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

85 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide education and information about clinical trials and clinical trials participation. Investigators also aim to see if education makes a difference in increasing knowledge of clinical trials and clinical trials participation.

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 data supports the effectiveness of the Clinical Trials Education Program treatment?

The research on improving patient satisfaction with medication side-effects education and enhancing patient and family-centered care through education suggests that well-structured educational programs can lead to better patient understanding and satisfaction, which may support the effectiveness of the Clinical Trials Education Program. ^{1 2 3 4 5}

Is the Clinical Trials Education Program generally safe for humans?

The research articles focus on improving the reporting and management of adverse events (unwanted side effects) in clinical trials, which is crucial for ensuring safety. While they don't directly address the safety of the Clinical Trials Education Program itself, they highlight the importance of accurate adverse event reporting to enhance patient safety in clinical trials. ^{6 7 8 9 10}

Research Team

Clement K Gwede, PhD, MPH, RN, FAAN

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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)

I speak English or Spanish.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Ambulatory orthopaedic surgery patients' knowledge with internet-based education. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Process and outcome measures in specialty surgery: early steps in defining quality. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Brazil pubmed.ncbi.nlm.nih.gov

Nursing educational intervention for the identification of Adverse Events in hemodialysis. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Practical aspects of medication safety]. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of benefits derived from a computerized data management system for clinical trials data. [2018]