Doctor Communication Intervention for Patient Safety in Pacemaker/ICD Procedures

(Veteran CIEDs Trial)

SS
Overseen BySanket S Dhruva, MD MHS
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve patient safety during the implantation of pacemakers or implantable cardioverter-defibrillators (ICDs). It examines whether a specific communication method, involving academic training and performance feedback (known as the academic detailing and audit and feedback intervention), can influence doctors' choice of device models. The target participants are VA-based cardiac specialists who manage these heart devices and are open to new approaches.

As an unphased trial, this study allows patients to contribute to innovative methods that could enhance cardiac care practices.

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 prior data suggests that this intervention is safe for pacemaker/ICD procedures?

Research has shown that methods like academic detailing and audit and feedback are generally well-received by both doctors and patients. These methods aim to enhance communication and collaborative decision-making between doctors and patients. Studies have found that these approaches do not negatively impact patient safety; instead, they improve the quality of care.

This method has succeeded in other medical settings. For instance, one study noted better prescription practices without any safety issues. Both doctors and patients involved in these methods reported feeling more confident and informed.

Although specific safety data for this context is lacking, the nature of the method suggests it is low-risk. It involves no new medications or invasive procedures, only improved communication and decision-making support.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving doctor-patient communication, which is a new approach for enhancing patient safety during pacemaker and ICD procedures. Unlike standard treatments that primarily focus on the medical aspects, this intervention uses academic detailing and audit and feedback to directly engage VA cardiac electrophysiologists. By doing so, it aims to foster better communication and understanding, which could lead to fewer complications and improved outcomes. This approach is particularly promising as it targets the human element of healthcare, potentially transforming how safety is ensured in these procedures.

What evidence suggests that this intervention is effective for improving patient safety in pacemaker/ICD procedures?

Research shows that certain methods can improve healthcare practices. For instance, these methods have reduced the unnecessary use of multiple medications in both young and older adults. Using clinical decision support with regular feedback has also prevented kidney problems during some medical procedures. Additionally, decision aids have increased patient involvement in care decisions. In this trial, the intervention arm involves VA cardiac electrophysiologists receiving an academic detailing and audit and feedback intervention. These findings suggest that the intervention might improve the choice of pacemaker or ICD leads for veterans, enhancing patient safety.26789

Who Is on the Research Team?

SS

Sanket Shishir Dhruva, MD MHS

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
Improving adherence to coronary heart disease secondary prevention medication guidelines at a community hospital.Bailey, TC., Noirot, LA., Gage, BF., et al.[2018]
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.
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]
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.
The practice of reporting adverse events in a teaching hospital.Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Citations

Effect of Clinical Decision Support With Audit and Feedback ...Effect of clinical decision support with audit and feedback on prevention of acute kidney injury in patients undergoing coronary angiography.
Experiences implementing a suite of decision aids for ...The DECIDE-ICD Trial assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at seven sites.
Effectiveness of implementation interventions in improving ...Primary outcomes included: proportion of eligible patients offered guideline-recommended pharmacotherapy, self-care education, left ventricular function ...
Use of Academic Detailing With Audit and Feedback to ...Conclusions: Polypharmacy decreased among young and older adults after academic detailing with audit and feedback. Although further research is ...
Periprocedural Management and Multidisciplinary Care ...This scientific statement provides an inclusive framework for the periprocedural management of patients with these devices.
Project DetailsAim 3: To conduct a pilot study to determine the effect of an academic detailing and audit and feedback intervention on the specific CIED lead models implanted ...
Final Results From the Pivotal Study | CirculationAt 2 years, ATP was programmed “off” in 2.8% of patients because of pacing sensation during in-clinic electrical testing; however, no patient ...
Remote monitoring of pacemakers and defibrillatorsResults from the survey showed that 86.5% of patients and 91.6% of physicians reported feeling safer using RM. Because 16% of the total cases had a large number ...
Effect of Clinical Decision Support With Audit and ...Results The first academic detailing intervention resulted in a prescription-to-alert ratio increase from 32.6 to 51.7%, a 19.1% absolute increase when ...
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