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临床试验/NCT00636675
NCT00636675已完成不适用

Outcomes of Nursing Management Practice in Nursing Homes

Duke University2 个研究点 分布在 1 个国家目标入组 1,726 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,726
试验地点
2
主要终点
Fall Related Process Measures

研究概览

简要总结

Clinical trials have identified interventions that reduce adverse outcomes such as falls in nursing home (NH) residents but attempts to translate these into practice quality improvement (QI) techniques have not been successful. Using a complexity science framework, our previous study showed that low connection, information flow, and cognitive diversity among NH staff explains quality of care for complex problems such as falls. Our pilot of "Connect," a multi-component intervention that encourages staff to engage in network-building and use simple strategies to make new connections with others, enhance information flow, and use cognitive diversity, suggests that staff can improve the density and quality of their interactions. This 5-year study uses a prospective, cluster-randomized, outcome assessment blinded design, with NHs (n=16) randomized to either Connect and a falls QI program (Connect + Falls) or QI alone (Falls). About 800 residents and 576 staff will participate. Specific aims are to, in nursing homes: 1) Compare the impact of the Connect intervention plus a falls reduction QI intervention (Connect+Falls) to a falls reduction QI intervention (Falls) on fall risk reduction indicators (orthostatic blood pressure, sensory impairment, footwear appropriateness, gait; assistive device; toileting needs, environment, and psychotropic medication); 2) Compare the impact of Connect+Falls to Falls alone on fall rates and injurious falls, and determine whether these are mediated by the change in fall risk reduction indicators; 3) Compare the impact of Connect+Falls to Falls alone on complexity science measures (communication, participation in decision making, local interactions, safety climate, staff perceptions of quality) and determine whether these mediate the impact on fall risk reduction indicators and fall rates and injurious falls. Cross-sectional observations of complexity science measures are taken at baseline, at 3 months, at 6 months, and at 9 months. Resident fall risk reduction indicators, fall rates, and injurious falls are measured for the 6 months prior to the first intervention and the 6 months after the final intervention is completed. Analysis will use a 3-level mixed model to account for the complex nesting of patients and staff within nursing homes, and to control for covariates associated with fall risk, including baseline facility fall rates and staff turnover rates.

详细描述

Although clinical trials have identified interventions that reduce adverse outcomes such as falls in nursing home (NH) residents, attempts to translate those interventions into practice using current standard of care quality improvement (QI) programs[1, 2] have not led to expected improvements.[3, 4] Barriers encountered in previous studies point directly to a need for effective nursing management practices (NMPs).[1, 3, 5] Many studies now show that relationship-oriented NMPs such as open communication, participation in decision-making, teamwork, and leadership result in better resident outcomes.[5-10] Our recent case-studies described how NMPs work in day-to-day practice, and identified new NMPs associated with better NH care. We found that staff at all levels engaged in these NMPs, albeit erratically, suggesting that NHs have substantial untapped capacity to provide better resident care.[11-15] Thus a new intervention that fosters systematic use of NMPs may provide a foundation for more effective QI programs.

QI programs are the current standard for improving resident outcomes for common and costly conditions such as falls, pressure ulcers, pain, and depression. Such geriatric syndromes are inherently multifactorial, requiring modification of multiple risk factors to improve outcomes.[16, 17] Clinical trials using study staff to implement multiple risk factor reduction have improved resident outcomes,[18-20] but QI programs teaching existing NH staff to implement multiple risk factor reduction have not shown significant effects.[1, 21-24] One proposed reason for this failure is that QI programs seek to change individual clinician behavior but fail to account for the interactive dynamics of care. We propose that CONNECT, an intervention to foster systematic use of NMPs, will enhance the effectiveness of a Falls QI program in NHs by strengthening the one-on-one staff interactions that are necessary for clinical problem-solving about geriatric syndromes.

We have developed the Connect intervention based on complexity science and empirical research[25] to target these local interactions among staff in a new approach to facilitating organizational learning. Connect is a multicomponent intervention that includes: 1) helping staff learn new strategies to improve the effectiveness of day-to-day interactions; 2) helping staff identify important relationships and encouraging interaction at the point of care; and 3) mentoring to reinforce and sustain newly acquired interaction behaviors. Complexity science and empirical research suggest that interaction patterns determine information flow, ease of knowledge transfer, and capacity to monitor behaviors and outcomes in health care settings. [10, 26-28] Thus, Connect has the potential to improve resident outcomes when combined with QI programs for clinical problems such as falls. Falls is an excellent outcome for this initial test of Connect because: 1) there is ample evidence that multifactorial risk factor reduction interventions effectively reduce fall rates in NHs; 2) accepted practice guidelines and fall prevention programs exist;[29-32] and 3) falls is an important clinical problem in its own right.

The specific aims of this longitudinal, two arm, randomized intervention study are:

Aim 1: Compare the impact of the Connect intervention plus a falls reduction QI intervention (Connect+Falls) to the falls reduction QI intervention alone (Falls) on fall-related process measures in nursing home residents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (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

入选标准

  • Eligible residents will be long-term care residents at least 65 years of age who have resided in the NH at least 6 months and are likely to survive at least 6 months. Residents must be potentially at risk for falls, which we define as ambulatory or transfer-independent as recorded on the Minimum Data Set.

排除标准

  • 未提供

研究组 & 干预措施

Fall QI

Experimental

Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.

干预措施: Falls QI (Behavioral)

Connect & Falls QI

Experimental

Connect is delivered, followed by Falls. Behavioral intervention to improve staff interaction for better care planning and execution. Connect will be delivered, followed by the Falls quality improvement intervention.

干预措施: Connect (Behavioral)

结局指标

主要结局

Fall Related Process Measures

时间窗: 6 months post intervention

Mean of the total number of fall risk reduction indicators (steps staff have taken to reduce fall risk) that were documented in residents with high fall risk. These included orthostatic blood pressure measurement/intervention; sensory impairment evaluation/intervention; footwear; exercise/assistive device intervention; toileting schedule; environmental modification; psychoactive medication reduction; and vitamin D supplements. Note that this measure is NOT related to staff but rather residents in the nursing home, therefore the numbers are different from participant flow. The residents were not considered enrolled participants in the study.

次要结局

  • Fall Rates(6 months post intervention)
  • Change in Weighted Average of Staff Interaction Scales(baseline to post intervention, an average of 6 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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