A Toolkit for Implementation of Clinical Genomic Testing: Using a Combined Stakeholder and Evidence-Driven Approach

Author(s):  
Natalie Taylor ◽  
Janet C Long ◽  
Clara Gaff ◽  
Kathryn North ◽  
Jeffrey Braithwaite ◽  
...  

Abstract BACKGROUNDThe complexity of clinical genomics – testing your entire genetic information for health benefit – is a rapidly evolving field demanding swift clinical practice change at multiple levels as widespread testing in healthcare becomes a reality. We aimed to a) describe a combined stakeholder- and evidence-driven approach to developing a toolkit for implementing genomics into the Australian health system, and b) hypothesise key steps in the change to Theoretical Domains Framework (TDF) domains via coded implementation strategies and associated mechanistic links. METHODSThe TDF was used to analyse interview data from 16 nongenetic medical specialists using genomics in practice. Barriers and enablers were identified for three key target behaviour areas across the genomic testing process: 1) identifying patients, 2) test ordering/reporting, and 3) providing results. Barriers were grouped by distinct TDF domains, and, where barriers overlapped, ‘overarching’ domains were identified. Intuitive enabling strategies generated by clinicians were aligned with identified barriers, and retrospectively coded against evidence-based behaviour change techniques (BCTs). Additional theory-driven strategies were developed to address remaining identified barriers. Using structured expert consensus processes, members of the research team participated in a series of workshops to discuss and agree theory-informed links and propose mechanisms through which specific implementation strategies would address TDF-based barriers.RESULTSA total of 32 barriers were coded against TDF domains and constructs, and eight overarching TDF domains were identified on 13 occasions. Across all target behaviour areas, 21 BCTs were represented within the 30 intuitive enabling strategies generated by clinicians, found to be used on 49 occasions. Of these, nine (18%) aligned with a corresponding distinct TDF domain coded barrier that has previously demonstrated statistically significant mechanistic links. 20 new implementation strategies were developed to address nine remaining barriers using a theory-driven approach.CONCLUSIONThis study provides rich detail of crucial stages in intervention development, aiming to ensure implementation strategies are both evidence-informed and contextually appropriate. All barriers were mapped to the TDF, implementation strategies coded against BCTs, and standardised hypothesised behavioural pathways have been proposed, making potential underlying theory explicit. Next steps will be to test toolkit effectiveness for facilitating scale-up of genomics across Australia.

2017 ◽  
Vol 150 (3) ◽  
pp. 198-205 ◽  
Author(s):  
Beatriz Teixeira ◽  
Paul A. M. Gregory ◽  
Zubin Austin

Background: The pace of practice change in community pharmacy over the past decade has been significant, yet there is little evidence documenting implementation of change in the profession. Methods: Kotter’s change management model was selected as a theoretical framework for this exploratory qualitative study. Community pharmacists were interviewed using a semistructured protocol based on Kotter’s model. Data were analyzed and coded using a constant-comparative iterative method aligned with the stages of change management outlined by Kotter. Results: Twelve community pharmacists were interviewed. Three key themes emerged: 1) the profession has successfully established the urgency to, and created a climate conducive for, change; 2) the profession has been less successful in engaging and enabling the profession to actually implement change; and 3) legislative changes (for example, expansion of pharmacists’ scope of practice) may have occurred prematurely, prior to other earlier stages of the change process being consolidated. Interpretation: As noted by most participants, allowing change is not implementing change: pharmacists reported feeling underprepared and lacking confidence to actually make change in their practices and believe that more emphasis on practical, specific implementation tactics is needed. Conclusions: Change management is complex and time and resource intensive. There is a need to provide personalized, detailed, context-specific implementation strategies to pharmacists to allow them to take full advantage of expanded scope of practice.


2021 ◽  
Author(s):  
Lyndal Trevena ◽  
Olivia Mac ◽  
Danielle M Muscat ◽  
Mina Bakhit ◽  
Heather L Shepherd ◽  
...  

Abstract BackgroundDespite the development of theory-driven frameworks to guide implementation strategies, their application thus far has largely been limited to evaluating effectiveness within specific contexts. This study describes the use of these frameworks to inform a scale-up strategy for shared decision making (SDM) implementation across a state-wide government-funded health program. MethodsTailored SDM strategies were implemented in three multidisciplinary osteoarthritis care teams over a 3-6 month period during 2019-20 in New South Wales, Australia. Staff interviews occurred across 3 timepoints based on the Organisational Readiness for Change Scale, the Theoretical Domains Framework and the Preparation for Decision-Making (PreP-DM) Scales. Patient interviews based on the PreP-DM were also completed. A hybrid inductive-deductive thematic analysis was followed by mapping the results to the Consolidated Framework for Implementation Research (CFIR) and the OMERACT core domains for SDM. Finally, a ranked list of Expert Recommendations for Implementing Change (ERIC) was derived using a published tool.Results47 interviews were conducted with 18 staff along with 20 interviews with patients. We identified 39 themes for SDM implementation across the five CFIR domains: 1) Interventions need to be flexible to align with different clinical workflows and busy clinics; 2) Outer Settings such as senior managers should formally endorse SDM and clinical protocols and standards need to better align with an SDM approach; 3) Inner Setting teams need early engagement, role clarification and communities of practice in SDM; 4) Individuals are strongly motivated by better patient outcomes and need SDM training and support; and 5) Processes such as patient-reported measures and feedback along with adequate resourcing were key. Recommended strategies therefore focussed on Stakeholder Engagement, Evaluative and Iterative Strategies, Education and Training and Adaptation/Tailoring to the Context. Skills in the identification of decision points, values clarification and deliberation were particularly challenging for staff.ConclusionsTheory-driven scale-up strategies can be developed using qualitative research within demonstration sites. By combining the CFIR and TDF frameworks and prior mapping to the ERIC strategies, health system and program planners can obtain a relevant and evidence-informed roadmap for implementation across complex health systems.


Author(s):  
Mary A. Kennedy ◽  
Sara Bayes ◽  
Robert U. Newton ◽  
Yvonne Zissiadis ◽  
Nigel A. Spry ◽  
...  

Abstract Background Exercise has emerged as a promising therapy for people with cancer. Novel programs have been developed to translate research into practice; however, implementation barriers have limited their success in part because successful translation of exercise oncology research into practice requires context-specific implementation plans. The aim of this study was to employ the implementation mapping protocol to develop an implementation plan to support programming of a co-located exercise clinic and cancer treatment center. Methods The Implementation Mapping protocol, which consists of five specific iterative tasks, was used. A stakeholder advisory group advised throughout the process. Results A comprehensive needs assessment was used to identify the organization’s general manager as the program adopter; oncologists, center leaders, and various administrative staff as program implementers; and the operations manager as the program maintainer. Twenty performance objectives were identified. The theoretical domains framework was used to identify likely determinants of change, which informed the selection of eight individual implementation strategies across the individual and organizational levels. Finally, an evaluation plan was developed which will be used to measure the success of the implementation plan in the project’s next phase. Conclusion The Implementation Mapping protocol provided a roadmap to guide development of a comprehensive implementation plan that considered all ecological domains, was informed by theory, and demonstrated an extensive understanding of the implementation context. Strong research-practitioner partnerships and effective stakeholder engagement were critical to development of the plan.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Libby Haskell ◽  
Emma J. Tavender ◽  
Catherine L. Wilson ◽  
Sharon O’Brien ◽  
Franz E. Babl ◽  
...  

Abstract Background Despite international guidelines providing evidence-based recommendations on appropriate management of infants with bronchiolitis, wide variation in practice occurs. This results in infants receiving care of no benefit, with associated cost and is potentially harmful. Theoretical frameworks are increasingly used to develop interventions, utilising behaviour change techniques specifically chosen to target factors contributing to practice variation, with de-implementation often viewed as harder than implementing. This paper describes the stepped process using the Theoretical Domains Framework (TDF) to develop targeted, theory-informed interventions which subsequently successfully improved management of infants with bronchiolitis by de-implementing ineffective therapies. Explicit description of the process and rationale used in developing de-implementation interventions is critical to dissemination of these practices into real world clinical practice. Methods A stepped approach was used: (1) Identify evidence-based recommendations and practice variation as targets for change, (2) Identify factors influencing practice change (barriers and enablers) to be addressed, and (3) Identification and development of interventions (behaviour change techniques and methods of delivery) addressing influencing factors, considering evidence of effectiveness, feasibility, local relevance and acceptability. The mode of delivery for the intervention components was informed by evidence from implementation science systematic reviews, and setting specific feasibility and practicality. Results Five robust evidence-based management recommendations, targeting the main variation in bronchiolitis management were identified: namely, no use of chest x-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline. Interventions developed to target recommendations addressed seven TDF domains (identified following qualitative clinician interviews (n = 20)) with 23 behaviour change techniques chosen to address these domains. Final interventions included: (1) Local stakeholder meetings, (2) Identification of medical and nursing clinical leads, (3) Train-the-trainer workshop for all clinical leads, (4) Local educational materials for delivery by clinical leads, (5) Provision of tools and materials targeting influencing factors, and prompting recommended behaviours, and (6) Audit and feedback. Conclusion A stepped approach based on theory, evidence and issues of feasibility, local relevance and acceptability, was successfully used to develop interventions to improve management of infants with bronchiolitis. The rationale and content of interventions has been explicitly described allowing others to de-implement unnecessary bronchiolitis management, thereby improving care.


2020 ◽  
Author(s):  
Mary Ann Kennedy ◽  
Sara Bayes ◽  
Robert U. Newton ◽  
Yvonne Zissiadis ◽  
Nigel A. Spry ◽  
...  

Abstract Background Exercise has emerged as a promising therapy for people with cancer. Novel programs have been developed to translate research into practice; however, implementation barriers have limited their success in part because successful translation of exercise oncology research into practice requires context-specific implementation plans. The aim of this study was to employ the implementation mapping protocol to develop an implementation plan to support programming of a co-located exercise clinic and cancer treatment center.Methods The Implementation Mapping protocol, which consists of five specific iterative tasks, was used. A stakeholder advisory group advised throughout the process.Results A comprehensive needs assessment was used to identify the organization’s general manager as the program adopter; oncologists, center leaders, and various administrative staff as program implementers; and the operations manager as the program maintainer. Twenty performance objectives were identified. The theoretical domains framework was used to identify likely determinants of change, which informed the selection of eight individual implementation strategies across the individual and organizational levels. Finally, an evaluation plan was developed which will be used to measure the success of the implementation plan in the project’s next phase. Conclusion The Implementation Mapping protocol provided a roadmap to guide development of a comprehensive implementation plan that considered all ecological domains, was informed by theory, and demonstrated an extensive understanding of the implementation context. Strong research-practitioner partnerships and effective stakeholder engagement were critical to development of the plan.


2021 ◽  
Vol 13 (13) ◽  
pp. 7216
Author(s):  
Paul H. Park ◽  
Cyprien Shyirambere ◽  
Fred Kateera ◽  
Neil Gupta ◽  
Christian Rusangwa ◽  
...  

Background: The majority of countries in sub-Saharan Africa are ill-prepared to address the rising burden of cancer. While some have been able to establish a single cancer referral center, few have been able to scale-up services nationally towards universal health coverage. The literature lacks a step-wise implementation approach for resource-limited countries to move beyond a single-facility implementation strategy and implement a national cancer strategy to expand effective coverage. Methods: We applied an implementation science framework, which describes a four-phase approach: Exploration, Preparation, Implementation, and Sustainment (EPIS). Through this framework, we describe Rwanda’s approach to establish not just a single cancer center, but a national cancer program. Results: By applying EPIS to Rwanda’s implementation approach, we analyzed and identified the implementation strategies and factors, which informed processes of each phase to establish foundational cancer delivery components, including trained staff, diagnostic technology, essential medicines, and medical informatics. These cancer delivery components allowed for the implementation of Rwanda’s first cancer center, while simultaneously serving as the nidus for capacity building of foundational components for future cancer centers. Conclusion: This “progressive scaling” approach ensured that initial investments in the country’s first cancer center was a step toward establishing future cancer centers in the country.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
M. A. Arden ◽  
M. Hutchings ◽  
P. Whelan ◽  
S. J. Drabble ◽  
D. Beever ◽  
...  

Abstract Background Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. Methods Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. Results Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. Conclusions The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.


BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e025101 ◽  
Author(s):  
Leah Ffion Jones ◽  
Rebecca Owens ◽  
Anna Sallis ◽  
Diane Ashiru-Oredope ◽  
Tracey Thornley ◽  
...  

ObjectivesCommunity pharmacists and their staff have the potential to contribute to antimicrobial stewardship (AMS). However, their barriers and opportunities are not well understood. The aim was to investigate the experiences and perceptions of community pharmacists and their teams around AMS to inform intervention development.DesignInterviews and focus groups were used to explore the views of pharmacists, pharmacy staff, general practitioners (GPs), members of pharmacy organisations and commissioners. The questioning schedule was developed using the Theoretical Domains Framework which helped inform recommendations to facilitate AMS in community pharmacy.Results8 GPs, 28 pharmacists, 13 pharmacy staff, 6 representatives from pharmacy organisations in England and Wales, and 2 local stakeholders participated.Knowledge and skills both facilitated or hindered provision of self-care and compliance advice by different grades of pharmacy staff. Some staff were not aware of the impact of giving self-care and compliance advice to help control antimicrobial resistance (AMR). The pharmacy environment created barriers to AMS; this included lack of time of well-qualified staff leading to misinformation from underskilled staff to patients about the need for antibiotics or the need to visit the GP, this was exacerbated by lack of space. AMS activities were limited by absent diagnoses on antibiotic prescriptions.Several pharmacy staff felt that undertaking patient examinations, questioning the rationale for antibiotic prescriptions and performing audits would allow them to provide more tailored AMS advice.ConclusionsInterventions are required to overcome a lack of qualified staff, time and space to give patients AMS advice. Staff need to understand how self-care and antibiotic compliance advice can help control AMR. A multifaceted educational intervention including information for staff with feedback about the advice given may help. Indication for a prescription would enable pharmacists to provide more targeted antibiotic advice. Commissioners should consider the pharmacists’ role in examining patients, and giving advice about antibiotic prescriptions.


Author(s):  
Samantha Pollard ◽  
Deirdre Weymann ◽  
Jessica Dunne ◽  
Fatemeh Mayanloo ◽  
John Buckell ◽  
...  

AbstractGenomic testing is becoming routine for diagnosing rare childhood genetic disease. Evidence underlying sustainable implementation is limited, focusing on short-term endpoints such as diagnostic yield, unable to fully characterize patient and family valued outcomes. Although genomic testing is becoming widely available, evidentiary and outcomes uncertainty persist as key challenges for implementation. We examine whether the current evidence base reflects public tolerance for uncertainty for genomics to diagnose rare childhood genetic disease. We conducted focus groups with general population parents in Vancouver, Canada, and Oxford, United Kingdom, to discuss expectations and concerns related to genomic testing to diagnose rare childhood genetic disease. Applying a purposive sampling technique, recruitment continued until thematic saturation was reached. Transcripts were analysed using thematic analysis. Thirty-three parents participated across four focus groups. Participants valued causal diagnoses alongside management strategies to improve patient health and wellbeing. Further, participants valued expanding the evidence base to reduce evidentiary uncertainty while ensuring security of information. Willingness to pay out of pocket for testing reflected perceived familial health benefit. Diagnostic yield fails to fully capture valued outcomes, and efforts to resolve uncertainty better reflect public priorities. Evaluations of genomic testing that fully integrate valued endpoints are necessary to ensure consistency with best practices and public willingness to accept the uncertain familial benefit.


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