A Prototype for a Randomised Controlled Trial Comparing Usual Care with Individualised Case Management for the Rehabilitation of Employed Stroke Patients and the effects on Health and Vocational Outcomes and Long Term Public Sector Costs
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
Results - Of 19 participants [7 (37%) women, mean age 49 y (range 30 – 60 y), median NIHSS 2 (range 0 – 7)], one withdrew, one was managed by ACC, one was found to be a non- resident and discharged, and two had subsequent non-stroke-related health events that prevented return to work. Of the remaining 14, 12 (86%) returned to fulltime work within 12 months of stroke. Case managers referred participants as indicated to physiotherapy, occupational therapy, speech language therapy, medical, vocational rehabilitation, clinical exercise physiology, dietitian, driving assessment, and psychology services. Case managers also assisted participants in their contacts with social support and Work and Income services. Case management processes and the research protocol were refined by this pilot study. Discussion - A prior study showed that only 50% of NZ stroke patients aged <65 y are in paid work 12 months post-stroke. This pilot study indicates that case management could help a larger percentage of patients return to work. Conclusion - A randomised controlled trial of individualised case management is warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. The patient has been diagnosed with mild stroke by a consultant responsible for his or her care, with that diagnosis being recorded in the patient’s record.
- •2. The patient was in paid employment prior to the stroke with paid employment being defined as working for 60 hours or more at a pay rate at or above the national minimum wage in the fortnight prior to the onset of the stroke (or in receipt of paid leave of those hours and at that pay rate);
- •3. The patient is a NZ citizen or permanent resident or holding a residence class visa and ordinarily resident in NZ including at the time of the stroke.
排除标准
- •1. Moderate and severe stroke – as defined by a NIHSS score of 9 or higher at the time of recruitment. Patients who have a higher score that drops during the course of their admission become eligible if the score is below 9 within two weeks of stroke onset. Patients with moderate to severe stroke or severe stroke are expected to have a low probability of recovery to a point that would permit them to return to work within the one year study period.
- •2. Subarachnoid haemorrhage – A review by the Cochrane Collaboration has recommended that trials of rehabilitation interventions in stroke exclude patients with subarachnoid haemorrhage owing to the differences in natural history and management with this condition.
- •3. Patients with disability insurance – These patients would be likely to receive some form of intervention if they hold income or disability insurance with a private insurance company and hence it would not be possible to randomly allocate them to usual care”.
- •4. Pregnancy. It is difficult to assess the impact of a return to work intervention on (working) pregnant women because a significant proportion will receive paid parental leave of up to one year from the birth of the child. Their inclusion in RESTORES might therefore bias the outcome estimates downwards in intention-to-treat analyses.
- •5. Patients eligible for Accident Compensation Corporation (ACC) funded treatment. These will include patients with stroke due to trauma (e.g. through traumatic carotid artery dissections) or due to treatment injury.