Drug company stresses new approach to data collection
Drug company stresses new approach to data collection
Follow-up surveys should be part of the intervention
Riding high on the results of six-month follow-up data from a pilot project for its Asthma Self-Management Program (ASMP), Research Triangle Park, NC-based pharmaceutical company GlaxoWellcome is gearing up for a major push into the arena of disease management. Its major selling point? A unique approach to data collection and analysis that company officials contend should spark the interest of employers and health plans.
"We run our [disease management programs] using the skills we’ve acquired in designing, managing, and analyzing data from clinical trials," says Gary Slatko, MD, MBA, vice president of operations in the care management division at GlaxoWellcome. "[To analyze data], you simply look at whether the patient has received a set of interventions [and which ones], look at the outcomes, and then use regression techniques to determine which combinations of interventions had the largest impact on which sets of patients."
Implemented at eight sites, including managed care organizations, allergy specialty clinics, and corporations, the asthma project consisted of eight-week patient education sessions. A pre-project survey revealed that 57% of prospective participants felt anxiety or depression because of their asthma. Of the 140 people who completed the program, more than 90% reported no emotional problems three months later. Six months later, 75% continued to report no problems.
Thirty percent of patients also reported fewer difficulties performing daily indoor or outdoor work. In addition, whereas 27% of the project participants had missed at least one day of work or school due to asthma in the previous month, only 3.2% missed a day or more three months following the project. The graduation rate for patients enrolled in the program was 85%. All participants reported that they would recommend ASMP to others. Although many of the patients in the early phase of the program suffered from only mild to moderate asthma, the expanded program, which encompasses 16 sites and about 480 participants, is enrolling patients with more severe symptoms.
Slatko attributes much of Glaxo Wellcome’s success in disease management to effective pre-screening. "One of the most important steps before you intervene is to try to stratify an index of the patients as to whether they are at high, medium, or low risk for subsequent decompensation," he says. "Then you would design your program in order to apply the most intensive and expensive combination of interventions toward the patients that are going to be at highest risk."
With all of its disease management programs, including asthma, HIV, and gastroesophageal reflux disease, Glaxo’s care managers consult a "wide spectrum of data sources" when collecting data, says John Paul, PhD, director of clinical economics and outcomes assessment at Glaxo Wellcome. Among the most important sources, particularly when working with managed care organizations, is retrospective medical claims data, which Glaxo uses not only for measuring outcomes but to identify prospective patients on the front end.
"We want to work to learn what types of physician guidelines and practice guidelines are in place," Paul says. "We take the claims data and try to assess the current status of the diseases, what the needs are, using the data to help identify patients."
Data collection reinforces learning
Paul adds that, occasionally, when retrospective claims data are deemed inadequate, Glaxo’s care managers supplement it with pharmacy claims data, laboratory data, or even perform a screening survey to get patient-reported data upfront. "Some plans now have health-risk appraisals, or even SF-36s as part of their routine care program," Paul says. "And often these can be linked in with claims experience. You can build a fairly sophisticated algorithm for selecting patients by combining these different data sources."
In addition, having such data upfront allows disease managers to establish a baseline with which they can compare outcomes data to assess a program’s impact, Paul says.
For example, baseline information for ASMP focuses on patients’ basic knowledge of these diseases. After the educational intervention, care managers follow-up to retest patients’ knowledge at three, six, nine and 12 months to assess the impact of the program over time.
"We know that after eight weeks of intensive classes, they’re probably at the peak of what they’ve learned and absorbed," Paul acknowledges. "So the impact over time would reflect perhaps a decay in their learning on the program. We’ve seen this with ASMP, where their knowledge, attitudes, and practice actually decline over time."
Paul notes, however, that the process of collecting such follow-up data should be regarded as being as much a part of the intervention as the teaching phase of the program. "That’s one of the points I try to make with my implementation and development colleagues," says Paul. "When we ask people if they’re regularly using their asthma diary to record symptoms, if they’re using their peak flow meter and recording the results, and if they’re confident that they know how to manage an asthma attack, we’re not just seeking outcomes data. We’re also hoping that this will serve as a new stimulus for their learning. They’ll say, Oh, I haven’t been using my peak flow meter, but I’m glad you reminded me.’"
Device feeds peak flow data to docs
Although Glaxo Wellcome’s asthma program doesn’t make provisions for feeding patient information back to primary care physicians, the program does make an option called airWatch available to purchasers. AirWatch is an electronic peak flow monitoring and data system capable of automatically feeding back to physicians and other health care providers information about patients’ respiratory status. Manufactured by Enact Health Management Systems, based in Mountain View, CA, the airWatch device includes a small modem. A patient connects the modem to a telephone line, presses a button on the peak flow meter, and data are sent electronically to a central computer. The computer then generates a report based on the data, which is sent to the patient’s designated physician.
"The use of feedback devices and other tools to feed information back to the provider is probably a core technology to disease management in general," says Slatko. "But the importance depends on the disease state being managed." Slatko contends that in less stable chronic conditions, such as congestive heart failure, the need for effective feedback is more urgent. For such conditions, Glaxo care managers communicate with physicians by telephone on a weekly or bi-weekly basis.
[For more information about Glaxo Wellcome’s disease management efforts, contact:
John Paul, PhD, director of clinical economics and outcomes assessment, care management division, GlaxoWellcome, Five Moore Drive, PO Box 13398, Research Triangle Park, NC 27709. Telephone: (919) 848-2687.
Gary H. Slatko, MD, MBA, vice president of operations, care management division, GlaxoWellcome, Five Moore Drive, PO Box 13398, Research Triangle Park, NC 27709. Telephone: (919) 848-2687.]
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