL Institute of Chid Heath, UK NIHR Journas Library Editor-in-Chief Professor Tom Waey Director, NIHR Evauation, Trias and Studies and Director of the HTA Programme, UK NIHR Journas Library Editors Professor Ken Stein Chair of HTA Editoria Board and Professor of Pubic Heath, University of Exeter Medica Schoo, UK Professor Andree Le May Chair of NIHR Journas Library Editoria Group (EME, HS&DR, PGfAR, PHR journas) Dr Martin Ashton-Key Consutant in Pubic Heath Medicine/Consutant Advisor, NETSCC, UK Professor Matthias Beck Chair in Pubic Sector Management and Subject Leader (Management Group), Queen s University Management Schoo, Queen s University Befast, UK Professor Aieen Carke Professor of Heath Sciences, Warwick Medica Schoo, University of Warwick, UK Dr Tessa Criy Director, Crysta Bue Consuting Ltd, UK Dr Peter Davidson Director of NETSCC, HTA, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Dr Tom Marsha Reader in Primary Care, Schoo of Heath and Popuation Sciences, University of Birmingham, UK Professor Wiiam McGuire Professor of Chid Heath, Hu York Medica Schoo, University of York, UK Professor Geoffrey Meads Honorary Professor, Business Schoo, Winchester University and Medica Schoo, University of Warwick, UK Professor Jane Norman Professor of Materna and Feta Heath, University of Edinburgh, UK Professor John Powe Consutant Cinica Adviser, NICE, UK Professor James Raftery Professor of Heath Technoogy Assessment, Wessex Institute, Facuty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Keijnen Systematic Reviews Ltd, UK Professor Heen Roberts Professoria Research Associate, University Coege London, UK Professor Heen Snooks Professor of Heath Services Research, Institute of Life Science, Coege of Medicine, Swansea University, UK Pease visit the website for a ist of members of the NIHR Journas Library Board: Editoria contact: nihredit@southampton.ac.uk NIHR Journas Library

7 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Abstract Reducing acoho-reated harm in disadvantaged men: deveopment and feasibiity assessment of a brief intervention deivered by mobie teephone IK Crombie, 1 * DW Faconer, 1 L Irvine, 1 B Wiiams, 2 IW Ricketts, 3 G Humphris, 4 J Norrie, 5 P Rice 6 and PW Sane 7 1 Schoo of Medicine, University of Dundee, Dundee, UK 2 Nursing, Midwifery and Aied Heath Professions (NMAHP) Research Unit, University of Stiring, Stiring, UK 3 Schoo of Computing, University of Dundee, Dundee, UK 4 Schoo of Medicine, University of St Andrews, St Andrews, UK 5 Centre for Heath Care Randomised Trias, University of Aberdeen, Aberdeen, UK 6 NHS Substance Abuse Services, Stracathro Hospita, Brechin, UK 7 The Erskine Practice, Arthurstone Medica Centre, Dundee, UK *Corresponding author i.k.crombie@dundee.ac.uk Background: Sociay disadvantaged men suffer substantia harm from heavy drinking. Brief acoho interventions are effective in reducing consumption when deivered via heath care. There is a need for taiored brief interventions for disadvantaged men who sedom attend heath care. Objectives: (1) To investigate the best ways to recruit and retain disadvantaged men in a study aimed at reducing the frequency of heavy drinking. (2) To identify the type of content and timing of the deivery that is most ikey to engage disadvantaged young to midde-aged men in an intervention deivered by text messages. (3) To determine whether or not the intervention is ikey to be an acceptabe way to infuence the frequency of heavy drinking. Design: A three-phase study invoving the deveopment of the recruitment strategy and the intervention, an assessment of the feasibiity of a randomised controed tria, and a post-study evauation. Setting: Community-based study, conducted in Dundee, UK. Participants: Disadvantaged men aged years who had two or more episodes of heavy drinking ( 8 units in a singe session) in the preceding month. Two recruitment strategies were empoyed: recruitment through genera practice (GP) registers and recruitment through a community outreach strategy. Interventions: Focus groups expored drinking motives and behaviours of the target group. The intervention aso drew on reviews of the iterature on: acoho brief interventions, text message studies, communication theory and behaviour change theories and techniques. The intervention group received 36 text messages with images sent over a 28-day period. Main outcome measures: The outcome measures evauated the ikey success of a fu tria: recruitment of the participants; construction and deivery of a theoreticay and empiricay based intervention that successfuy engages disadvantaged men; potentia for the intervention to infuence binge drinking. Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. v

8 ABSTRACT Resuts: The focus group anayses identified that persona experience and knowedge of the harmfu effects of acoho was widespread. Furthermore, there was a discrepancy between frequent binge drinking and perceived socia expectations and duties. This coud usefuy be targeted in the intervention. Theoreticay and empiricay based behaviour change strategies were successfuy rendered in attractive, coourfu, brief text messages. Both recruitment strategies (GP registers and community outreach) proved successfu and a tota of 67 men were recruited, exceeding the target of 60. The participants were at high risk of harm because of frequent episodes of heavy binge drinking. Baseine interviews estabished that those recruited through community outreach drank substantiay more and had more frequent binge drinking sessions than those recruited through GP registers. Retention at foow-up was 96%. Extensive process evauation was conducted. The evauation showed that 95% of text messages were successfuy deivered to participants' teephones. Furthermore, there was a high eve of engagement with text messages which sought responses. Most men repied to these texts, often giving carefuy structured persona responses. Anayses of the responses indicated a high eve of engagement with key components of the behaviour change strategy. Post-tria evauation showed high eves of satisfaction with the intervention. Concusions: This study has shown that disadvantaged men can be recruited and retained in an acoho intervention tria. A theoreticay and empiricay based intervention was successfuy deivered by text message. Furthermore, the messages were we received and eicited the types of response intended. A fu tria of the intervention, incorporating a cost-effectiveness study, shoud be carried out. Study registration: This study is registered as ISRCTN Funding: The Nationa Institute for Heath Research Pubic Heath Research programme. vi NIHR Journas Library

9 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Contents List... of abbreviations. Scientific summary... Chapter 1 Structure of the report Introduction The chapters of the report Chapter 2 Research objectives Introduction Research questions of the fu-scae tria of the nove intervention Research questions of the feasibiity study Ethica approva User group representatives Protoco amendments Chapter 3 Introduction Acoho and brief interventions Intervention deivery by mobie teephone Behaviour change interventions and disadvantaged peope Recruitment The need for the feasibiity study Chapter 4 Understanding drinking motives and behaviours Introduction Methods Resuts Discussion Concusion Chapter 5 Deveoping the text messages Introduction Design features of pubished acoho brief interventions Design features of pubished text message studies Behaviour change theories Concusions from the iterature review Constructing a ogica sequence of messages Design decisions Basis for the intervention Improving the messages Discussion Chapter 6 Recruitment strategies Introduction Methods Resuts Discussion xi xiii Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. vii

10 CONTENTS Chapter 7 Randomisation and baseine characteristics Introduction Methods Resuts Comparison of subjects recruited by the two samping strategies Discussion Chapter 8 Retention strategy Introduction Deveoping a retention strategy Appication of recommended retention strategies Summary Chapter 9 Outcome assessment Introduction Methods Resuts Discussion Chapter 10 Nove methods for process evauation Introduction Research questions Methods Resuts Discussion Concusion Chapter 11 Post-tria assessment Introduction Aims Methods Resuts Discussion Chapter 12 Summary and concusions Main findings Does the feasibiity study indicate that a fu tria shoud be conducted? Modifications to the fu randomised controed tria Acknowedgements References Appendix 1 Study protoco Appendix 2 Letter of invitation, participant information eafet and consent form viii NIHR Journas Library

11 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Appendix 3 Screening questionnaire Appendix 4 Baseine questionnaire Appendix 5 Foow-up questionnaire Appendix 6 Post-tria assessment Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. ix

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13 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 List of abbreviations DMQ Drinking Motives Questionnaire RSOD risky singe occasion drinking FAST GP HAPA MI MMS Fast Acoho Screening Test genera practice/genera practitioner heath action process approach motivationa interviewing Mutimedia Messaging Service SIMD SMS TPB TTM Scottish Index of Mutipe Deprivation Short Message Service theory of panned behaviour transtheoretica mode RDS respondent-driven samping A abbreviations that have been used in this report are isted here uness the abbreviation is we known (e.g. NHS), or it has been used ony once, or it is a non-standard abbreviation used ony in figures/tabes/appendices, in which case the abbreviation is defined in the figure egend or in the notes at the end of the tabe. Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xi

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15 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Scientific summary Background Acoho-reated morbidity and mortaity present a major pubic heath chaenge. The cost of acoho to society has been estimated at more than 55B per year in Engand and more than 3.5B per year in Scotand. Peope who are sociay disadvantaged are at a markedy higher risk of deveoping acoho-reated diseases. Brief interventions deivered to midde-aged men in heath-care settings are effective in reducing acoho consumption. However, this approach may not work with disadvantaged young to midde-aged men who are sedom in contact with heath services. Thus, there is a need to deveop aternative methods of deivering brief interventions to this high-risk group. Given the scae of the current probem, the deivery methods need to be abe to reach arge numbers of individuas at ow cost. The mobie teephone is an attractive method to deiver interventions to arge numbers of peope. This approach is we suited to young to midde-aged men because ownership of mobie teephones is high in this group. Text messaging has been used to modify adverse heath behaviours and to increase heath-care uptake. Recent systematic reviews suggest that brief interventions by mobie teephone can infuence behaviour. The aim of this study was to deveop and test the feasibiity of a brief intervention deivered by mobie teephone. The intervention was intended to reduce the frequency of binge drinking among young to midde-aged disadvantaged men. Research questions 1. What are the best ways to recruit and retain disadvantaged men in a study aimed at reducing the frequency of heavy drinking? 2. What is the type of content and timing of the deivery that is most ikey to engage disadvantaged young to midde-aged men in an intervention deivered by text messages? 3. Is the intervention ikey to be an acceptabe way to infuence frequency of heavy drinking? Methods Ethica approva for a aspects of the study was obtained from the East of Scotand Research Ethics Service (reference number 09/S1401/78). To inform the design of the recruitment strategies and the intervention, six focus groups were carried out, five with men and one with women. Focus group participants were purposivey recruited from severa venues in areas of high deprivation. Focus group discussions were digitay recorded and transcripts were anaysed using framework anaysis. Three researchers were invoved in the anaysis to ensure reiabiity of interpretation and coding. The feasibiity of a fu tria was assessed by carrying out a the stages of a doube-bind randomised controed tria. The study group comprised disadvantaged men aged years iving in the community. Men were incuded in the study if they had two or more episodes of heavy drinking ( 8 units in a singe session) in the preceding month. Excusion criteria were: men currenty attending care at an Acoho Probem Service; and men who woud not be contactabe by mobie teephone for any part of the intervention and foow-up period. Two recruitment strategies were tested: etters of invitation from genera practices (GPs) and respondent-driven samping (RDS). Participants were randomised to the intervention or contro group using a web-based randomisation system provided by the Gasgow Cinica Trias Unit. Randomisation was Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xiii

16 SCIENTIFIC SUMMARY stratified by recruitment strategy and restricted with a bock size of four. On competion of the baseine questionnaire participants were sent: an initia 10 gift voucher; a 5 gift voucher for each week of the study; and a 10 voucher for competing the outcome assessment. The intervention was a series of 36 Short Message Service (SMS) and Mutimedia Messaging Service (MMS) messages deivered by mobie teephone. The content of the intervention text messages was derived from seven types of iterature: acoho brief interventions; text message interventions; two psychoogica modes [theory of panned behaviour and the transtheoretica mode (TTM)], motivationa interviewing, communication theory and reviews of specific behaviour change techniques. The texts were organised according to the stages of the TTM. The text messages emphasised the credibiity of the source (University of Dundee), used the informa stye and abbreviations of everyday text messages and made frequent use of humour. A variety of techniques were empoyed to increase message effectiveness: taioring of messages; use of gain-framed texts; pairing of messages; and incusion of questions to promote interactivity. The messages were constructed to take advantage of the conventiona pattern of heavy weekend drinking. Messages were designed to tap into three windows of opportunity: before weekend drinking; after a heavy drinking episode; and mid-week sobriety. The contro group received 34 SMS and MMS messages on genera heath promotion, which did not incorporate behaviour change techniques. Baseine and foow-up interviews were conducted by teephone, with the interviewer bind to treatment status. Questions on acoho consumption were taken from the US Behaviora Risk Factor Surveiance System. This enabed tota consumption and frequency of binge drinking to be measured. In addition, the frequency of drinking substantiay in excess of the conventiona binge drinking eve (i.e. 16 units in a session) was recorded. The Fast Acoho Screening Test (FAST) was used to determine hazardous drinking because it is short and thus suitabe for teephone use. Questions on refusa skis were taken from the Drinking Refusa Sef-efficacy Questionnaire. The Readiness to Change Questionnaire was used to measure the stage of intention to reduce consumption. Questions were aso asked on knowedge of harms of acoho, benefits of moderate drinking, the current definition of binge drinking and whether or not participants perceived their current drinking to be harmfu. Extensive process evauation was undertaken. The deivery of the intervention was assessed from data captured by the computer system which monitored intervention deivery. The frequency of responses to these questions provided a measure of engagement with the intervention and assessed retention in the study. Content anaysis of the responses given provided a method to ascertain the nature of engagement with components of the behaviour change intervention. Interviews with a subsampe of men were conducted post tria to investigate the reported acceptabiity and impact of the study. Resuts Focus group anaysis found that expanations for current drinking patterns, and the way these have changed over time, appear rooted in shifts in three interacting conceptua areas: private purpose (the individua's persona reasons for drinking); socia roes (expectations, duties and sanctions on drinking); and concrete experience (of the adverse effects of excess drinking). The set of socia expectations stem from recognition of the person's wider socia roes and responsibiities (empoyee, husband/partner, parent) and abiities (sef-discipine/contro, abiity to toerate acoho, judge imits and resist socia pressure). Drinking motives had changed significanty from when the men were younger. This was accompanied by a shift from freedom to enjoy the peasures of acoho to freedom from ife stresses through the use of acoho. Persona experience and knowedge of the harmfu effects of acoho was detaied and widespread. There was often a marked discrepancy between an individua's drinking habits and the intended aims of drinking. Thus, brief interventions coud highight the mismatch between being drunk, and success in sociaising, working, doing good turns and feeing good about onesef. xiv NIHR Journas Library

17 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Both recruitment strategies (GP and RDS) proved successfu, and 67 men were recruited, exceeding the target of 60 participants. Recruitment by RDS required prior fiedwork to estabish suitabe venues for recruitment. Fexibe recruitment strategies invoving mutipe attempts at contact at different times of the day and days of the week were essentia. There were substantia differences between the men recruited by the two methods. The men recruited by RDS were more ikey to be unempoyed and ess ikey to be married than those recruited through GPs. They aso drank more than twice as much as the men recruited through GP practices (139.5 units per month vs 65.5 units per month; p = 0.003) and had many more binge drinking days (57% of RDS-recruited men had over five binge drinking days per month compared with 17% of GP-recruited men; p = 0.002). Consequenty, these men were aso much more ikey to have frequent episodes (more than one per month) where they forgot what they had done foowing a binge drinking session (54% of RDS-recruited men vs 6% of GP-recruited men; p = 0.001). At baseine the participants were spread across the age range years, amost four-fifths were in the owest two deprivation decies and over haf ony had schoo-eve quaifications. Most men (84%) were cassified as hazardous drinkers (positive FAST). The common pattern of acoho consumption was one of occasiona heavy drinking episodes interspersed between periods of compete abstinence. The men a had reguar binge drinking sessions, with one-third having six or more binge drinking sessions per month. More than two-thirds of the men had binge drinking sessions at which they consumed more than twice the conventiona binge drinking eve (8 units of acoho in a session). However, more than three-quarters of participants had at east 21 acoho-free days per month, so that average weeky consumption was modest. Few men (5%) knew the conventiona definition of binge drinking and most were unaware that this eve of drinking is harmfu. Athough most men were drinking hazardousy, ony 25% beieved their drinking to be harmfu. The Readiness to Change Questionnaire showed that most men (61%) were in the pre-contempation stage and few were taking action to cut down. At the 3-month foow-up, 64 of 67 men (96%) competed the outcome interview. The reasons for the high foow-up rate coud incude a friendy initia contact, incentives for participation, or the humorous non-nagging intervention. Athough not powered to detect effectiveness, the resuts of the feasibiity study are compatibe with the intervention being effective. The men in the intervention group reported a arger reduction in the frequency of binge drinking (the primary outcome of the fu tria). The reduction in the frequency of binge drinking days was accompanied by an increase in the frequency of moderate drinking days. Consistent with this, the Readiness to Change Questionnaire showed that more men in the intervention group had moved out of the pre-contempation stage and more were taking action to cut down. Extensive process evauation was carried out. Ninety-five per cent of the SMS text messages were deivered to the participants' teephones. There was a high eve of engagement with the text messages which sought responses. Most men (88%) had repied to at east one response-seeking text message, with more than haf (53%) repying to at east seven of the nine texts which sought a response. Many of the repies were carefuy structured persona messages. For exampe, a question about what participants woud do if they spent ess on acoho eicited the response: saving that money woud hep me take my girfriend out for a mea now and then. Asked about reasons for drinking ess, one man repied: I reay wanna stay out of troube and not become the person I can be after a few too many. At the end of the study most men (94%) fet that taking part in the study was worthwhie. They aso reported that they tod friends and famiy about the study: 95% to at east one person, 40% to five or more peope. A post-tria evauation showed high eves of satisfaction with the study. Opportunities to improve the recruitment strategy and the intervention were identified. Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xv

18 SCIENTIFIC SUMMARY Concusions This feasibiity study has demonstrated the feasibiity of a stages of a tria of a theory-based intervention deivered by text messages. The fexibe recruitment strategies meant the target sampe size of individuas from a hard-to-reach group was exceeded. The intervention, taiored to the target group and deivered through a medium famiiar to the participants, promoted high eves of engagement. Loss to foow-up was very ow. A very high proportion of the men were cassed as hazardous drinkers and thus woud be referred for brief interventions. A common pattern of drinking invoved occasiona episodes of very heavy drinking interspersed with periods of abstinence. This is ikey to be causing substantia harm. Men recruited through the RDS were most at risk because they binge drink much more frequenty and consume much arger amounts. Such men are ikey to be missed by heath service-based interventions. The interactive nature of the intervention was successfu in engaging participants. This feasibiity study has identified a new and very usefu too for process evauation in assessing compex interventions deivered eectronicay. Content anaysis of responses to text messages measured the extent of engagement with components of the behaviour change strategy, identified ambiguity in messages and highighted gaps in the intervention and areas for improvement. The process measures showed that the men engaged seriousy with the text messages. They aso showed that key components of the behaviour change strategy had the desired impact on the participants. In summary, this study has successfuy tested the feasibiity of a aspects of a behaviour change intervention study which used text messages to deiver a brief acoho intervention to disadvantaged men in eary mid-ife. As the target group has been itte studied and the design and deivery of the intervention posed interesting chaenges, the study provided the opportunity to make a series of important empirica and methodoogica advances. This study design has demonstrated the potentia to recruit, engage and modify drinking behaviour among disadvantaged young to midde-aged men. We recommend that a fu tria of the intervention be carried out to assess the effectiveness of the intervention. We further recommend that a cost-effectiveness study be incorporated into the tria to determine whether or not the approach is truy a ow-cost method of reaching arge numbers of disadvantaged men. Study registration This study is registered as ISRCTN Funding The Nationa Institute for Heath Research Pubic Heath Research programme. xvi NIHR Journas Library

19 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Chapter 1 Structure of the report Introduction This study assessed the feasibiity of a randomised controed tria to determine the impact of a nove intervention deivered by text message on drinking behaviour among disadvantaged young to midde-aged men. This was achieved by carrying out a of the stages of a pragmatic randomised controed tria, with a particuar focus on how we each stage was conducted. The aim of this cose scrutiny was to identify whether or not a fu tria woud succeed and what improvements coud be made to the conduct and ikey effectiveness of the tria. The study was conducted in three phases. Phase 1 comprised six focus groups to deveop the recruitment strategy, to optimise the design of the text messages and images and to determine the most acceptabe sequence for their deivery. Five focus groups were conducted with men and one focus group with women. The focus groups expored drinking behaviour and attitudes and beiefs about drinking, its benefits and harms. The findings from this phase were aso used to hep deveop the intervention. Phase 2 invoved the panned recruitment of 60 participants who were randomised to receive either the acoho intervention or genera heath promotion messages. This phase was conducted in a series of distinct steps. As the target group was disadvantaged young to midde-aged men, recruitment to the study was given carefu attention. The intervention was a series of interactive text messages and images designed using messaging theory, socia cognition modes, motivationa interviewing (MI) and systematic reviews of interventions to tacke acoho probems. The intervention was deivered to mobie teephones using a programmed computer system. Participants were foowed up for 3 months to assess retention, wiingness to respond to text messages and to compete the fina assessment of drinking behaviour. The aim of this assessment was to determine whether or not the outcomes coud be readiy measured on the participants. Athough the feasibiity study was not powered to detect changes in drinking behaviour, it coud give an indication of whether or not the intervention might be effective in a fu tria. Phase 3 invoved interviews with 20 participants to assess the acceptabiity of the intervention, the impact it had on their wiingness to moderate their drinking and factors that might imit their abiity to drink ess. The aim was to assess the acceptabiity of a aspects of the study and to identify opportunities to improve the intervention. The chapters of the report This report is aid out as a series of 12 chapters which provide a forensic anaysis of the design, conduct and outcome of the feasibiity study. Chapter 2 begins with an outine of the research objectives of the feasibiity study. Chapter 3 identifies the motivation for the study and then expores the main design chaenges which needed to be addressed. This is foowed by eight chapters which provide a description of the series of interinked substudies which were conducted to meet the aims of the feasibiity study. Each chapter is sef-contained, comprising an introduction, methods and resuts sections, together with a discussion which summarises the main findings and assesses their significance in the ight of previous research. This approach is appropriate because each substudy had a distinct purpose and a specific set of methods. Combining methods or discussion sections into singe chapters woud ose the cose reationship between methods, resuts and discussion which is essentia for a fu forensic evauation. The individua substudies are: Chapter 4, Understanding drinking motives and behaviours Chapter 5, Deveoping the text messages Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 1

20 STRUCTURE OF THE REPORT Chapter 6, Recruitment strategies Chapter 7, Randomisation and baseine characteristics Chapter 8, Retention strategy Chapter 9, Outcome assessment Chapter 10, Process evauation Chapter 11, Post-tria assessment. Chapter 12, Summary and concusions, has three inked aims. It presents a concise synthesis of the main findings from the whoe feasibiity study, together with their impications for future research. It then assesses the extent to which the feasibiity study met its aims. Finay, it makes recommendations for modifications to the protoco which wi improve the conduct and outcome of the proposed fu tria. 2 NIHR Journas Library

21 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Chapter 2 Research objectives Introduction The overa objective of this feasibiity study was to deveop and test the feasibiity of an intervention deivered by text messages to reduce the frequency of heavy drinking among young to midde-aged disadvantaged men. This invoved conducting a the stages of a randomised controed tria. The intervention has been deveoped from brief interventions that have been successfu when deivered face to face, but is deivered by a series of text messages and images. This provides a method for reaching arge numbers of peope at ow cost. If the deveopment and feasibiity testing are successfu, the intervention wi be tested in a fu-scae randomised controed tria in a further study for which new funding wi be sought. Research questions of the fu-scae tria of the nove intervention Prior to the feasibiity study it was thought that the research questions for the fu tria woud focus on the effectiveness of the intervention, and on the behavioura antecedents of reduced heavy drinking. Specificay it woud investigate whether or not a brief intervention deivered by mobie teephone coud: 1. reduce the frequency of heavy drinking by disadvantaged men 2. increase awareness of the harms of excessive drinking 3. increase intentions to avoid becoming drunk 4. increase sef-efficacy for refusing drinks. These questions were to be reassessed in the ight of the findings of this feasibiity study. Research questions of the feasibiity study The feasibiity study was concerned with the practica issues of recruitment and intervention deveopment and deivery. Successfu competion of a these stages is a prerequisite for a fu tria of a compex intervention to reduce the frequency of heavy drinking among young to midde-aged disadvantaged men. The specific questions were: 1. What are the best ways to recruit and retain disadvantaged men in a study aimed at reducing the frequency of heavy drinking? 2. What is the type of content and timing of the deivery of a series of text messages and images that is most ikey to engage young to midde-aged men? 3. Is the intervention ikey to be an acceptabe way to infuence the frequency of heavy drinking? Ethica approva Ethica approva for a aspects of the study was obtained from the East of Scotand Research Ethics Service (reference number 09/S1401/78). Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 3

22 RESEARCH OBJECTIVES User group representatives Two men, one a reformed heavy drinker, the other a continuing heavy drinker, were recruited to the Research Group. They attended steering group meetings, where they shared their views on drinking cutures, and the attitudes, beiefs and experiences of drinkers. They were the first to raise two important issues: the prevaence of very heavy binge drinking and the fact that many drinkers in the target age range, years, wi have suffered, or know someone who has suffered, serious harm from acoho. They aso advised on the construction of the intervention text messages and stressed the importance of phrasing texts in appropriate anguage. This heped ensure that the interventions were acceptabe and the outcomes were reevant and measurabe. Protoco amendments The intended sampe size was exceeded (67 participants instead of 60). This occurred in recruitment of participants through primary care. Invitation etters were sent out in batches and a men who were eigibe and wiing to take part were incuded in the study. Recruitment from the fina batches of etters ed to more men being recruited than intended. The intervention was modified in the ight of findings from the focus groups. MI was added because it provided a convenient technique for presenting components of the intervention. The transtheoretica mode (TTM) was added to the intervention design because it offered a ogica framework for designing and sequencing of messages. This approach was appropriate because it was anticipated that most participants woud be in the pre-contempation stage. The number of text messages which was sent was increased from the proposed 28 to 36 for two reasons: (1) texts were inserted which asked participants to respond to specific questions that probed key components of the behaviour change strategy; and (2) some messages were sent in pairs, with the second one sent a few minutes after the first. These devices promoted increased thinking time, a technique used in MI. The protoco proposed that a post-tria evauation be conducted to identify ways to improve the study. This was expanded to incude an extensive process evauation of the fideity of deivery of the intervention. It aso assessed the extent of engagement of the study participants with the main behaviour change components of the intervention. The aim of these evauations was to provide a series of detaied recommendations to improve the acceptabiity and impact of the intervention. 4 NIHR Journas Library

23 DOI: /phr01030 PUBLIC HEALTH RESEARCH 2013 VOL. 1 NO. 3 Chapter 3 Introduction The morbidity and mortaity caused by acoho are a major pubic heath chaenge. The prevaence of acoho misuse and its cost to society has risen substantiay over the ast 20 years. 1 It is currenty estimated at more than 55B per year in Engand 1 and more than 3.5B per year in Scotand. 2 These costs occur through ost productivity, increased heath-care and other pubic sector costs, and through crime and socia disruption. In , there were over 1 miion hospita admissions in Engand for acoho-reated conditions. 3 These figures incuded 177,400 admissions for menta and behavioura disorders and 43,100 for iver disease which were soey due to acoho. A tota of 6584 deaths were due to acoho, of which two-thirds were due to iver disease. The cost of acoho to the NHS in Engand is 2.7B (at prices). The major costs of acoho to society come from socia disruption, crime and costs to the economy. Acoho was associated with more than 500,000 crimes in Engand in It was a contributory factor in up to 1 miion assauts and 125,000 instances of domestic vioence. 4 Some 17 miion working days are ost each year because of drinking. Acoho-reated harms are not eveny distributed in the popuation. Peope who are sociay disadvantaged are at a substantiay higher risk of deveoping acoho-reated diseases. 5,6 Tacking the cuture of drinking among this group in order to prevent acoho-reated probems in ater ife is a priority for research. This introduction reviews the main issues to be addressed for the design and deivery of a brief acoho intervention to disadvantaged young to midde-aged men. Acoho and brief interventions Extensive evidence shows that brief interventions deivered in heath-care settings are effective in reducing acoho consumption These interventions were deveoped for midde-aged and oder men attending heath care. However, the group who binge drink most frequenty are young to midde-aged disadvantaged men. 11 Existing brief intervention studies mainy recruit through heath-care settings. However, men aged years are sedom in contact with heath services. They wi therefore not be reached by current initiatives to tacke excessive drinking deivered through heath-care settings, so aternative approaches are needed. Targeting this group woud ead to reductions in heavy drinking before chronic heath harms deveop. It woud aso prevent the accidents, vioence, socia disruption and crimina activities associated with episodes of heavy drinking. This group may be receptive to brief interventions; one recent survey reported that among current drinkers, 32% of men aged years fet the need to cut down on their drinking. 11 Thus, there is a need to deveop brief interventions which are appropriate for disadvantaged young men. Brief interventions are commony based on modes from socia psychoogy, such as the theory of panned behaviour (TPB). 12 Many of the interventions use MI, 13,14 a person-centred technique which encourages individuas to identify possibe inconsistencies between what they do (get drunk) and what they want to achieve (sociaise, find a partner). Recent reviews have identified theoretica constructs and specific behaviour change techniques which shoud form part of behaviour change interventions. 15,16 A further requirement for brief interventions is to reach arge numbers of individuas. Traditiona face-to-face interventions are imited in the numbers of individuas they can reach. 17 Over 8 miion peope in Engand have an acoho misuse disorder. 18 In Engand, 26% of men aged years exceed the recommended imit of 21 units per week. 3 In Scotand, over 30% of men aged years binge drink each week. 11 Given the scae of current probems there is a pressing need for interventions which can be deivered to arge numbers of individuas at ow cost. Queen's Printer and Controer of HMSO This work was produced by Crombie et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 5

24 INTRODUCTION Intervention deivery by mobie teephone The mobie teephone is an attractive method to deiver interventions to arge numbers of peope at very ow cost. This approach is we suited to young to midde-aged men because their ownership of mobie teephones is high. Text messaging has been used to modify adverse heath behaviours 19,20 and to increase heath-care uptake. 21,22 Recent systematic reviews suggest that brief interventions by mobie teephone are beneficia. 23,24 However, none of the primary studies to date has addressed acoho and none were directed at disadvantaged men. Deivering a brief intervention by mobie teephone text messages faces the chaenge that the texts are imited to 160 characters (incuding spaces and punctuation). The chaenge for this study was to incorporate the components of behaviour change theory and specific behaviour change techniques in a series of text messages which woud be effective with disadvantaged men. Unfortunatey, itte can be earned from previous text message intervention studies as few of them have been based expicity on theories of behaviour change. 16 Behaviour change interventions and disadvantaged peope Two recent extensive reviews provide a consistent and deepy worrying assessment of the current situation on socia disadvantage. 25,26 Heath behaviour varies substantiay by socioeconomic status, with disadvantaged individuas being more ikey to have adverse heath behaviours and to suffer poorer heath outcomes. 25 There is a marked socia cass variation in the uptake of preventive services, with the most disadvantaged being the east ikey to take them up. Few intervention studies have addressed the impact of interventions on sociay disadvantaged groups. There is some evidence that disadvantaged individuas are harder to recruit and retain in research studies. Avaiabe studies on behaviour change are often of poor methodoogica quaity. Most evidence is avaiabe from studies of smoking cessation, which show that success rates are ower in individuas from disadvantaged areas. Nonetheess, there is evidence that interventions can be effective in disadvantaged individuas. The recent reviews concuded that there is an urgent need for high-quaity studies of interventions targeted at groups of ow socioeconomic status. Recruitment Participation rates in research studies have been faing over the ast 30 years. 27,28 Severa studies have found that many trias strugge to recruit their intended sampe sizes. 29,30 There is now considerabe interest in strategies to increase recruitment rates. 31,32 As peope from deprived areas are more difficut to recruit to research studies, the recruitment strategy for trias targeting this group needs to be designed with particuar care. Reying soey on recruitment through heath care, the traditiona method for trias of brief interventions, 8,9,36 may not succeed as the target group is heathy and sedom in contact with heath services. Thus, aternative recruitment strategies may be needed. Respondent-driven samping (RDS) was deveoped to survey hard-to-reach groups, particuary those who engage in stigmatised or iega behaviours. 37,38 RDS was designed to overcome the imitations of other techniques such as snowba samping and key informant samping. The technique assumes that the target popuation is distributed through a number of sociay networked groups, making it suitabe for a group behaviour such as drinking. It has been extensivey and successfuy used with injecting drug users and groups at high risk of human immunodeficiency virus infection NIHR Journas Library