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Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation.

ABSTRACT: Chronic obstructive pulmonary disease is generally progressive and associated with reduced physical activity. Both pharmacological therapy and exercise training can improve exercise capacity; however, these are often not sufficient to change the amount of daily physical activity a patient undertakes. Behaviour-change self-management programmes are designed to address this, including setting motivational goals and providing social support. We present and discuss the necessary methodological considerations when integrating behaviour-change interventions into a multicentre study.PHYSACTO is a 12-week phase IIIb study assessing the effects on exercise capacity and physical activity of once-daily tiotropium+olodaterol 5/5 µg with exercise training, tiotropium+olodaterol 5/5 µg without exercise training, tiotropium 5 µg or placebo, with all pharmacological interventions administered via the Respimat inhaler. Patients in all intervention arms receive a behaviour-change self-management programme to provide an optimal environment for translating improvements in exercise capacity into increases in daily physical activity. To maximise the likelihood of success, special attention is given in the programme to: (1) the Site Case Manager, with careful monitoring of programme delivery; (2) the patient, incorporating patient-evaluation/programme-evaluation measures to guide the Site Case Manager in the self-management intervention; and (3) quality assurance, to help identify and correct any problems or shortcomings in programme delivery and ensure the effectiveness of any corrective steps. This paper documents the comprehensive methods used to optimise and standardise the behaviour-change self-management programme used in the study to facilitate dialogue on the inclusion of this type of programme in multicentre studies.The study has been approved by the relevant Institutional Review Boards, Independent Ethics Committee and Competent Authority according to national and international regulations. The results of this study will be disseminated through relevant, peer-reviewed journals and international conference presentations.NCT02085161.

SUBMITTER: Bourbeau J

PROVIDER: S-EPMC4823464 | biostudies-other | 2016 Apr

REPOSITORIES: biostudies-other

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Project description:BackgroundEffective and scalable behaviour change interventions to increase use of existing toilets in low income settings are under debate. We tested the effect of a novel intervention, the '5 Star Toilet' campaign, on toilet use among households owning a toilet in a rural setting in the Indian state of Gujarat.MethodsThe intervention included innovative and digitally enabled campaign components delivered over 2 days, promoting the upgrading of existing toilets to achieve use by all household members. The intervention was tested in a cluster randomised trial in 94 villages (47 intervention and 47 control). The primary outcome was the proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use. We applied a separate questionnaire tool that masked open defecation questions as a physical activity study, and excluded households surveyed at baseline from the post-intervention survey. We calculated prevalence differences using linear regression with generalised estimating equations.ResultsThe primary study outcome was assessed in 2483 households (1275 intervention and 1208 control). Exposure to the intervention was low. Post-intervention, toilet use was 83.8% in the control and 90.0% in the intervention arm (unadjusted difference + 6.3%, 95%CI 1.1, 11.4, adjusted difference + 5.0%, 95%CI -0.1, 10.1. The physical activity questionnaire was done in 4736 individuals (2483 intervention and 2253 control), and found no evidence for an effect (toilet use 80.7% vs 82.2%, difference + 1.7%, 95%CI -3.2, 6.7). In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%). Process evaluation suggested that insufficient campaign intensity may have contributed to the low impact of the intervention.ConclusionThe study highlights the challenge in achieving high intervention intensity in settings where the proportion of the total population that are potential beneficiaries is small. Responder bias may be minimised by masking open defecation questions as a physical activity study. Over-reporting of toilet use may be further reduced by avoiding repeated surveys in the same households.Trial registrationThe trial was registered on the RIDIE registry ( RIDIE-STUDY-ID-5b8568ac80c30 , 27-8-2018) and retrospectively on clinicaltrials.gov ( NCT04526171 , 30-8-2020).

Project description:BackgroundDecreasing ineffective or harmful healthcare practices (de-implementation) may require different approaches than those used to promote uptake of effective practices (implementation). Few psychological theories differentiate between processes involved in decreasing, versus increasing, behaviour. However, it is unknown whether implementation and de-implementation interventions already use different approaches. We used the behaviour change technique (BCT) taxonomy (version 1) (which includes 93 BCTs organised into 12 groupings) to investigate whether implementation and de-implementation interventions for clinician behaviour change use different BCTs.MethodsIntervention descriptions in 181 articles from three systematic reviews in the Cochrane Library were coded for (a) implementation versus de-implementation and (b) intervention content (BCTs) using the BCT taxonomy (v1). BCT frequencies were calculated and compared using Pearson's chi-squared (χ2), Yates' continuity correction and Fisher's exact test, where appropriate. Identified BCTs were ranked according to frequency and rankings for de-implementation versus implementation interventions were compared and described.ResultsTwenty-nine and 25 BCTs were identified in implementation and de-implementation interventions respectively. Feedback on behaviour was identified more frequently in implementation than de-implementation (Χ2(2, n=178) = 15.693, p = .000057). Three BCTs were identified more frequently in de-implementation than implementation: Behaviour substitution (Χ2(2, n=178) = 14.561, p = .0001; Yates' continuity correction); Monitoring of behaviour by others without feedback (Χ2(2, n=178) = 16.187, p = .000057; Yates' continuity correction); and Restructuring social environment (p = .000273; Fisher's 2-sided exact test).ConclusionsThere were some significant differences between BCTs reported in implementation and de-implementation interventions suggesting that researchers may have implicit theories about different BCTs required for de-implementation and implementation. These findings do not imply that the BCTs identified as targeting implementation or de-implementation are effective, rather simply that they were more frequently used. These findings require replication for a wider range of clinical behaviours. The continued accumulation of additional knowledge and evidence into whether implementation and de-implementation is different will serve to better inform researchers and, subsequently, improve methods for intervention design.

Project description:BackgroundImaging is overused in the management of low back pain (LBP). Interventions designed to decrease non-indicated imaging have predominantly targeted practitioner education alone; however, these are typically ineffective. Barriers to reducing imaging have been identified for both patients and practitioners. Interventions aimed at addressing barriers in both these groups concurrently may be more effective. The Behaviour Change Wheel provides a structured framework for developing implementation interventions to facilitate behavioural change. The aim of this study was to develop an implementation intervention aiming to reduce non-indicated imaging for LBP, by targeting both general medical practitioner (GP) and patient barriers concurrently.MethodsThe Behaviour Change Wheel was used to identify the behaviours requiring change, and guide initial development of an implementation intervention. Preliminary testing of the intervention was performed with: 1) content review by experts in the field; and 2) qualitative analysis of semi-structured interviews with 10 GPs and 10 healthcare consumers, to determine barriers and facilitators to successful implementation of the intervention in clinical practice. Results informed further development of the implementation intervention.ResultsPatient pressure on the GP to order imaging, and the inability of the GP to manage a clinical consult for LBP without imaging, were determined to be the primary behaviours leading to referral for non-indicated imaging. The developed implementation intervention consisted of a purpose-developed clinical resource for GPs to use with patients during a LBP consult, and a GP training session. The implementation intervention was designed to provide GP and patient education, remind GPs of preferred behaviour, provide clinical decision support, and facilitate GP-patient communication. Preliminary testing found experts, GPs, and healthcare consumers were supportive of most aspects of the developed resource, and thought use would likely decrease non-indicated imaging for LBP. Suggestions for improvement of the implementation intervention were incorporated into a final version.ConclusionsThe developed implementation intervention, aiming to reduce non-indicated imaging for LBP, was informed by behaviour change theory and preliminary testing. Further testing is required to assess feasibility of use in clinical practice, and the effectiveness of the implementation intervention in reducing imaging for LBP, before large-scale implementation can be considered.

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Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation.

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