CHARLESTOWN, Mass. — Temple University School of Medicine recently selected PHT Corp.’s LogPad for use in a novel study investigating the potential clinical benefit of using call centers, staffed by pulmonary medical personnel, to support and follow up with Pennsylvania residents suffering from chronic obstructive pulmonary disease (COPD). This trial evaluates the impact patient access to a call center may have on reducing hospitalizations and deaths due to COPD exacerbations and on improving patient quality of life, lung function and everyday activity levels.
In the study, 400 subjects enrolled at four Pennsylvania sites, coordinated by Temple, will be assigned individual LogPads on which they will record and transmit symptom and quality of life data on a daily basis. The LogPad, implemented by PHT on Palm Inc. handheld devices, automatically calculates a graded score from baseline and triggers an on-screen alert telling the patient to contact the call center if certain thresholds are reached. At the same time, PHT StudyWorks™ allows call center personnel to review real-time reports online, enabling them to prepare for a subject’s call or to identify and contact patients who triggered an alert but chose not to call.
“COPD patients frequently have prodromal symptoms that herald an impending exacerbation which are rarely reported to their physicians,” said Gerard J. Criner, M.D., professor of medicine at Temple University School of Medicine and director of the Temple Lung Center at Temple University Hospital. “The capability for caregivers to identify early warning signs of an exacerbation in real time is lacking. Improving the classification and quantification of symptoms that herald an exacerbation may greatly benefit those who suffer from COPD.”
According to the Pennsylvania Department of Health, which awarded more than $4.7 million to implement PA-SCOPE, COPD was responsible for 8 million office visits, 1.5 million emergency room visits, 726,000 hospitalizations and 119,000 deaths in the year 2000 throughout the United States. The disease is especially problematic in Pennsylvania, where chronic respiratory lung diseases are the fourth leading cause of death and the age-adjusted mortality rate for COPD is 80 percent higher than the national average. In fact, Pennsylvania spends at least $400 million per year treating acute episodes of COPD.
It is difficult to imagine the feasibility of implementing this study on paper. The graded scoring on the LogPad removes the burden from subjects to perform manual daily calculations of their score for two years. With a paper diary, subjects could potentially make calculation mistakes or forget to complete them every day. In addition, real-time access to subject diary compliance, symptom and triggered alert data empowers site staff with information on symptom scores and alerts every day, rather than only during study visits.
“The main benefit of PHT’s solution is the ability to review the patient symptom data in real time,” said Carla Grabianowski, RN, BSN, CCRP, research nurse coordinator (Pulmonary & Critical Care Medicine) at Temple University Hospital. “In this study, patients go six months between study visits. If we had used paper diaries for the study, we may not have had any information during this time. It would have been harder to track compliance and whether patients were scoring correctly. Most importantly, it would have been difficult to know whether a patient in the group with access to the call center number was exhibiting early signs of an exacerbation and in need of call center intervention if those patients simply chose not to call when they should have.”
While results of the study are preliminary, PA-SCOPE is a novel use case of electronic patient diaries, which are normally employed to collect ePRO data evaluating the effects of a study drug.
For more details on the study, review the full case study located online at www.phtcorp.com/Experience/case_studies.asp.