20/04/2017 Very Brief Interventions Study: Potential efficacy, fidelity, feasibility and acceptability of techniques to promote physical activity in primary.

Name: 20/04/2017 Very Brief Interventions Study: Potential efficacy, fidelity, feasibility and acceptability of techniques to promote physical activity in primary.
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Description: 20/04/2017 Very Brief Interventions Study: Potential efficacy, fidelity, feasibility and acceptability of techniques to promote physical activity in primary.

20/04/2017 Very Brief Interventions Study: Potential efficacy, fidelity, feasibility and acceptability of techniques to promote physical activity in primary care Sally Pears and Katie Morton BPS Process Evaluation Seminar. Norwich, 25 October 2013

VBI Programme Team Vijay Singh GC (WS5) Marc Suhrcke (WS5)
Stephen Sutton (CI, Director) Wendy Hardeman (Deputy Director, PI Pilot Trial) Laura Lamming (WS1) Dan Mason (WS1) Simon Cohn (WS2) Philip Miles (WS2) Katie Morton (WS3) Sally Pears (WS3) Maaike Bijker (WS3) Richard Parker (WS3) Joanna Mitchell (WS4) Ed Wilson (WS5) Ann Louise Kinmonth Gillian Orrow Sue Boase Simon Griffin David Ogilvie Toby Prevost Janet Watkinson PPI Panel Funder: National Institute for Health Research Sponsors: University of Cambridge Cambridgeshire & Peterborough CCG

20/04/2017 Overview VBI programme (Very Brief Interventions to promote physical activity): rationale, aims and workstreams Process Evaluation: The case of VBI VBI Feasibility Study and Pilot Trial: testing promising VBIs prior to a substantive trial Sally 3

VBI Programme: rationale
20/04/2017 VBI Programme: rationale Important to reduce the public health burden due to inactive lifestyles. Only 6% of men and 4% of women meet current PA recommendations for 30mins per day. [Health Survey for England 2008] Need for scalable interventions which can reach a large proportion of the adult population (in addition to more intensive interventions targeting those at higher risk). NHS Health Checks aim to lower risk of developing heart disease, stroke, diabetes and kidney disease (early detection / prevention). Health Checks offer an ideal opportunity to deliver brief physical activity advice of approximately five minutes to a large proportion of the population. Very brief physical activity advice should be relatively easy and inexpensive to implement on a large scale, and a small effect could translate into a significant public health benefit. Sally Everyone is at some risk of developing heart disease, stroke, diabetes, kidney disease and some forms of dementia. An NHS Health Check aims to help you lower your risk of developing these common but often preventable diseases.

20/04/2017 VBI Programme: Aims To develop and evaluate very brief interventions (VBIs) to increase physical activity that could be delivered by a practice nurse or health care assistant (HCA) in an NHS Health Check (HC) or other primary care consultation Patients aged 40-74, not currently diagnosed with vascular disease or with certain high risk factors (e.g. high blood pressure or cholesterol) already treated by medication Sally Everyone is at some risk of developing heart disease, stroke, diabetes, kidney disease and some forms of dementia. An NHS Health Check aims to help you lower your risk of developing these common but often preventable diseases.

Pilot Work Substantive Trial
Development work Pilot Work Substantive Trial Evidence synthesis Estimate cost and effectiveness of promising VBIs from studies/reviews Feasibility Study & Pilot Trial Develop and pilot materials Test feasibility, acceptability, fidelity and potential efficacy Select best-best VBI Main trial Estimate cost and effectiveness of best-bet VBI Qualitative study Integration of VBIs in NHS health checks Expert Consultation Shortlist VBIs Health Economics Resource use of promising VBIs Economic model of cost-effectiveness of VBIs 20/04/2017 Sally VBI Programme: Workstreams

Process Evaluation: the case of VBI
20/04/2017 Process Evaluation: the case of VBI “Process evaluation may be used to assess fidelity and quality of implementations, clarify causal mechanisms and identify contextual factors associated with variation in outcomes” [MRC guidance for complex interventions]* This talk: process evaluation in parallel with a pilot trial. Pilot Trial: evaluates several promising very brief interventions to promote physical activity in primary care against a control condition. Process Evaluation: used to inform the decision about the best-bet intervention to be evaluated in a substantive trial. Criteria for this selecting the best-bet VBI: include feasibility, acceptability, and fidelity (in addition to efficacy). *Moore et al. (2013) Process evaluation in complex public health intervention studies: the need for guidance. JECH (Online First) Sally 7

Pilot work: two phases 1 Feasibility study 2 Pilot trial 20/04/2017
Sally

Feasibility Study (Phase 1)
20/04/2017 Feasibility Study (Phase 1) Objectives: To develop and optimise promising VBI’s (identified from Evidence Synthesis, Qualitative Study and Expert Consultation) To develop and test pilot intervention protocols, training manual, intervention materials and quality assurance (fidelity) instruments Process Evaluation: Fidelity Feasibility Acceptability of the VBIs Sally

Pilot Trial (Phase 2) Objectives:
20/04/2017 Pilot Trial (Phase 2) Objectives: To test the fidelity, feasibility, acceptability AND potential efficacy of the VBIs. To decide which single or combined VBI to take forward to evaluation in a substantive trial. Process Evaluation: Intervention Fidelity Intervention Feasibility Intervention Acceptability Intervention Uptake Outcome Evaluation: Efficacy Sally

20/04/2017 Walk Dance Swim Run Stretch Cycle Move! Feasibility Study (Phase 1): Fidelity, Feasibility & Acceptability of the VBI’s Sally

Generation of VBI Short-list for Phase 1
20/04/2017 Generation of VBI Short-list for Phase 1 Sources of Evidence Evidence Synthesis Scoping Review of BCTs (behaviour change techniques) Team Discussions Expert Consultations (practitioners, academics, end-users) Qualitative study Four VBIs ALL Interventions Included: - Physical Activity Assessment; PA recommendations; Face-to-face discussion; Written materials VBI 1: Motivational - Benefits of PA - Ways of increasing PA - Signposting to local resources, etc. VBI 2: Action Planning - Ways of increasing PA - Planning Activity (What, When, Where, & With Whom) VBI 3: Pedometer - 10,000 steps goal - Verbal instruction to record steps VBI 4: PA Diary - Ways of increasing PA - Record daily activity - Compare activity and goals - Review/set new goals each week Evidence to identify promising components of VBIs – including BCTs, clusters of BCTs (e.g. MI), and tools to deliver BCTs (e.g. Pedometer)

Feasibility Study (Phase 1)
20/04/2017 Feasibility Study (Phase 1) Participants N=68 Recruited from 2 practices (3 Healthcare Assistants & 1 Nurse) Received a Health Check plus one of the 4 VBIs VBI 4: PA Diary N=17 VBI 1: Motivational N= 16 VBI 2: Action Planning N= 17 VBI 3: Pedometer N=18 Process Evaluation Health Check (plus VBI) Recordings [fidelity and feasibility] Participant Interviews [feasibility and acceptability] Practitioner Interviews and on-going feedback [feasibility and acceptability] KM slide: add details here to process evaluation Evidence to identify promising components of VBIs – including BCTs, clusters of BCTs (e.g. MI), and tools to deliver BCTs (e.g. Pedometer) – KM to add details about interviews…..

Feasibility Study (Phase 1): Main Findings
20/04/2017 Feasibility Study (Phase 1): Main Findings Fidelity Fidelity was quite high and did not differ across the four VBIs. Nurses / Health Care Assistants often went into ‘telling mode’ rather than asking questions. Feasibility All VBIs fitted comfortably into 5 minutes at the end of the Health Check. Nurses/HCAs reported that all VBIs were relatively easy to deliver. NO patient wrote an Action Plan or Set a Goal (Activity Diary) during the intervention. Acceptability Nurses/HCAs reported that all VBIs seemed to be acceptable to patients. Patients reported that the HC was a good time to discuss PA and that having a discussion about PA was very useful. Patients reported that they appreciated being asked (rather than told) how they could improve their PA. The majority of patients said they would use the materials given and they intended to increase their PA.

Feasibility Study (Phase 1): Main Findings
20/04/2017 Feasibility Study (Phase 1): Main Findings Other Findings…. Nurses / HCAs reported that they felt telling people the PA recommendations was a good idea (and something they weren’t already doing as part of the Health Check). The majority of patients reported that they were not aware of the PA recommendations (they just knew they should ‘do more’). A number of patients reported that completing the Physical Activity Assessment helped make them aware of how little PA they were doing / where they could make improvements. Suggestions for Improvement The vast majority of patients reported that there was nothing more that could have been said or done to help / encourage them to increase their physical activity. However: Some patients commented that they would have liked more tips for how to increase their PA. And many patients commented that they would have liked a Follow-up consultation (to have someone ‘checking up’ on their activity).

VBI 3: Motivational & Pedometer
20/04/2017 Selecting VBIs for Evaluation in a Pilot Trial (Phase 2) Sources of Evidence From the Feasibility Study (Phase 1): Health Check Recordings [fidelity and feasibility] Participant Interviews [feasibility and acceptability] Practitioner Interviews [feasibility and acceptability] Three VBIs ALL Interventions Include: - Physical Activity Assessment; PA recommendations; Face-to-face discussion; Written materials VBI 1: Motivational - Benefits of PA - Ways of Increasing PA - Signposting, etc. - Action Planning - Activity Diary VBI 2: pedometer - 10,000 steps goal - Step Chart & Pedometer VBI 3: Motivational & Pedometer - Benefits of PA - Ways of Increasing PA - Signposting, etc. - Action Planning - Activity Diary - 10,000 steps goal - Step Chart & Pedometer What decisions we took about VBIs to take forward tp Phase 2 and Why we chose to combine VBIs No one-size fits all, and as no single VBI stood out, decided to try different combinations – a range of BCTs may work best. As no patient wrote a goal or action plan during the health check in Phase 1, we decided to keep the action planning / goal setting in but not to ask patients to write a plan during the health check itself. Changes to training and intervention materials to encourage practitioners to ‘ask rather than tell’ Which feedback we were able to take on board and which not Unable to add a follow-up at this stage but decided to explore this possibility more in the process evaluation in Phase 2 – by asking questions about follow-up in the questionnaire.

20/04/2017 Walk Dance Swim Run Stretch Cycle Move! Pilot Trial (Phase 2): Fidelity, Feasibility, Acceptability AND Efficacy Sally

Pilot Trial (Phase 2) Participants
20/04/2017 Pilot Trial (Phase 2) Participants N=384, recruited from 8 practices (So far: 298 recruited; follow-up data from 168) 18 practitioners trained [9 Nurses and 9 Health Care Assistants] Randomised to Control (Health Check only) or one of 3 Intervention conditions (Health Check plus VBI) using an adapted cluster randomised design. VBI 1: Motivational VBI 2: Pedometer VBI 3: Motivational & Pedometer Control KM slide: Add details here In terms of the data collected in phase 2 – all data is collected at 4 weeks post hc. The primary outcome is….. Secondary outcomes include…..(all measured by questionnaire) All questionnaires completed at home – wore accelerometer and then completed questionnaire. Outcome and Process Evaluation (4 weeks post Health Check)

Outcome and Process Evaluation
20/04/2017 Outcome and Process Evaluation Outcome Evaluation Objective physical activity (ActiGraph GT3X+) [efficacy] Self-reported physical activity (RPAQ) [efficacy] Process Evaluation Questionnaire: recall, use of VBI materials, use of behaviour change techniques, feasibility, acceptability, and beliefs about being more physically active [fidelity, feasibility and intervention uptake] In a sub-sample: Health Check (plus VBI) recordings [fidelity and feasibility]: n=64 (2 per condition per practice) Participant Interviews [feasibility and acceptability]: n=48 (2 per VBI per practice) Practitioner Interviews and on-going feedback [feasibility and acceptability]: n=16 (1 per practitioner) KM slide

Pilot Trial (Phase 2): Process Evaluation Measures
20/04/2017 Pilot Trial (Phase 2): Process Evaluation Measures 1. Intervention Fidelity i.e. was the intervention delivered faithfully 2. Intervention Feasibility e.g. could the intervention be delivered within 5 minutes; was the training provided to practitioners sufficient etc. 3. Intervention Acceptability i.e. was the intervention acceptable to both practitioners and patients 4. Intervention Uptake e.g. did participants recall receiving the intervention; did they use the intervention materials; what aspects of the intervention did they find the most useful; etc. Patient Interviews Practitioner Interviews & Ongoing Feedback Follow-Up Questionnaire Health Check & VBI Recordings

Process Evaluation: Example Questions
20/04/2017 Process Evaluation: Example Questions Patient Interviews “Do you think the discussion of physical activity was tailored to you as an individual?” “Do you think you will increase your physical activity after the discussion in today’s Health Check?” Practitioner Interviews & Ongoing Feedback “How did you feel the physical activity intervention flowed following on from the Health Check (i.e., the transition from the routine Health Check to delivering the PA intervention?)” “How did patients respond to the physical activity intervention?” Follow-Up Questionnaire “What are the key things you remember about the discussion of physical activity?” “Please rate how useful you found each Step in the Step-by-Step Guide by ticking the appropriate number, and writing any comments you have about each step.” [not at all useful, somewhat useful, very useful]

Phase 2 (Very) Preliminary Findings
20/04/2017 Phase 2 (Very) Preliminary Findings Questionnaire Data (n=80): Participants who received a VBI were more likely to remember that PA was discussed in the Health Check. About a third of participants in all groups reported that they would like a follow-up appointment. Patient Interviews (n=40): Health Check is a good time to discuss PA. Many reported that they already understood the importance of PA. No distinction between interventions. Sally

The additional ‘challenges’!
20/04/2017 The additional ‘challenges’! Phase 1 Poor initial recruitment of GP practices Low number of health checks per week Logistical issues: participant recruitment Communication challenges Health check – control condition Phase 2 Randomisation Participant recruitment concerns: Participant Invitation Sheet (PIS) wording/invite procedures? Data collection: objective PA measures KM slide: Link these explicitly to process evaluation. I.e. process evaluation can help to identify challenges related to the study (in addition to the content/delivery of the interventions themselves), eg recruitment, retention, system factors. This it can inform the design of a trial (sample size calculations) and provide insight into how the context might influence the implementation of the intervention and its effects. Katie Before Sally discusses the findings of Phase 1, I wanted discuss briefly some of the challenges (from a study coordination perspective) and how we overcame these throughout Phase 1. I imagine some of these might be relevant to other groups implementing interventions within in GP practices. First of all, practice recruitment was initially a challenge – some reported they would like to be in Phase 2 (i.e. they didn’t like the idea that this study was developing and refining interventions to be used in a larger trial down the line). Concerned about the audio recordings (i.e. all consultations recorded…worried that ‘patients won’t approve’). Another reason was that some practices did not hold enough HC’s per week. Another issue related to the logistical issues surrounding participant recruitment. For example, our recruitment strategy was initially to provide patients with a letter that invited them to their health check (which is what happens normally) and also invites them to the VBI study. We stated that even if they don’t want to be part of the VBI study – they are still eligible and encouraged to go for their health check. This was posted out with a PIS and sample consent form by the practices. However, this recruitment strategy did not reflect the invite procedures in both practices as these 2 practices also recruited a lot of HC participants on an ad hoc basis (i.e., patient already in practice for something else). This led us to submit an amendment to be able to recruit in waiting room for Phase 2 (i.e., participants provided with PIS and sample consent for in waiting room ahead of HC). Communication was also a challenge due to the fact we had to interview every patient– therefore we had to know when this appointment was happening. This required good communication between myself and the ‘contact’ person at the practice – i.e., they needed to check the practice records each week to see how many ppts for next week and what time. Issues arose if reception were not informed of study (i.e., new receptionist) so didn’t note that the appointment was for the VBI study – sometimes only booked 15 minute slot so not enough for the research study…. Another challenge was the question around what to do with the control condition in Phase 2 as we learnt that the HC was v. different in both practices – which led us to consider what should be the control condition as a usual HC might encompass different components. Finally – as part of the VBI, participants were handed out a PA questionnaire to complete in the waiting room which informed the delivery of the VBI – however we soon realised that this would nnot be possible in Phase 2 (as it didn’t happen if we weren’t there!) – i..e, automatic check in means participants don’t always see receptionist and practices unable to guarantee this could be given out to everyone. We can’t post it as this would mean it goes to everyone (and we don’t want control participants to recevie this for Phase 2) – meant we had to change VBI slightly to remove the need for the completion of the PA questionnaire. So generally speaking – these highlight the importance of piloting aspect of intervention delivery and participant recruitment ready for the feasibility RCT in Phase 2. In terms of the challenges we have faced WRT Phase 2: the randomisation was still a challenge – with 3 different VBI’s plus control – it was decided it still needed to be an adapted clustered design whereby different VBI (or control) each week (to prevent contamination as much as possible). Although this proves difficult logistically to ensure practices have the correct VBI packs for the correct weeks: Involves going in person to practice every other week with clearly labelled boxes for subsequent 2 weeks and making sure everyone in the practice knows what is happening each week. Again, we have had some challenges with participant recruitment in some practices although these have hopefully been resolved now – For example, at first recruitment was struggling in the more rural practices – practices concerned that invite for HC plus VBI and the lengthy PIS was putting people off - not only the study but also the HC. Tried different approach in some practices (to utilise waiting room booklet) – sent out simple initial letter to HC only – then when booked – told verbally about VBI (so indicated whether they would like to take part) then when turn up – provided with in depth booklet to read in waiting room (and can ask nurse/reception any question in person). Boosted recruitment in one practice by 150% in 2 weeks –this raises important questions about the PIS’s that we are required to send out in interventions studies Finally, one challenge we are currently contending with is the difficulty getting questionnaires/accelerometers back in timely fashion! We estimated….2 days post – 7 wearing and 4-5 days to post back – however in total – participants are taking about 3 weeks to return everything – most completed and worn. Also problem of people not returning after 5-6 weeks – despite phoning/leaving messages Setting up ‘text’ reminder and reduced time to ring to remind (being to polite at first!) When we have spoken to people – these indicate having worn for a least a couple of days but simply forgotten to post back – just need a prompt! 23

Process Evaluation: Benefits and Challenges
20/04/2017 Process Evaluation: Benefits and Challenges Benefits: Information about intervention content and delivery Highlights challenges associated with recruitment, retention and wider system factors that are important for the main trial. Challenges: Interpreting multiple sources of data to decide best-bet intervention Logistical challenges (i.e., wide geographical area) KM slide: experiences as regard conducting the process evaluation i.e. the benefits (what have we learned that we otherwise would not have known? Lessons learned: Recruitment methods and data collection strategies Importance of piloting! and the challenges (e.g., multiple sources of data, logistical problems related to interviews over a wide geographical area etc).

What Have We Learned So Far?
Key conclusions: VBIs are acceptable and feasible within a health check. Process evaluation invaluable to the development of feasible and acceptable VBIs Process evaluation crucial for piloting procedures to be utilised in the main trial Next steps: Data analysis (quantitative & qualitative) Deciding which VBI to take forward to the main trial. KM slide - What would you recommend to the audience - who are all involved in process evaluation - about what they should do and should not do? I'd conclude the presentation with 'next steps'.Add to this….Anything else to add? No baseline measures to determine changes in PA Not all uncertainties addressed: Difficult to determine how well baseline measures can be incorporated into the main trial Individual randomisation in the main trial?

Acknowledgements This presentation presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG ). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

20/04/2017 Very Brief Interventions Study: Potential efficacy, fidelity, feasibility and acceptability of techniques to promote physical activity in primary.

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20/04/2017 Very Brief Interventions Study: Potential efficacy, fidelity, feasibility and acceptability of techniques to promote physical activity in primary.

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