The effects of additional care by a pulmonary nurse for asthma and COPD patients at a respiratory outpatient clinic: results from a double blind, randomized clinical trial

OBJECTIVE: To assess the effects of additional information based nursing care program in the treatment of asthma and COPD patients at a pulmonary outpatient clinic. METHODS: In a double blind, randomized clinical trial, 191 patients were allocated to an additional care group or control group. Patients in the intervention group received a protocol-based education program on individual basis by a pulmonary nurse on individual basis (average duration 60 min per patient). All patients were masked for the trial objectives. Effectiveness was expressed in terms of knowledge, inhalation technique, self-management, exacerbation rate (primary outcomes), and health-related quality of life and satisfaction with care received (secondary outcomes). The time interval between the initial and final assessments was 6 months. RESULTS: Ninety-seven patients were randomized into the additional care group and 94 into the control group, of which 157 had a complete dataset. (Un)adjusted analyses did not show differences between treatment groups in terms of knowledge, inhalation technique, self-management, health-related quality of life, and satisfaction with care. Multivariate logistic regression adjusting for baseline covariates showed a significant treatment effect with regard to exacerbation rate (odds ratio=0.35; 95% confidence limits: 0.13/0.94, p=0.04). CONCLUSION: With the exception of exacerbation rate, we could not demonstrate efficacy of additional nursing care in a broad range of outcome parameters. PRACTICE IMPLICATIONS: At present we do not recommend to implement our patient-tailored education program in daily practice.