scholarly journals Effect of Transitional Care Model-Based Interventions for Patients with Stroke and Their Caregivers on Increasing Caregiver Competence and Patient Outcomes: A Study Protocol for a Randomized Controlled Trial

Author(s):  
Yasemin Demir Avci ◽  
◽  
Sebahat Gozum ◽  
2021 ◽  
Vol 12 ◽  
Author(s):  
Won Kee Chang ◽  
Won-Seok Kim ◽  
Min Kyun Sohn ◽  
Sungju Jee ◽  
Yong-Il Shin ◽  
...  

Introduction: Early supported discharge (ESD) is a transitional care model aimed at facilitating post-acute stroke patients' discharge to home. Previous studies have demonstrated that ESD provides equivalent patient and caregiver outcomes with superior cost-effectiveness compared to conventional rehabilitation (CR). This study intends to examine the feasibility of ESD in Korea.Methods and Analysis: This study is designed as a multicenter assessor-blinded, randomized controlled trial. Ninety post-acute stroke patients with mild to moderate disability (modified Rankin Scale 1–3) will be recruited from three university hospitals (30 patients per hospital) in Korea and allocated to either the ESD group or the CR group in a 1:1 ratio. Patients in the ESD group will receive individualized discharge planning and goal setting, a 4-week home-based rehabilitation program, and liaison service to community-based resources by a multidisciplinary team. Patients in the CR group will receive rehabilitation practices according to their current hospital policy.Outcomes: The primary outcome is the Korean version of the modified Barthel Index, and the primary endpoint was post-onset 3 months. Clinical outcomes, patient/caregiver reported outcomes, and socioeconomic outcomes will be measured at baseline, 1 month after discharge, 2 months after discharge, and 3 months after onset.Discussion: The efficacy and cost-effectiveness of ESD can vary according to the healthcare system and sociocultural aspects. To establish ESD as an alternative transitional care model for post-acute stroke patients in Korea, its feasibility needs to be examined in prior. This study will add evidence on the applicability of ESD in Korea.Ethical Considerations: The study protocol was reviewed and approved by the Institutional Review Board of Seoul National University Bundang Hospital (IRB number B-2012/654-308). The study protocol was registered at ClinicalTrials.gov (Identifier NCT04720820). Disseminations will include submission to peer-reviewed journals and presentations at conferences.


2021 ◽  
pp. 106620
Author(s):  
Mary D. Naylor ◽  
Karen B. Hirschman ◽  
Kathleen McCauley ◽  
Elizabeth Shaid ◽  
Alexandra L. Hanlon ◽  
...  

2015 ◽  
Vol 49 (3) ◽  
pp. 214-222 ◽  
Author(s):  
Maria Cvach ◽  
Kathleen J. Rothwell ◽  
Ann Marie Cullen ◽  
Mary Grace Nayden ◽  
Nicholas Cvach ◽  
...  

Medical alarm signals are important for alerting clinicians to life-threatening conditions, but the high rate of false alarms can be problematic. Reduction in alarm signals may lead to increased staff responsiveness to alarms and create a quieter environment for patients. The effect of these changes on patient outcomes is uncertain. Methods: We conducted a pilot, prospective, randomized, controlled trial in the cardiac care unit (CCU) to test a study protocol and data collection instruments and to examine the differences in alarms between usual care and altered settings. Subjects were randomized daily to either standard or altered CCU alarm settings. Secondary outcomes included the number of clinically significant events (CSEs) detected, event-triggered interventions (ETIs), frequency of alarms per monitored bed, and patient complications. Results: Over the two-week study time frame, 22 unique patients were enrolled. There were 1,710 alarms over 163 hours of monitoring in the standard group and 1,165 alarms over 169 hours in the study group (P < 0.001). There were more CSEs detected (14 vs. 3) and ETIs (12 vs. 2) in the study group, but sample size was too small to determine efficacy. No cardiac arrests or adverse patient outcomes were observed in either group. All patients were discharged from the hospital. Study protocol and outcomes were feasible and lessons were learned. Conclusion: This study demonstrated feasibility of a study protocol for conducting a randomized controlled trial to evaluate CSEs, ETIs, frequency of alarms, and adverse patient outcomes when altering default alarm settings. A longer study can be performed using a similar study design.


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