Cleveland Clinic Foundation

Patient, Primary Care Provider, and Specialist Perceptions of the da Vinci Surgical System in Urology; Understanding the Interaction between Marketing and Clinical Practice

INTRODUCTION:
Minimally invasive approaches to the treatment of surgical disease have improved patient quality of life and recovery time. The �learning curve� for laparoscopy is however substantial, and in large part has limited the wide spread availability of these techniques to major academic centers. This is especially the case when a surgical procedure has a significant reconstructive component. The da Vinci Surgical System by Intuitive Corporation, which received FDA approval in July 2000, has had a significant impact on the dissemination of advanced minimally invasive techniques into routine clinical use. In part because of its high costs and the allure of robotic technology, the system has been heavily marketed by both Intuitive Surgical and by clinicians as providing superior surgical results. Research attempting to evaluate the equivalency and/or superiority of da Vinci assisted laparoscopic surgery is currently underway at multiple centers. Little is known about the effects that marketing has had on the four major players driving the utilization and acquisition of these systems. These players include patients, primary care referral physicians, specialists, and hospital administrators. It is important to better define the sources of knowledge, motivating factors, and interactions that are influencing these players in order to improve understanding at all levels and avoid purely market driven decision making. While the da Vinci Surgical System is approved for several specialty applications, one of its primary initial applications has been in urology, specifically for the surgical treatment of prostate cancer which will be the emphasis of this study.

Background:
Surgical robotics initially developed as a byproduct of military research. While the term �surgical robotics� encompasses several categories of robotic systems used for surgery of varying complexity, we use the term in its common usage to refer to the da Vinci Surgical System, a master-slave type minimally invasive system that is currently in widespread use. According to the company�s website as of August 2006, 320 sites in the United States have systems installed while 57 additional sites exist elsewhere in the world. (8 Germany, 3 aus, 2 austria, 5 belgium, 1 czech, 7 france, 13 italy, 1 japan, 4 netherlands, 1 romania, 2 saudi Arabia, 3 spain, 2 sweden, 4 switzerland, 1 taiwan). These systems utilize instruments engineered with a mechanical wrist that facilitates both dissection and suturing in a laparoscopic environment. The surgeon acts as the �master� controlling all movements of the �slave� robotic instruments. This system has been shown to ease the �learning curve� thus allowing inexperienced laparoscopists or even open surgeons to become proficient at complex cases in a shorter period of time.

At a cost of approximately one million dollars, the da Vinci system (Intuitive Corp., Sunnyvale, CA) represents a capital investment similar to imaging technologies such as CT and MRI scanners. The financial constraints placed on hospitals by these large capital investments require ongoing aggressive and liberal use of the system by the medical staff to make their purchase worthwhile[San Francisco Business Times-1/12/04].

In a similar fashion, the da Vinci system has become part of the technology race for many hospitals. Marketing of these devices to referral physicians and to the public is intended to generate demand for and utilization of these systems. By providing this novel technology, hospitals and physician groups argue this is an important component of capturing or maintaining market share. Advertising and exposure to this technology occurs through professional journals, popular press (newspapers, magazines, and the web), provider mailings, and hospital websites. The extent and more importantly the effect of this marketing has not been described. An important target of advertisers is patients because they influence self referral behavior and subsequent provider behavior. This type of �direct to consumer� method of advertising has been well established in the case of pharmaceuticals[Mintzes et al CMAJ 2003].

Primary Care Physicians:
The understanding level regarding advanced surgical robotic technology by primary care physicians who act as the referral base is unknown. The specific influences that the availability of this technology has on referral patterns are also unknown. This is an important issue for hospitals and departments as they grapple with decisions to make costly capital acquisitions that need to be financially beneficial in the long term.

A study of 141 family practice physicians and their referral behaviors over a period of 15 business days revealed several important trends [Forrest et al JFP 02]. Surgical specialists are the largest single group (45.4%) that family practice physicians refer their patients to. Among male patients, referrals to Urologists are the second most common type overall. Specific physicians are recommended 86.2% of the time. This suggests that establishing a relationship with their referring physicians is very important for specialists in gaining and maintaining business. When asked about the factors that influenced them to choose a particular specialist, technical capacity (which can be interpreted to mean availability of surgical robotics in today�s climate) was ranked third after personal knowledge of the specialist and quality of prior feedback. Requirement of patient�s health plan was ranked a distant sixth.

Patients:
Potential factors influencing patient�s seeking specialists offering da Vinci surgery include the perceived benefits of a shorter hospital stay, less pain, less blood loss, less scarring, faster recovery, better oncologic outcomes, better functional outcomes (continence and potency for prostatectomy), a gestalt of getting �best available care�, getting most advanced surgeons, and shorter operative times. Patients may therefore initiate self referrals, request specific referrals from their primary care physicians, and/or urology specialists.

Urology Specialists:
Motivational factors for urologists to obtain or refer to specialists with da Vinci robotic surgery access include perceived greater surgical precision, ability to perform advanced minimally invasive surgery, improved outcomes, decreased length of stays, and decreased postoperative pain. Marketing factors include potential increased referrals and increased revenue. Groups are also influenced by their ability to recruit talent while academic training centers may have to consider their ability to attract top residency trainees.

Hospitals:
Hospitals and large groups that are purchasing these systems are influenced by market factors. Perceived benefits include market share growth, increase in patients, recruitment and retention of top surgical talent, and enhanced hospital reputation by having availability of the latest technology.

PURPOSE:
1) To define referring provider beliefs regarding the importance of minimally invasive surgical procedures and the use of surgical robotics.
2) To define how the availability of surgical robotics influences the referral patterns of primary care providers.
3) To assess correlations between physician demographics and physician perception/referral practices.
4) To determine motivating factors for patients seeking out robotic surgical technology in their care
5) To determine the understanding level of patients regarding robotic surgical technology
6) To assess correlations between patient demographics and robotic surgical technology seeking behavior
7) To determine specialist perceptions about the clinical utility of robotic surgical technology
8) To determine specialist perceptions about the marketing utility of robotic surgical technology
9) To determine how the adoption of robotic surgical technology is affecting provider recommendations about prostate cancer treatment

METHODS & PROCEDURES:
This is an investigator initiated questionnaire study. Identical web based and paper versions of surveys will be used with separate surveys for each of three target groups: patients, primary care referral physicians, and urologists. Techniques to maximize response rate will be used, including limiting length of surveys and incentives. Completed questionnaires will be kept confidential.

The CCF database will be reviewed to assess the percentages of self referral, primary care referrals, and urologist referrals

Data analysis:
At end of emailing period, completed questionnaires will be analyzed to assess for baseline demographics, distribution of opinions, and correlations for predictors of physician opinions and practice concerning the da Vinci system.

SUBJECT SELECTION:
Patients will be recruited from past and future patients being referred to the Cleveland Clinic Foundation (CCF) for robotic and/or laparoscopic prostatectomy. Additional patients will be selected from other sites representing different levels of specialization. CCF represents a highly specialized national center of referral. UC Davis represents a moderately specialized regional center of referral. (To be determined) represents a minimally specialized community center. This variation in patients will provide a more accurate reflection of the heterogeneous population of patients presenting for prostate cancer care.

Primary care referral physicians will be recruited from the CCF primary care network and from referring physicians from out of network who have referred patients to CCF in the past. Additional primary care physicians will be selected from the AAFP and Internal Medicine directories to provide a broader selection of subjects.

Urologists will be recruited from the American Urological Association directory of members which includes a broad range of specialization.

Expect to email five hundred questionnaires with an expected response rate of 50%. Incentives may consist of a $5 dollar gift cards to Starbucks, Wal-Mart, or iTunes to improve response rates.

RISKS:
No physical, psychological, social, or legal risks. Returned questionnaires will be analyzed in an anonymous fashion.

BENEFITS:
No direct clinical benefit. Incentives will consist of a $5 dollar gift cards to Starbucks, Wal-Mart, or iTunes to improve response rates.

RISK-BENEFIT RATIO:
Minimal risk to subjects outweighed by benefit of enhanced understanding of study questions for clinicians and industry. Improved understanding is useful to specialists in assessing impact of acquiring da Vinci systems on their practice and useful to patients and providers in making informed decisions about treatment options.