Clinical Trials Education for Improving KAP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educating people about clinical trials can increase their understanding and willingness to participate. Participants will engage in the Clinical Trials Education Program, led by Community Health Educators who provide information on the importance of clinical trials. It suits English or Spanish speakers living in the Tampa Bay Area who can give informed consent. As an unphased trial, this study offers a unique opportunity to enhance knowledge about clinical trials and contribute to improving community awareness.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this education program is safe?

Research has shown that education programs about clinical trials focus on explaining how these trials work and why they are important. These programs remain safe because they are educational, not medical treatments.

Attending these programs resembles going to a class or seminar. No reports of physical side effects exist because participants do not take any medicine or undergo medical procedures. The goal is to help participants understand and learn more about participating in clinical trials.

Overall, these education programs are well-received because they provide information, not medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clinical Trials Education Program because it focuses on boosting knowledge and awareness about clinical trials themselves, rather than a specific medical condition. Unlike other educational methods that might only touch on the basics, this program leverages Community Health Educators to provide in-depth education on the significance and process of participating in clinical trials. This personalized approach aims to empower individuals with a better understanding, potentially leading to higher participation rates and more diverse trial populations, which can ultimately improve the development of new treatments.

What evidence suggests that this education program is effective for increasing knowledge of clinical trials?

Research has shown that education programs about clinical trials can greatly increase knowledge and understanding. In this trial, participants will receive education through the Clinical Trials Education Program, which aims to enhance awareness and comfort with clinical trial participation. Studies have found that structured learning about clinical trials increases awareness and comfort with participation. This education explains the purpose, benefits, and possible risks of clinical trials, enabling better decision-making about joining a trial. Additionally, informed participants can improve the quality of clinical research by providing better feedback and staying engaged. ^{6 7 8 9 10}

Who Is on the Research Team?

Clement K Gwede, PhD, MPH, RN, FAAN

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers who can give informed consent and live in the Tampa Bay Area (Hillsborough, Pinellas, Polk, or Pasco county). It's not specified who cannot participate.

Inclusion Criteria

Able to provide informed consent

Reside in the Tampa Bay Area (Hillsborough, Pinellas, Polk or Pasco county)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education Intervention

Community Health Educators provide Clinical Trial Education to increase knowledge of Clinical Trials and the importance of Clinical Trial participation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in knowledge and beliefs about clinical trials after the educational intervention

Immediately after intervention

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Trials Education Program

Trial Overview The study is testing a Clinical Trials Education Program to see if it effectively increases understanding and participation in clinical trials among participants.

How Is the Trial Designed?

Group I: Clinical Trials Education Experimental Treatment 1 Intervention

Community Health Educators (CHE) will provide Clinical Trial Education to increase knowledge of Clinical Trials and the importance of Clinical Trial participation.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The implementation of a computerized data management system for clinical trials significantly reduced transcription errors and overlooked adverse events, with errors dropping from 17% to 0% and overlooked events from 35% to 3%.

Using the computerized system also decreased the time needed to evaluate clinical information and report adverse events by 2-4 months, enhancing compliance with regulations and allowing for quicker identification of potential risks to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of benefits derived from a computerized data management system for clinical trials data. Elting, LS., Bodey, GP.[2018]

A survey of 509 clinical research associates (CRAs) and research nurses (RNs) revealed significant variability in adverse event (AE) reporting practices, with only 51.2% using standardized methods, highlighting a need for improved training and consistency.

Respondents identified major challenges in AE reporting, such as differences in trial protocols and definitions, and expressed strong support for additional resources like online reporting modules and standardized tracking forms to enhance reporting accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report. Miller, TP., Marx, MZ., Henchen, C., et al.[2023]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

The ongoing study in Kentucky, Ohio, and Oklahoma has already reported thousands of cases, highlighting a strong commitment from surgical practitioners to exceed patient education standards.

Although data collection is still in progress, early observations have identified areas for improvement, and hospital teams are actively implementing process improvements to enhance surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process and outcome measures in specialty surgery: early steps in defining quality. Polk, HC., Lewis, JN., Garrison, RN., et al.[2019]

Adverse drug events (ADE) are common in hospitals and outpatient care, leading to increased patient suffering, higher costs, and longer hospital stays, highlighting the urgent need for effective reduction strategies.

Implementing electronic prescribing tools, clinical pharmacists, and advanced identification systems like bar-coding can significantly enhance patient safety, but these technologies must be integrated thoughtfully into existing workflows to be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Practical aspects of medication safety]. Hug, B.[2013]

A new pain management pathway for total joint replacement patients at Virginia Mason Medical Center led to the identification of gaps in patient education and communication regarding pain management.

The development of an evidence-based patient education tool, using quality improvement strategies, improved communication between patients and providers and enhanced pain assessment accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better pain management after total joint replacement surgery: a quality improvement approach. Gillaspie, M.[2019]

A quality improvement program aimed at enhancing medication education for post-acute neurosurgical patients led to increased patient satisfaction scores, highlighting the importance of effective communication about medications and their side effects.

The program utilized strategies like patient handouts, nurse education, and the 'teach back' method, which proved successful in reinforcing understanding and improving patient experiences related to medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using evidence to improve satisfaction with medication side-effects education on a neuro-medical surgical unit. Ahrens, SL., Wirges, AM.[2022]

An educational program for nursing technicians significantly improved their understanding of how to recognize and record Adverse Events (AEs) in hemodialysis patients, with test scores increasing from an average of 3.7 to 4.2 out of 5 after the intervention.

The program effectively combined classroom and online learning, demonstrating that such training methods can enhance the knowledge and skills of healthcare professionals in managing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing educational intervention for the identification of Adverse Events in hemodialysis. Pássaro, PG., D'Ávila, R.[2019]

Internet-based education significantly improved patients' knowledge levels more than face-to-face education with a nurse in a study involving 147 ambulatory orthopedic surgery patients.

Both education methods were effective in enhancing knowledge, but there was no difference in the sufficiency of knowledge between the two groups, indicating that online education is a viable alternative in ambulatory care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory orthopaedic surgery patients' knowledge with internet-based education. Heikkinen, K., Leino-Kilpi, H., Salanterä, S.[2017]

Implementing a weekly postoperative class for caregivers of patients who underwent total joint replacement surgery has improved their understanding and preparedness for the recovery process after discharge.

Surveys indicate that this educational initiative enhances family-centered care, helping caregivers feel more equipped to support patients during their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative total joint replacement class for support persons: enhancing patient and family centered care using a quality improvement model. Mazaleski, A.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02274818

Study Details | NCT02274818 | Individualized Comparative ... The main protocol will examine patient safety and costs as well as quality of education. The "Time and Motion" substudy examines additional educational outcomes ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/10872981.2020.1757883

Evaluating the effectiveness of undergraduate clinical ... Medical schools should use a variety of measures to evaluate the effectiveness of their clinical curricula. Both outcome measures and process measures should ...

3. pcori.org pcori.org/research-related-projects/about-our-research/research-we-fund

Research We Fund PCORI funds patient-centered comparative clinical effectiveness research (CER) and CER-related projects.

4. hqlo.biomedcentral.com hqlo.biomedcentral.com/articles/10.1186/s12955-019-1220-z

The impact of patient-reported outcome (PRO) data from ... PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics.

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00494-2/fulltext

Real-world data: bridging the gap between clinical trials ... We explore the challenges of RWD and discuss key questions that clinicians, patients, and regulators will need to consider when faced with positive efficacy ...

6. ucsc-extension.edu ucsc-extension.edu/certificates/clinical-trials-design-and-management

Clinical Trials Design and Management Identify the role biostatistics plays in designing the clinical protocol and evaluating the resulting safety and efficacy data. Clinical Trials Design and ...

7. diaglobal.org diaglobal.org/en/course-listing/elearning/2023/02/pre-marketing-clinical-trial-safety

Pre-Marketing Clinical Trial Safety The module covers drug safety requirements, ethical safeguards, informed consent, review boards, data safety, reporting, risk assessment, and pre-marketing ...

8. globalhealthtrainingcentre.tghn.org globalhealthtrainingcentre.tghn.org/data-safety-and-monitoring-boards-clinical-trials/

Data Safety and Monitoring Boards for Clinical Trials Upon completion of the course you will have gained an understanding of: What a Data Safety Monitoring Board does; The existing regulations and where the gaps ...

9. about.citiprogram.org about.citiprogram.org/

Research, Ethics, Compliance, and Safety Training CITI Program provides training courses for colleges and universities, healthcare institutions, technology and research organizations, and governmental ...

10. nei.nih.gov nei.nih.gov/grants-and-training/policies-and-procedures/guidelines-data-and-safety-monitoring-clinical-trials

Guidelines for Data and Safety Monitoring of Clinical Trials The National Eye Institute (NEI) has established the following guidelines for the appropriate oversight and monitoring of the conduct of clinical trials.