scholarly journals The Development of Theory-Informed Participant-Centred Interventions to Maximise Participant Retention in Randomised Controlled Trials

2021 ◽  
Author(s):  
Rumana Newlands ◽  
Eilidh Duncan ◽  
Shaun D Treweek ◽  
Jim Elliott ◽  
Justin Presseau ◽  
...  
Keyword(s):  
Behaviour Change ◽  
Theoretical Domains Framework ◽  
Potential Effect ◽  
Ethics Committee ◽  
Behaviour Change Techniques ◽  
Clinic Attendance ◽  
Behaviour Change Interventions ◽  
Randomised Controlled ◽  
Trial Participants

Abstract BackgroundA failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention. MethodsThis study used a multi-phase sequential mixed methods approach informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions based on participant accounts were described and developed in a co-design workshop with trial participants. We then assessed acceptability and feasibility of two of the prioritised retention interventions during a focus group, which also included a questionnaire, involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). ResultsEight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed based on suggestions provided by trial participants: 1. Incentives and rewards for follow-up clinic attendance; 2. Goal setting for improving questionnaire return; 3. Self-monitoring to improve questionnaire return and/or clinic attendance; and 4. Motivational information to improve questionnaire return and clinic attendance. Seventeen trial stakeholders (participants, trialists, ethics committee members) contributed to the evaluation of acceptability and feasibility of the retention interventions, which were generally positive with some areas for consideration highlighted. ConclusionsThis is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess their effectiveness and assess resource implications.

scholarly journals Supporting medicines management for older people at care transitions – a theory-based analysis of a systematic review of 24 interventions

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Justine Tomlinson ◽  
Iuri Marques ◽  
Jonathan Silcock ◽  
Beth Fylan ◽  
Judith Dyson
Keyword(s):  
Older People ◽  
Behaviour Change ◽  
Complex Intervention ◽  
Care Transitions ◽  
Theoretical Domains Framework ◽  
Behaviour Change Techniques ◽  
Medicines Management ◽  
Post Discharge ◽  
Behaviour Change Technique ◽  
Randomised Controlled

Abstract Background Older patients are at severe risk of harm from medicines following a hospital to home transition. Interventions aiming to support successful care transitions by improving medicines management have been implemented. This study aimed to explore which behavioural constructs have previously been targeted by interventions, which individual behaviour change techniques have been included, and which are yet to be trialled. Method This study mapped the behaviour change techniques used in 24 randomised controlled trials to the Behaviour Change Technique Taxonomy. Once elicited, techniques were further mapped to the Theoretical Domains Framework to explore which determinants of behaviour change had been targeted, and what gaps, if any existed. Results Common behaviour change techniques used were: goals and planning; feedback and monitoring; social support; instruction on behaviour performance; and prompts/cues. These may be valuable when combined in a complex intervention. Interventions mostly mapped to between eight and 10 domains of the Theoretical Domains Framework. Environmental context and resources was an underrepresented domain, which should be considered within future interventions. Conclusion This study has identified behaviour change techniques that could be valuable when combined within a complex intervention aiming to support post-discharge medicines management for older people. Whilst many interventions mapped to eight or more determinants of behaviour change, as identified within the Theoretical Domains Framework, careful assessment of the barriers to behaviour change should be conducted prior to intervention design to ensure all appropriate domains are targeted.

scholarly journals Using the Theoretical Domains Framework to investigate clinicians’ behavioural determinants of antimicrobial prescribing in Qatar

2021 ◽  
Vol 29 (Supplement_1) ◽  
pp. i20-i22
Author(s):  
H Talkhan ◽  
D Stewart ◽  
T McIntosh ◽  
H Ziglam ◽  
P V Abdulrouf ◽  
...  
Keyword(s):  
Systematic Review ◽  
Scale Score ◽  
Behaviour Change ◽  
Theoretical Domains Framework ◽  
Free Text ◽  
Behaviour Change Interventions ◽  
Antimicrobial Prescribing ◽  
Behavioural Determinants ◽  
Inferential Analysis ◽  
Determinants Of Implementation

Abstract Introduction A recent systematic review by Talkhan et al demonstrated the need for theoretically based behaviour change interventions in this area. [1] For development of such complex interventions, emphasis should be placed on using theory to systematically identify behavioural determinants of antimicrobial prescribing. Aim To identify and quantify clinicians’ behavioural determinants of antimicrobial prescribing in Qatar. Methods This cross-sectional survey is part of a multi-phase explanatory, sequential mixed methods PhD project in Qatar. Questionnaires were distributed (online and paper based) to all doctors (~4,000) and pharmacists (~400) within Hamad Medical Corporation (HMC, the main healthcare provider). The questionnaire was developed with reference to the Determinants of Implementation Behaviour Questionnaire (a generic questionnaire derived from the 14 theoretical domains of the Theoretical Domains Framework, TDF). [2] Each item was presented as a 5-point Likert scale (scored 5=Strongly agree to 1=Strongly disagree). Personal and practice demographics were also collected for data contextualisation. The draft questionnaire was reviewed for face/content validity by an expert panel of six researchers in Qatar and the UK with experience in the use of the TDF, followed by ‘Think aloud’ testing and piloting. Analysis investigated the behavioural determinants and influential factors through descriptive, principal component analysis (PCA) and inferential analysis. Ethics approval was granted from a UK university and HMC. Results In total, 535 responses were received, 339 (63.4%) from doctors and 196 (36.6%) from pharmacists. Respondents were predominantly male, 346 (64.7%). Just over half (n=285, 53.3%) had ≤ 5 years’ experience as health professionals. PCA showed a three component (C) solution with components incorporating a number of questionnaire items labelled: ‘Guidelines compliance’ (C1 with 8 items), ‘Influences on prescribing’ (C2 with 7 items) and ‘Self-efficacy’ (C3 with 5 items) in prescribing/recommendation activity. A scale score for each respondent was calculated through summation of Likert scores for the relevant questionnaire items within each component. These scales had high internal reliability (Cronbach’s alpha all >0.7) showing consistency in response between component items indicating statistical appropriateness for developing scales. The median score (possible scale range, midpoint) for each scale was C1, 32 (8 to 40, 24), C2, 26 (7 to 35, 21) and C3, 20, (5 to 25, 15). By way of example Table 1 shows levels of agreement for items in C2. This shows lower levels of agreement than C1 scale with the median scale score (26) closer to the midpoint (21) indicating that respondents had less positive views. Inferential analysis using these scale scores and free text analysis is in progress. Conclusion A theoretical basis was used throughout providing insights to behavioural determinants for the development of a theory-based behaviour change intervention. Preliminary results suggest that social influences, staff development and quality monitoring may be useful targets for behaviour change interventions to improve antimicrobial prescribing practice. Limitations include potential social desirability bias and focus on one healthcare organisation/country in the Middle East which may limit generalisability of findings. More in-depth exploration is required to select and test appropriate linked theory-based behaviour change techniques. References 1. Talkhan H, Stewart D, McIntosh T, Ziglam H Palli Valapila, A; Moza Sulaiman H, Diab M, Cunningham S. The use of theory in the development and evalu​ation of behaviour change interventions to improve antimicrobial prescribing: a systematic review. J Antimicrob Chemother. 2020;75(9):2394–2410, Available from https://doi.org/10.1093/jac/dkaa154 [Accessed 12 Oct 2020]. 2. Huijg JM, Gebhardt WA, Dusseldorp E, Verheijden MW, van der Zouwe N, Middelkoop BJ, Crone MR. Measuring determinants of implementation behaviour: psychometric properties of a questionnaire based on the Theoretical Domains Framework. Implement. Sci. 2014;9(1):33.

scholarly journals A behaviour change intervention to reduce home exposure to second hand smoke during pregnancy in India and Bangladesh: a theory and evidence-based approach to development

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Veena A. Satyanarayana ◽  
Cath Jackson ◽  
Kamran Siddiqi ◽  
Prabha S. Chandra ◽  
Rumana Huque ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Behaviour Change ◽  
Delphi Survey ◽  
Behaviour Change Techniques ◽  
Evidence Based ◽  
Behaviour Change Intervention ◽  
Behaviour Change Interventions ◽  
Modified Delphi ◽  
Qualitative Interview Study ◽  
At Home

Abstract Background Home exposure to secondhand smoke (SHS) is highly prevalent amongst pregnant women in low- and middle-income countries like India and Bangladesh. The literature on the efficacy of behaviour change interventions to reduce home exposure to SHS in pregnancy is scarce. Methods We employed a theory and evidence-based approach to develop an intervention using pregnant women as agents of change for their husband’s smoking behaviours at home. A systematic review of SHS behaviour change interventions led us to focus on developing a multicomponent intervention and informed selection of behaviour change techniques (BCTs) for review in a modified Delphi survey. The modified Delphi survey provided expert consensus on the most effective BCTs in reducing home exposure to SHS. Finally, a qualitative interview study provided context and detailed understanding of knowledge, attitudes and practices around SHS. This insight informed the content and delivery of the proposed intervention components. Results The final intervention consisted of four components: a report on saliva cotinine levels of the pregnant woman, a picture booklet containing information about SHS and its impact on health as well strategies to negotiate a smoke-free home, a letter from the future baby to their father encouraging him to provide a smoke-free home, and automated voice reminder and motivational messages delivered to husbands on their mobile phone. Intervention delivery was in a single face-to-face session with a research assistant who explained the cotinine report, discussed key strategies for ensuring a smoke-free environment at home and practised with pregnant women how they would share the booklet and letter with their husband and supportive family members. Conclusion A theory and evidence-based approach informed the development of a multicomponent behaviour change intervention, described here. The acceptability and feasibility of the intervention which was subsequently tested in a pilot RCT in India and Bangladesh will be published later.

scholarly journals Estimating the reproducibility & transparency of smoking cessation behaviour change interventions

2020 ◽  
Author(s):  
Emma Norris ◽  
Yiwei He ◽  
Rachel Loh ◽  
Robert West ◽  
Susan Michie
Keyword(s):  
Open Access ◽  
Behaviour Change ◽  
Conflict Of Interest ◽  
Open Data ◽  
Smoking Behaviour ◽  
Funding Source ◽  
Behaviour Change Intervention ◽  
Behaviour Change Interventions ◽  
Replication Studies ◽  
Randomised Controlled

Introduction: Activities promoting research reproducibility and transparency are crucial for generating trustworthy evidence. Evaluation of smoking interventions is one area where vested interests may motivate reduced reproducibility and transparency. Aims: Assess markers of transparency and reproducibility in smoking behaviour change intervention evaluation reports.Methods: One hundred evaluation reports of smoking behaviour change intervention randomised controlled trials published in 2018-2019 were identified. Reproducibility markers of pre-registration, protocol sharing, data-, materials- and analysis script-sharing, replication of a previous study and open access publication were coded in identified reports. Transparency markers of funding and conflict of interest declarations were also coded. Coding was performed by two researchers, with inter-rater reliability calculated using Krippendorff’s alpha.Results: Seventy-one percent of reports were open access and 73% pre-registered. However, only 13% provided accessible materials, 7% accessible data and 1% accessible analysis scripts. No reports were replication studies. Ninety-four percent of reports provided a funding source statement and eighty-eight percent of reports provided a conflict of interest statement.Conclusions: Open data, materials, analysis and replications are rare in smoking behaviour change interventions, whereas funding source and conflict of interest declarations are common. Future smoking research should be more reproducible to enable knowledge accumulation.

scholarly journals Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: a randomised controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1524 ◽  
Author(s):  
David Crane ◽  
Harveen Kaur Ubhi ◽  
Jamie Brown ◽  
Robert West
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Behaviour Change Techniques ◽  
Full Version ◽  
Intention To Treat ◽  
Support Programmes ◽  
Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods:  This was a two-arm randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

scholarly journals Breaking barriers: using the Behavior Change Wheel to develop a tailored intervention to overcome workplace inhibitors to breaking up sitting time

2019 ◽  
Author(s):  
Samson O Ojo ◽  
Daniel P. Bailey ◽  
Marsha L. Brierley ◽  
David J. Hewson ◽  
Angel M. Chater
Keyword(s):  
Behaviour Change ◽  
Theoretical Domains Framework ◽  
Office Workers ◽  
Sitting Time ◽  
Mental Wellbeing ◽  
Behaviour Change Techniques ◽  
Tailored Intervention ◽  
Structured Interviews ◽  
Behaviour Change Technique ◽  
Break Up

Abstract Background: The workplace is a prominent domain for excessive sitting. The consequences of increased sitting time include adverse health outcomes such as cardiovascular disease and poor mental wellbeing. There is evidence that breaking up sitting could improve health, however, any such intervention in the workplace would need to be informed by a theoretical evidence-based framework. The aim of this study was to use the Behaviour Change Wheel (BCW) to develop a tailored intervention to break up and reduce workplace sitting in desk-based workers. Methods: The BCW guide was followed for this qualitative, pre-intervention development study. Semi-structured interviews were conducted with 25 office workers (26-59 years, mean age 40.9 [SD=10.8] years; 68% female) who were purposively recruited from local council offices and a university in the East of England region. The interview questions were developed using the Theoretical Domains Framework (TDF). Transcripts were deductively analysed using the COM-B (Capability, Opportunity, Motivation – Behaviour) model of behaviour. The Behaviour Change Technique Taxonomy Version 1 (BCTv1) was thereafter used to identify possible strategies that could be used to facilitate change in sitting behaviour of office workers in a future intervention. Results: Qualitative analysis using COM-B identified that participants felt that they had the physical Capability to break up their sitting time, however, some lacked the psychological Capability in relation to the knowledge of both guidelines for sitting time and the consequences of excess sitting. Social and physical Opportunity was identified as important, such as a supportive organisational culture (social) and the need for environmental resources (physical). Reflective and automatic Motivation was highlighted as a core target for intervention. Seven intervention functions and three policy categories from the BCW were identified as relevant. Finally, 39 behaviour change techniques (BCTs) were identified as potential active components for an intervention to break up sitting time in the workplace. Conclusions: The TDF, COM-B model and BCW can be successfully applied through a systematic process to understand the drivers of behaviour of office workers to develop a co-created intervention that can be used to break up and decrease prolonged sitting in the workplace.

scholarly journals Breaking barriers: using the Behavior Change Wheel to develop a tailored intervention to overcome workplace inhibitors to breaking up sitting time

2019 ◽  
Author(s):  
Samson O Ojo ◽  
Daniel P. Bailey ◽  
Marsha L. Brierley ◽  
David J. Hewson ◽  
Angel M. Chater
Keyword(s):  
Behaviour Change ◽  
Theoretical Domains Framework ◽  
Office Workers ◽  
Sitting Time ◽  
Mental Wellbeing ◽  
Behaviour Change Techniques ◽  
Tailored Intervention ◽  
Structured Interviews ◽  
Behaviour Change Technique ◽  
Break Up

Abstract Background: The workplace is a prominent domain for excessive sitting. The consequences of increased sitting time include adverse health outcomes such as cardiovascular disease and poor mental wellbeing. There is evidence that breaking up sitting could improve health, however, any such intervention in the workplace would need to be informed by a theoretical evidence-based framework. The aim of this study was to use the Behaviour Change Wheel (BCW) to develop a tailored intervention to break up and reduce workplace sitting in desk-based workers. Methods: The BCW guide was followed for this qualitative, pre-intervention development study. Semi-structured interviews were conducted with 25 office workers (26-59 years, mean age 40.9 [SD=10.8] years; 68% female) who were purposively recruited from local council offices and a university in the East of England region. The interview questions were developed using the Theoretical Domains Framework (TDF). Transcripts were deductively analysed using the COM-B (Capability, Opportunity, Motivation – Behaviour) model of behaviour. The Behaviour Change Technique Taxonomy Version 1 (BCTv1) was thereafter used to identify possible strategies that could be used to facilitate change in sitting behaviour of office workers in a future intervention. Results: Qualitative analysis using COM-B identified that participants felt that they had the physical Capability to break up their sitting time, however, some lacked the psychological Capability in relation to the knowledge of both guidelines for sitting time and the consequences of excess sitting. Social and physical Opportunity was identified as important, such as a supportive organisational culture (social) and the need for environmental resources (physical). Reflective and automatic Motivation was highlighted as a core target for intervention. Seven intervention functions and three policy categories from the BCW were identified as relevant. Finally, 39 behaviour change techniques (BCTs) were identified as potential active components for an intervention to break up sitting time in the workplace. Conclusions: The TDF, COM-B model and BCW can be successfully applied through a systematic process to understand the drivers of behaviour of office workers to develop a co-created intervention that can be used to break up and decrease prolonged sitting in the workplace.

scholarly journals A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
D. E. Patton ◽  
J. J. Francis ◽  
E. Clark ◽  
F. Smith ◽  
C. A. Cadogan ◽  
...  
Keyword(s):  
Pilot Study ◽  
Process Evaluation ◽  
Behaviour Change ◽  
Older Patients ◽  
Controlled Trial ◽  
Theoretical Domains Framework ◽  
Self Report ◽  
Community Pharmacies ◽  
Behaviour Change Techniques ◽  
Limited Effectiveness

Abstract Background Adhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. Previous interventions designed to address this have been largely complex in nature but have shown limited effectiveness and have rarely used theory in their design. It has been recognised that theory (‘a systematic way of understanding events or situations’) can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change. Methods As part of a non-randomised pilot study, pharmacists in 12 community pharmacies across Northern Ireland (n = 6) and London, England (n = 6), will be trained to deliver the intervention to older patients who are prescribed ≥ 4 regular medicines and are non-adherent (self-reported). Ten patients will be recruited per pharmacy (n = 120) and offered up to four tailored one-to-one sessions, in the pharmacy or via telephone depending on their adherence, over a 3–4-month period. Guided by an electronic application (app) on iPads, the intervention content will be tailored to each patient’s underlying reasons for non-adherence and mapped to the most appropriate solutions using established behaviour change techniques. This study will assess the feasibility of collecting data on the primary outcome of medication adherence (self-report and dispensing data) and secondary outcomes (health-related quality of life and unplanned hospitalisations). An embedded process evaluation will assess training fidelity for pharmacy staff, intervention fidelity, acceptability to patients and pharmacists and the intervention’s mechanism of action. Process evaluation data will include audio-recordings of training workshops, intervention sessions, feedback interviews and patient surveys. Analysis will be largely descriptive. Discussion Using pre-defined progression criteria, the findings from this pilot study will guide the decision whether to proceed to a cluster randomised controlled trial to test the effectiveness of the S-MAP intervention in comparison to usual care in community pharmacies. The study will also explore how the intervention components may work to bring about change in older patients’ adherence behaviour and guide further refinement of the intervention and study procedures. Trial registration This study is registered at ISRCTN: 10.1186/ISRCTN73831533

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