scholarly journals Innovation in Times of Uncertainty: Clinical Trials in Nursing Homes During SARs-CoV-2

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 103-103
Author(s):  
Joan Carpenter
Keyword(s):  
Clinical Trial ◽  
Nursing Homes ◽  
Research Question ◽  
Complex Interventions ◽  
Lessons Learned ◽  
Video Conference ◽  
Trial Protocols ◽  
Potential Failure ◽  
The Impact ◽  
Existing Data

Abstract In March 2020 the Centers for Medicare & Medicaid Services (CMS) announced restrictions on visitors and nonessential personnel in nursing homes to protect residents and facilities from SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) outbreaks. At the time, these measures were “temporary” but they continued well into 2021 resulting in a prolonged pause on in-person study activities in a palliative care clinical trial in 12 nursing homes. This session will address the impact of this pause and decisions made to overcome the potential failure of the trial. Of utmost importance was respecting nursing homes rapidly changing context, continued communication with the site leadership, transitioning to phone and video-conference study activities, and designing a retrospective study using existing data to answer a different but similar research question. As clinical researchers move forward implementing trials and complex interventions in nursing homes, we must use the lessons learned to design flexible trial protocols.

scholarly journals Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S40-S47 ◽  
Author(s):  
Amy Callis ◽  
Victoria M Carter ◽  
Aparna Ramakrishnan ◽  
Alison P Albert ◽  
Lansana Conteh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Community Engagement ◽  
Information Needs ◽  
Human Subjects ◽  
Lessons Learned ◽  
Accurate Information ◽  
Community Acceptance ◽  
Institutional Review ◽  
The Impact

Abstract Communication contributed to 4 important aspects of the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE): recruiting participants, supporting Human Subjects Protection, building trust in the community to support the trial, and mitigating the impact of rumors and misinformation. Communication was particularly important because STRIVE was Sierra Leone’s first vaccine clinical trial and was implemented during a public health emergency. Communication efforts began months prior to trial launch, building awareness and support through sensitization sessions with stakeholders and community leaders. Community engagement activities continued throughout the trial to maintain relationships with leaders and stakeholders and disseminate accurate information, fostering trust in the trial. The communication team led recruitment with hundreds of information sessions for potential participants, facilitating the informed consent process. Communication efforts continued post-enrollment, supporting ongoing voluntary participation in the trial. Informal formative activities during the trial yielded insights on participants’ perceptions and information needs. While Centers for Disease Control and Prevention Institutional Review Board–approved activities and materials did not change, this flexible strategy allowed for responsive interactions with participants. The trial success and its community acceptance illustrated STRIVE’s successful communications efforts, owing in large part to this flexibility and commitment to community engagement. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Resilient Clinical Trial Infrastructure in Response to the COVID-19 Pandemic: Lessons Learned from the TOGETHER Randomized Platform Clinical Trial

2022 ◽  
Author(s):  
Jamie I. Forrest ◽  
Angeli Rawat ◽  
Felipe Duailibe ◽  
Christina M. Guo ◽  
Sheila Sprague ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Health System ◽  
Lessons Learned ◽  
Research Groups ◽  
Safety And Efficacy ◽  
Target Sample Size ◽  
The World ◽  
Trial Protocols ◽  
New Evidence

In response to the COVID-19 pandemic, clinical research groups across the world developed trial protocols to evaluate the safety and efficacy of treatments for COVID-19. Despite this initial enthusiasm, only a small portion of these protocols were implemented. Of those implemented, a fraction successfully recruited their target sample size to analyze and disseminate findings. More than a year and a half into the COVID-19 pandemic, only a few clinical trials evaluating treatments for COVID-19 have generated new evidence. Productive randomized platform clinical trials evaluating COVID-19 treatments may attribute their success to intentional investments in developing resilient clinical trial infrastructures. Health system resiliency discourse provides a conceptual framework for characterizing attributes for withstanding shocks. This framework may also be useful for contextualizing the attributes of productive clinical trials evaluating COVID-19 therapies. We characterize the successful attributes and lessons learned in developing the TOGETHER Trial infrastructure using a health system resiliency framework. This framework may be considered by clinical trialists aiming to build resilient trial infrastructures capable of responding rapidly and efficiently to global health threats.

scholarly journals Examining Caregiver-Resident Communication and Apathy in Dementia in Nursing Homes During the COVID-19 Pandemic

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 310-310
Author(s):  
Diane Berish ◽  
Yo-Jen Liao ◽  
Marie Boltz ◽  
Ying-Ling Jao
Keyword(s):  
Nursing Homes ◽  
Data Collection ◽  
Facial Expressions ◽  
Nursing Home Residents ◽  
Lessons Learned ◽  
Daily Routines ◽  
Video Recordings ◽  
Vital Component ◽  
Communication Approach ◽  
The Impact

Abstract This presentation shares lessons learned from conducting a study examining the impact of staff caregivers’ communication approach on apathy in residents with dementia in nursing homes. Due to COVID-19 restrictions, this study had to be paused and required major revisions to continue, which resulted in significant delays and increased expenses. Additionally, this study required in-person data collection and video recordings to capture staff caregivers’ communication with residents with dementia during caregiving activities. However, due to the pandemic, nursing home residents’ daily routines have been significantly changed, making it challenging to capture the nature of caregiver-resident interactions. Furthermore, using masks created unforeseen barriers for capturing communication between staff caregivers and residents including difficulties in identifying residents’ facial expressions, which are a vital component of assessing apathy. The presentation describes approaches to communication with founders, collaborators, and clinical sites and discusses strategies to recruit participants and conduct data collection.

A Study of Outcomes of the Poverty Alleviation Programme In Batticaloa District Of Sri Lanka

GIS Business ◽  
2019 ◽  
Vol 13 (4) ◽  
pp. 41-53
Author(s):  
V. Navirathan ◽  
A.M. M. Mustafa
Keyword(s):  
Poverty Alleviation ◽  
Research Question ◽  
Development Program ◽  
Lessons Learned ◽  
Standard Of Living ◽  
Primary Data ◽  
Poverty Level ◽  
Actual Impact ◽  
Future Economic Development ◽  
The Impact

The major aim of this thesis was to explore the impact of poverty alleviation programmes on poverty alleviation in Batticaloa district. The objective of this study is to examine whether the Poverty alleviation Programmes increase the income level of the beneficiaries in Batticaloa District and examinewhether the contribution of Poverty alleviation Programme to increasethe standard of living of the beneficiaries living in the Batticaloa District. The research question developed for this study was what are the outcomes of poverty alleviation programmes on poverty alleviation of Samurdhi beneficiaries in Batticaloa district? There are many poverty alleviation institutions and other institutions which are providing livelihood support to improve the standard of living and to alleviate the poverty level. But, the actual impact of those facilities on poverty alleviation was not known. To find the actual impact, the above research question was developed. Primary data were collected from people who were Samurdhi beneficiaries from Manmunai South Eruvil PattuDS Division, Koralaipattu South DS division and Manmunai South West DS Division in Batticaloa District. The proportionate random sampling method was used to obtain 200 responses from the population. Completed questionnaires were analyzed using SPSS-20 tool package and the collected data were used to test the model using univariate and multiple regression analysis. The coefficient of the constant was positive and statistically significant in the model. All independent variables such as Income, Saving, Wellbeing, Coping Strategies, Entrepreneurial Skill, Employment and Gender Balance of the respondent in the research had a positive and statistically significant coefficient at 5% level. This result revealed that the Poverty alleviation programme moderately impacts on poverty alleviation in Batticaloa district. In order to alleviate the poverty, the identification and formulation of the efficient Samurdhi Programme areessential. Therefore, the major purpose of this study is to analyze the outcomes of Poverty alleviation programme and lessons learned to future economic development program which could be implemented effectively, and economical.

scholarly journals Developing an Initial Program Theory to Explain How Patient-Reported Outcomes Are Used in Health Care Settings: Methodological Process and Lessons Learned

2020 ◽  
Vol 19 ◽  
pp. 160940692091629
Author(s):  
Rachel Flynn ◽  
Kara Schick-Makaroff ◽  
Adrienne Levay ◽  
Joanne Greenhalgh
Keyword(s):  
Health Care ◽  
Patient Reported Outcomes ◽  
Research Question ◽  
Complex Interventions ◽  
Lessons Learned ◽  
Program Theory ◽  
Health Care Settings ◽  
Central Aspect ◽  
Patient Reported ◽  
Initial Program

A central aspect of any theory-driven realist investigation (synthesis or evaluation) is to develop an initial program theory (IPT). An IPT can be used to frame and understand how, for whom, why, and under what contexts complex interventions work or not. Despite well-established evidence that IPTs are a central aspect to any realist investigation, there is wide variation and a lack of methodological discussion on how to develop an IPT. In this article, we present the approach that we used to develop an IPT of how patient-reported outcomes (PROs) are used in health care settings. Specifically, we completed a systematic review to extract tacit theories reported in the literature. The benefit of this approach was that it provided a rigorous review of the literature in the development of IPTs. The challenges included (1) rediscovering what is already well established in the theoretical literature, (2) generating an overabundance of partial candidate theories, and (3) extensive use of time and resources for what was the first stage to our larger funded research study. Our recommendations to other scholars considering this approach are to ensure that they (1) live within their means and (2) narrow the scope of the research question and/or develop a conceptual framework using middle-range theories. These methodological insights are highly relevant to researchers embarking on a realist investigation, tasked with developing an IPT.

scholarly journals Nursing Homes and COVID-19: Staff Experiences

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 248-248
Author(s):  
Verena Cimarolli ◽  
Joann Reinhardt ◽  
Sheryl Zimmerman
Keyword(s):  
Nursing Homes ◽  
Low Income ◽  
The United States ◽  
Lessons Learned ◽  
Nursing Assistants ◽  
Work Related ◽  
New Findings ◽  
Transportation Research ◽  
The Impact

Abstract Nursing homes (NHs) faced an unprecedented crisis during the rapid spread of COVID-19. This pandemic has had a devastating impact on both NH residents and workers who are often on the frontlines providing hands-on care. These workers are vulnerable to the health risks of COVID-19 due to daily exposure to residents with COVID-19, residence in areas with high infection rates, and challenges specific to low-income workers (e.g. reliance on mass transportation). Research has highlighted the experiences of NH workers during the pandemic to learn how to better support them now and during future pandemics. This symposium will add to this research and present new findings from studies conducted in the United States to capture the unique experiences of NH employees. First, Bryant illustrates specific COVID-19-related challenges that NH frontline workers faced and how these workers’ experiences compare to workers in other long-term services and support settings. Reinhardt reports findings from a qualitative study examining the multi-level challenges experienced by nursing assistants during the pandemic. Cimarolli examines if quality of employer communication and workers’ perceived COVID-19-related preparedness mitigate the impact of work-related stress on NH workers’ decision to resign. Franzosa shares recommendations based on priorities identified by nursing assistants and administrators to build future resilience based on lessons learned. Finally, Simpson identifies factors associated with states’ decisions to adopt COVID-19 testing mandates for workers in NHs. Dr. Zimmerman discusses study findings and their contributions for creating supportive NH work environments to ensure most optimal NH worker and resident quality of life.

OPTIMISATION OF PHARMACY CONTENT IN PAEDIATRIC ONCOLOGY AND HAEMATOLOGY CLINICAL TRIAL PROTOCOLS. EXPERIENCE OF CHEMOTHERAPY PHARMACY ADVISORY SERVICE (CPAS) FROM 2011 TO PRESENT

2016 ◽  
Vol 101 (9) ◽  
pp. e2.67-e2
Author(s):  
Rachel Greer ◽  
Sally Harvey
Keyword(s):  
Clinical Trial ◽  
Patient Safety ◽  
Clinical Research ◽  
Paediatric Oncology ◽  
Cancer Clinical Trial ◽  
Research Network ◽  
Advisory Service ◽  
Trial Protocols ◽  
The Impact ◽  
Protocol Review

AimClarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in protocols have the potential to delay research and jeopardise both patient safety and the collection of credible data. The Chemotherapy and Pharmacy Advisory Service (CPAS) was established in 2007 by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical trial protocols. This abstract describes the scope of CPAS, its methodology of mandated protocol review and an analysis of the issues found and reported in paediatric oncology and haematology trials.MethodAll paediatric oncology and haematology clinical trial protocols from 2011 to present were included in this study. A review checklist was developed by CPAS and used by the review panel, consisting of pharmacists, doctors and nurses, to standardise the evaluation of all protocols. Once completed, all reviews were collated and any queries and inconsistencies were fed back to Chief Investigators and study sponsors. The most common remarks made at protocol review were summarised and categorised through retrospective analysis. It is at the discretion of the study Sponsor and Chief Investigator to accept any recommendations or amendments based on the findings. In order to evaluate the impact of the service, Chief Investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from Chief Investigators have been collated and acceptance rates determined.ResultsA total of 13 paediatric protocols were reviewed during this period. The mean number of comments per protocol was 32 and these mainly concerned the drug regimen, support medication, dose calculation, drug information and administration. Eleven of the Chief investigators returned responses to their protocols reviews. All responses were positive with an overall acceptance rate of 82% of the proposed protocol changes.ConclusionReview by CPAS of pharmacy content of paediatric oncology and haematology clinical trial protocols prior to final approval is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct and/or patient safety. This analysis has highlighted that the majority of suggestions were deemed clinically significant and effectively incorporated into the final protocols. The refinement of existing and development of further pharmacy-related guidance documents by CPAS might support more effective and safer clinical research.

scholarly journals The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute

2020 ◽  
Author(s):  
Sara M Tolaney ◽  
Christine A Lydon ◽  
Tianyu Li ◽  
Jiale Dai ◽  
Andrea Standring ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Statistical Significance ◽  
Median Number ◽  
Lessons Learned ◽  
Interventional Treatment ◽  
Serious Adverse Events ◽  
Drug Dosing ◽  
Dana Farber Cancer Institute ◽  
The Impact

Abstract Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19–related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients.

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