Evaluating the Cost Effectiveness of STEADI Older Adult Fall Prevention in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- Medically treated falls reported in patient surveys
研究概览
简要总结
Stopping Elderly Accidents, Deaths, and Injuries (STEADI) is an intervention to prevent falls among older adults developed by the Centers for Disease Control & Prevention (CDC). Studies piloting the intervention have shown promising results; however, more evidence is needed to show that the intervention can be implemented cost-effectively on a larger scale in a real-world integrated health system. To this end, NORC partnered with Emory University School of Medicine to evaluate the effectiveness and cost-effectiveness of the STEADI intervention.
This study aims to answer the following research questions to fill remaining knowledge gaps about STEADI:
- Does STEADI significantly reduce falls among the target population compared to the standard of care?
- Does partial implementation of some selected STEADI modules, also significantly reduce falls among the target population as compared to the standard of care?
- Does the net present value of falls and resulting injuries averted by STEADI implementation exceed the net present value of the costs of STEADI implementation and the incremental costs that result from it?
Using a mixture of qualitative interview and quantitative performance measures, the study evaluates and describes this case of STEADI implementation within selected primary care clinics of Emory Healthcare. NORC partnered with Emory University School of Medicine to implement different aspects of STEADI in a real-world primary care setting, document experiences implementing the intervention, measure implementation costs, and compare the outcomes of the STEADI intervention compared to control version of the intervention.
详细描述
The STEADI Options Trial (STEADI Trial) is a randomized control trial implemented in five Emory Healthcare primary care clinics during September 1, 2020, and December 31, 2021. The trial compared patients who received a one-time implementation of the STEADI-based fall prevention (intervention) to a control group receiving standard care. Patients were randomized based on the provider for their next scheduled routine primary care visit. Due to the COVID-19 pandemic, investigators adapted the intervention to implement it via video or phone supported telemedicine encounters conducted by a designated project nurse.
The study contacted eligible patients, screened them for fall risk using the Stay Independent Screener, consented and enrolled patients with a fall risk, conducted intervention assessments via video or phone (with video preferred), and transferred the results of the assessments to the patient's providers for intervention at the patient's next scheduled routine primary care visits. Primary care providers outside the study team were responsible for acting on assessment information.
Investigators collected data on recruitment, assessments, health service utilization, prescriptions, fall events, implementation costs, and all-cause outpatient and inpatient charges incurred over one year using administrative and electronic health records and patient surveys.
STEADI-based fall prevention was implemented in five primary care clinics operated as part of the Emory Healthcare System selected based on the willingness of their leadership to participate, geographic and sociodemographic diversity of their patient population within the Atlanta Metro Area, and size of the geriatric population they served. The CDC was responsible for project oversight and fall prevention expertise, NORC designed the study protocol and data collection instruments and managed the project, and Emory was responsible for clinical implementation.
Emory hired three clinical research interviewers (CRIs) and a clinical research nurse (CRN) to conduct recruitment, coordination, and assessments. CRIs were responsible for screening patients for fall risk, recruiting and enrolling those at risk, scheduling STEADI assessments, and conducting pre-assessment coordination calls. The CRN was responsible for conducting assessments, providing patient education, creating recommendations based on assessment information, and disseminating those recommendations to the patient's provider. Providers were responsible for acting on recommendations through the creation of clinical referrals to services or managing medications.
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
- None
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
- •With a non-acute outpatient visit scheduled at one of the five participating primary care clinics during the study period
- •Stay Independent Screening (SIS) score of 4 or higher or an answer of "yes" to one of following three key questions in the SIS:
- •"Have you fallen in the past year?"
- •"Do you feel unsteady when standing or walking?"
- •"Do you worry about falling?"
- •English proficient
- •Access to an able-bodied person to help with gait and balance assessments
排除标准
- •Evidence in medical record of severe cognitive deficiencies (such as advanced Alzheimer's or dementia).
研究组 & 干预措施
Control
After being enrolled in the study, the patient would receive usual care from their provider.
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Gait and balance assessment (Behavioral)
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Medication review (Behavioral)
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Comorbidity review (Behavioral)
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Fall history (Behavioral)
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Assessment of feet/footwear (Behavioral)
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Assessment of visual acuity (Behavioral)
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Home safety risk assessment (Behavioral)
STEADI Intervention
For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.
干预措施: Vitamin D Deficiency (Behavioral)
Physical Therapy Assessment Only
For those assigned to the PT assessment only arm, the clinical research nurse would only conduct gait and balance assessments and would make recommendations about need for physical therapy services, conveyed to primary care provider for referrals.
干预措施: Gait and balance assessment (Behavioral)
Medical management assessment only
For those assign to the medical management assessment arm, only patients' medication usage would be assessed for polypharmacy (using 5 or more medications) or use of pharmaceutical classes that increase risk for falls. Recommendations for making changes to dosing levels or reducing number of medications would be conveyed to primary care provider.
干预措施: Medication review (Behavioral)
结局指标
主要结局
Medically treated falls reported in patient surveys
时间窗: Within one year after patient completes STEADI assessment
Self-reports of falls that were treated in a medical setting (regardless of whether it was treated at a study affiliated site)
Non-medically treated falls reported in patient surveys
时间窗: Within one year after patient completes STEADI assessment
Self-reports of falls that were not treated in a medical setting,
Falls recorded in the Electronic Medical Record.
时间窗: Within one year after patient completes STEADI assessment.
Falls identified in Emory Electronic Health Record as determined by the presence of ICD-10 diagnosis codes (W00-W19).
Total cost of all medical services
时间窗: Within one year after patient completes STEADI assessment
Cumulative health care allowable charges (or payments if available from claims data) for all patient services as observed in electronic health records, the estimated costs of services rendered outside of Emory Healthcare, the per person cost of screening and assessment, and the per person cost of STEADI-based fall prevention implementation.
次要结局
- Use of primary care medical services(Within one year after STEADI assessment)
- Benzodiazepine dosage(Within one year after STEADI assessment)
- Use of eye care services(Within one year after STEADI assessment)
- Antipsychotics usage(Within one year after STEADI assessment)
- Hypnotics usage(Within one year after STEADI assessment)
- Antidepressant usage(Within one year after STEADI assessment)
- Use of physical therapy medical services(Within one year after STEADI assessment)
- Use of occupational therapy medical services(Within one year after STEADI assessment)
- Use of podiatry services(Within one year after STEADI assessment)
- Level of polypharmacy(Within one year after STEADI assessment.)
- Antihistamine usage(Within one year after STEADI assessment)
- Opioid dosage(Within one year after STEADI assessment)
研究者
Dr. David Rein
Program Area Director
National Opinion Research Center