scholarly journals Identifying Enablers of Participant Engagement in Clinical Trials of Consumer Health Technologies: A Qualitative Study of flu@home (Preprint)

10.2196/26869 ◽  
2020 ◽  
Author(s):  
Spurthy Dharanikota ◽  
Cynthia M LeRouge ◽  
Victoria Lyon ◽  
Polina Durneva ◽  
Matthew Thompson
Keyword(s):  
Clinical Trials ◽  
Qualitative Study ◽  
Consumer Health ◽  
Health Technologies ◽  
Participant Engagement

From the Frontlines: A Qualitative Study of Staff Experiences With Clinical Event Debriefing

2021 ◽  
Author(s):  
Meghan M. Galligan ◽  
Mary Haggerty ◽  
Heather A. Wolfe ◽  
Dawn Debrocco ◽  
Katherine Kellom ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Inductive Reasoning ◽  
Improve Patient Care ◽  
Barriers And Facilitators ◽  
Clinical Event ◽  
Frontline Staff ◽  
Factors Affecting ◽  
Participant Engagement ◽  
Practice Recommendations ◽  
Staff Experiences

OBJECTIVES Clinical event debriefing (CED) can improve patient care and outcomes, but little is known about CED across inpatient settings, and participant experiences have not been well described. In this qualitative study, we sought to characterize and compare staff experiences with CED in 2 hospital units, with a goal of generating recommendations for a hospital-wide debriefing program. METHODS We conducted 32 semistructured interviews with clinical staff who attended a CED in the previous week. We explored experiences with CED, with a focus on barriers and facilitators. We used content analysis with constant comparative coding to understand priorities identified by participants. We used inductive reasoning to develop a set of CED practice recommendations to match participant priorities. RESULTS Three primary themes emerged related to CED barriers and facilitators. (1) Factors affecting attendance: most respondents voiced a need for frontline staff inclusion in CED, but they also cited competing clinical duties and scheduling conflicts as barriers. (2) Factors affecting participant engagement: respondents described factors that influence participant engagement in reflective discussion. They described that the CED leader must cultivate a psychologically safe environment in which participants feel empowered to speak up, free from judgment. (3) Factors affecting learning and systems improvement: respondents emphasized that the CED group should generate a plan for improvement with accountable stakeholders. Collectively, these priorities propose several recommendations for CED practice, including frontline staff inclusion. CONCLUSIONS In this study, we propose recommendations for CED that are derived from first-hand participant experiences. Future study will explore implementation of CED practice recommendations.

Pharmacist-led cardiovascular risk prevention in Western Canada: a qualitative study

2020 ◽  
Author(s):  
Anita I Kapanen ◽  
Annalijn I Conklin ◽  
Barbara Gobis ◽  
Larry Leung ◽  
Jamie Yuen ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Workplace Health Promotion ◽  
Medication Management ◽  
Free Text ◽  
Cvd Risk ◽  
Enabling Factors ◽  
Risk Factor Management ◽  
External Resources ◽  
Participant Engagement ◽  
Risk Management Programme

Abstract Objectives Preventing cardiovascular diseases (CVD) is a public health and policy priority, including for employers. A novel CVD risk management programme that included medication management was delivered by pharmacists to employees of a Canadian university. This qualitative study describes the experiences and perceptions of participants who received individual health consultations in this programme. Methods A qualitative study design using free-text responses was adopted. Data (5658 words) came from evaluation surveys completed by 119 programme participants were iteratively coded and thematically analysed. Key findings We identified four themes characterising participant experiences of pharmacist-led CVD prevention. Theme one was labelled self-efficacy because personalised health information and advice on CVD risk factor management empowered participants to make improvements for their health. Participants expressed a range of positive responses about the longer consultations, supportive communication and safe setting of their pharmacist-led encounters; hence, Theme two is labelled pharmacists’ interpersonal skills. The wider context of the programme included a number of enabling factors (Theme three) that either supported or limited participant engagement in the programme. A number of changes to behaviour and health measures were identified and participant suggestions to expand and continue the programme further contributed to perceptions of positive programme impact (Theme four). Conclusions This study raises questions about how external resources and broader determinants might enable, or hinder, future programme success and sustainability. It also highlights the need for greater understanding and communication of the importance of primary prevention and the role of pharmacists in CVD risk reduction and workplace health promotion.

scholarly journals Baby Boomers’ Adoption of Consumer Health Technologies: Survey on Readiness and Barriers

2014 ◽  
Vol 16 (9) ◽  
pp. e200 ◽  
Author(s):  
Cynthia LeRouge ◽  
Craig Van Slyke ◽  
Deborah Seale ◽  
Kevin Wright
Keyword(s):  
Baby Boomers ◽  
Consumer Health ◽  
Health Technologies

scholarly journals Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022353 ◽  
Author(s):  
Catherine Henshall ◽  
Parth Narendran ◽  
Robert C Andrews ◽  
Amanda Daley ◽  
Keith A Stokes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Type 1 Diabetes ◽  
Qualitative Study ◽  
Qualitative Methodology ◽  
Cell Function ◽  
Retention Rates ◽  
Newly Diagnosed ◽  
Advance Study ◽  
New Onset

ObjectivesRegular physical exercise may preserve β cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies.DesignQualitative methodology using individual face-to-face (n=6) and telephone interviews (n=14). Interview transcripts were thematically analysed using the framework method.SettingThe study took place at five participating UK hospitals.ParticipantsTwenty participants, aged 19–55 years, in the Exercise for Type 1 Diabetes study were interviewed to explore their study experiences and identify motivators and deterrents towards the study. Participants in control and intervention arms were interviewed, as were people with T1D who had completed (n=16) and withdrawn (n=4).ResultsParticipants revealed barriers and facilitators to retention; the majority were generalisable to clinical trials of people with newly diagnosed T1D. Coming to terms with a diagnosis of T1D, lack of time, work pressures, level of health professional support, volume, clarity and consistency of information and feedback and a desire for knowledge about their condition were all cited as influencing factors to trial retention.ConclusionsTo our knowledge, this is the first qualitative study to examine the experience of being involved in an exercise trial by people with T1D. Findings suggest appointments could be shorter, available outside of working hours and planned longer in advance; study information should be clear, consistent and in electronic and paper formats; questionnaires need minimising; healthcare support and feedback needs providing regularly; thought is required around how to support non-exercising arm participants. These considerations may improve participant retention rates in new-onset T1D studies.

scholarly journals Digital Health Applications for Pharmacogenetic Clinical Trials

Genes ◽  
2020 ◽  
Vol 11 (11) ◽  
pp. 1261
Author(s):  
Hetanshi Naik ◽  
Latha Palaniappan ◽  
Euan A. Ashley ◽  
Stuart A. Scott
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Digital Health ◽  
Clinical Care ◽  
Vital Signs ◽  
Medication Administration ◽  
Therapeutic Interventions ◽  
Participant Engagement ◽  
Patient Reported ◽  
Health Related

Digital health (DH) is the use of digital technologies and data analytics to understand health-related behaviors and enhance personalized clinical care. DH is increasingly being used in clinical trials, and an important field that could potentially benefit from incorporating DH into trial design is pharmacogenetics. Prospective pharmacogenetic trials typically compare a standard care arm to a pharmacogenetic-guided therapeutic arm. These trials often require large sample sizes, are challenging to recruit into, lack patient diversity, and can have complicated workflows to deliver therapeutic interventions to both investigators and patients. Importantly, the use of DH technologies could mitigate these challenges and improve pharmacogenetic trial design and operation. Some DH use cases include (1) automatic electronic health record-based patient screening and recruitment; (2) interactive websites for participant engagement; (3) home- and tele-health visits for patient convenience (e.g., samples for lab tests, physical exams, medication administration); (4) healthcare apps to collect patient-reported outcomes, adverse events and concomitant medications, and to deliver therapeutic information to patients; and (5) wearable devices to collect vital signs, electrocardiograms, sleep quality, and other discrete clinical variables. Given that pharmacogenetic trials are inherently challenging to conduct, future pharmacogenetic utility studies should consider implementing DH technologies and trial methodologies into their design and operation.

scholarly journals PO 8300 REGIONAL CENTER FOR REGULATORY EXCELLENCE IN CLINICAL TRIAL OVERSIGHT – TRAINING 2017

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A28.1-A28
Author(s):  
Delese Darko ◽  
Yvonne Adu-Boahen
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Good Clinical Practice ◽  
Training Programme ◽  
Fellowship Training ◽  
Training Methods ◽  
Health Technologies ◽  
Trial Oversight ◽  
The Impact

BackgroundThe competencies of the various national medicines regulatory agencies (NMRAs) in Africa vary which leads to generally porous regulatory systems for clinical trial oversight. Consequently, many trials have been conducted under unacceptable conditions compromising participants’ safety and data credibility and resulted in questionable outcomes that are used for making scientific judgement in addressing issues of public health in Africa.To improve the safety and quality of health technologies in Africa, the New Partnership for African Development (NEPAD) agency launched a programme to designate Regional Centres of Regulatory Excellence (RCOREs) with the specific objective of bridging existing gaps between African NMRAs through strengthening regulatory capacity of African Union member states. The Food and Drugs Authority (FDA), Ghana, was designated as RCORE for Clinical Trials oversight in May 2014.MethodsTo achieve the RCORE objectives, the FDA collaborated with the School of Public Health (SPH), University of Ghana to develop a training manual and piloted a training programme with funds from the International AIDS Vaccine Initiative (IAVI) through NEPAD.The programme, consisting of 4 compulsory modules, was organised from 6–30 November 2017 for 10 participants from Zambia, Sierra Leone, Liberia, Rwanda and Ghana. Interactive training methods in the form of theoretical and practical sessions were employed.ResultsThe pilot RCORE training was successful with expected training objectives achieved. Participants gained hands-on experience through activities like observing Good Clinical Practice inspection and a Technical Advisory Committee Meeting. Participants were given template tools to assist in developing regulatory guidelines and forms in their respective countries.A follow-up questionnaire was circulated to participants to assess the impact of the training on their work. Feedback „indicates that regulation of clinical trials has improved in their respective institutions.ConclusionThis pilot fellowship training was successful, „leading to the improvement of clinical trial regulation in the participating countries.

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