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RRP 11-438 – HSR Study

RRP 11-438
Pilot to Implement Radical PCI in VA Catheterization Laboratories
Christopher L. Bryson, MD MS
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, WA
Funding Period: July 2012 - September 2013
Percutaneous coronary intervention (PCI) is part of the comprehensive treatment of coronary heart disease, used as a life-saving treatment for a subgroup of high-risk heart attack patients (ST-segment-elevation myocardial infarctions) and to control chest pain in angina patients whose symptoms cannot be managed medically. Approximately 14,000 PCI procedures are performed in the VA system annually. PCI is generally safe, but the most common modifiable adverse events in patients undergoing PCI are bleeding complications, approximately two-thirds of which are related to the location of the vascular access site. PCI is typically performed by accessing the femoral artery (groin) though it can also be performed via the radial artery (wrist). While both access sites are standards of care, bleeding is easier to control in the radial artery, and both randomized trials and registry analyses have demonstrated the safety, efficacy, and improved outcomes associated with routine use of radial-access PCI (rPCI) compared to femoral-access PCI (fPCI). While rPCI has been widely adopted in other countries, it is technically more challenging and most interventionalists are trained primarily in femoral access. As a result, radial PCI accounts for approximately 16% of PCIs in the US. Editorial literature identifies possible barriers to adoption and implementation of rPCI in VA. While training opportunities are limited, some interventionalists still successfully implement radial programs. Currently, there is limited research on determinants and evidence-based implementation strategies to increase the use of rPCI in appropriate cases.

The specific research aims were: 1) to determine current use and barriers to use of rPCI in VA cardiac catheterization labs (cath labs) and 2) to adapt and pilot a coaching intervention in preparation for a larger randomized trial to increase the proportion of rPCI done in VA cardiac catheterization labs.

This mixed-method study included semi-structured interviews and a national survey with VA interventional cardiologists and cath lab staff (e.g., nurse manager, cath lab technician) to understand factors influencing rPCI use and identify potential refinements or additions to the rPCI training program (Aim 1). We also adapted and pilot tested the effectiveness of a current private sector rPCI educational training program that used a reverse-site visit (i.e., trainees visiting an experienced lab where they participated in a full day training session including hands-on training) followed by a coaching visit (i.e., trainees visited at their lab by coaches) (Aim 2). Five VA cath labs sites were recruited with at least one interventional cardiologist accompanied by a cath lab nurse and/or radiology technician attending the educational training program (reverse site visit). One site dropped out of the study, and four sites completed the training (held in July 2012). Two additional VA cath labs were recruited to serve as control sites; staff from the control sites did not attend the training program. Staff from the intervention sites attended a day-long educational training program in Chicago, IL. It included education on the benefits of radial PCI, safety procedures, practice using a radial simulator, and opportunity to observe a live rPCI case. The intervention site participants also received a coaching visit for assistance with overcoming any material and technical challenges to implementing rPCI and in order for the research team to gather feedback from the participants about the training program.

Telephone interviews on barriers and facilitators to rPCI implementation were conducted with intervention site staff before and after the pilot rPCI training program, and once with staff at the control sites. Interview findings were used to create a structured survey that was fielded nationally to VA interventionalists identified in the VA Cardiac Assessment, Reporting and Tracking - Cath Lab (CART-CL) database. The survey assessed extent of experience with rPCI, perceptions of rPCI, prevalence of barriers to rPCI use, and interest in training for rPCI use. The CART-CL database was used to assess proportion of rPCI performed at intervention and control sites and a bleeding complication composite. We are also performing qualitative comparative analysis (QCA), and assessed cost data. QCA is a technique to identify associations among many variables based on Boolean logic, to determine if there are combinations of barriers or perceptions of rPCI strongly associated with cath lab rPCI rates. We assessed cost data in anticipation of a cost-effectiveness component of a larger future intervention study.

The baseline telephone interviews were conducted with participating cath lab staff members (n=8). Staff from four VA cath labs participated in the day-long rPCI educational training program (intervention) in July, and received follow-up coaching visits from study staff. The survey was refined based on the preliminary findings from the interviews and the intervention, and fielded to VA interventionalists nationally in February 2013 (n=78 out of 235 survey recipients [33% response rate] from 48 of the 65 cath labs surveyed [73% of sites]). Results from the interviews and survey showed that the most prevalent barriers interventional cardiologists cited were concerns about increased radiation exposure to the interventional cardiologist (63% of respondents cited as major or minor barrier) and to other cath team members (51% of respondents), and the steep learning curve (44%). However, even among these, most respondents rated them as minor rather than major barriers. Other barriers such as difficulty obtaining necessary equipment (25%), lack of support from cath lab staff (23%), and lack of training opportunities (18%), were cited less frequently by our survey respondents.

Respondents were asked to choose whether rPCI or fPCI was "much better," "better," or "somewhat better" for several patient care and procedure variables ("no difference" option given as well). Majorities of interventionalists rated rPCI as superior for ease of monitoring patients following the procedure (52%), comfort for patients (60%), allowing patients to go home sooner (65%), fewer vascular access complications (69%), and fewer bleeding complications (72%). However, majorities rated fPCI superior for technical results (i.e., procedure success rate) and faster procedure time. Favorable perceptions of rPCI, though not rPCI barriers, were correlated with higher rPCI rates per site. In multivariate analyses, perceptions of rPCI as equal to or better than fPCI for procedure time, and the proportion of diagnostic cases performed radially were positively associated with site-level rPCI volume. This is consistent with the supposition that once interventionalists become proficient with rPCI, procedure times cease to present a barrier. Any efforts to support greater rPCI implementation may benefit from acknowledging that procedure times for rPCI are initially longer, but ultimately decrease to as fast as or faster than fPCI procedure times. The fact that no reported barriers were associated with site-level radial rates suggests that no single barrier is a sufficient obstacle to preclude rPCI implementation.

In post-coaching intervention interviews, participants reported favorably on the coaching intervention. Cath lab nurses and radiology technicians reported that the training helped identify specific material or technique changes that addressed barriers or concerns, such as better placement of arm boards to reduce radiation exposure, use of hydrophilic catheters (to reduce arterial spasms, increasing patient comfort and reducing procedure delays), and changes to discharge policies to take advantage of the ability to discharge patients sooner. There were not significant changes in rPCI rates at pilot sites in the 3 month period after the coaching intervention, though the pilot was not powered to detect a change.

Discovering which barriers to implementing rPCI are the most prevalent in combination with piloting and refining an intervention to increase the uptake of rPCI has greatly informed our larger, VA-wide proposal. We are using the results of this pilot to launch a larger dissemination and implementation trial to test the reach, safety, effectiveness and cost-effectiveness of our piloted intervention. We hope to improve patient satisfaction and outcomes and decrease VA costs by increasing rPCI uptake nationally.

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Journal Articles

  1. Schopfer DW, Takemoto S, Allsup K, Helfrich CD, Ho PM, Forman DE, Whooley MA. Cardiac rehabilitation use among veterans with ischemic heart disease. JAMA internal medicine. 2014 Oct 1; 174(10):1687-9. [view]
  2. Tsai TT, Box TL, Gethoffer H, Noonan G, Varosy PD, Maddox TM, Fihn SD, Gross TP, Jesse RL, Rumsfeld JS. Feasibility of proactive medical device surveillance: the VA Clinical Assessment Reporting and Tracking (CART) program. Medical care. 2013 Mar 1; 51(3 Suppl 1):S57-61. [view]
  3. Helfrich CD, Tsai TT, Rao SV, Lemon JM, Eugenio EC, Vidovich MI, Shroff AR, Speiser BS, Bryson CL. Perceptions of advantages and barriers to radial-access percutaneous coronary intervention in VA cardiac catheterization laboratories. Cardiovascular revascularization medicine : including molecular interventions. 2014 Sep 1; 15(6-7):329-33. [view]
Conference Presentations

  1. Helfrich CD, Rao SV, Eugenio EC, Vidovich MI, Shroff AR, Speiser BS, Neely EL, Sulc CA, Orlando RM, Sayre G, Liu C, Bradley SM, Bryson CL. Factors Influencing Adoption of Radial Access for Percutaneous Coronary Intervention in the Veterans Affairs Health Care System. Poster session presented at: American Heart Association Quality of Care and Outcomes Research Council Annual Scientific Session; 2014 Jun 4; Baltimore, MD. [view]
  2. Helfrich CD, Tsai TT, Jesse RL, Fihn SD, Rumsfeld JS. Perceived Barriers and Facilitators of Adoption of Radial PCI among Participants in a Pilot Training Program. Poster session presented at: American Heart Association Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Annual Scientific Sessions; 2013 May 16; Baltimore, MD. [view]

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