scholarly journals Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Lona Roll ◽  
Kristin Stegenga ◽  
Verna Hendricks-Ferguson ◽  
Yvonne J. Barnes ◽  
Brooke Cherven ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Participation ◽  
Research Process ◽  
Direct Care ◽  
Cell Transplant ◽  
Music Therapists ◽  
Practice Nurses ◽  
Clinical Research Coordinators ◽  
Smart Study ◽  
Adult Resilience

Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses) include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA) undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals Clinical Trial Units in Italy: the perception of the Clinical Research Coordinators

2016 ◽  
Vol 27 ◽  
pp. iv111 ◽  
Author(s):  
C. Cagnazzo ◽  
O. Nanni ◽  
S. Campora ◽  
P. Frati ◽  
R. Camisa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Clinical Research Coordinators

scholarly journals Meeting the challenges of public engagement, research impact and research participation as a baby and child lab

2021 ◽  
Vol 5 (2) ◽  
Author(s):  
Gideon Salter ◽  
Tina Altdörfer ◽  
Geraldine Brown ◽  
Malinda Carpenter
Keyword(s):  
Public Engagement ◽  
Developmental Psychology ◽  
Effective Means ◽  
Knowledge Exchange ◽  
Research Participation ◽  
Research Impact ◽  
Research Process ◽  
Future Research ◽  
Young Infants ◽  
Local Stakeholders

As well as conducting research in developmental science, baby and child labs face additional pressures. They must demonstrate public engagement and research impact, while also recruiting enough participants to conduct research, something that can be particularly challenging with infants and young children. These different pressures compete for time and resources, leaving researchers struggling to engage effectively in all such activities. Here we describe a low-cost, easy-to-implement, enjoyable and effective means of simultaneously addressing the challenges of recruitment, public engagement and research impact. It started with a process of listening and knowledge exchange with relevant local stakeholders to discern the interests and needs of the local infant community (including families, health professionals and businesses). This process led to the establishment of a fortnightly educational and support group for pregnant women and mothers of young infants, which met in the lab. This group combined peer discussion, presentations on developmental psychology, and ‘taster’ activities for mothers and infants from local businesses. Data collected from questionnaires from the first and final sessions indicated significant improvements in participants’ understanding of relevant concepts in developmental psychology, and showed that participants found this information helpful and reported using it at home. Participants also reported feeling more socially connected and more confident as mothers as a result of the group. The group also served to boost research participation, with 94 per cent of participants subsequently taking part in lab research or signing up to be contacted about future research. This approach can be employed by baby and child labs looking for ways to effectively and enjoyably promote public engagement and research impact, and for those looking to establish strong relationships with local stakeholders. The success of this strategy demonstrates that the aims of recruitment, public engagement and research impact need not be competing pressures on researchers’ time, but can be mutually supporting aspects of the research process.

scholarly journals Researchers’ perspectives on the role of study partners in dementia research

2014 ◽  
Vol 26 (10) ◽  
pp. 1649-1657 ◽  
Author(s):  
Betty S. Black ◽  
Holly Taylor ◽  
Peter V. Rabins ◽  
Jason Karlawish
Keyword(s):  
Academic Research ◽  
Research Participation ◽  
Research Process ◽  
Institutional Review Boards ◽  
Enrollment Decisions ◽  
Caregiver Support ◽  
Institutional Review ◽  
Dementia Research ◽  
Role Responsibilities

ABSTRACTBackground:Study partners for dementia research participants are vital to the research process, but little is known about their role, responsibilities, and experiences. Study partners are usually family members or friends – often the patient's informal caregiver – who are knowledgeable about and usually accompany the participant to study visits. This study examines researchers’ perspectives on the role of study partners in dementia research.Methods:Qualitative data collection and analytic methods were used. Semi-structured individual interviews with principal investigators, study coordinators, and research nurses (i.e. researchers; n = 17) at two academic research sites were recorded, transcribed, and content analyzed to identify themes in the data.Results:According to researchers, study partners either make or help make research enrollment and post-enrollment decisions, serve as knowledgeable informants for the participants, manage the logistics that enable participants to comply with a study's protocol, and provide comfort and encouragement for the patient to engage in and complete a study. Researchers describe ideal qualities of study partners as being able to provide reliable information, being dependable and adherent to the protocol, and not expecting a benefit. They also report that study partners may face both practical and emotional challenges during research participation. However, researchers believe that study partners derive dementia-related education, caregiver support, and satisfaction from their involvement in research.Conclusions:Investigators, potential study partners, and institutional review boards should be aware of study partners’ research responsibilities, challenges, and their interests as caregivers.

Abstract 128: Can Response Adaptive Randomization Increase Participation in Acute Stroke Trials?

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Jason Tehranisa ◽  
William J Meurer
Keyword(s):  
Clinical Trial ◽  
Acute Stroke ◽  
Research Participation ◽  
Cross Sectional Survey ◽  
Multivariable Logistic Regression Model ◽  
Cross Sectional ◽  
Absolute Increase ◽  
Adaptive Randomization ◽  
The Impact ◽  
Stroke Trial

Introduction: Acute stroke trials may be improved by using response-adaptive randomization (RAR) because it works in favor of the trial population on average. With RAR, the ratio of participants assigned to each trial arm is adjusted to favor the better performing treatment using outcome information from earlier participants in the clinical trial. Hypothesis: When presented a hypothetical acute stroke trial, more patients would agree to a RAR versus a standard clinical trial with all other aspects of trial held constant. Methods: This cross-sectional survey included adult ED patients presenting without stroke or other critical illness. A standardized protocol was used and subjects were randomized to view either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. Adequacy of the informed consent process was measured by ICQ-4. A multivariable logistic regression model was fitted to estimate the impact of RAR, while controlling for demographic factors and patient understanding of the design. Results: A total of 418 subjects (210 standard 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% CI: 3.7 to 22.2%). The trials were generally well understood by the participants (Table); however standard randomization appeared to be better understood. The RAR group had a higher odds ratio of agreeing to research (O.R. 1.89, 95% CI [1.2 - 2.9]), while adjusting for patient level factors. Conclusion: The RAR trial attracted more research participation than standard randomization and has potential to increase recruitment and offer benefit to future trial participants.

Olfactory Mucosal Auto-transplantation in Spinal Cord Injury: A Clinical Trial, Saudi Arabia

2021 ◽  
pp. 11
Author(s):  
Ahmad Najib Ashraf ◽  
Abdulaziz Shebreen
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Sensory Function ◽  
Cell Transplant ◽  
Loss Of Function ◽  
Neurological Improvement ◽  
Cord Injury ◽  
Distinctive Property ◽  
Independent Life

Introduction: Spinal cord injury (SCI) results in loss of nervous tissue and consequently loss of motor and sensory function. Despite significant improvements in the early medical and surgical management of SCI, there is no effective treatment available that restores the injury-induced loss of function to a degree that an independent life can be guaranteed. Restoration of function and reversal of paralysis following SCI is among the most daunting challenges in all of neuroscience research. Methodology: We decided to study the outcomes in chronic SCI (CSCI) after autologous olfactory mucosal transplantation into the spinal cord following detethering of the cord. The human surgical procedure of autologous olfactory mucosal transplantation was first developed by Carlos Lima and his colleagues. These investigators provided guidance for the surgical procedures in this study and the procedures on the first six participants were performed in their presence. Result: Patients were screened at different centers in the kingdom. A stringent inclusion and exclusion criteria were applied. Patients for this clinical trial were selected from individuals that suffered an SCI at least 12 months before their assessment and were chronically paraplegic or tetraplegic. The final twenty participants were selected after screening more than 125 patients.  While some of them were rejected for medical reasons, some refused to participate upon receiving a full briefing and some of them were unable to fulfill the required psychosocial criteria. Conclusion: The details of the patients and the changes observed in their conditions post olfactory mucosal auto-transplantation will be discussed in detail in oral presentation with graphic results with marked significant improvement in motor and sensory levels of SCI patients as compared to before transplantation of olfactory mucosa. Olfactory unsheathing cells (OECs) are glia cells and continuous axon extension and successful topographic targeting of the olfactory receptor neurons responsible for the sense of smell (olfaction). Due to this distinctive property, OECs have been trialed in human cell transplant therapies to assist in the repair of central nervous system injuries, particularly those of the spinal cord. Although many studies have reported neurological improvement, therapy remains inconsistent and requires further improvement.

Abstract 167: Factors Influencing the Decision to Accept or Decline to Participate in Clinical Research: A Qualitative Study

2018 ◽  
Vol 11 (suppl_1) ◽  
Author(s):  
Fiona Ecarnot ◽  
Romain Chopard ◽  
Francois Schiele ◽  
Nicolas Meneveau
Keyword(s):  
Clinical Trial ◽  
Qualitative Study ◽  
Clinical Research ◽  
Emotional Health ◽  
Research Participation ◽  
Two Dimensions ◽  
Trial Participation ◽  
Main Concern ◽  
Inclusion Criteria ◽  
General Behaviour

Introduction: Guidelines rely on evidence-based data, and clinical research is key to providing this evidence-base. Yet the factors that influence a patient’s decision to participate (or not) in research remain poorly documented. We aimed to investigate the factors that determine the decision to accept or decline clinical trial participation, using a qualitative approach. Methods: Single-centre, qualitative study using semi-directive interviews with patients (pts) who had been invited to participate in a randomized clinical trial and who had given their decision. Both pts who refused and pts who accepted were included. There were no inclusion criteria; all pts who met the inclusion criteria of the selected trial and had been approached for consent were eligible. Pts also completed a questionnaire rating 16 statements examining reasons for accepting or declining trial entry. Verbatim from the interviews were analysed using a grounded theory (GT) approach. Results: To date, 14 patients have been interviewed; average age 75±7 years. Two pts did not know if they were currently participating in a trial or not; 1 said he was not participating although he had provided consent. From a GT perspective, the main concern of patients does not appear to be the question of research participation, but rather the fact of being sick, and their overriding preoccupation is how to return to their previous state of wellbeing and overcome the current acute episode. Regarding the decision to participate in research, the main themes that arose were: (1) the positive value of the trial for the patient (benefitting from the intervention; interest in receiving closer and/or more regular follow-up due to trial participation), although some pts clearly do not understand the concept of randomization; (2) the level of engagement in the process of care (some pts do not bother to read the information given to them, but just accept what is proposed without question, while others decline immediately without reading trial information). Two dimensions emerge, namely physical and emotional health, with a spectrum ranging from fragile to robust. Where the patient is situated on this spectrum appears to influence their attitude towards research participation. Conclusions: The decision to participate (or not) in clinical research appears to be more related to the patient’s general behaviour and attitude when sick, rather than any specific trial-related constraints or advantages. The level of comprehension of pts who have been through the consent process casts a doubt on the “informed” character of the consent.

A randomized, open-label, phase 3 study of low-dose selinexor and lenalidomide (Len) versus len maintenance post autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma (NDMM): ALLG MM23, Sealand.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS8055-TPS8055
Author(s):  
Hang Quach ◽  
Masa Lasica ◽  
David Routledge ◽  
Anna Kalff ◽  
Andrew Lim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nuclear Export ◽  
Low Dose ◽  
Performance Status ◽  
Cell Transplant ◽  
Weekly Schedule ◽  
Open Label ◽  
Phase 3 ◽  
Clinical Trial Registration ◽  
National Cooperative

TPS8055 Background: Len maintenance post ASCT is standard of care for patients (pts) with NDMM. Deep responses (CR or better) post ASCT correlates with better progression free survival (PFS). In a meta-analysis of len maintenance post ASCT (McCarthy PL et al. J Clin Oncol. 2017), only 10.7% of pts achieve CR post ASCT, and 72% of pts who discontinued len maintenance did so because of progressive disease (PD). Selinexor is a selective inhibitor of nuclear export that blocks exportin 1, thus retaining tumour suppressor proteins within the nucleus while blocking proto-oncoprotein translation. It is approved in combination with bortezomib and dexamethasone (dex) for pts with MM who have had at least 1 prior line of treatment, or with dex for pts with penta-refractory MM by the FDA. The oral bioavailability and weekly schedule of selinexor makes it suitable in combination with len for maintenance therapy. Given the encouraging activity (ORR 92%) and tolerability of selinexor, len and dex from the phase 1b/2 STOMP study, we hypothesise that combination low-dose selinexor and len (XR) will be well tolerated and effective, increasing CR and MRD negativity rate post ASCT, thus prolonging PFS compared to len. Methods: ALLG MM23 SeaLAND, is an ongoing randomised, multi-centre, phase 3 trial. Eligible pts ( > 17 years of age) have measurable disease, have undergone 3-6 cycles (C) of induction containing a proteasome inhibitor (PI) and/or immunomodulatory drug and recovered post melphalan-conditioned ASCT with adequate haematopoiesis, renal and liver function, and with ECOG performance status. Registration occurs prior to ASCT with screening between 75 to 115 days post ASCT. The study includes a lead-in safety phase of 20 patients with XR: Len 10mg daily days 1 to 21 and Selinexor 40mg weekly in a 28-day cycle. If well tolerated, Selinexor escalates to 60mg po weekly from C2 and Len to 15mg po daily from C4. Two safety reviews will occur after the 10th and 20th patients completes C2, respectively. Upon meeting safety criteria, a sample size of 290 pts will be randomised 1:1 to XR or lenalidomide (R). Therapy will continue until PD. The primary endpoint is PFS at 3 years post randomisation. Secondary endpoints include ORR and MRD-negativity rate (International Myeloma Working Group Response Criteria), PFS on next treatment line (PFS2), OS, safety and tolerability, quality of life, and cost effectiveness. Main analysis occurs after 232 patients complete 3-years of follow-up. Exploratory objective is to correlate immunological and molecular profiles to treatment response and resistance. ALLG MM23 SeaLAND is a multisite bi-national investigator-initiated trial lead by Australia and New Zealand’s national cooperative group, the Australasian Leukaemia & Lymphoma Group. Clinical trial registration: ACTRN12620000291987p. Clinical trial information: 12620000291987.

Increasing the Participation of Women and Minority Populations in Clinical Trials

2016 ◽  
Vol 8 (2) ◽  
pp. 16-25
Author(s):  
Michelle Lee D'Abundo ◽  
Saliha Akhtar ◽  
Cynthia Israel
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Online Advertising ◽  
Research Process ◽  
Minority Populations ◽  
Future Trends ◽  
Clinical Trial Research ◽  
Use Of Technology ◽  
Participation Of Women ◽  
Healthcare Interventions

Increasing the participation of women and minorities in clinical trials is a challenge for the healthcare industry. The lack of diversity in clinical trials prevents the tailoring of healthcare interventions specifically for women and minorities. The purpose of this paper is to explore how technology-oriented strategies can be applied in the clinical trial research process to increase the recruitment of women and minorities in clinical trials. An overview of clinical trials, the stakeholders, and current issues in diversifying recruitment are provided. In order to recruit diverse participant populations, the use of online advertising, social media, e-newsletters, tablets, smartphones, and apps are detailed. Lessons from previous use of technology in recruitment are outlined as well as future trends. With the support of clinical trial stakeholders, the current technology-oriented strategies available seem promising as methods for increasing the participation of women and minorities in clinical trials.

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