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临床试验/NCT04242186
NCT04242186已完成不适用

Nursing Home Prevention of Injury in Dementia (NH PRIDE)

Hebrew SeniorLife4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
4
主要终点
Number of Residents Who Accepted Osteoporosis Treatment Recommendations

研究概览

简要总结

The purpose of this study is to develop a consistent approach to prevent falls with injury in nursing home (NH) residents. A centralized Injury Liaison Service (ILS) will be developed and tested in four nursing home facilities (two in the Durham, North Carolina area and two in the Boston, Massachusetts area). The ILS will combine successful elements of a Fracture Liaison Service (FLS) and video telehealth staff education (ECHO) models with the goal of decreasing injurious falls in nursing home residents.

The ILS Program has four main components:

  1. Automated identification of NH residents at high risk for falls with injury
  2. Recommendations by the ILS nurse to manage medications, including deprescribing medications associated with falls and a prescription for osteoporosis medications
  3. Video telehealth sessions to educate staff
  4. Shared decision making with residents and/or families.

The central hypothesis of this study is that the ILS model will reduce injurious falls by changing care delivery in two areas: deprescribing psychoactive and cardiometabolic drugs to reduce falls, and increasing osteoporosis treatment to prevent injury in the setting of a fall.

Qualitative interviews will be conducted with nursing home staff to gain a better understanding of effective and non-effective injury prevention strategies. Information from these interviews will be incorporated into the study design. Outcome measures will focus on acceptability, demand, practicality, and feasibility of the program, as well as safety.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Facility inclusion criteria:
  • More than 80 long-stay beds
  • Within 30 miles of Boston, Massachusetts or Durham, North Carolina
  • Resident inclusion criteria:
  • Age ≥ 60 years
  • NH length of stay ≥ 30 days
  • Estimated 2-year risk of hip fracture ≥ 6% using FRAiL model
  • Provider inclusion criteria:
  • The NH-PRIDE intervention will target the "usual" providers including nurses, certified nursing assistants (CNAs), physicians, nurse practitioners (NPs), and physician assistants (PAs) routinely caring for NH patients. Nurses should be providing care at a NH facility for a minimum of 2 shifts most weeks. Physicians, NPs, and PAs should spend, on average a minimum of four hours weekly in nursing home care. We estimate there will be 10 providers for the qualitative interviews on injurious falls prevention, 20 providers (4 from each facility) in the televideo sessions, and 60 providers (15 per facility) to participate in the post-intervention questionnaires.
  • Additional eligibility criteria for providers include:
  • Worked in the facility for ≥ 90 days
  • Can communicate in English (in order to participate in interviews and questionnaires),
  • Over 21 years of age.
  • Proxy/resident inclusion criteria:
  • We will recruit 10 residents/proxies to participate in qualitative interviews on falls prevention. Residents/family must meet the following criteria:
  • Affiliated resident has lived in the facility for ≥ 30 days
  • Can communicate in English
  • Over 21 years of age
  • Able to provide informed consent to participate in the interviews

排除标准

  • Facility exclusion criteria:
  • Population not primarily English speaking
  • Evidence of institutional instability at time of recruitment
  • Provider exclusion criteria:
  • Does not provide routine care to NH residents (e.g., visiting hospice provider)
  • Does not speak English
  • Is less than 21 years old
  • Resident exclusion criteria:
  • Advanced dementia as defined by Cognitive Performance Scale (CPS) = 6
  • Life expectancy < 6 months, as indicated by Minimum Data Set (MDS) assessment
  • Living in nursing home for less than 30 days
  • Proxy has communicated wish to opt-out of study Residents will not be excluded from the study based on any specific diagnosis (e.g., congestive heart failure or schizophrenia); however, the algorithm used to make recommendations for medication management will consider individual co-morbidities.
  • Proxy/resident exclusion criteria for interviews:
  • Affiliated resident has lived in the facility for < 30 days
  • Cannot communicate in English
  • Less than 21 years of age
  • Unable to provide informed consent to participate

结局指标

主要结局

Number of Residents Who Accepted Osteoporosis Treatment Recommendations

时间窗: 4 months

Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death

时间窗: 6 months

Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey

时间窗: 6 months

Number of Staff Members Who Attended One or More ECHO Sessions

时间窗: 6 months

Number of High-risk Residents According to the FRAiL Model

时间窗: baseline

Number of High-risk Residents With One or More Deprescribing Recommendations

时间窗: 4 months

Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations

时间窗: 4 months

Number of Residents Who Accepted One or More Deprescribing Recommendations

时间窗: 4 months

Number of High-risk Residents With a Recommendation for Osteoporosis Treatment

时间窗: 4 months

Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations

时间窗: 4 months

次要结局

  • Average Number of Deprescribing Recommendations That Were Made for Each Resident(4 months)
  • Average Number of Adverse Drug Events(4 months)
  • Number of Injurious Falls(4 months)

研究者

发起方
Hebrew SeniorLife
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Berry

Associate Professor in Medicine

Hebrew SeniorLife

研究点 (4)

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