The Science Journal of the American Association for Respiratory Care
Background: Clinical research depends on reliable follow-through in every aspect of the project. A system must be in place to identify all potential study patients, to successfully enroll and follow eligible subjects, and to characterize those lost in the enrollment and follow-up process. A large, nationally funded study at our institution piloted the use of hospital-based Respiratory Care Practitioners (RCP) to execute these aspects of an outcomes-based research project. The project manager, as well as telephone, in-patient and home care follow-up, and data abstraction and entry personnel were recruited from the Respiratory Care Department.
Methods: A prospective cohort study of children age 2 years and older treated in an ED for acute asthma exacerbation was undertaken. The goal of the study was to identify, at the time of ED visit, significant historical and clinical patient characteristics for the development of a prediction model of ED disposition. ED RCP's were involved in subject identification, patient enrollment, clinical assessment and treatment during the acute exacerbation, and in inpatient and outpatient follow-up. Three main outcomes were measured: need for hospital admission, clinical severity, and functional status. Clinical severity was measured on all asthma patients with a validated scoring system. Both functional assessment and clinical severity were measured at the time of ED visit, 24 hours (as in-patient, telephone interview or home visit) and two weeks after discharge. Interrater reliability indicated substantial interobserver agreement among RCP's and ED physicians.1
Results: 679 patients have been enrolled to date. 98% of all eligible patients were identified and approached by the ED RCP, 7% refused, 91% were successfully enrolled. Twenty-five percent of enrolled patients were admitted and followed-up as in-patients. Five percent of patients discharged from ED received a home visit at 24 hours. The remainder of enrolled patients had follow-up at 24 hours by telephone interview. All patients were contacted by telephone for two-week follow-up. Enrollment, clinical assessment and treatment by RCP's was part of routine patient care. Outpatient follow-up and data management (abstraction and data base entry) was completed by RCP's hired by the study on an hourly basis.
|Percent eligible enrolled||91%|
|Successful telephone follow-up||93%|
|Successful in-patient follow-up||96%|
Conclusions: Our experience has proven that the utilization of hospital-based Respiratory Care Practitioners in a large, nationally funded outcomes-based research project can provide excellent enrollment, assessment, follow-up and data management.
1. Stevens, Gorelick, Schultz. Interrater Agreement in the Evaluation of Pediatric Asthma Severity. Academic Emergency Medicine. May 1999 (abstract)