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临床试验/NCT00743951
NCT00743951已完成不适用

Feasibility Study: Does Screening Plus Patient Decision Aids Reduce Unnecessary Surgical Referrals for Total Joint Arthroplasty in Practices With Long Waiting Lists for Surgical Consults?

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
2
主要终点
Feasibility of Data Collection at Month 12

研究概览

简要总结

Ministries of Health consider wait lists for total joint replacement a top priority. Research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. When decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option.

The study objective is to pilot test the feasibility of a trial evaluating the effects of patient decision aids on reducing unnecessary surgical referrals for total joint replacement, when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility.

The investigators expect to provide evidence of feasibility (e.g. ease of recruiting patients, delivering the interventions, measuring patient outcomes) and sample size needed for a larger scale study. This study should also provide evidence for planning implementation of the interventions and standardized training across other centers.

详细描述

Background:

Current research priorities to manage wait times for total joint arthroplasty (TJA) indicate the need to establish benchmarks that consider patient preferences. Among clinically appropriate candidates for this procedure, patients' preferences for surgery is very low; between 8.5 and 14.9% of clinically ideal candidates were definitely willing to consider TJA.However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indications for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. Therefore, patient decision aids may have a role in ensuring that wait list reforms address under-use of surgical procedures that informed patients need and want, while preventing the over-use of procedures that informed patients do not value. If they were used in combination with screening for surgical eligibility, they might also prevent inappropriate referrals for surgery (i.e., patients who are not clinically eligible or who would not want surgery even if they were clinically eligible).

Objective:

To pilot test the feasibility of a trial evaluating the incremental effects of patient decision aids on reducing unnecessary surgical referrals for TJA, when used in combination with a general practitioner intake clinic that screens patients for surgical eligibility.

Participants & Setting:

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

性别
All
接受健康志愿者

入选标准

  • Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited

排除标准

  • Patients with inflammatory arthritis
  • Previous TJA
  • Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.

结局指标

主要结局

Feasibility of Data Collection at Month 12

时间窗: Data collection occurred at month 12

Feasibility was the number of participants who completed data collection at 12 months

次要结局

  • Wait Times(Data collection occurred at surgeon consult and month 12.)
  • Participant's Knowledge(Data collection occurred at week 2)
  • Number of Participants With Sufficient Decision Quality(Data collection occurred at week 2 (knowledge and values) and month 12 (patients' chosen option).)
  • Number of Participants With no Decisional Conflict(Data collection occurred at week 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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