When push comes to shove: implementing VBAC practice guidelines.

Clinical practice guidelines are an emerging feature of American health care.[1] In both the public and the private sectors, in both fee-for-service and prepaid systems, such guidelines are being proposed to improve the quality of medical outcomes and to minimize health care expenditures.[2] Although much has been written about the theoretical promise of such guidelines,[3] real-world examples of their successful application are limited.[4] Actual implementation is critical, because, without compliance from both medical practitioners and their patients, clinical practice guidelines become purely academic exercises without any impact on the quality of care or its costs.

An example of clinical practice guidelines application with significant implications for the guideline movement exists with vaginal birth after C-section (VBAC) guidelines.[5] These guidelines are based on outcomes research,[6] have been endorsed by the American College of Obstetrics and Gynecology,[7] and can markedly improve the quality and decrease the cost of obstetrical care.[8] Implementation of these guidelines represents an excellent opportunity to examine the potential of outcomes-based clinical practice guidelines to change American medical practice.

To evaluate the degree of implementation of VBAC guidelines, a mail survey of 159 members of the American College of Physician Executives was conducted. Those surveyed include medical directors of HMOs, hospitals, insurance companies, and physician group practices. The sample represents a broad cross-section of practice settings, systems of care, and geographic locations. Many of these individuals have responsibility for the application of VBAC guidelines to large populations, and their responses describe the current status of efforts to implement VBAC guidelines and indicate the success of reducing C-section rates by applying such clinical practice guidelines.

Genesis of the VBAC Guidelines

In 1916, E. B. Cragin wrote, "Once a Cesarean, always a Cesarean."[9] This clinical dictum was appropriate at that time, given the lack of antibiotics, the use of the classical (vertical) uterine incision, and the infrequent use of the primary C-section.[10] The operation was performed only as a last resort to prevent maternal mortality and constituted less than 2 percent of all deliveries.[11] To subject a woman with a prior C-section to a trial of labor was to invite injury or death.

Times have changed. Better anesthetic techniques, the ability to transfuse the mother safely, and the fetal monitor have increased indications for this procedure.[12] Additionally, medical malpractice concerns, physician convenience, and patient preference have also encouraged the use of C-sections as an alternative to vaginal delivery.[13] The result has been an increase in the rate of C-sections to 24.7 percent of all American hospital deliveries, numbering almost 1,000,000 annually[14] and, since 1981, the most frequently performed major operation in the United States.

This dramatic increase in the number of C-sections has been viewed with concern, particularly because some studies have shown repeat C-sections being performed for reasons other than medical necessity.[17] Increased rates of C-section have been associated with private insurance, higher socioeconomic status, presence of a hospital neonatal unit, and the proprietary status of a hospital.[16] Both government bodies and medical specialty societies have sought to decrease the number of medically inappropriate C-sections.

Of the one million annual C-sections, 36 percent are performed as repeat procedures.[18] The most frequent indication for C-sections nationally is a prior delivery by cesarean section.[19] Studies have projected that up to 90 percent of women with a prior C-section can deliver vaginally and avoid a repeat procedure.[20] This means that as many as 300,000 C-sections could be eliminated annually with appropriate application 6f VBAC guidelines.[21] Hospital stays are several days longer and professional and facilities fees are substantially higher for C-section than for vaginal birth,[22] with a result that several hundred million dollars could be saved annually by implementing these guidelines.[20] Additionally, more than 50 outcome studies on more than 12,000 women with prior C-sections have clearly demonstrated that both mother and infant enjoy improved morbidity and mortality outcomes when VBAC is attempted.[23] Based on these considerations the National Institutes of Health has proposed VBAC guidelines[24] that have been endorsed by the American College of Obstetrics and Gynecology and are recognized as the standard for obstetrical practice in the United States.[25]

VBAC guidelines are outcomes-based, widely accepted, and capable of improving both the quality and the cost of medical care. Their implementation represents an opportunity to test the power of clinical practice guidelines to change medical practice. The responsibility for implementing VBAC guidelines and changing practice patterns will fall on those directing clinical services and those establishing reimbursement for medical procedures, chiefly the medical directors of managed care, hospital, and insurance organizations. Medical directors should therefore be an excellent source of information on the effectiveness of VBAC guidelines in changing clinical patterns of practice.

Study Design

To evaluate efforts currently under way to implement VBAC guidelines, the authors surveyed a sample of physicians in management positions. Members of the American College of Physician Executives (ACPE) Societies on Managed Care Organizations, Hospitals, and Insurance were identified. These physicians represent a variety of organizations, roles, and clinical perspectives and were chosen more because they encompass a broad range of health care perspectives, than for being representative of overall U.S. medical practice.

A survey instrument was developed to assess:

* The organizational role of the physician executive responding to the survey.

* The current VBAC policies, practices, and results of that organization.

* The attitude of the respondent toward physician, patient, and hospital accountability for implementing VBAC guidelines.

In addition to the standard questionnaire items, a clinical scenario was introduced to assess medical directors' attitudes and to present an unambiguous medical indication for attempting a VBAC. Respondents were asked to address questions relating to quality, accountability, and financial consequences of a decision not to pursue a VBAC.

The survey instrument (see figure, left) was reviewed by obstetricians and medical directors and piloted on an initial sample of physicians in management prior to its use with the ACPE membership. It was mailed to the study population, and a repeat survey was mailed six weeks later to those who had not responded to the first mailing.

The returned surveys were reviewed for completeness and consistency, and the results were entered into a Paradox database, including individual comments. The results were analyzed using standard statistical methods, but, because of small sample size and nonrandom sampling of the study population, the results are best interpreted as a descriptive summary rather than as a strictly quantitative analysis.

Results

Of the 155 medical directors surveyed, 64 (41 percent) returned surveys that were essentially complete. Another 16 responses (10 percent) were limited or unusable and are omitted from the analysis. The organizations that these medical directors represent and selected summaries of the findings are shown in table 1, page 33. The membership of HMOs averaged 95,000, and the distribution by model type was 16 percent group, 12 percent staff, 40 percent IPA, and 32 percent mixed. HMO contractual arrangements with OB/GYN providers for professional services included 60 percent fee-based, 27 percent salary, 7 percent capitation, and 13 percent other, principally global service contracts.

[TABULAR DATA OMITTED]

Regarding hospitals, the average number of beds was 460. Most were describe as "community," "general," or "medical-surgical," although a few were HMO-based. Surprisingly, the majority (77 percent) do not contract with manage care organizations.

The "other" medical directors represented insurance companies, medical groups, or physician-hospital organizations (PHOs) or were retired or independent consultants. There were no consistent measures of deliveries, C-sections, or VBACs noted by this group, and they are not included in the analysis.

Organizational VBAC performance was measured as the percentage of women with previous C-sections who underwent vaginal birth and was assessed against various organizational features. Cross-tabulated VBAC rates against these characteristics are presented for features most likely to influence provider VBAC performance, such as whether there is an organizational policy on VBAC; whether conformance to this policy is monitored for the institution as a whole; whether individual providers are held accountable by the organization for VBAC decisions; and, for HMOs, whether the financial incentive to perform C-sections has been removed by salary, capitation, global fees, or some other mechanism.

A detailed analysis was performed of those institutions having high VBAC rates, arbitrarily defined as rates of 50 percent or higher. The results are presented in table 2, page 34. While none of the high-VBAC HMOs are IPA models, in two of them OB/GYN providers are paid on a fee basis.

Table 2.

High VBAC (>50) Organizations and Their Performance Characteristics

                                     HMO            Hospital
Number                                7               5

VBAC rates
  Average                            66%              60%
  Range                             55-80%           50-70%

Have VBAC Policy                      86%              60%

Monitor conformance                   75%             100%

Hold providers accountable            67%              60%

Remove financial incentives           71%

Finally, to assess how the medical directors perceived the issue of VBAC implementation regarding their personal and organizational values, they were asked to respond to a clinical scenario typical of most VBAC opportunities. Their responses are recorded in table 3, page 34.

Table 3.

          Medical Director Responses to VBAC Clinical Scenario

                               HMO      Hospital     Other    Total

VBAC failure is
  QA issue                     56%        25%         38%       43%

OB/GYN should be
  confronted                   64         39           50       54

Patient liable for
  extra charges                24         24           33       25

Physician should be
 paid only at vaginal
 delivery rate                 48         76           50       58

Hospital should be
 paid only for
 a vaginal delivery            37         30           43       35

Conclusions

The nonrandom nature of the physicians and organizations represented in the ACPE means that these study results cannot be interpreted as representative of the United States as a whole. This sampling bias also means that the findings on which organizational activities and features are correlated with high VBAC rates may not hold for the U.S. medical community as a whole. Nevertheless, we believe the results are of value because of the leadership role medical directors play in creating practice standards and in their medical communities and organizations. Leaders seldom reflect population current norms.

Similarly, the relatively small number of respondents made significance testing unreasonable, particularly when subgroups are being compared. Any of our conclusions are open to the challenge, therefore, that the findings are not statistically significant. The nature of the study and the nonrandom sampling would have made these efforts vulnerable to that criticism even if larger numbers had been included. In spite of this limitation, the results have descriptive validity and remain useful as a starting point for discussion on the complex issues that VBAC implementation raises.

* The level of VBAC implementation varies greatly across organizations. Respondents averaged a 40 percent VBAC rate, which is considerably greater than for the United States as a whole, and ranged from 0 to 80 percent. This finding is encouraging, confirming the leadership role that medical directors take in responding to challenges and opportunities. It is perhaps most significant that the vast majority of respondents were able to report their C-section and VBAC rates, which suggests that this is being actively tracked and managed across their organizations as an issue of importance. Achieving VBAC rates of 50 percent and higher requires a major change in routine OB/GYN practice and the dedication of time and energy to the objective of encouraging VBACs.

* There is little difference between hospitals and HMOs. Most hospitals have a financial incentive to encourage C-sections, while most HMOs have financial incentives to encourage VBACs. It is perhaps surprising, therefore, to see the relative similarity in how medical directors from each camp view and respond to this issue. There were more noticeable differences between these two groups in attitude revealed by responses to the clinical scenario, but even here the differences were relatively modest.

* The impact of financial incentives is modest. While there were trends toward higher VBAC rates when financial incentives for performing C-sections were removed, the overall impact appeared to be modest. It did not appear to account for the success of the high-VBAC organizations, although the finding that no fee-based HMO appeared in the high-VBAC group is suggestive. Even this finding however. is brought into question by the fact that two of the seven High-VBAC HMOs pay for OB/GYN services on a fee basis that would provide higher reimbursement for a C-section than for a VBAC.

* There is no clear organizational activity that determines a high VBAC rate. While having a VBAC policy, monitoring VBAC performance, holding providers accountable, and removing financial incentives to perform C-sections may have some positive relation to good VBAC performance, none of these efforts appeared to be well correlated with VBAC outcomes. As is the case with most medical care management issues, the answer appears to be complex and not easily amenable to a single "magic bullet."

* There is limited consensus among medical directors on VBAC accountability. Less than half of medical directors felt that failure to attempt an appropriate VBAC was a significant quality of care issue, but a somewhat higher number felt that the responsible OB/GYN provider should be confronted. This seeming paradox suggests that most look at failure to attempt VBAC as an issue primarily of utilization and are unaware or unimpressed with the improved clinical outcomes that VBAC offers. There was a similar split among medical directors regarding which party should be liable for the financial consequences of failing to perform a VBAC: physician, hospital, or patient. Almost one third were unwilling to hold any of these parties accountable. Without greater consensus, it seems unlikely that HMOs or hospitals can adopt consistent, effective practices to increase VBAC rates.

* The VBAC issue inspires strong opinions. In addition to written comments, it became clear from informal conversations and through phone calls that respondents had strong personal feelings that were evoked by this study. First, medical directors expressed various degrees of concern with the impact on physician decisionmaking that actively addressing the VBAC issue would require. Second, and more significant, medical directors had concerns with patient autonomy. Many others questioned the intent to challenge patient preferences that actively promoting VBACs requires. Gender concerns were also raised, noting that many OB/GYN providers and medical directors are male and are making policies and establishing procedures that affect women's health issues. Clearly, an active effort to implement a VBAC policy must deal with these attitudes to be successful.

It is rare in clinical medicine to have the amount of confirmatory evidence that exists regarding the safety and benefit of VBAC guidelines. It is also unusual to have the degree of professional society recognition and endorsement of these findings, with such clear imperatives for how physicians should practice medicine. It is disappointing, therefore, that, 10 years after adoption and promulgation of these guidelines, there is no more widespread implementation than exists at present. While some organizations have responded admirably to this challenge, both in this study and in other reports, it remains an issue of concern that these results have not become the norm.

Outcomes-based clinical practice guidelines are currently being advocated as the mechanism that will both improve the quality of the health care that the United States enjoys and reduce the costs of the medical treatment for which we must pay. The study reported here raises the concern that even when such guidelines become available, their implementation may be too limited to have a material impact on the cost or quality of health care.

References

[1.] U.S. General Accounting Office. Practice Guidelines: The Experience of Medical Specialty Societies. Washington, D.C.: U.S. General Accounting Office; 1991. GAO publication GAO/PEMD-91-11. [2.] Roper, W., and others. "Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice." New England Journal of Medicine. 319(18):1197-202, Nov. 3, 1988. [3.] Field, M., and Lohr, K., Eds. Clinical Practice Guidelines: Directions for a New Program. Washington, D.C.: National Academy Press; 1990. [4.] Lomas, J., and others. "Do Practice Guidelines Guide Practice? The Effect of a Consensus Statement on the Practice of Physicians." New England Journal of medicine. 321(19):1306-11, Nov. 9, 1989. [5.] Lomas, J., and others. "Opinion Leaders vs Audit and Feedback to Implement Practice Guidelines: Delivery after Previous Cesarean Section." JAMA. 265(17):2202-7, May 1, 1991. [6.] Rosen, M., and others. "Vaginal Birth after Cesarean: A Meta-Analysis of Morbidity and Mortality." Obstetrics and Gynecology. 77(3):465-70, March 1991. [7.] American College of Obstetricians and Gynecologists. Guidelines for Vaginal Delivery after a Cesarean Childbirth. Washington, D.C.: Committee on Obstetrics, Maternal and Fetal Medicine, American College of Obstetricians and Gynecologists, 1982. [8.] Martin, J., and others. "Vaginal Birth after Cesarean Section: The Demise of Routine Repeat Abdominal Delivery." Obstetrics/Gynecology Clinica North American 15:719-36, 1988. [9.] Cragin, E. "Conservatism in Obstetrics." New York Medicine Journal 104(1):1-3, Jan. 1916. [10.] Boley, J. "The History of Cesarean Section." Canadian Medical Association Journal 145(4):319-22, April 1991. [11.] Sewell, J. Cesarean Section-A Brief History. Washington, D.C.: Americad College of Obstetricians and Gynecologists, 1993. [12.] Gabert, H. "History and Development of Cesarian Operation. "Obstetrics and Gynecology Clinica North American 15(4):591-605, April 1988. [13.] Joseph, G., add others. "Vaginal Birth after Cesarean Section: The Impact of Patient Resistance to a Trial of Labor." American Journal of Obstetrics and Gynecology 164(6, Pt. 1): 1441-7, June 1991. [14.] Taffel, S., add others. "1989 U.S. Cesarean Section Rate Steadies-VBAC Rate Rises to Nearly One in Five." Birth 18(2):73-7, June 1991. [15.] Placek, P., and Taffel, S. "Vaginal Birth after Cesarean (VBAC) in the 1980s." American Journal of Public Health 78(18):512-5, May 8, 1988. [16.] Stafford, R. "The Impact of Nonclinical Factors on Repeat Cesarean Section." JAMA 265(5):59-63, Feb.2, 1991. [17.] Eddy, D., and Billings, J. "The Quality of Medical Evidence: Implications for Quality of Care." Health Affairs 7(2):19-32, Spring 1988. [18]. Shiono, P., and others. "Reasons for the Rising Cesarean Delivery Rates: 1978-1984." Obstetrics and Gynecology 69(5):696-700, May 1987. [19.] Anderson, G., and Lomas, J. "Determinants of the Increasing Cesarean Birth Rate: Ontario Data, 1979-1982." New England Journal of Medicine 311(14):887-92, Oct. 4, 1984. [20.] "Births by Cesarian: Cost Changes, 1982-83 to 1986." Statistical Bulletin of Metropolitan Life Insurance Co. 69(3):18-25, July-Sept. 1988. [21.] Flamm, B., and others. "Vaginal Birth after Cesarean Delivery: Results of a 5-Year Multicenter Collaborative Study." Obstetrics and Gynecology 76(5):750-4, Nov. 1990. [22]. Spellacy, W. "Vaginal Birth after Cesarean: A Reward/Penalty System for National Implementation." Obstetrics and Gynecology 78(2):316-7, Aug. 1991. [23.] Pridjian, G. "Labor after Prior Cesarean Section." Clinical Obstetrics and Gynecology 35(3):445-56, Sept. 1992. [24.] National Institutes of Health. The Cesarean Birth Task Force: Cesarean Childbirth. NIH Publication No. 82-2067. Bethesda, Md.: National Institutes of Health, 1981. [25.] American College of Obstetrics and Gynecology. New Guidelines for VBAC: Statement of the Committee on Obstetrics: Maternal and Fetal Medicine. Washington, D.C.: American College of Obstetricians and Gynecologists, 1988.

Once again, Dr. LaRue was receiving complaints from the nursing staff and others on the medical-surgical units, about Dr. Lash, his Associate Medical Director. Dr. Lash was charged with working with using staff, physicians, and other members of the patient care team to implement patient care programs at the hospital. The most complex effort at the moment was a shift in approach on the nursing units to a disease management structure. Dr. LaRue had given Dr. Lash the overall approach that was to be used in constructing the disease management systems and had asked him to oversee the development of protocols and guidelines for the care of pediatric asthmatic and diabetic patients.

Because these two disease management programs were meant to be test cases for the development of a total disease management system at the hospital, Dr. LaRue was very thorough in his presentation to Dr. Lash. When he felt confident that Dr. Lash understood both the substance of the undertaking and the timetable that needed to be followed, he had asked Dr. Lash to proceed as independently as possible, reporting back only when he needed clarification or had a document developed sufficiently to present to the entire staff. He had hoped that Dr. Lash would grab hold of the project and not, as had been his custom, delay and defer endlessly to others for input.

Now, he learned, Dr. Lash was proceeding as he had in the past on projects. Nurses told him that Dr. Lash had provided no input to the process, instead waiting for others to make suggestions and then joining the bandwagon when a consensus developed. The nurses and others were frustrated because the project had no leadership and was taking far more energy and time than any of them had to give. Dr. LaRue's fear was that the whole thing would founder in this test stage and make it very difficult to ever make the move to the desired structure for patient care.

Although Dr. LaRue had discussed these deficiencies with Dr. Lash in the past, the new evidence seemed to make some kind of specific action imperative. He just couldn't afford to see this hospital initiative crippled in its infancy. He wanted Dr. Lash to succeed, but not at the cost of project failure. What, he wondered, should his next steps with Dr. Lash be?

Medical Director Survey Information Regarding VBAC Attitudes and Practices

I. Respondent information

A. Geographical location

B. Organization and VBAC practices

1. HMO Medical Director

a. Number of members

b. Number of deliveries annually

c. Number of C-sections annually

d. Percentage of previous C-sections delivered via VBAC

2. Hospital Medical Director

a. Number of beds

b. Number of deliveries annually

c. Number of C-sections annually

d. Percentage of previous C-sections delivered via vbac

3. Other Medical Director

a. Organization (insurance company, medical group, etc.)

b. Number of lives/patients

c. Number of deliveries

d. Number of C-sections annually

e. Percentage of previous C-sections delivered via VBAC II. Medical Care Management

A. HMO

1. Model type

2. Contractual relationship with physicians and hospitals

B. Hospitals

1. Managed care organization (MCO) contracting practices

2. Contractual relationship with MCOs

C. Other settings

1. Contractual relationships with payors and providers III. Organizational VBAC characteristics

A. HMO

1. VBAC policy

2. VBAC performance monitoring

3. VBAC reimbursement

B. Hospital

1. VBAC policy

2. VBAC performance monitoring

3. VBAC reimbursement

C. Others

1. VBAC policy

2. VBAC performance monitoring

3. VBAC reimbursement IV. Medical Director VBAC attitude

A. Is failure to attempt an appropriate VBAC a quality issue?

B. Should the provider be held a countable for this failure?

C. What are appropriate financial consequences for failure to attempt VBAC?

1. Should the Ob/GYN be reimbursed at a vaginal delivery rate?

2. Should a woman who insists on a C-section be liable for the extra charges?

3. Should a hospital be reimbursed only for a vaginal delivery?