Nursing clinical research protocol education program.

We prospectively investigated the large-scale implementation of a respiratory-therapist-driven protocol (TDP) that included 117 respiratory care practitioners (RCPs) managing 1,067 patients with respiratory failure over 9,048 patient days of mechanical ventilation. During a 12-mo period, we reintroduced a previously validated protocol that included a daily screen (DS) coupled with spontaneous breathing trials (SBTs) and physician prompt, as a TDP without daily input from a physician or "weaning team." With graded, staged educational interventions at 2-mo intervals, RCPs had a 97% completion rate and a 95% correct interpretation rate for the DS. The frequency with which patients who passed the DS underwent SBTs increased throughout the implementation process (p < 0.001). As the year progressed, RCPs more often considered SBTs once patients had passed a DS (p < 0.001), and physicians ordered more SBTs (46 versus 65%, p = 0.004). Overall, SBTs were ordered more often on the medicine than on the surgical services (81 versus 63%, p = 0.001), likely reflecting medical intensivists' prior use of this protocol. Important barriers to protocol compliance were identified through a questionnaire (89 respondents, 76%), and included: Physician unfamiliarity with the protocol, RCP inconsistency in seeking an order for an SBT from the physician, specific reasons cited by the physician for not advancing the patient to a SBT, and lack of stationary unit assignments by RCPs performing the protocol. We conclude that implementation of a validated weaning strategy is feasible as a TDP without daily supervision from a weaning physician or team. RCPs can appropriately perform and interpret DS data more than 95% of the time, but significant barriers to SBTs exist. Through a staged implementation process, using periodic reinforcement of all participants in ventilator management, improved compliance with this large-scale weaning protocol can be achieved.

Clinical Protocols↗

PubMed1999

Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research.

OBJECTIVE: Policy and clinical management decisions depend on data on the health and cost impacts of psychiatric treatments under usual care, i.e., effectiveness. Clinical trials, however, provide information on treatment efficacy under best-practice conditions. An understanding of the design, analysis, and conventions of both efficacy and effectiveness studies can lead to research that better informs clinical and societal questions. METHOD: This paper contrasts the strengths and limitations of clinical trials and effectiveness studies for addressing policy and clinical decisions. These research approaches are assessed in terms of outcomes, treatments, service delivery context, implementation conventions, and validity. RESULTS: Clinical trials and effectiveness research share problems of internal and external validity despite more attention to internal validity in clinical trials (e.g., randomization, blinding, standardized protocols) and to external validity in effectiveness studies (e.g., community-based treatments, representative samples). CONCLUSIONS: To develop research at the interface of clinical trials and effectiveness studies, research goals must be redefined, and methods, such as cost-utility and econometric analyses, must be shared and developed. Development of hybrid designs that combine features of efficacy and effectiveness research will require separation of conventions such as frequency of follow-up, intensity of measurement, and sample size from the central scientific issues of aims and validity.

Clinical Protocols↗