None listed
Conditions
Brief summary
The RESTORES Trial Prototype (n=20) will be delivered in preparation for a future Randomised Controlled Trial (n=300). RESTORES is a new social investment initiative, funded by the Ministry of Social Development, which will provide additional case managed rehabilitation services to people in the workforce who experience a mild stroke, with a view to helping them return to work and retain employment.
Interventions
A Case Manager, who is an Allied Health Professional with a post graduate qualification in vocational rehabilitation, will carry out an individual needs assessment with the participant within 15 days of their randomisation. Depending on the timeliness of the participant's discharge, this process may happen in the hospital setting (pre or post discharge), in the Case Manager's place of work, or in the participant's home if preferred.
The needs assessment, which usally takes 1.5 hours to comp
A Case Manager, who is an Allied Health Professional with a post graduate qualification in vocational rehabilitation, will carry out an individual needs assessment with the participant within 15 days of their randomisation. Depending on the timeliness of the participant's discharge, this process may happen in the hospital setting (pre or post discharge), in the Case Manager's place of work, or in the participant's home if preferred. The needs assessment, which usally takes 1.5 hours to complete, aims to establish participant centred goals, as well as to understand the barriers that are hindering the participant returning to work, conducting leisure activities and carrying out daily life tasks. Based on this assessment, the Case Manager will arrange rehabilitation and vocational services to meet the individual participant's needs. For example, this might include access to a clinical exercise physiologist, a speech language therapist, a business mentor or a driving assessor. Again, some of these services will be delivered in a participant's home and some at the provider's place of work. The Case Manager will also work closely with the participant's GP and employer. The Case Manager will contact the participant at least fortnightly to assess their needs, review their progress and discuss recommendations. The mode of contact will be mutually agreed between the Case Manager and the participant and could be via phone or face to face in either the participant's home or the Case Manager's place of work. Depending on the participant's needs, this fortnightly catch up could last between 15 minutes and an hour. The Case Manager will work closely with each participant for up to one year.
Sponsors
Waitemata District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed