Better Respiratory Education and Treatment Help Empower (BREATHE) study: Methodology and baseline characteristics of a randomized controlled trial testing a transitional care program to improve patient-centered care delivery among chronic obstructive pulmonary disease patients.

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of hospitalizations. Interventional studies focusing on the hospital-to-home transition for COPD patients are few. In the BREATHE (Better Respiratory Education and Treatment Help Empower) study, we developed and tested a patient and family-centered transitional care program that helps prepare hospitalized COPD patients and their family caregivers to manage COPD at home. METHODS: In the study's initial phase, we co-developed the BREATHE transitional care program with COPD patients, family-caregivers, and stakeholders. The program offers tailored services to address individual patients' needs and priorities at the hospital and for 3months post discharge. We tested the program in a single-blinded RCT with 240 COPD patients who were randomized to receive the program or 'usual care'. Program participants were offered the opportunity to invite a family caregiver, if available, to enroll with them into the study. The primary outcomes were the combined number of COPD-related hospitalizations and Emergency Department (ED) visits per participant at 6months post discharge, and the change in health-related quality of life over the 6months study period. Other measures include 'all cause' hospitalizations and ED visits; patient activation; self-efficacy; and, self-care behaviors. DISCUSSION: Unlike 1month transitional care programs that focus on patients' post-acute care needs, the BREATHE program helps hospitalized COPD patients manage the post discharge period as well as prepare them for long term self-management of COPD. If proven effective, this program may offer a timely solution for hospitals in their attempts to reduce COPD rehospitalizations.

Effect of local anesthetics on patient recovery after transrectal biopsy.

OBJECTIVES: To determine the analgesic efficacy of local anesthetics injected lateral to the seminal vesicles before prostate biopsy, during and immediately after the procedure, because pain is a common side effect of transrectal ultrasound-guided prostate biopsy. METHODS: Patients were randomized to receive 5 mL of either 1% lidocaine or sterile normal saline injected (under ultrasound guidance) lateral to the seminal vesicles bilaterally before performance of the prostate biopsies, with the patient and physician unaware of the treatment group. Five minutes after the injection, a series of 12 prostate biopsies were performed. A visual analog scale (VAS) for pain at rest and with activity was obtained before the biopsy (preprocedure VAS) and immediately (intraprocedure VAS) and 30 minutes (postprocedure VAS) after the biopsy. Surveys examining the patients' expectations for biopsy pain were administered before and immediately after the biopsy. RESULTS: No significant differences were found between the groups with regard to demographic data, VAS pain scores at rest and with activity, and survey results. CONCLUSIONS: Injection of lidocaine lateral to the seminal vesicles before prostate biopsy did not diminish biopsy-associated pain.