Implementation science communications最新文献

Background: Longer-acting cabotegravir (CAB) is a novel, safe, and efficacious pre-exposure prophylaxis (PrEP) for HIV prevention. As we near a time for CAB scale-up, the experience of global leaders in PrEP research and implementation can be leveraged to identify optimal strategies for scaling and integrating CAB into existing PrEP infrastructure worldwide.

Methods: We recruited leaders of HIV prevention clinical trials and large PrEP programs through a combination of purposive and snowball sampling for participation in individual interviews. We conducted interviews using a semi-structured guide that compared CAB to oral PrEP and sought perspectives on barriers and strategies for CAB scale-up. Interviews were conducted virtually, audio recorded, and transcribed. We used thematic analysis, grounded in an adapted version of the Intervention Scalability Assessment Tool (ISAT), to identify critical elements for optimizing delivery of CAB.

Results: From October 2021 to April 2022, we interviewed 30 participants with extensive experience in PrEP research, care, and programming. Participants worked in all seven WHO regions and reported a median of 20 years working in HIV and 10 years in PrEP. Participants agreed that CAB was efficacious and discrete, therefore having the potential to address current concerns about oral PrEP adherence and stigma. Participants indicated direct and indirect costs for provider training, expansion of existing medical infrastructure, and the current medication cost of CAB as major concerns for roll out. The true cost to the end-user and health system were unknown. There were some conflicting strategies on how to best address product targeting, presentation of efficacy, and timing of product availability with scale-up. Some thought that targeting CAB for the general population could normalize PrEP and decrease stigma, while others thought that prioritizing key populations could optimize impact by targeting those with highest risk. Overall, participants emphasized that to ensure successful CAB scale-up, communities and stakeholders must be involved at every stage of planning and implementation.

Conclusions: Our evaluation found that although there is a clear and urgent need for additional HIV PrEP options beyond daily oral PrEP, CAB scale-up must be thoughtful, flexible, and based in lessons learned from oral PrEP rollout.

Background: Back pain is very common and a leading cause of disability worldwide. Due to health care system inequalities, Indigenous communities have a disproportionately higher prevalence of injury and acute and chronic diseases compared to the general Canadian population. Indigenous communities, particularly in northern Canada, have limited access to evidence-based spine care. Strategies established in collaboration with Indigenous peoples are needed to address unmet healthcare needs, including spine care (chiropractic and movement program) services. This study aimed to understand the views and perspectives of Cross Lake community leaders and clinicians working at Cross Lake Nursing Station (CLNS) in northern Manitoba regarding the implementation of the Global Spine Care Initiative (GSCI) model of spine care (MoC) and related implementation strategies.

Method: A qualitative exploratory design using an interpretivist paradigm was used. Twenty community partners were invited to participate in semi-structured interviews underpinned by the Theoretical Domains Framework (TDF) adapted to capture pertinent information. Data were analyzed deductively and inductively, and the interpretation of findings were explored in consultation with community members and partners.

Results: Community leaders (n = 9) and physicians, nurses, and allied health workers (n = 11) emphasized: 1) the importance of contextualizing the MoC (triaging and care pathway) and proposed new services through in-person community engagement; 2) the need and desire for local non-pharmacological spine care approaches; and 3) streamlining patient triage and CLNS workflow. Recommendations for the streamlining included reducing managerial/administrative duties, educating new incoming clinicians, incorporating follow-up appointments for spine pain patients, and establishing an electronic medical record system along with a patient portal. Suggestions regarding how to sustain the new spine care services included providing transportation, protecting allocated clinic space, resolving insurance coverage discrepancies, addressing misconceptions about chiropractic care, instilling the value of physical activity for self-care and pain relief, and a short-term (30-day) incentivised movement program which considers a variety of movement options and offers a social component after each session.

Conclusion: Community partners were favorable to the inclusion of a refined GSCI MoC. Adapting the TDF to unique Indigenous needs may help understand how best to implement the MoC in communities with similar needs.

Background: Depression is the most diagnosed mental health condition among people living with HIV. Collaborative care is an effective intervention for depression, typically delivered in primary care settings. The HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) clinical intervention involves a depression care team housed off-site that supports depression care delivery by HIV care providers. In a randomized controlled trial, HITIDES significantly improved depression symptoms for veterans living with HIV and delivered cost savings. However, no HIV clinics in the Veterans Health Administration (VHA) have implemented HITIDES; as such, it is unclear what implementation strategies are necessary to launch and sustain this intervention.

Methods: This hybrid type-3 effectiveness-implementation trial examines the implementation and effectiveness of HITIDES in 8 VHA HIV clinics randomly assigned to one of two implementation arms. Each arm uses a different implementation strategy package. Arm 1 includes an intervention operations guide; an on-site clinical champion who, with the help of a peer community of practice, will work with local clinicians and leadership to implement HITIDES at their site; and patient engagement in implementation tools. Arm 2 includes all strategies from Arm 1 with assistance from an external facilitator. The primary implementation outcomes is reach; secondary outcomes include adoption, implementation dose, depressive symptoms, and suicidal ideation. We will conduct a budget impact analysis of the implementation strategy packages. We hypothesize that Arm 2 will be associated with greater reach and adoption and that Arm 1 will be less costly.

Discussion: Preliminary work identified implementation strategies acceptable to veterans living with HIV and HIV care providers; however, the effectiveness and cost of these strategies are unknown. While the depression care team can deliver services consistently with high quality, the ability of the depression care team to engage with HIV care providers at sites is unknown. Findings from this study will be used to inform selection of implementation strategies for a broad rollout to enhance depression and suicide care for people living with HIV.

Trial registration: ClinicalTrials.gov ID: NCT05901272, Registered 10 May 2023, https://clinicaltrials.gov/study/NCT05901272.

Background: Implementation science scholars have made significant progress identifying factors that enable or obstruct the implementation of evidence-based interventions, and testing strategies that may modify those factors. However, little research sheds light on how or why strategies work, in what contexts, and for whom. Studying implementation mechanisms-the processes responsible for change-is crucial for advancing the field of implementation science and enhancing its value in facilitating equitable policy and practice change. The Agency for Healthcare Research and Quality funded a conference series to achieve two aims: (1) develop a research agenda on implementation mechanisms, and (2) actively disseminate the research agenda to research, policy, and practice audiences. This article presents the resulting research agenda, including priorities and actions to encourage its execution.

Method: Building on prior concept mapping work, in a semi-structured, 3-day, in-person working meeting, 23 US-based researchers used a modified nominal group process to generate priorities and actions for addressing challenges to studying implementation mechanisms. During each of the three 120-min sessions, small groups responded to the prompt: "What actions need to be taken to move this research forward?" The groups brainstormed actions, which were then shared with the full group and discussed with the support of facilitators trained in structured group processes. Facilitators grouped critical and novel ideas into themes. Attendees voted on six themes they prioritized to discuss in a fourth, 120-min session, during which small groups operationalized prioritized actions. Subsequently, all ideas were collated, combined, and revised for clarity by a subset of the authorship team.

Results: From this multistep process, 150 actions emerged across 10 priority areas, which together constitute the research agenda. Actions included discrete activities, projects, or products, and ways to shift how research is conducted to strengthen the study of implementation mechanisms.

Conclusions: This research agenda elevates actions to guide the selection, design, and evaluation of implementation mechanisms. By delineating recommended actions to address the challenges of studying implementation mechanisms, this research agenda facilitates expanding the field of implementation science, beyond studying what works to how and why strategies work, in what contexts, for whom, and with which interventions.

Background: Hip fracture surgery under general or spinal anesthesia is a common procedure for older adults in the United States (US). Although spinal or general anesthesia can be appropriate for many patients, and the choice between anesthesia types is preference-sensitive, shared decision-making is not consistently used by anesthesiologists counseling patients on anesthesia for this procedure. We designed an Option Grid™-style conversation aid, My Anesthesia Choice─Hip Fracture, to promote shared decision making in this interaction. This study will refine the aid and evaluate its implementation and effectiveness in clinical practice.

Methods: The study will be conducted over 2 phases: qualitative interviews with relevant clinicians and patients to refine the aid, followed by a stepped wedge cluster randomized trial of the intervention at 6 settings in the US. Primary outcomes will include the percentage of eligible patients who receive the intervention (intervention reach) and the change in quality of patient/clinician communication (intervention effectiveness). Secondary outcomes addressing other RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) domains will also be collected. Outcomes will be compared between baseline data and an active implementation period and then compared between the active implementation period and a sustainment period. Implementation strategies are guided by three constructs from the Practical, Robust Implementation and Sustainability Model (PRISM): intervention, recipients, and implementation and sustainability infrastructure.

Discussion: This is a novel, large-scale trial evaluating and implementing a shared decision-making conversation aid for anesthesia choices. Strong buy-in from site leads and expert advisors will support both the success of implementation and the future dissemination of results and the intervention. Results from this study will inform the broader implementation of this aid for patients with hip fractures and can lead to the development and implementation of similar conversation aids for other anesthesia choices.

Trial registration: ClinicalTrials.gov, NCT06438640.

Introduction: Healthy School Recognized Campus (HSRC) is a Texas A&M AgriLife Extension initiative that promotes the delivery of multiple evidence-based physical activity and nutrition programs in schools. Simultaneous delivery of programs as part of HSRC can result in critical implementation challenges. The study examines how the inner setting constructs from the Consolidated Framework for Implementation Research (CFIR) impact HSRC program delivery.

Methods: We surveyed (n = 26) and interviewed (n = 20) HSRC implementers (n = 28) to identify CFIR inner setting constructs related to program acceptability, appropriateness, and feasibility. Using a concurrent mixed-methods design, we coded interviews using the CFIR codebook, administered an inner setting survey, tested for relationships between constructs and implementation outcomes via chi-square tests, and compared quantitative and qualitative results.

Results: Stakeholders at schools that implemented one program vs. more than one program reported no differences in acceptability, appropriateness, or feasibility outcomes (p > .05); however, there was a substantial difference in reported program minutes (1118.4 ± 951.5 vs. 2674.5 ± 1940.8; p = .036). Available resources and leadership engagement were related to HSRC acceptability (r = .41; p = .038 and r = .48; p = .012, respectively) and appropriateness (r = .39; p = .046 and r = 0.63; p = .001, respectively). Qualitative analyses revealed that tangible resources (e.g., curriculum, a garden) enabled implementation, whereas intangible resources (e.g., lack of time) hindered implementation. Participants also stressed the value of buy-in from many different stakeholders. Quantitative results revealed that implementation climate was related to HSRC acceptability (r = .46; p = .018), appropriateness (r = .50; p = .009), and feasibility (r = .55; p = .004). Learning climate was related to HSRC appropriateness (r = .50; p = .009). However, qualitative assessment of implementation climate subconstructs showed mixed perspectives about their relationship with implementation, possibly due to differences in the compatibility/priority of different programs following COVID-19. Networks/communication analysis showed that schools have inner and outer circles of communication that can either benefit or hinder implementation.

Conclusion: Few differences were found by the number of programs delivered. Implementation climate (i.e., compatibility, priority) and readiness for implementation (i.e., resources and leadership engagement) were important to HSRC implementation. Strategies that focus on reducing time-related burdens and engaging stakeholders may support HSRC's delivery. Other constructs (e.g., communication, access to knowledge) may be important to the implementation of HSRC but need further exploration.

Background: Our research team partnered with primary care and quality improvement staff in Federally Qualified Community Health Centers (CHCs) to develop Partnered and Equity Data-Driven Implementation (PEDDI) to promote equitable implementation of evidence-based interventions. The current study used a human-centered design methodology to evaluate the usability of PEDDI and generate redesign solutions to address usability issues in the context of a cancer screening intervention.

Methods: We applied the Cognitive Walkthrough for Implementation Strategies (CWIS), a pragmatic assessment method with steps that include group testing with end users to identify and prioritize usability problems. We conducted three facilitated 60-min CWIS sessions with end users (N = 7) from four CHCs that included scenarios and related tasks for implementing a colorectal cancer (CRC) screening intervention. Participants rated the likelihood of completing each task and identified usability issues and generated ideas for redesign solutions during audio-recorded CWIS sessions. Participants completed a pre-post survey of PEDDI usability. Our research team used consensus coding to synthesize usability problems and redesign solutions from transcribed CWIS sessions.

Results: Usability ratings (scale 0-100: higher scores indicating higher usability) of PEDDI averaged 66.3 (SD = 12.4) prior to the CWIS sessions. Scores averaged 77.8 (SD = 9.1) following the three CWIS sessions improving usability ratings from "marginal acceptability" to "acceptable". Ten usability problems were identified across four PEDDI tasks, comprised of 2-3 types of usability problems per task. CWIS participants suggested redesign solutions that included making data fields for social determinants of health and key background variables for identifying health equity targets mandatory in the electronic health record and using asynchronous communication tools to elicit ideas from staff for adaptations.

Conclusions: Usability ratings indicated PEDDI was in the acceptable range following CWIS sessions. Staff identified usability problems and redesign solutions that provide direction for future improvements in PEDDI. In addition, this study highlights opportunities to use the CWIS methodology to address inequities in the implementation of cancer screening and other clinical innovations in resource-constrained healthcare settings.

Background: The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention.

Methods: Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future.

Results: Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner.

Conclusions: Application of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT.

Trial registration: (ISRCTN: 46385239 ). Registered on July 30, 2020.

Background: Long-acting injectable cabotegravir plus rilpivirine (LAI CAB/RPV) has several potential benefits over daily oral formulations for HIV treatment, including the potential to facilitate long-term adherence and reduce pill fatigue. We aimed to assess facilitators of and barriers to LAI CAB/RPV implementation and delivery through the perspectives of physicians and clinical staff, and the experiences of LAI CAB/RPV use among people living with HIV (PLWH) at a Ryan-White supported safety-net clinic in North Texas.

Methods: We conducted semi-structured interviews with recruited clinic staff (physicians, nurses, and support staff) involved with LAI CAB/RPV implementation and PLWH who switched to LAI CAB/RPV and consented to participate in individual interviews. Data were collected from July to October 2023. Our interview guide was informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM), and Proctor Implementation Outcomes frameworks. Qualitative data were analyzed using a rapid qualitative analysis approach to summarize key themes.

Results: We recruited and interviewed 15 PLWH who transitioned to LAI CAB/RPV and 11 clinic staff serving these patients. PLWH conveyed that emotional and informational support from family or a trusted clinician influenced their decision to switch to LAI CAB/RPV. PLWH also reported that injectable treatment was more effective, convenient, and acceptable than oral antiretroviral therapy. Clinic staff and physicians reported that staff training, pharmacist-led medication switches, flexible appointments, refrigeration space and designated room for injection delivery facilitated implementation. Clinic staff cited medication costs, understaffing, insurance prior authorization requirements, and lack of medication access through state drug assistance programs as critical barriers.

Conclusions: Our study offers insights into real-world experiences with LAI usage from the patient perspective and identifies potential strategies to promote LAI CAB/RPV uptake. The barriers to and facilitators of LAI CAB/RPV program implementation reported by clinic staff in our study may be useful for informing strategies to optimize LAI CAB/RPV programs.