• Development of Customizable Implementation Guides to Support Clinical Adoption of Pharmacogenomics: Experiences of the Implementing GeNomics In pracTicE (IGNITE) Network

      Duong, Benjamin Q; Arwood, Meghan J; Hicks, J Kevin; Beitelshees, Amber L; Franchi, Francesco; Houder, John T; Limdi, Nita A; Cook, Kelsey J; Obeng, Aniwaa Owusu; Petry, Natasha; et al. (Dove Press, 2020-07)
      Introduction: Clinical adoption of genomic medicine has lagged behind the pace of scientific discovery. Practice-based resources can help overcome implementation challenges. Methods: In 2015, the IGNITE (Implementing GeNomics In pracTicE) Network created an online genomic medicine implementation resource toolbox that was expanded in 2017 to incorporate the ability for users to create targeted implementation guides. This expansion was led by a multidisciplinary team that developed an evidence-based, structured framework for the guides, oversaw the technical process/build, and pilot tested the first guide, CYP2C19-Clopidogrel Testing Implementation. Results: Sixty-five resources were collected from 12 institutions and categorized according to a seven-step implementation framework for the pilot CYP2C19-Clopidogrel Testing Implementation Guide. Five months after its launch, 96 CYP2C19-Clopidogrel Testing Implementation Guides had been created. Eighty percent of the resources most frequently selected by users were created by IGNITE to fill an identified resource gap. Resources most often included in guides were from the test reimbursement (22%), Implementation support gathering (22%), EHR integration (17%), and genetic testing workflow steps (17%). Conclusion: Lessons learned from this implementation guide development process provide insight for prioritizing development of future resources and support the value of collaborative efforts to create resources for genomic medicine implementation.
    • Impact of patient involvement on clinical practice guideline development: A parallel group study

      Armstrong, M.J.; Mullins, C.D.; Gronseth, G.S. (BioMed Central Ltd., 2018)
      Background: Patient and public involvement (PPI) is recognized as a key component of clinical practice guideline development with important implications for guideline implementability. The impact of PPI on guidelines, however, has not been rigorously assessed. Better understanding of the impact of PPI must start with guideline question formation, which drives all subsequent development steps. The aim of this study was to investigate the effect of PPI on guideline question formation and validate a conceptual model of patient and public contributions to guidelines. Methods: For development of a clinical practice guideline on the topic of using amyloid positron emission tomography in the diagnosis of dementia, we convened two parallel guideline development groups, one with and one without patient representatives. Participating physicians were randomized to group assignment. Each group developed Population, Intervention, Comparator, Outcome, Time (PICOT) questions and identified key benefits and harms to incorporate in guideline development. Analysis included a descriptive comparison of proposed PICOT questions, benefits, and harms between groups and a qualitative analysis of discussion themes from audio recordings of the question development retreats. Results: Proposed guideline questions, benefits, and harms were largely similar between groups, but only the experimental group proposed outcomes relating to development of cognitive impairment at specific time points and rate of progression. The qualitative analysis of the discussions occurring during guideline question development demonstrated key differences in group conduct and validated the proposed conceptual model of patient and public contributions to guidelines. PPI influenced the conduct of guideline development, scope, inclusion of patient-relevant topics, outcome selection, and planned approaches to recommendation development, implementation, and dissemination with implications for both guideline developers and the guideline development process. Conclusions: Evidence of how PPI impacts guideline development underscores the importance of engaging patient stakeholders in guideline development and highlights developer- and guideline-specific outcomes of PPI, both of which have implications for guideline implementation. It also raises the question of whether guidelines developed without such input are acceptable for use. PPI should be considered an essential element of trustworthy guideline development for purposes of development and funding. Copyright 2018 The Author(s).
    • Implementation of peer specialist services in VA primary care: a cluster randomized trial on the impact of external facilitation

      Chinman, Matthew; Goldberg, Richard; Daniels, Karin; Muralidharan, Anjana; Smith, Jeffrey; McCarthy, Sharon; Medoff, Deborah; Peeples, Amanda; Kuykendall, Lorrianne; Vineyard, Natalie; et al. (Springer Nature, 2021-06-07)
      Background: Over 1100 veterans work in the Veterans Health Administration (VHA) as peer specialists (PSs)-those with formal training who support other veterans with similar diagnoses. A White House Executive Action mandated the pilot reassignment of VHA PSs from their usual placement in mental health to 25 primary care Patient Aligned Care Teams (PACTs) in order to broaden the provision of wellness services that can address many chronic illnesses. An evaluation of this initiative was undertaken to assess the impact of outside assistance on the deployment of PSs in PACTs, as implementation support is often needed to prevent challenges commonly experienced when first deploying PSs in new settings. Methods: This study was a cluster-randomized hybrid II effectiveness-implementation trial to test the impact of minimal implementation support vs. facilitated implementation on the deployment of VHA PSs in PACT over 2 years. Twenty-five Veterans Affairs Medical Centers (VAMCs) were recruited to reassign mental health PSs to provide wellness-oriented care in PACT. Sites in three successive cohorts (n = 7, 10, 8) over 6-month blocks were matched and randomized to each study condition. In facilitated implementation, an outside expert worked with site stakeholders through a site visit and regular calls, and provided performance data to guide the planning and address challenges. Minimal implementation sites received a webinar and access to the VHA Office of Mental Health Services work group. The two conditions were compared on PS workload data and veteran measures of activation, satisfaction, and functioning. Qualitative interviews collected information on perceived usefulness of the PS services. Results: In the first year, sites that received facilitation had higher numbers of unique veterans served and a higher number of PS visits, although the groups did not differ after the second year. Also, sites receiving external facilitation started delivering PS services more quickly than minimal support sites. All sites in the external facilitation condition continued in the pilot into the second year, whereas two of the sites in the minimal assistance condition dropped out after the first year. There were no differences between groups on veterans' outcomes-activation, satisfaction, and functioning. Most veterans were very positive about the help they received as evidenced in the qualitative interviews. Discussion: These findings demonstrate that external facilitation can be effective in supporting the implementation of PSs in primary care settings. The lack of significant differences across conditions after the second year highlights the positive outcomes associated with active facilitation, while also raising the important question of whether longer-term success may require some level of ongoing facilitation and implementation support. Trial registration: This project is registered at ClinicalTrials.gov with number NCT02732600 (URL: https://clinicaltrials.gov/ct2/show/NCT02732600 ).
    • Post-acute long-term care COVID-19 medication optimization survey: Informing medication management initiatives.

      Kim, Catherine; Francis, Emily; Kim, Woo Ree; Brandt, Nicole (Elsevier, 2022-02-14)
      The Medication Management Guide (MMG) provides guidance on strategies to optimize medication management in PA-LTC and simplify administration to reduce the transmission risk of COVID-19. The objectives of this study were to evaluate the utility of the MMG, determine the barriers and facilitators of the MMG implementation in PALTC sites to help inform future research and initiatives. Individuals who accessed MMG during the pandemic (April 2020-March 2021) were contacted to elicit feedback on this tool via an online survey. The survey response rate was 7.7% (156/2,018) after three rounds of emails. Respondents consisted of 31% (n=49) pharmacists, 27% (n=42) physicians, 11% (n=18) nurses, and 12% (n=19) nurse practitioners. The “Other” respondents (11%, n=17) included dieticians (n=4), physician assistants (n=3), pharmacy technicians (n=3), students (n=1), consultants (n=1), and educators (n=2). From these respondents, 77% (n=122) took tactics to optimize medications at their facilities during COVID-19.
    • The potential effects of deploying SARS-Cov-2 vaccines on cold storage capacity and immunization workload in countries of the WHO African Region

      Ortiz, Justin R; Robertson, Joanie; Hsu, Jui-Shan; Yu, Stephen L; Driscoll, Amanda J; Williams, Sarah R; Chen, Wilbur H; Fitzpatrick, Meagan C; Sow, Samba; Biellik, Robin J; et al. (Elsevier Ltd., 2021-02-19)
      Background: SARS-CoV-2 vaccines will be deployed to countries with limited immunization systems. Methods: We assessed the effect of deploying SARS-Cov-2 vaccines on cold storage capacity and immunization workload in a simulated WHO African Region country using region-specific data on immunization, population, healthcare workers (HCWs), cold storage capacity (quartile values for national and subnational levels), and characteristics of an approved SARS-CoV-2 vaccine. We calculated monthly increases in vaccine doses, doses per vaccinator, and cold storage volumes for four-month SARS-CoV-2 vaccination campaigns targeting risk groups compared to routine immunization baselines. Results: Administering SARS-CoV-2 vaccines to risk groups would increase total monthly doses by 27.0% for ≥ 65 years, 91.7% for chronic diseases patients, and 1.1% for HCWs. Assuming median nurse density estimates adjusted for absenteeism and proportion providing immunization services, SARS-CoV-2 vaccination campaigns would increase total monthly doses per vaccinator by 29.3% for ≥ 65 years, 99.6% for chronic diseases patients, and 1.2% for HCWs. When we applied quartiles of actual African Region country vaccine storage capacity, routine immunization vaccine volumes exceeded national-level storage capacity for at least 75% of countries, but subnational levels had sufficient storage capacity for SARS-CoV-2 vaccines for at least 75% of countries. Conclusions: In the WHO African Region, SARS-CoV-2 vaccination campaigns would substantially increase doses per vaccinator and cold storage capacity requirements over routine immunization baselines. Pandemic vaccination campaigns would increase storage requirements of national-level stores already at their limits, but sufficient capacity exists at subnational levels. Immediate attention to strengthening immunization systems is essential to support pandemic responses. © 2021 The Authors
    • Process evaluation of an implementation study in dementia care (EIT-4-BPSD): stakeholder perspectives

      Behrens, Liza; Boltz, Marie; Riley, Kiernan; Eshraghi, Karen; Resnick, Barbara; Galik, Elizabeth; Ellis, Jeanette; Kolanowski, Ann; Van Haitsma, Kimberly (Springer Nature, 2021-09-23)
      Background: Behavioral and psychological symptoms of distress in dementia (BPSD) are major drivers of poor quality of life, caregiver burden, institutionalization, and cost of care in nursing homes. The Evidence Integration Triangle (EIT)-4-BPSD in nursing homes was a pragmatic Hybrid III trial of an implementation strategy to help staff use evidence-based non-pharmacological interventions to prevent and manage BPSD. This study aimed to describe and explore the stakeholders’ perceptions of the process to implement the EIT-4-BPSD strategy including its utility, and the barriers and facilitators to implementation in real-world settings. Methods: EIT-4-BPSD was a multi-layer implementation strategy that engaged nursing home stakeholder groups to define community specific goals towards reducing BPSD over a 12-month period. Stakeholder groups from nursing homes that completed all 12-months of the implementation strategy were invited to participate in this process evaluation study. Qualitative data from focus group transcripts were analyzed using a conventional content analysis. Emerging codes were sorted into categories, then organized in meaningful clusters based on the domains of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. Results: The EIT-4-BPSD implementation strategy was completed in 21 nursing homes; 93 stakeholders participated in focus groups. Over half of participating nursing homes reported meeting their BPSD goals as expected or more. Challenges, facilitators, and contextual factors reported by stakeholder members explains variability in the implementation of EIT-4-BPSD strategy in 11 key categories: family; staff; organizational; staff, environmental, and resident outcomes; utility of EIT resources; adoption barriers and facilitators; care process adaptations; and future planning. Conclusion: Stakeholders offered guidance on salient factors influencing the feasibility and utility of EIT-4-BPSD adoption and implementation to consider in future implementation research that aims to improve behavioral well-being in NH residents living with dementia. Engagement of family and staff at all levels of the organization (Management, leadership, and direct care); and measurement of staff, environmental, and resident outcomes were perceived as critical for future implementation success. While regulations, finances, and competing demands on staff time were perceived as reducing implementation success. Trial Registration: The Testing the Implementation of EIT-4-BPSD study was registered in the ClinicalTrials.gov (NCT03014570) January 9, 2017. © 2021, The Author(s).
    • Scaling up Evidence-Based Interventions in US Public Systems to Prevent Behavioral Health Problems: Challenges and Opportunities

      Fagan, A.A.; Bumbarger, B.K.; Barth, R.P. (Springer New York LLC, 2019)
      A number of programs, policies, and practices have been tested using rigorous scientific methods and shown to prevent behavioral health problems (Catalano et al., Lancet 379:1653–1664, 2012; National Research Council and Institute of Medicine, 2009). Yet these evidence-based interventions (EBIs) are not widely used in public systems, and they have limited reach (Glasgow et al., American Journal of Public Health 102:1274–1281, 2012; National Research Council and Institute of Medicine 2009; Prinz and Sanders, Clinical Psychology Review 27:739–749, 2007). To address this challenge and improve public health and well-being at a population level, the Society for Prevention Research (SPR) formed the Mapping Advances in Prevention Science (MAPS) IV Translation Research Task Force, which considered ways to scale up EBIs in five public systems: behavioral health, child welfare, education, juvenile justice, and public health. After reviewing other efforts to scale up EBIs in public systems, a common set of factors were identified as affecting scale-up in all five systems. The most important factor was the degree to which these systems enacted public policies (i.e., statutes, regulations, and guidance) requiring or recommending EBIs and provided public funds for EBIs. Across systems, other facilitators of scale-up were creating EBIs that are ready for scale-up, public awareness of and support for EBIs, community engagement and capacity to implement EBIs, leadership support for EBIs, a skilled workforce capable of delivering EBIs, and data monitoring and evaluation capacity. It was concluded that the following actions are needed to significantly increase EBI scale-up in public systems: (1) provide more public policies and funding to support the creation, testing, and scaling up of EBIs; (2) develop and evaluate specific frameworks that address systems level barriers impeding EBI scale-up; and (3) promote public support for EBIs, community capacity to implement EBIs at scale, and partnerships between community stakeholders, policy makers, practitioners, and scientists within and across systems.
    • Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach

      Newhouse, R.; Janney, M.; Gilbert, A. (BioMed Central Ltd., 2018)
      Background: Alarming rates of unhealthy alcohol, non-prescription drug, and tobacco use highlight the preventable health risks of substance abuse and the urgent need to activate clinicians to recognize and treat risky use. Screening, brief intervention, and referral to treatment (SBIRT) is an efficacious and effective processes to identify, reduce and prevent risky use of substances. This paper describes a study protocol testing implementation of a toolkit to enhance use of SBIRT in acute care settings to recognize and address patient risky alcohol, drug, and tobacco use. Methods: This study uses a phased cluster randomized mixed method design to test nurse-led implementation of an SBIRT toolkit on one medical-surgical unit at 14 acute care hospitals (critical access, community and academic health centers). Medical surgical units will be randomly assigned to implement the SBIRT toolkit (engagement and communication, assessment, planning, training, and evaluation tools) or a wait-list usual care control group that begins implementation 6 months later. Primary endpoints are documentation of SBIRT delivery in randomly selected electronic medical records at baseline, 6 months and 12 months after group 1 implementation (61 records per unit per time period, N = 2562). Two surveys will be administered to unit nurses: smoking cessation activities will be assessed at baseline and SBIRT use will be assessed on randomly-selected days after implementation. In addition, site coordinators will complete a baseline capacity assessment, an implementation fidelity survey post-implementation, and a structured interview at the end of the study. Multilevel mixed-effects effects logistic and linear models will be used to analyze use of SBIRT and cost outcomes. Discussion: This study will guide subsequent SBIRT implementation, dissemination, and spread across rural, community and urban healthcare systems throughout the state and beyond. The long-term objective is to activate clinicians to recognize, intervene and refer people with risky substance use to improve health and decrease substance use disorders.