Effect of a Case Manager to Assist the Rehabilitation for Lumbar Spinal Fusion Patients. A Randomised Controlled Trial.
Condition: Rehabilitation; Spinal Fusion; Case Managers
Study type: Interventional

Summary: 
      The aim of the current study is to examine the effect of a case manager-assisting
      rehabilitation program compared to usual physical rehabilitation for patients undergoing a
      lumbar spinal fusion on functional disability, pain, and return to work. Furthermore, to
      explore if the case manager-assisted rehabilitation program is cost-effective in a societal
      perspective compared to usual rehabilitation.

      Participants: 82 patients undergoing a lumbar spinal fusion due to disc degeneration or
      spondylolisthesis. Participants are adults of both gender.

      Patients are included from Aarhus University Hospital, Denmark, and Region Hospital of
      Silkeborg, Denmark. Participants will be block randomised at each centre. The participants
      were randomized 1:1 to case manager-assisted rehabilitation (intervention group) or usual
      physical rehabilitation (control group). Both groups received usual physical rehabilitation.
      The patients in the intervention group meet pre-operatively with a case manager in order to
      set a plan for their return to daily activities and work. The intervention also included
      post-surgical meetings, phone meetings, work place visits, or voluntary roundtable meetings.
    

Detailed description: 
      The past decades have seen an increase in the numbers of patients undergoing lumbar spinal
      surgery due to degenerative diseases in the lumbar spine. The return to work rates following
      a lumbar spinal fusion have been reported to be between 35 and 50 percentages one year after
      the surgery and between 50-63% at 2-3-year after the surgery.

      The aim of the current study is to examine the effect of a case manager-assisting
      rehabilitation program compared to usual physical rehabilitation for patients undergoing a
      lumbar spinal fusion on functional disability, pain, and return to work. Furthermore, to
      explore if the case manager-assisted rehabilitation program is cost-effective in a societal
      perspective compared to usual rehabilitation.

      A total of 82 patients were included from Aarhus University Hospital, Denmark, and Region
      Hospital of Silkeborg, Denmark. Participants were block randomised at each centre. The
      participants were randomized 1:1 to case manager-assisted rehabilitation (intervention group)
      or usual physical rehabilitation (control group), by use of sealed envelopes. Both groups
      received usual physical rehabilitation. The patients in the intervention group meet
      pre-operatively with a case manager in order to set a plan for their return to daily
      activities and work. The intervention also included post-surgical meetings, phone meetings,
      work place visits, or voluntary roundtable meetings.

      Statistical analysis:

      For the power calculation, the Oswestry Disability Index was used. Based on another study in
      process at the time of the planning of the study, and in accordance to other research the
      standard deviation was set to 17 points. With a minimal clinical important difference of 12
      points, a power of 80%, and a two sided significance level of 0.05, a total of 66 patients
      (33 in each group) should be included. I order to account for a 20% lost to follow-up a total
      om 80 patient should be included.

      Data will be entered twice into EpiData and any divergence will be corrected according to the
      original material. STATA 14.1 will be used for statistical evaluation. The risk of a type 1
      error was set to 5%. The data will be analyzed according to the intention-to-treat principle.

      I order to compare the two groups a mixed model for repeated measurements with an
      unstructured covariance matrix will be used to test the effect on Oswestry Disability Index,
      back pain, and leg pain.

      I order to evaluate the patients' return to work following the surgery, the cumulative
      incidence proportion of time to first spell of 4 weeks of return to work within a 2-year
      period will be calculated and compared by the log rank test. The relative cumulative incidens
      of a spell of 4 weeks' return to work will be analysed in a generalized linear regression
      model using the pseudo values method adjusted for time until old age pension and disability
      pension.

      The primary outcome used in the economic evaluation are functional disability as measured by
      the Oswestry Disability Index. Furthermore, health-related quality of life was measured by
      the EuroQol 5-dimensions (EQ-5D) and valued by Danish preference weights in order to
      calculate Quality Adjusted Life Years (QALY).

      The resource use, costs, and outcomes will be analysed as arithmetic means with 95%
      bootstrapped confidence intervals based on non-parametric bootstrapping (10,000 replicates),
      and after discounting at an annual rate of 3%. To assess the cost-effectiveness, costs and
      outcomes will be transformed into a uni-dimensional measure of incremental net benefit for a
      range of hypothetical values of willingness to pay per unit of effect: incremental net
      benefit = (EA - EB) * willingness to pay per effect unit - (CA - CB), where C denotes costs
      and E denotes effects with A and B referring to comparators.

      The study protocol was approved by the Danish Data Protection Agency (J.nr.2010-41-444), and
      the local Ethical Committee (J.nr.M-20100038)
    

Intervention name(s): Case manager assisted rehabilitation; Usual physical rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to receiving usual physical rehabilitation the patients in the intervention group had a case manager assigned. A team of three case managers delivered the intervention: a medical doctor specialized in social medicine, an occupational therapist, and a social worker. The case managers were all experienced case managers for non-surgical low back pain patients. The allocation to the case manager was random, and all patients had a main case manager assigned. The case managers involved the other case managers if their special knowledge were needed. Barriers for the patient's rehabilitation were discussed with the multidisciplinary team also including a surgeon, a physiotherapist, and a nurse.; The patients received usual physical rehabilitation at their community rehabilitation unit, and had no case manager assigned.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Fusion; Case Managers; Rehabilitation