Clinical research nursing pathways: The development and evaluation of a nursing research internship program using the RE-AIM framework.

Background: In 2018 a Nursing Research Internship program was started within a major referral and tertiary teaching centre in Australia. Aim: We aimed to evaluate the first 12 months of the program using an implementation science framework. Methods: This was a qualitative study. Following ethical approval n = 20 semi -structured interviews were recorded and transcribed verbatim. Participants included nurses with clinical, research and management roles who had engaged in or supported a Nursing Research Internship program. The Framework Method was conducted to analyse the findings. Results: Key themes identified included 'What is the impact of a Nursing Research Internship program?'; 'Why do a Nursing Research Internship program?'; 'How do we do a Nursing Research Internship program?'; 'How do we sustain a Nursing Research Internship program?'. Positive impacts were identified for clinical nurses and their teams, for the hospital and health service, and for patients and families. Identified key components included protected research time, specialist support (including library, statistics, health economist, implementation scientist), regulatory support (ethics and governance procedures) and access to a computer and IT resources. The Nursing Research Internship program required support from nurse clinicians, nurse managers and nurse academics. Conclusion: A structured Nursing Research Internship program supports clinical nurses to answer research questions identified directly from clinical practice.

Factors Influencing Integration and Usability of Model-Informed Precision Dosing Software in the Intensive Care Unit.

BACKGROUND: Antimicrobial dosing in critically ill patients is challenging and model-informed precision dosing (MIPD) software may be used to optimize dosing in these patients. However, few intensive care units (ICU) currently adopt MIPD software use. OBJECTIVES: To determine the usability of MIPD software perceived by ICU clinicians and identify implementation barriers and enablers of software in the ICU. METHODS: Clinicians (pharmacists and medical staff) who participated in a wider multicenter study using MIPD software were invited to participate in this mixed-method study. Participants scored the industry validated Post-study System Usability Questionnaire (PSSUQ, assessing software usability) and Technology Acceptance Model 2 (TAM2, assessing factors impacting software acceptance) survey. Semistructured interviews were used to explore survey responses. The framework approach was used to identify factors influencing software usability and integration into the ICU from the survey and interview data. RESULTS: Seven of the eight eligible clinicians agreed to participate in the study. The PSSUQ usability scores ranked poorer than the reference norms (2.95 vs. 2.62). The TAM2 survey favorably ranked acceptance in all domains, except image. Qualitatively, key enablers to workflow integration included clear and accessible data entry, visual representation of recommendations, involvement of specialist clinicians, and local governance of software use. Barriers included rigid data entry systems and nonconformity of recommendations to local practices. CONCLUSION: Participants scored the MIPD software below the threshold that implies good usability. Factors such as availability of software support by specialist clinicians was important to participants while rigid data entry was found to be a deterrent.

Exploring Unmet Needs in Prostate Cancer Care: A Cross-sectional Descriptive Study.

Background and objective: Prostate cancer, the most common cancer among men worldwide, has significant impact on quality of life. Supportive care needs for those affected by prostate cancer are not well understood. This study aims to describe patient-reported unmet needs and explore supportive care priorities of men treated for prostate cancer. Methods: A cross-sectional survey was distributed to all men who had accessed prostate cancer services (including surgical, radiation, and medical oncology treatment modalities) at a tertiary hospital. The survey included qualitative questions exploring patient experience and a validated patient-reported outcome measure (Supportive Care Needs Survey Short Form 34). Clinical information was collected. Analyses included, descriptive statistics, multivariate logistic regression models and qualitative analyses using a framework method. Key findings and limitations: A total of 162 participants provided survey data. Domains about information, self-management, and sexual function were the highest ranked items with unmet needs. A qualitative analysis also identified "relationships", "information", and "the value of hindsight" constructs. Participants who identified three or more unmet needs expressed treatment regret (odds ratio 5.92, 1.98-22.23, p = 0.01). Conclusions and clinical implications: Understanding the unmet needs of patients may better inform supportive care interventions that address what is important to patients. Importantly, participants valued relationships. There may be opportunities to better meet the needs of patients by improving access to information and self-management resources, particularly around sexuality. Further research is warranted. Patient summary: Prostate cancer and its treatment impacts are not well understood. Prioritisation of relationships and improving access to information and self-management resources are important. Further attention to prostate cancer supportive care in clinical practice is needed.

Using Implementation Science in Nursing Research.

OBJECTIVES: Clinical research continues to build knowledge that can potentially improve clinical and health service outcomes; however, integrating evidence into routine care is challenging, resulting in a knowledge practice gap. The field of implementation science is a resource available for nurses to translate evidence into their practice. This article aims to provide nurses with an overview of implementation science, illustrate its value integrating evidence into practice, and show how it can be applied with high rigor in nursing research practice. DATA SOURCES: A narrative synthesis of the implementation science literature was conducted. A series of case studies were purposively selected to demonstrate the application of commonly used implementation theories, models, and frameworks across health care settings relevant to nursing. These case studies demonstrate how the theoretical framework was applied and how the outcomes of the work reduced the knowledge practice gap. CONCLUSION: Implementation science theoretical approaches have been used by nurses and multidisciplinary teams to better understand the gap between knowledge and practice for better informed implementation. These can be used to understand the processes involved, identify the determinants at play, and undertake an effective evaluation. IMPLICATIONS FOR NURSING PRACTICE: By using implementation science research practice, nurses can also build a strong foundation of evidence about nursing clinical practice. As an approach, implementation science is practical and can optimize the valuable nursing resource.

The impact of coronavirus disease 2019 on genitourinary and prostate cancer care and clinical trials: A qualitative exploration of the Australian and New Zealand experience.

PURPOSE: This qualitative study aimed to understand the impact of the coronavirus disease 2019 pandemic from March to November 2020 on healthcare delivery and clinical trials for genitourinary (GU) cancers in Australia. METHODS: Annually a pre-conference workshop is hosted by the Australian New Zealand Urogenital and Prostate Cancer Trials Group for supportive care health professionals. In November 2020, those that selected to attend were invited to participate in a focus group. Workshop and focus group discussions were recorded and transcripts were analyzed thematically. RESULTS: Seventy-two individuals involved in GU cancer care and clinical trials took part. Participants described negative changes to GU cancer care and clinical trials from the pandemic due to reduced clinical services and increased wait times. Trial recruitment was paused temporarily during lockdowns, and standard treatment protocols were used to limit hospital visits. Trial process changes included electronic capture of informed consent, home delivery of oral medications, and delegations of assessments. These changes increased administrative activity for clinical trial teams and Human Research Ethics Committees. A transition to telehealth enabled continuity of service delivery and trials but reduced the opportunity for face-to-face patient consultations with increasing concern about the failure to detect supportive care needs. CONCLUSION: The pandemic has prompted a critical review of service delivery and clinical trials for people with GU cancers.

Teletrials, the new norm? Expert recommendations for teletrials into the future: Findings from the Clinical Oncology Society of Australia Clinical Trial Research Professionals Group Workshop.

INTRODUCTION: The Australasian Teletrial Model was piloted in co-funded sites across Australia. The purpose was to extend the reach of clinical trials using telemedicine to improve equity and access to this treatment pathway for oncology patients. Experts across Australia gathered to share the learnings of implementation so that future directions can be effective and sustainable. METHODS: The 1-day workshop was attended in person and virtually. Attendees were invited to analyze and disseminate the results. Recordings from the presentations were coded independently by three researchers and synthesized. The results were sent to the authorship team for further review to build consensus on the findings in three drafts. RESULTS: Four key themes were identified: "Being on the Same Page," "Building Foundations," "Key Roles in Teletrials," and "Incentives." Although there were many successes that were accelerated by the COVID-19 pandemic, there is work still to be done. CONCLUSION: The Australasian Teletrial Model has been identified as acceptable and feasible. Future directions need to continue to work on streamlining regulatory processes, implementation and monitoring, and build knowledge to further build networks across Australia.

From doctors to ancillary staff: Regional and metropolitan cancer workforce perceptions and distress resulting from COVID-19 pandemic adaptations.

INTRODUCTION: The declaration of the COVID-19 pandemic has resulted in necessary and rapid changes to health service delivery. In the Australian context, it has been broadly identified that these impacts have been felt by health care workers (HCW) providing care. We aimed to capture oncology HCW perceptions of support, stress, personal ability to meet needs and institutional preparedness across longitudinal periods of COVID-19 response in the early stages of the pandemic. METHODS AND MATERIALS: An electronic survey was developed to measure the weekly impacts and distress experienced by HCW during the early phases of the pandemic. Hospital email communications relating to pandemic directives were noted. HCW included nursing, medical, ancillary staff and allied health team members at 2 study sites, 1 metropolitan and 1 regional center in Queensland, Australia. Descriptive statistics were applied to quantitative data, and a framework analysis for qualitative data. Key themes were synthesized using mixed methods approaches. RESULTS: A total of 176 HCW consented to participate. Four key themes were identified. Key theme 1 was strategies for protection, and included the subthemes of self-isolation, using personal protective equipment (PPE), protecting patients and families and each other. Key theme 2 was navigating rules and keeping up, and included the subthemes of compliance, exceptions, conflict and complex decision fatigue. Key theme 3 was tempered optimism, with subthemes including this is grief, pride in one's place and strategies for coping. Key theme 4 was framing the new normal, with subthemes including using technology, second wave and uncertainty. CONCLUSION: Staff groups reported the emotional impacts of rapid change across clinical areas and centers. Distress corresponded to rapid change amid uncertainty, rather than reported infection rates. These findings give insight into the experiences of patient facing oncology HCW during periods of uncertainty, potentially informing policy in the future.

Resilience and ongoing quality care for cancer clinical trials during COVID-19: Experience from a tertiary hospital in Australia.

BACKGROUND: The COVID-19 pandemic has forced rapid system-wide changes to be implemented within cancer care at an alarming pace. Clinical trials are a key element of comprehensive cancer care. Ensuring the continuing safe conduct of cancer clinical trials in the context of a pandemic is challenging. METHODS: We aimed to describe the COVID-19 pandemic response of a Cancer Care Clinical Research Unit (CRU) of a tertiary hospital in Queensland, Australia. We used a mixed methods approach for this case study. Emailed directives from CRU managers to all CRU staff sharing were qualitatively analysed and mapped against our unit activities over longitudinal time points. Data from patient recruitment and protocol deviations were analysed using descriptive statistics. RESULTS: Mapping activity from 11 March to 30 September 2020 revealed rapid change during the first 2 weeks. Four key strategies to accommodate change were identified: supporting patients and families, introduction of telehealth, accessing investigational product, and social distancing. Early in the pandemic we recognised that our core key stakeholders were integral to our response. When compared to the previous 12 months, our recruitment numbers dropped markedly in early phases of the response but recovered over time, as we accommodated internal and external impacts. CONCLUSION: Our experience of agility as a necessity, adapting to support patients, and managing both clinical research activity and sponsors during the height of the pandemic response is presented here in order to inform future disaster response planning by clinical trial organisations.

The utility of the implementation science framework "Integrated Promoting Action on Research Implementation in Health Services" (i-PARIHS) and the facilitator role for introducing patient-reported outcome measures (PROMs) in a medical oncology outpatient department.

PURPOSE: We evaluated the utility of the implementation science framework "Integrated Promoting Action on Research Implementation in Health Services" (i-PARIHS) for introducing patient-reported outcome measures (PROMs) into a medical oncology outpatient department. The i-PARIHS framework identifies four core constructs for implementation, including Facilitation, Innovation, Context and Recipients. METHODS: A pilot study used the i-PARIHS framework to identify PROM implementation barriers and enablers to inform facilitation support strategies, such as training clinicians and staff, workflow support, technical support and audit and feedback. Pre- and post-implementation surveys were completed by 83 and 72 staff, respectively, (nurses, doctors and allied health), to assess perceived knowledge, enablers, barriers and utility of PROMs; and acceptability of the PROM intervention was also assessed post-implementation. RESULTS: Important barriers included time constraints and previous experiences with technology. Enablers included good leadership support and a culture of learning. Facilitation strategies were used to overcome barriers identified in the i-PARIHS core domains. Compared to before the intervention, staff surveys showed improvement in perceived usefulness, perceived understanding and interpretation skills for PROMs. Staff perceptions about lack of time to use PROMs during visits remained a major perceived barrier post-implementation. CONCLUSION: The i-PARIHS framework was useful for guiding the implementation of PROMs in routine oncology care. The four core i-PARIHS constructs (Facilitation, Innovation, Context and Recipients) identified factors that directly impacted implementation, with Facilitation having a particularly important role to overcome these barriers. Oncology clinics and health systems considering implementing PROMs should consider having a dedicated Facilitator available during PROM implementation.

Statistical process control assessed implementation fidelity of patient-reported outcome measures (PROMs) in routine care.

OBJECTIVES: Ensuring implementation fidelity of patient-reported outcome measures (PROMs) in the complex clinical setting remains exigent. We aimed to integrate the routine use of PROM reports in day-to-day patient care and assess the implementation outcomes using statistical process control (SPC) methods. STUDY DESIGN AND SETTING: This prospective pilot study used an implementation science framework to integrate PROMs. SPC analysis was applied to track patient completion rates and staff acknowledgment rates over time. Daily observational data across clinical areas were collected to assess potential variations. RESULTS: Data were available from 324 patient encounters over 14 weeks. On average, 78% (52% to 100%) of eligible patients entering the clinic completed the PROMs; staff acknowledged 78% (50-100%) of these patient reports. Most patterns of fluctuation were inside the control frame. Dips in compliance relating to changes in clinic daily routine, including the introduction of the second randomized clinic, were quickly resolved with a structured response. CONCLUSION: Implementation of PROMs was feasible with reasonable patient completion and staff acknowledgment rates. Fidelity was vulnerable to barriers impacting the daily routine or unusual events in the clinics, suggesting that greater standardization and integration into clinic processes may yet further improve compliance and consistency of reporting.

What is needed by staff to implement PROMs into routine oncology care? A qualitative study with the multi-disciplinary team.

INTRODUCTION: The aim of this study was to identify strategies to implement patient-reported outcome measures (PROMs) into routine oncology outpatients' clinical care. METHODS: Qualitative focus groups were conducted with staff from multiple disciplines using a semistructured interview guide, with supporting data collected in field notes. Data were analysed using a Directed Content Analysis guided by an implementation science framework. The synthesis of the extracted data aimed to identify key requirements which correspond to intrinsic enablers and barriers for implementation. RESULTS: 52 staff members from the multi-disciplinary team participated. Data extracted showed five key themes and three key requirements regarding implementation of PROMs. Staff would consider using PROMs if there was strong research evidence that demonstrates benefits for patient outcomes, if PROM data was relevant to current clinical practice, and if applied appropriately in the specific setting. These findings add pragmatic detail and new knowledge to the current evidence on pathways to PROM implementation. This data can be used to inform implementation of PROMs into health services. CONCLUSION: Staff have valuable tacit knowledge of what works in practice that offers a unique opportunity to increase successful implementation of a PROM intervention for patient symptom reporting.

Doripenem population pharmacokinetics and dosing requirements for critically ill patients receiving continuous venovenous haemodiafiltration.

OBJECTIVES: Doripenem is a newer carbapenem with little data available to guide effective dosing during renal replacement therapy in critically ill patients. The objective of this study was to determine the population pharmacokinetics of doripenem in critically ill patients undergoing continuous venovenous haemodiafiltration (CVVHDF) for acute kidney injury (AKI). METHODS: This was an observational pharmacokinetic study in 12 infected critically ill adult patients with AKI undergoing CVVHDF and receiving 500 mg of doripenem intravenously every 8 h as a 60 min infusion. Serial blood samples were taken on 2 days of treatment and used for population pharmacokinetic analysis with S-ADAPT. RESULTS: The median (IQR) age was 62 (53-71) years, the median (IQR) weight was 77 (67-96) kg and the median (IQR) APACHE II score was 29 (19-32). The median blood, dialysate and replacement fluid rates were 200, 1000 and 1000 mL/h, respectively. A two-compartment linear model with doripenem clearance described by CVVHDF, renal or non-renal mechanisms was most appropriate. The mean value for total doripenem clearance was 4.46 L/h and volume of distribution was 38.0 L. Doripenem clearance by CVVHDF was significantly correlated with the replacement fluid flow rate and accounted for ∼30%-37% of total clearance. A dose of 500 mg intravenously every 8 h achieved favourable pharmacokinetic/pharmacodynamics for all patients up to an MIC of 4 mg/L. CONCLUSIONS: This is the first paper describing the pharmacokinetics/pharmacodynamics of doripenem in critically ill patients with AKI receiving CVVHDF. A dose of 500 mg intravenously every 8 h was appropriate for our CVVHDF settings for infections caused by susceptible bacteria.