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Journal of Occupational & Environmental Medicine:
doi: 10.1097/JOM.0b013e3181a7de5a
Original Articles

A Review and Analysis of the Clinical and Cost-Effectiveness Studies of Comprehensive Health Promotion and Disease Management Programs at the Worksite: Update VII 2004–2008

Pelletier, Kenneth R. PhD, MD(hc)

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Author Information

From the Department of Medicine, University of Arizona School of Medicine, Tucson, Ariz; and Department of Medicine, University of California School of Medicine (UCSF), San Francisco, Calif.

Address correspondence to: Kenneth R. Pelletier, PhD, MD(hc), American Health Association, 1990 North California Blvd., Suite 830, Walnut Creek, CA 94596; E-mail: drkrpelletier@aol.com.

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Abstract

Objective: To conduct the seventh periodic review and analysis of the clinical and cost-effectiveness research conducted in worksite/corporate environments between 2004 and 2008.

Methods: A literature search of US-based research was conducted using a multistage process including MEDLINE, ADI, EDGAR, CARL, Inform, Lexis-Nexis, as well as direct inquiries to key researchers in this area of expertise.

Results: From 2004 to 2008, there were 16 new studies that met the Inclusion/Exclusion criteria. These studies are critiqued and entered into a data table consisting of 13 variables and citations of the 16 new studies.

Conclusions: Clinical and cost-effectiveness research in the worksite/corporate environment continues to evolve although there was only one randomized clinical trial conducted during the most recent interval. There are innovations in pilot studies, quasi-experimental methodologies, and econometric modeling as indicative of future trends.

This article is the seventh in a series of critical reviews of the clinical and cost-effectiveness studies of comprehensive, multifactorial, health promotion, and disease management programs conducted in corporate worksites. As with these previous reviews, the purpose of this article is to review and assess the experimental and quasi-experimental research trials that have focused on clinical and/or cost outcomes of worksite health promotion and disease management interventions. Comprehensive worksite programs are those that provide an ongoing, integrated, program of health promotion and disease management that integrates specific components into a coherent, ongoing program, which is consistent with corporate objectives and includes program evaluation of clinical and/or cost outcomes. This article focuses on peer review studies published during 2004 to 2008. In terms of identifying emerging trends, this commentary draws upon the previous six reviews as well as the new studies conducted during the last 4 years.

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Inclusion and Exclusion Criteria

A comprehensive search was conducted using a multistage process that included a MEDLINE, ERIC, ADI, EDGAR, CARL, Inform, Lexis-Nexis databases, and direct inquires to worksite researches and corporate medical directors. This literature search, focused on 2004 to 2008, resulted in identifying 16 new studies to which the following inclusion criteria were applied to research conducted in the United States; results published in English; minimal methodological quality of a nonexperimental design with premeasures and postmeasures but no comparison group; quasi-experimental or premeasures and postmeasures with a nonrandomized control group; to a true experimental design with premeasures and postmeasures plus a randomized control group evaluated for clinical and/or cost outcomes. Exclusion criteria were studies research projects conducted outside of the United States and non-English publications. That resulted in the identification of 16 studies for this seventh, analytic review.

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Findings Extraction Methods

Finding extraction and analysis of the 16 studies was undertaken by the author and medical student research assistants by extracting the relevant population, intervention design, clinical results, and cost outcomes from the published article. Findings are summarized in a table format as in previous reviews that extracts and describes each study by: 1) study author(s) and publication date; 2) corporate site; 3) purpose of the evaluation; 4) employee population; 5) number of percent of programs participants; 6) number of employees included in the evaluation; 7) brief description of the intervention; 8) evaluation design; 9) evaluation time period; 10) clinical and cost outcomes; 11) research rating; and, 12) most significant findings and conclusions. During the most recent review period, several studies have been conducted using econometric, statistical methodologies rather than formal research designs. To accommodate this innovation, the specific type of econometric modeling is included under the “Intervention Design” column of the Table. Another addition in response to the last 4 years is the inclusion of a new Web site or “url” column for the studies cited in the table rather than just a hard copy citation. Based on these 16 studies, a brief methodological critique is conducted. Conclusions regarding study quality and new trends during the time period of 2004 to 2008 are discussed.

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Major Conclusions

Results from randomized clinical trials and quasi-experimental designs suggest that providing individualized, risk reduction for all employees including high-risk employees within the context of comprehensive programming is the critical element of worksite interventions.1 Despite the acknowledged limitations of the current methodologies of the 16 new studies during 2004 to 2008, the vast majority of more than 153, including the current 16 studies, research studies to date indicate positive clinical and cost outcomes. There is one important caveat in this and all research that studies, which do not demonstrate statistically significant results, tend not to be published and may result in a publication bias of positive outcomes. It is important to note that there has been a marked decline in both the quantity and quality of studies during 2004 to 2008. With an increasing demand for clinical and cost outcomes to justify corporate investments in health promotion and disease management, this is an ominous trend. Of the 16 studies published in 2004 to 2008, only one was a true experimental design.2 This decline in both the number and quality of studies is the lowest than in the previous five reviews and is potentially a major, negative impact on the corporate health promotion and disease management field.

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Background

Comprehensive health promotion and disease management programs have evolved significantly in both large and small worksites during the last three decades. Historically, the first published worksite disease management intervention was conducted in 1974 at Gimbel’s Department store in New York City. That early intervention focused on screening asymptomatic employees for hypertension. Based on that screening of 180 employees, there were 94 identified hypertensives who were retained in treatment for 1 year with 81% achieving satisfactory blood pressure reduction.3 An impressive prototype especially since hypertension still remains one of the most poorly controlled risk factors for cardiovascular disease. Large self-insured and self-administered corporate medical plans are placing more emphasis upon comprehensive health promotion and disease management programs.

Inherent to managed care is increasing emphasis on both clinical and cost effectiveness.4 With the current generation of worksite programs, there is a greater emphasis upon disease management with high-risk employees, combinations of public health and individualized behavioral risk management, and utilization of telemedicine delivery technologies and inclusion of performance and productivity measures in the economic analyses.3,5,6 Disease management programs may be more likely than general health promotion programs to generate return on investment (ROI) because they focus on high-risk individuals who typically impact medical or related costs, such as absenteeism and productivity, in the near term. However, that possibility has yet to be demonstrated by rigorous research. During the 2004 to 2008 interval, 7 of the 16 new studies2,7–12 reported positive ROI.

Increasingly, the research evidence supporting both the clinical and cost effectiveness of such programs is becoming more compelling. Previous literature reviews of the clinical and cost outcomes of comprehensive, health promotion and disease management programs in the worksite have been published by this author13–18 and other researchers.19,20 Based upon these reviews of overall, comprehensive health promotion and disease management programs in worksites, 137 studies have been cited in a previous series of six reviews.13–18 Collectively, these reviews clearly indicate that comprehensive interventions do evidence both clinical and cost effectiveness.19–23 Studies cited in this article and in previous reviews are providing corporations, health insurance providers, managed care organizations, consulting firms, and government with the preliminary data to guide program design, implementation, with clinical and cost-outcome evaluations.

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Data Sources

For this review and commentary of multifactorial health promotion programs in worksites focused on risk factor and/or disease management, a literature search was conducted using a multistage process that included a MEDLINE, ERIC, ADI, EDGAR, CARL, Inform, and Lexis-Nexis bibliographic search of databases, a manual search of specific journals, a reference list search, and direct inquiries to worksite health promotion and disease management researchers. This search resulted in the identification of 16 new studies, which met the selected by inclusion/exclusion criteria of studies that examined the clinical and/or cost outcomes of such multifactorial programs. Analysis consists of an analytic literature review of the data findings of the new studies from 2004 to 2008 as well as relevant findings from earlier studies and previous reviews.

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Inclusion and Exclusion Criteria

For purposes of this analytic review, comprehensive worksite-based health promotion and disease management programs refer to, “Those programs that provide an ongoing, integrated, program of health promotion and disease prevention that integrates the particular components (ie, smoking cessation, stress management, lipid reduction, etc) into a coherent, ongoing program that is consistent with corporate objectives and includes program evaluation.” This review is limited to articles that meet these criteria. Single-risk factor interventions, even though they might be reported as clinical and cost effective, such as smoking cessation and hypertension screening, are not included. Studies or demonstration projects of a nonexperimental design were also excluded. Anecdotal, purely descriptive, and qualitative studies were excluded. All cited research has been published in peer review journals between 2004 and 2008. All articles were published in English and all research was conducted in worksites in the continental United States.

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Findings Extraction and Analysis

Extraction and analysis of the 16 studies was undertaken by the author and medical student research assistants by citing the relevant population, intervention design, clinical results, and cost outcomes from the published article. Each article was read in its entirety, versus the abstract only, to ensure that the reported clinical and cost outcomes were both assessed by an appropriate research design and that the stated results were supported by the reported data. Because it is crucial to consider the methodological rigor of the research methodology included in each study, the resulting table only includes research that fulfills one of three categories: 1) nonexperimental design with preoutcomes and postoutcomes but no comparison group (***); 2) quasi-experimental conducted study with premeasure and postmeasure and a nonrandomized comparison or control group (****); or 3) study with premeasures and postmeasures plus a randomized comparison or control group with clinical and/or cost outcomes (*****). These studies are summarized in Table 1.

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Emerging Trends in Worksite Health Promotion and Disease Management Interventions

For the 2000 to 2004 time period, there are 12 significant trends that are evident from this updated review.

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Fewer Clinical Trials

An unfortunate, marked decrease in the number of formal randomized, control trials in worksites. Only one study2 was conducted as a rigorous, true experimental design or randomized clinical trial (RCT). This may be due to the difficulty in obtaining either government or private foundation funding for such research.

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Increase in Demonstration Projects

Based on this observation, there is a major trend toward companies conducting very focused, preexperimental or nonexperimental demonstration disease management programs on areas that are of specific importance to the employer.2,7–10,19–27 This trend was first noted in the previous reviews of 2001 and 200418 and continues more strongly in the last 4 years. Although these are not at the usual level of randomized control trials sophistication, they do represent both the most significant trends from 2000 through 2004. Although lacking in experimental rigor, the nonexperimental and even preexperimental pilot studies do indicate new areas of innovation for future programs and evaluation using more rigorous methodologies. Such demonstration projects by corporations are commendable especially if they are precursors more formal research designs and analysis.

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Observational Studies

Following from this trend is an additional one where companies conduct an observational study to track the preclinical and postclinical and cost outcomes of participants versus nonparticipants in comprehensive worksite programs. Most notable are the Citibank studies conducted by Ozminkowski et al.28

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Long-Term Follow-Up Studies

Significant, long-term follow-up to existing programs indicating sustained risk, morbidity, and cost reductions at 4 years with Johnson & Johnson29; an ROI analysis conducted by highmark of its employee wellness program during 4 years12; and, a prospective ROI projection of the Dow Chemical Company’s risk-reduction programs during 10 years.30

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Statistical Modeling of Projected Risks and/or Return on Investment

Within the last 4 years, there has been an emergence of predictive statistical modeling to monetize the linkages between changes in risk factors and the subsequent impact on ROI. Among these published research studies are an estimate of the ROI from changes in employee risk factors at Dow30; estimated savings gained from the participation of a Medicare population of 59,324 retirees who used a Health-Risk Assessment compared with those who did not11; and most recently, development of a low cost, accurate ROI estimation model to evaluate outcomes from a worksite-based obesity management intervention.31

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New Outcome Measures

Development of new measurements to link medical and productivity/performance costs such as the “Presenteeism” or “SPS6” scale32 as well as more sophisticated data integration systems continuing the pioneering research by Burton at BankOne33 and predictive projections linking medical risks and costs during a 10-year interval.31 Also assessments of a positive impact on short-term disability (STD) and long-term disability (LTD)34 and STD only.35

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Health and Productivity Management (HPM) Strategies

Very significantly is the extension of ROI analyses to include other outcomes resulting from health interventions such as performance and productivity. Very few newly approved pharmaceuticals actually save money, but they can improve health at a reasonable expense.32 In the pharmacy literature, net increases in spending that are up to $50,000 may be deemed acceptable or cost effective, if these dollars will save at least one quality-adjusted year of life.36 However, this widely accepted methodology has rarely been used when considering the value of health improvement programs.32 By contrast, the more demanding objective of realizing net savings has generally been required in evaluations of health and productivity management (HPM) programs. As employers and payers realize that investments in HPM are long term in nature and that there may be a significant lag between improvements in health and savings in medical expenditures or improvements in productivity, the significance of documenting ROI may become more sophisticated. This is more likely to occur if it can be demonstrated that investments that yield cost-effectiveness in the short run will subsequently lead to net cost savings in the intermediate and long run.

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Participant Versus Nonparticipant Studies

Employer oriented studies that are purely observational of participants versus nonparticipants7,37–40 do demonstrate both clinical and cost outcomes but are confounded by the classical issue of self-selection and noncomparable companion groups.

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Preexperimental Studies

Many of the preexperimental studies11,24,27,30,40–42 again seem to indicate both clinical and cost effectiveness but in lacking any comparison group, these findings may or may not prove to be substantiated by more rigorous future assessments.

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More Sophisticated Economic Analyses

A recent economic analysis of 10 years of economic outcomes from these 12 current studies as well as those cited in previous reviews13–17 concluded that the evidence is “very strong for average reductions in sick leave, health plan costs, worker’s compensation, and disability costs of slightly more than 25%.”43 Whether the clinical and cost outcomes to date are this positive or not is clearly a matter of different interpretation of the research data to date. However, given the clear methodological flaws in the study designs and evaluations combined with the lack of standardization of the clinical and especially the cost outcomes, this issue remains to be resolved by the future and more rigorous, true experimental, RCTs conducted in worksites over multiple years with adequate follow-up times.

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Utilizing New Information Technologies

Information technologies such as personal health records, electronic medical records, interconnectivity, web-based health improvement programs, and information portals will strongly influence the efficiency of health care delivery and health improvement efforts. These technologies will evolve into an interconnected system with appropriate tracking, reminders, oversight, reporting, and communication components. Standardized information systems will enable the sharing of the most basic health information (eg, medical history, diagnostic test results, and vital signs) to the most sophisticated (eg, nanotechnology-based remote biometric screening information).44 Such innovations will generate the information infrastructure whereby health promotion services are provided to keep the healthy population well. Furthermore to provide disease, demand, and case management to individuals who are already at high risk, disabled, or with diagnosed chronic conditions to prevent exacerbation of their illness. Seamless health management is required for a sustainable health care system. A significant component of that system is integration of the multidimensional interventions that support the population, including disease management, utilization management, primary care delivery, and health improvement programs.45 Additionally, nanotechnology will permit ongoing, noninvasive monitoring and telemetry of an array of vital signs, including heart rate and regularity, aerobic capacity, glucose/insulin levels, blood pressure, sleep patterns, stress levels at the neurophysiological and hormonal level, and other indicators of ongoing health status.46 Thus, the process of biometric screening will evolve substantially in the coming years, to take advantage of this new technology. Ongoing, in vivo information for self-care and for remote monitoring of ongoing health and/or illness status may then serve as the basis for developing, maintaining, or enhancing personalized risk management interventions. Superordinate to individual imaging technologies, biomonitors, nanotechnology, and more effective behavioral change will be a “telemedicine” delivery model.18 Computers, e-mail, cell phones, and other evolving wireless devices will create a convenience of access and use that is known to be a major determinant of sustained healthy behavior. Such a telemedicine model may be more cost effective than our current infrastructure. Although this is yet to be determined, it has the potential for disseminating relevant, timely, and targeted health information to patients and their health care providers.

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New Government Funded Studies

At the present time, there are several large studies underway to assess innovative HPM models. Among these studies are the Centers for Medicare and Medicaid Services’ Senior Risk Reduction Demonstration,47 the National Heart Lung and Blood Institute’s Obesity Management in the Workplace studies,48 and the Centers for Disease Control and Prevention’s Health Protection Research Initiative.49 It is likely that such programs will be favorably influenced by these ongoing and newly funded research studies. Further, these studies will increase our knowledge about the relative effectiveness of behavioral change interventions and the manner in which these programs can be delivered most efficiently. Computer-based interactive programs, plus health coaching, specialized referrals, and financial incentives need to be further developed and evaluated. Clinical and cost-effectiveness studies behavior change in such areas as improving pharmacological compliance, weight loss, and smoking cessation are still evolving. Large-scale government research will likely inform future program design and implementation.50 Armed with better and more practical data on what works, federal, state, and local governments can play a larger role in disseminating information about evidence-based programs, with the expectation that such dissemination will prompt more employers to adopt them. Through legislative or other initiatives, government agencies may also support financial incentives such tax credits to encourage employers to implement effective programs.51 Collaborative research efforts between the public and private sector are an encouraging direction.

One question that frequently arises is what type or types of interventions are most successful either in terms of implementation and/or outcomes. There is no readily generalizable answer to that question. As a best approximation, it is useful to consider the area of “best practices” of such interventions. As a caveat, it is important to note that not all workplace health promotion programs are created equal. There is a great deal of variation in program design and execution. To address what constitutes the best and promising practice, a necessary first step is to examine the outcomes of the most effective programs.52–55 By analyzing a series of benchmarking studies, it is possible to identify common themes. One such review56 identified six elements frequently found among best practices: 1) organizational commitment; 2) incentives for employees to participate; 3) effective screening and triage; 4) state-of-the-art theory and evidence-based interventions; 5) effective implementation; and, 6) ongoing program evaluation. Similarly, another assessment of the best practices components54 identified the following characteristics of sustainable programs: 1) linking of program to business objectives; 2) executive management support; 3) effective planning; 4) employee input when developing goals and objectives; 5) wide variety of program offerings; 6) effective targeting of high-risk individuals; 7) incentives to motivate employees to participate in the program, leading to high participation rates; 8) program accessibility; 9) effective communications; and, 10) evaluation of effectiveness. Many of the studies cited in this review as well as in the six prior publications, do have many but not all of these characteristics. Although not definitive, these checklists do provide a set of “best practices” that are more likely than not to insure a successful intervention in terms of both implementation and outcomes.

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Methodological Critique

Methodological rigor of worksite health promotion evaluation and disease management studies has evolved considerably during the past three decades. Methodological challenges continue to be formidable, and further innovation and refinement are necessary. All of the currently reviewed studies indicate favorable clinical and/or cost outcomes. As in the previous six reviews, there are caveats and limitations to all of these studies in terms of the actual research design, participation rates, attrition from the sample, self-selection, duration of the intervention, time intervals on follow up, publication bias, cost outcomes and/or ROI documentation, as well as the inherent limitations of nonexperimental demonstration and pilot projects.

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Discussion and Future Recommendations

For the 16 studies cited during the 2004 to 2008 time period, there is an increase in a trend toward a decrease in the number of formal randomized, control trials or quasi-experimental designs in worksites. This may be due to the difficulty in obtaining either government or private foundation funding for such research. However, it may indicate an acknowledgment of the limitations of the randomized, control trial especially in worksite programs. According to the report of the WHO European Working Group on Health Promotion Evaluation (Health Promotion Evaluation: Recommendations to Policymakers, WHO, 1998), “The use of randomized control trials to evaluate health promotion initiatives is, in most cases, inappropriate, misleading and unnecessarily expensive.”57 Based on this observation, there is a significant trend toward companies conducting very focused preexperimental, pilot projects in disease management areas that are of specific importance to the employer and evaluating such interventions as pre and post demonstration projects with clinical and/or cost outcomes.58–63 Such focused disease management interventions are clearly of more extensive use among employers in the last 4 years compared to formal, randomized, control trials.

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Conclusion

In reviewing the studies here, the most promising future directions seem to be with disease management programs that combine comprehensive plus high-risk interventions that focus on a dose response model of increasing levels of intensity. Although it is difficult and costly to conduct, randomized trials, such studies would greatly contribute to our understanding of what constitutes an effective intervention in terms of both clinical and cost outcomes. Results of the comprehensive, multifactorial, health promotion, and disease management interventions in worksites reviewed here provide guarded cautious optimism about the clinical and/or cost effectiveness of these worksite programs. Additionally, they provide initial insights regarding the critical components and characteristics of successful programs. It is significant to note that in May of 2004, the Centers for Disease Control issued the first major request for research proposals focused on clinical and cost outcome evaluations of worksite focused interventions. At this time, the most salient issue for managed care organizations and corporations to address is not whether worksite health promotion and disease management programs should be implemented to reduce risks and enhance productivity, but rather how such programs should be designed, implemented, and evaluated to achieve optimal clinical and cost effectiveness.

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