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临床试验/NCT01347619
NCT01347619已完成不适用

iADAPT: Off Label Use of Antipsychotics in the Nursing Home

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2010年11月1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
42
试验地点
2
主要终点
Aim 1 NEEDS ASSESSMENT - to describe interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG

研究概览

简要总结

The investigators propose to evaluate the effectiveness of 3 different methods to promote the dissemination and adoption of evidenced-based review guides into the nursing home setting. Specifically, the investigators will adapt Comparative Effectiveness Research (CER) Review products developed by the Agency for Healthcare Research and Quality (AHRQ), specifically related to off-label use of atypical antipsychotic drugs, to improve their penetration into practice in the nursing home (NH) setting.

The investigators propose the following specific aims:

AIM 1: NEEDS ASSESSMENT To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG in the NH setting; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting.

AIM 2: PRODUCTION OF THE TOOLKIT Guided by the needs assessment, the investigators will produce a toolkit containing tailored CERSG-based products targeting key audiences and stakeholders in the NH setting. The target audience(s) of the final CERSG-based products will be identified in Aim 1, and will potentially include: (a) facility leadership [NH administrator, Medical Director, Director of Nursing]; (b) prescribers and consultant pharmacists; (c) nursing staff [registered nurses, licensed practical nurses, and certified nurse assistants].

AIM 3: EVALUATING THE EFFECTIVENESS OF THE TOOLKIT To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial. NHs in the first arm will receive the toolkit only and web access to the materials; NHs in the second arm will receive the toolkit, web access, periodic audit and feedback reports of antipsychotic prescribing to NH leadership, and faxed educational messages adapted from the AHRQ atypical antipsychotic CERSG to prescribers; and NHs in the third arm will receive the previous items plus face-to-face academic detailing. Primary outcomes of the evaluation are the RE-AIM evaluation domains (reach, efficacy, adoption, implementation, and maintenance).The investigators will also include an assessment of facility-level changes in the use of atypical antipsychotic drugs.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Qualidigm-affiliated Nursing Home facilities in Connecticut who agree to participate.
  • Participants in this study will include residents and employees of participating nursing homes or residents within these nursing homes. All members of this study population will be 18 years or older.

排除标准

  • Does not meet inclusion criteria

结局指标

主要结局

Aim 1 NEEDS ASSESSMENT - to describe interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG

时间窗: months 4-8

Aim 1 - To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting

Aim 2 - Guided by the needs assessment, we will produce a toolkit containing tailored CERSG-based products targeting key audiences and stakeholders in the NH setting.

时间窗: months 9-12

Aim 2 - Guided by the needs assessment, we will produce a toolkit containing tailored CERSG-based products targeting key audiences and stakeholders in the NH setting. The targets of the final CERSG-based products will be identified in Aim 1, and will potentially include: (a) facility leadership \[NH administrator, Medical Director, Director of Nursing\]; (b) prescribers and consultant pharmacists; (c) nursing staff \[registered nurses, licensed practical nurses, and certified nurse assistants\], and (d) residents and families.

Aim 3 - To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial

时间窗: months 31-36

Aim 3 - To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial. Primary outcomes of the evaluation are the RE-AIM evaluation domains (reach, efficacy, adoption, implementation, and maintenance).

Aim 1 NEEDS ASSESSMENT - to describe the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs

时间窗: months 4-8

Aim 1 - To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting.

Aim 1 NEEDS ASSESSMENT - to describe approaches to integrating comparative effectiveness research products into the NH setting

时间窗: months 4-8

Aim 1 - To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting.

次要结局

未报告次要终点

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerry Gurwitz

Executive Director, Meyers Primary Care Inst.

University of Massachusetts, Worcester

研究点 (2)

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