Dataset Information

IMPlementing IMProved Asthma self-management as RouTine (IMP²ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

ABSTRACT:

Background

Asthma is a common long-term condition and major public health problem. Supported self-management for asthma that includes a written personalised asthma action plan, supported by regular professional review, reduces unscheduled consultations and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in practice. The IMPlementing IMProved Asthma self-management as RouTine (IMP²ART) implementation strategy has been developed to address this challenge. The aim of this implementation trial is to determine whether facilitated delivery of the IMP²ART strategy increases the provision of asthma action plans and reduces unscheduled care in the context of routine UK primary care.

Methods

IMP²ART is a parallel group, cluster randomised controlled hybrid II implementation trial. One hundred forty-four general practices will be randomly assigned to either the IMP²ART implementation strategy or control group. Following a facilitation workshop, implementation group practices will receive organisational resources to help them prioritise supported self-management (including audit and feedback; an IMP²ART asthma review template), training for professionals and resources to support patients to self-manage their asthma. The control group will continue with usual asthma care. The primary clinical outcome is the between-group difference in unscheduled care in the second year after randomisation (i.e. between 12 and 24 months post-randomisation) assessed from routine data. Additionally, a primary implementation outcome of asthma action plan ownership at 12 months will be assessed by questionnaire to a random sub-group of people with asthma. Secondary outcomes include the number of asthma reviews conducted, prescribing outcomes (reliever medication and oral steroids), asthma symptom control, patients' confidence in self-management and professional support and resource use. A health economic analysis will assess cost-effectiveness, and a mixed methods process evaluation will explore implementation, fidelity and adaptation.

Discussion

The evidence for supported asthma self-management is overwhelming. This study will add to the literature regarding strategies that can effectively implement supported self-management in primary care to reduce unscheduled consultations and improve asthma outcomes and quality of life.

Trial registration

ISRCTN15448074. Registered on 2 December 2019.

SUBMITTER: McClatchey K

PROVIDER: S-EPMC10068707 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

IMPlementing IMProved Asthma self-management as RouTine (IMP<sup>2</sup>ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

McClatchey Kirstie K Hammersley Vicky V Steed Liz L Sheringham Jessica J Marsh Viv V Barat Atena A Delaney Brigitte B Hamborg Thomas T Fitzsimmons Deborah D Holmes Steve S Jackson Tracy T Ehrlich Elisabeth E Morgan Noelle N Saxon Ann A Preston Megan M Price David D Taylor Stephanie J C SJC Pinnock Hilary H

Trials 20230403 1

<h4>Background</h4>Asthma is a common long-term condition and major public health problem. Supported self-management for asthma that includes a written personalised asthma action plan, supported by regular professional review, reduces unscheduled consultations and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in practice. The IMPlementing IMProved Asthma self-management as RouTi ...[more]

PMID: 37013577

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Project description:Despite an overwhelming evidence base, supported self-management of asthma is poorly implemented into routine practice. Strategies for implementation must address organisational routines, as well as provide resources for patients and training to improve professionals' skills. We aimed to explore the priority that primary care practices attach to asthma self-management, to describe their existing asthma management routines, and to generate innovative implementation strategies. We recruited 33 participants (23 general practitioners; seven nurses; three administrative staff) from 14 general practices. The 12 interviews and three focus groups were transcribed, coded and analysed thematically. Supported self-management was largely a nurse-led task within clinic-based annual reviews. Barriers included poor attendance at asthma clinics, lack of time, demarcation of roles, limited access to a range of tailored resources, and competing agendas in consultation, often due to multimorbidity. Suggestions for initiatives to improve the provision of supported self-management included emphasising the evidence for benefit (to influence prioritisation), improving teamwork (including team-based education), organisational strategies (including remote consulting) which need to fit within existing practice routines. Technology offers some potential solutions (e.g., improved templates, 'app'-based plans), but must be integrated with the practice information technology systems. Building on these insights, we will now develop a theoretically-based implementation strategy that will address patient, professional, and organisational buy-in, provide team-based education and offer a range of practical options and tools, which can be adapted and integrated within existing routines of individual practices.OVERCOMING THE ORGANISATIONAL BARRIERS TO IMPLEMENTING ASTHMA SELF-MANAGEMENT: Understanding the routines of primary care practices can suggest strategies to implement supported self-management in general practice. Supported self-management of asthma including provision of individual action plans improves patient health and reduces the burden on healthcare services, but is not well implemented in routine practice. As part of a large-scale programme to implement self-management into UK general practice, Hilary Pinnock at the University of Edinburgh and co-workers conducted interviews and focus groups with 33 participants from 14 general practices to explore the organisational routines that hinder or enable professionals to provide support asthma self-management. Poor attendance at asthma clinics, demarcation of roles, lack of time and limited access to tailored resources were identified as specific barriers. Improvements suggested included improved teamwork between doctors and other medical healthcare professionals, comprehensive training, and improvements to IT systems.

Project description:BackgroundSupported self-management (SSM) for asthma reduces the risk of asthma attacks and improves asthma control and quality of life. SSM optimally includes patient-centred communication and behaviour change support, however, the extent to which this occurs in routine primary care is unclear. This project was nested within the IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) programme; a UK-wide trial evaluating an implementation strategy (including healthcare professional (HCP) training on behaviour change strategies and patient-centred care) to improve support for asthma self-management.ObjectiveTo provide an understanding of how healthcare professionals deliver SSM in UK clinical practice; through assessing time spent on SSM strategies, how and to what extent patient-centred care and behaviour change discussions are delivered, and to explore whether factors such as mode of review or implementation support influence delivery.Design, setting and participantsWe conducted an observational study using video-recordings of 12 HCPs delivering routine face-to-face and telephone asthma reviews (n = 64) in a sample of general practices participating in the IMP2ART trial (implementation n = 4; control n = 6). Analytical methods included: ALFA Toolkit Multi-Channel Video Observation (to code and quantify tasks undertaken); the Patient-Centred Observation Form; and The Behaviour Change Counselling Index (to assess patient-centeredness and behaviour change counselling used by HCPs).ResultsHCPs mostly spent time during routine asthma reviews discussing: an individual's asthma condition and management (average of 27.8% of consultation time); collaboratively reviewing and completing a personalised asthma action plan (6.3%) and training for practical self-management activities (5.4%). Areas of patient-centred care delivery and behavioural discussions included: creating and maintaining relationships, discussing asthma action plans and medication reconciliation. Professionals in IMP2ART implementation group practices delivered more SSM strategies. Comparison of face-to-face and remote consultations found no significant differences in HCP delivery of SSM.ConclusionsHCPs in UK primary care spent half the time in both face-to-face and remote asthma reviews delivering components of SSM suggesting that either mode of delivery may be acceptable. Reviews carried out in IMP2ART implementation group practices demonstrated more behaviour change and collaborative SSM strategies compared to those in the control group.Patient and public contributionAsthma UK Centre for Applied Research (AUKCAR) PPI members were involved throughout, including project conception, providing feedback on participant-facing documents, and discussing implications of study findings.

Project description:BackgroundSupported asthma self-management, incorporating an asthma action plan and annual clinical review, has been recommended by UK/global guidelines for over three decades. However, implementation remains poor, as only around a third of individuals receive basic asthma care, according to the UKs leading respiratory charity Asthma and Lung UK. A systematic review of implementation studies recommended that a whole systems approach targeting patients, healthcare professional education, and organisations is needed to improve implementation of supported asthma self-management in primary care. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a national Hybrid-II implementation cluster randomised controlled trial that aims to evaluate such an approach. This paper describes the development of the implementation strategy for IMP2ART with particular focus on the integration of multiple level theories.MethodsThe Medical Research Council design and evaluation of complex interventions framework and the Person-Based Approach to intervention development were used as guidance for stages of strategy development. Specifically, we (i) set up a multidisciplinary team (including practicing and academic clinicians, health psychologists, public health and patient colleagues), (ii) reviewed and integrated evidence and theory, (iii) developed guiding principles, (iv) developed prototype materials, and (v) conducted a pre-pilot study before final refinement.ResultsThe implementation strategy included resources for patients, team-based and individual healthcare professional education, practice audit and feedback, and an asthma review template, as well as a facilitator role accessible to primary care practices for 12 months. The synthesis of the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) and Capability, Opportunity, Motivation and Behaviour (COM-B) frameworks led to an evolved framework bringing together important implementation and behaviour change elements which will be used as a basis for the study process evaluation.ConclusionsA description of rigorous implementation strategy development for the IMP2ART study is provided along with newly theorised integration of implementation and behaviour change science which may be of benefit to others targeting implementation in primary care.Trial registrationISRCTN15448074. Registered on 2nd December 2019.

Project description:ObjectiveTo determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care.DesignPragmatic, two arm, cluster randomised controlled trial.SettingGeneral practices, serving a population in northwest England with high levels of deprivation.Participants5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices).InterventionPractice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation.Main outcome measuresPrimary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement.ResultsWe randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference.ConclusionsAn intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients' everyday lives.Trial registrationCurrent Controlled Trials ISRCTN90940049.

Project description:BackgroundImplementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.MethodsA pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.ResultsNineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.ConclusionsThis was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.Trial registrationISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:BackgroundAn estimated 8.2 million adults in the United States live with co-occurring mental health and substance use disorders. Although the benefits of integrated treatment services for persons with co-occurring disorders has been well-established, gaps in access to integrated care persist. Implementation research can address this gap. We evaluated if the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy was effective in increasing integrated services capacity among organizations treating persons with co-occurring disorders.MethodsThis study employed a cluster randomized waitlist control group design. Forty-nine addiction treatment organizations from the State of Washington were randomized into one of two study arms: (1) NIATx strategy (active implementation strategy), or (2) waitlist (control). The primary outcome was a standardized organizational measure of integrated service capability: the Dual Diagnosis in Addiction Treatment (DDCAT) Index. Intent-to-treat analyses and per-protocol analyses were conducted to address the following questions: (1) Is NIATx effective in increasing integrated service capacity? and (2) Are there differences in organizations that actually use NIATx per-protocol versus those that do not?ResultsFrom baseline to one-year post active implementation, both the NIATx strategy and waitlist arms demonstrated improvements over time in DDCAT Index total and DDCAT dimension scores. In intent-to-treat analyses, a moderate but statistically significant difference in improvement between study arms was seen only in the Program Milieu dimension (p = 0.020, Cohen's d = 0.54). In per-protocol analyses, moderate-to-large effects in Program Milieu (p = 0.002, Cohen's d = 0.91) and Continuity of Care (p = 0.026, Cohen's d = 0.63) dimensions, and in total DDCAT Index (p = 0.046, Cohen's d = 0.51) were found.ConclusionsOverall, organizations in both study arms improved DDCAT Index scores over time. Organizations in the NIATx strategy arm with full adherence to the NIATx protocol had significantly greater improvements in the primary outcome measure of integrated service capacity for persons with co-occurring disorders.Trail registrationClinicalTrials.gov, NCT03007940 . Retrospectively registered January 2017.

Project description:Malawi has successfully leveraged multiple delivery platforms to scale-up and sustain the implementation of preventive chemotherapy (PCT) for the control of morbidity caused by soil-transmitted helminths (STH). Sentinel monitoring demonstrates this strategy has been successful in reducing STH infection in school-age children, although our understanding of the contemporary epidemiological profile of STH across the broader community remains limited. As part of a multi-site trial evaluating the feasibility of interrupting STH transmission across three countries, this study aimed to describe the baseline demographics and the prevalence, intensity and associated risk factors of STH infection in Mangochi district, southern Malawi. Between October-December 2017, a community census was conducted across the catchment area of seven primary healthcare facilities, enumerating 131,074 individuals across 124 villages. A cross-sectional parasitological survey was then conducted between March-May 2018 in the censused area as a baseline for a cluster randomised trial. An age-stratified random sample of 6,102 individuals were assessed for helminthiasis by Kato-Katz and completed a detailed risk-factor questionnaire. The age-cluster weighted prevalence of any STH infection was 7.8% (95% C.I. 7.0%-8.6%) comprised predominantly of hookworm species and of entirely low-intensity infections. The presence and intensity of infection was significantly higher in men and in adults. Infection was negatively associated with risk factors that included increasing levels of relative household wealth, higher education levels of any adult household member, current school attendance, or recent deworming. In this setting of relatively high coverage of sanitation facilities, there was no association between hookworm and reported access to sanitation, handwashing facilities, or water facilities. These results describe a setting that has reduced the prevalence of STH to a very low level, and confirms many previously recognised risk-factors for infection. Expanding the delivery of anthelmintics to groups where STH infection persist could enable Malawi to move past the objective of elimination of morbidity, and towards the elimination of STH. Trial registration: NCT03014167.

Project description:IntroductionGlobally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services.Methods and analysisA non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported.Ethics and disseminationEthics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals.Trial registration numberAustralian New Zealand Clinical Trials Registry-ACTRN12622001010785.

Dataset Information

IMPlementing IMProved Asthma self-management as RouTine (IMP²ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

Background

Methods

Discussion

Trial registration

Publications

IMPlementing IMProved Asthma self-management as RouTine (IMP<sup>2</sup>ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

Similar Datasets

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Dataset Information

IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

Background

Methods

Discussion

Trial registration

Publications

IMPlementing IMProved Asthma self-management as RouTine (IMP<sup>2</sup>ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

IMPlementing IMProved Asthma self-management as RouTine (IMP²ART) in primary care: study protocol for a cluster randomised controlled implementation trial.