Doctor Communication Intervention for Patient Safety in Pacemaker/ICD Procedures

(Veteran CIEDs Trial)

Overseen By Sanket S Dhruva, MD MHS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Not willing to participate

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

Compensation: Varies

Number of Visits: 1

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.

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

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Academic detailing and audit and feedback intervention for patient safety in Pacemaker/ICD procedures?

Research shows that providing feedback on communication quality, such as explaining medical terms and checking patient understanding, can improve doctor-patient interactions. This suggests that similar feedback interventions could enhance communication and safety in pacemaker/ICD procedures. ^{1 2 3 4 5}

Is the Doctor Communication Intervention for Patient Safety in Pacemaker/ICD Procedures safe for humans?

The research articles do not provide specific safety data for the Doctor Communication Intervention or similar interventions like Academic detailing and audit and feedback intervention. They focus on adverse event reporting and patient safety indicators, but do not directly address the safety of these interventions in humans. ^{6 7 8 9 10}

How does the Doctor Communication Intervention for Patient Safety in Pacemaker/ICD Procedures differ from other treatments?

This treatment is unique because it focuses on improving doctor-patient communication to enhance patient safety during pacemaker or ICD procedures. Unlike traditional treatments that may focus on the medical or surgical aspects, this intervention aims to reduce medical errors by addressing communication gaps and biases, ensuring that patients receive clear and effective information from their healthcare providers. ^{1 4 11 12 13}

Research Team

Sanket Shishir Dhruva, MD MHS

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for cardiac electrophysiologists working at three Veterans Integrated Service Networks who implant pacemakers or ICDs in veterans. Participants must be willing to join the study.

Inclusion Criteria

Department of Veterans Affairs-based cardiac electrophysiologists who implant cardiovascular implantable electronic devices at three Veterans Integrated Service Networks (VISNs)

Exclusion Criteria

I am not willing to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Academic detailing and audit and feedback intervention implemented via videoconference

1 day

1 visit (virtual)

Evaluation

Quantitative evaluation of CIED lead models implanted over 3 months

3 months

Follow-up

Semi-structured interviews conducted to assess reasons for changes in CIED lead model selection

4 weeks

Treatment Details

Interventions

• Academic detailing and audit and feedback intervention

Trial Overview The study tests whether a strategy of academic detailing and audit and feedback can influence the choice of pacemaker or ICD lead models used by doctors in veteran patients.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

VA cardiac electrophysiologists receiving the intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Findings from Research

A randomized study demonstrated that a technology-assisted pharmacist intervention effectively improved physician adherence to medication guidelines for coronary heart disease (CHD) secondary prevention.

Patients in the intervention group had a higher proportion of being discharged on appropriate secondary prevention medications, indicating the intervention's efficacy in enhancing treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to coronary heart disease secondary prevention medication guidelines at a community hospital. Bailey, TC., Noirot, LA., Gage, BF., et al.[2018]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Integrating adverse event (AE) reporting into a mobile application used by physicians significantly increased AE reporting, with a more than 37-fold rise in reports (from 21 to 806).

The proportion of AE reports submitted by physicians also increased dramatically, from 0.1% to 12% of all reports, highlighting the effectiveness of this integration in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Adverse Event Reporting Into a Free-Text Mobile Application Used in Daily Workflow Increases Adverse Event Reporting by Physicians. Delio, J., Catalanotti, JS., Marko, K., et al.[2021]

The transition from ICD-9-CM to ICD-10-CM coding systems could lead to significant errors in hospital safety reporting, particularly affecting the accuracy of Patient Safety Indicators (PSIs) across 38,644 patients and 399 hospitals.

Out of 23 PSIs analyzed, 15 showed inaccuracies due to the complexity of coding translations, which could inflate reported safety incidents and complicate comparisons of hospital safety performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and remediation for Patient Safety Indicators in the transition to ICD-10-CM. Boyd, AD., Yang, YM., Li, J., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Examining the relationship between clinician communication and patient participatory behaviors in cardiology encounters. [2023]

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

Improving adherence to coronary heart disease secondary prevention medication guidelines at a community hospital. [2018]

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

Communication Coaching in Cardiology (CCC): A study protocol and methodological challenges and solutions of a randomized controlled trial in outpatient cardiology clinics. [2022]

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

Pilot study of a physician-delivered education tool to increase patient knowledge about CKD. [2021]

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

Benefit of Report Card Feedback After Point-of-Care Assessment of Communication Quality Indicators. [2022]

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

The practice of reporting adverse events in a teaching hospital. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Integrating Adverse Event Reporting Into a Free-Text Mobile Application Used in Daily Workflow Increases Adverse Event Reporting by Physicians. [2021]

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

Physician knowledge, attitudes, and behavior related to reporting adverse drug events. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Challenges and remediation for Patient Safety Indicators in the transition to ICD-10-CM. [2021]

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

Must We Bust the Trust?: Understanding How the Clinician-Patient Relationship Influences Patient Engagement in Safety. [2021]

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

Disparities in patient-resident physician communication and counseling: A multi-perspective exploratory qualitative study. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

What constitutes "competent error disclosure"? Insights from a national focus group study in Switzerland. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

Medical students' medication communication skills regarding drug prescription-a qualitative analysis of simulated physician-patient consultations. [2018]