Randomized Trial of Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 10
- 主要终点
- Change in Short Physical Performance Battery (SPPB) from admission
研究概览
简要总结
The investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (MT) up to three times daily, including weekends, to hospitalized medical patients. The aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the MTs, the index hospitalization and the first 30 days post enrollment.
详细描述
The investigator proposes to conduct a large randomized trial to test the impact of MTs (Mobility Technicians) on short and intermediate term outcomes for 3000 patients aged 65 years and older at 5 hospitals in 2 health systems. Patients will be randomized to receive supervised ambulation up to 3 times daily with a MT or to receive usual care. All participants will wear an accelerometer on their wrist to track their movement throughout the hospital stay. The study has 3 aims. First, the study will compare the mobility of patients at discharge (or 10 days) to assess the impact of the MTs on this outcome. Of particular interest is whether the use of MTs will increase the proportion of patients who can go home vs.post-acute care, and whether the improvements in mobility are sustained at 30 days. Second, the study will use predictive modeling to identify which patients are most likely to benefit from this intervention. Third, the study will assess the impact of the intervention on overall costs associated with the episode of care, including inpatient costs and the 30 days post enrollment. This information will be important to convince health systems to adopt this approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the inclusion criteria listed below to participate in this study:
- •≥65 years of age
- •Admitted to a medical service
- •Complete history and physical examination on file
- •6-Clicks score of 16-23
- •Insurance with Traditional Medicare or Medicare Advantage
排除标准
- •Any patient meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:
- •Significant language barrier that requires a translator (other than Spanish at Baystate site only)
- •Discharge planned for that day or the following day
- •Observation status
- •Surgical procedure planned
- •Patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation
- •Permanent residence in a skilled nursing facility
- •Comfort care measures only
- •>48 hours since admission
- •Active infection with COVID-19
- •Other active infection requiring contact or droplet precautions
- •Order for bedrest
研究组 & 干预措施
Usual Care
No intervention
Mobility Technician
Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session
干预措施: Mobility technician (Behavioral)
结局指标
主要结局
Change in Short Physical Performance Battery (SPPB) from admission
时间窗: Up to 10 days
Every patient will have an SPPB score on admission to the study. A blinded assessor will measure the SPPB again at discharge or on day 10 if the patient is still hospitalized. The primary outcome is change from admission to discharge. Investigators will also compare the percentage of patients who reach the minimal clinically important difference of 1 point. SPPB minimum value= 0 SPPB maximum value= 12 (higher score indicates a better outcome). If no blinded team member is available, the evaluation may be carried out by any unblinded team member. The blinding status of the evaluator will be noted in REDCap.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility(30 days post enrollment)
- Hospital-Acquired Complications(10 days)
- Total episode cost(Admission to 6 months after enrollment)
- RCSQ (Richards Campbell Sleep Questionnaire)(Days 1-10)
- Activities of Daily Living(30 days post enrollment)
- Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF)(30 days post enrollment)
- Frailty(30 days post enrollment)
- Mortality(30 days from admission)
- Falls post-discharge(30 days from admission)
- Number of Patients with Readmission within 30 days(30 days after discharge)
- Number of Patients Discharged to Home(date of randomization to date of discharge, up to 30 days)
- Length of Stay(date of admission to date of discharge, up to 30 days)
研究者
Michael Rothberg
Vice Chair for Research, Primary Care Institute
The Cleveland Clinic