Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,383
- 试验地点
- 2
- 主要终点
- Change in Gait Speed
研究概览
简要总结
This cluster randomized clinical trial seeks to provide large-scale, foundational evidence that high-intensity rehabilitation is effective and can be systematically implemented to improve functional outcomes for patients admitted to skilled nursing facilities following hospitalization. Additionally, this study will generate a descriptive overview of factors that predict implementation success while informing effective implementation strategies for future skilled nursing facilities innovation.
详细描述
In the U.S., 8.37 million adults over 65 will experience a hospital stay over the next year, which often has serious and long-lasting consequences including profound deterioration in physical function. Following a hospital stay, around 1.35 million patients with deconditioning require rehabilitation in a skilled nursing facility (SNF) each year to address the deleterious musculoskeletal and functional deficits from deconditioning. More than 64% of patients discharge from SNFs at functional levels that predispose them to adverse events, including rehospitalization, failing health, disability, institutionalization, or death. Physical function is a known modifiable predictor of these deleterious events, which can be addressed with rehabilitation. Therefore, more progressive and targeted musculoskeletal rehabilitation strategies that optimize physical function more effectively are needed.
Therefore, the purpose of this study is to determine the effectiveness of a high-intensity rehabilitation approach (also referred to as i-STRONGER) at multiple skilled nursing facilities (SNFs), while evaluating characteristics of successful implementation through a rigorous, pragmatic cluster randomized controlled trial (16 Intervention SNFs vs 16 Usual Care SNFs). The investigators will promote high-intensity rehabilitation delivery to patients in an effort to address poor physical function outcomes. Specifically, the investigators will train rehabilitation clinicians at Intervention sites using distance-based instruction and collect study outcomes via the electronic medical record. Additionally, the investigators will gather quantitative and qualitative data (mixed methods) to evaluate processes, clinician-specific characteristics, and facility-specific contexts of implementation. The study methods seek to maximize successful reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) across Intervention sites. The implementation strategy is informed by the RE-AIM framework and integrated with educational and behavioral theories to facilitate clinical adoption of high-intensity rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Investigators will not be blinded to the arms due to facility/clinician training required for this study design. Study sites [i.e., skilled nursing facilities (SNFs)] will be the unit of randomization. SNF study sites will be made broadly aware of the study initiative during the site recruitment process; however, the site will not be provided with detailed information about the intervention unless randomized to the Intervention arm. As such, clinicians, or rehabilitation care providers, at usual care sites will remain blinded to the intervention for the duration of the study. Clinicians will collect patient-level functional outcomes as part of their standard of care and all patients who are subjects of the intervention will not be aware of the group allocation in the study.
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rehabilitation staff at enrolled sites will participate in research activities, as indicated by group assignment.
- •Site Inclusion Criteria:
- •Aegis Therapies-contracted skilled nursing facility (SNF)
- •Admits approximately 15 patients per month for short term rehabilitation
- •Patient Inclusion Criteria:
- •At least 50 years of age
- •Admitted to a SNF from the hospital
- •Ambulatory upon SNF admission
排除标准
- •Contraindications to high-intensity resistance training, per American College of Sports Medicine Exercise Testing and Prescription
- •Lower extremity weight-bearing precautions
- •Neurological diagnosis (e.g., Cerebral vascular accident, Multiple Sclerosis, Parkinson's disease)
- •Subsequent SNF admission
研究组 & 干预措施
i-STRONGER
The high-intensity rehabilitation intervention, termed i-STRONGER, relies on principles of physiologic overload using an 8-repetition max (8RM) to promote muscle strengthening and emphasizes functional carryover for independence.
干预措施: i-STRONGER (Other)
Usual Care
The Usual Care SNFs will continue clinical practice as normal, and sites will not have any overlap of personnel or training with i-STRONGER SNFs.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in Gait Speed
时间窗: From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
Gait speed will be measured in meters/second using the time it takes to walk a 4-meter path at usual speed using a stopwatch.
次要结局
- Change in Short Physical Performance Battery (SPPB)(From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days)
- Post-discharge Rehospitalization Rate(From date of discharge from the SNF, assessed up to 30 days)