Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00175201 |
| Other study ID # |
KL-05-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2005 |
| Est. completion date |
December 31, 2008 |
Study information
| Verified date |
December 2022 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this randomised study a proactive care and rehabilitation intervention is compared to the
current care and rehabilitation in patients undergoing primary hip and knee replacement
surgery.
A cost efficacy analysis in a societal perspective is made from effect data in the randomised
controlled study together with cost data gathered during the perioperative and postoperative
period.
If the proactive care and rehabilitation intervention is cost effective the intervention is
going to be implemented in Ringkøbing County. This implementation proces is measured within a
monitoring project of all patients receiving hip or knee replacement surgery in Ringkøbing
County in the period 2003 to 2007.
Description:
BACKBROUND Hip and knee replacement are commonly performed surgical procedures, with more
than 800,000 hip operations carried out worldwide each year and with almost 550 hip and knee
replacements each year in Ringkoebing County. The main indicators for total hip or knee
replacement are intractable pain and/or limitation of function that cannot be managed by
conservative treatment alone. Leading causes of such pain include osteoarthritis, rheumatoid
arthritis, trauma, congenital abnormalities, dysplasia and osteochondritic disease. In the
absence of treatments that provide a cure for conditions such as osteoarthritis, management
is directed primarily towards relieving pain and re-ducing functional limitation. Joint
replacement is one surgical option when medical treatment has failed to provide adequate
symptom relief. Hip or knee replacement is a major surgical procedure that requires inpatient
physiotherapy and out-patient rehabilitation following a stay in hospital.
Regarding the effect of optimizing the perioperative period, no systemically critical reviews
of randomized controlled trials (RCT) could be identified. Only one RCT of the effect of a
clinical pathway in hip and knee arthroplasty could be identified, the study by Dowsey et al
from 1999, which concludes that the intervention gives a better effect and reduces the
average length of stay with 1.5 day. No cost data were reported in this study. A systematic
review of clinical pathways including the study by Dowsey et al and ten non-RCT studies
concludes that clinical pathways for total knee and total hip arthroplasty reduces costs and
length of stay. A significant and great reduction in length of stay is reported from two
resent Danish non-RCT, the study by Rasmussen et al, in which an accelerated and proactive
care was given and the study by Husted et al, in which no extra resources were allocated but
the care was given in a special unit focusing on a length of stay of maximal 8 days. However
nothing is known about the cost or effects of this accelerated and proactive care out-side
the hospital.
In summary the overall evidence level on accelerated perioperative care and rehabilitation
for patients undergoing total hip or knee replacement is scarce.
OBJECTIVES To investigate the cost efficacy of a focused and specialized care unit in
patients undergoing total hip or knee replacement
To investigate the cost effectiveness of a focused and specialized care unit in patients
under-going total hip or knee replacement
MATERIALS & METHODS: Randomized controlled intervention trial with cost efficacy and cost
effectiveness analysis. This study follows the recommendations by the CONSORT Statement.
Perioperative study - RCT Study subjects All patients planned to undergo a primary total hip
or total knee replacement at the Hospital in Holstebro, are at first contact to the hospital
invited to participate in the study. Exclusion criteria's are patients operated secondary to
a hip fracture, patients undergoing remission and patients who are not able to cooperate
normally during the perioperative period. All patients interested in participating in the
study are given written and oral information. After consent the participating patients
completes a baseline questionnaire and are randomized to one of the two groups.
Sample size The estimated sample size of the groups at followup was calculated using actual
data from the hospital in Holstebro from the year 2004 together with data from a pilot study
in 2005. The risk of performing a Type 1 error was set at 5% using a two-sided analysis, and
the power of detecting a true difference was set at 80%. The anticipated reduction of length
of stay was set at 2 days in the intervention group, from a mean length of stay of 8 days
with a standard deviation (SD) of 4 days to a mean length of stay of 6 days and SD of 2 days.
When using a two-sample comparison of means this gives a need for at least 80 patients, 40
persons in each group at follow-up.
Randomization Simple randomization ensuring equal distribution of operation area (hip:knee)
is performed by drawing an envelope from a box.
Intervention Control group Patients in the control group receive the current perioperative
care.
Intervention group Patients in the intervention group are given perioperative care and
rehabilitation according to the regime advocated by The Unit for Perioperative Nursing
Care,Rigshospitalet and in the study by Husted et al and. In this study the perioperative
care and rehabilitation is organized in a new proactive special care and rehabilitation unit
where the patients are gathered and the health care staff are focusing on a preselected
discharge day.
Attempts to reduce potential bias Masking of the patients is obtained by concealment of the
intervention in the other intervention groups, and by securing that the patients in the two
different groups are kept apart in different rooms. Masking of the treating therapists and
caretaking nurses are attempted by randomly allocating them to either usual or the new
preoperative care and rehabilitation unit. All personal allocated to the new preoperative
unit receive education and participates in a pre study period. After starting the
intervention period the treating therapists and caretaking nurses are not allowed to attend
the rooms of patients not allocated to their intervention arm. During the intervention period
physiotherapists and nurses are not allowed to discuss the intervention with persons in the
other intervention arm. Situation and circumstances where the protocol is not followed will
be registered using an intervention log book. The baseline and follow-up data collection is
performed with questionnaires and by measurements by a person not involved in the
intervention. No attempt is made to minimize the placebo or the Hawthorne effect, because the
different attention and time spent in the intervention is an important factor in the cost
effectiveness analysis. Potential contamination regarding the care given by nurses and
treating therapists is recorded via a structured observation of care and treatment before
baseline and in the latter part the study period. Compliance with exercise is collected
through the reporting of actual participation in planned training and questionnaires filled
inat day of discharge.
Follow-up Length of stay is recorded using register information and all other outcome
measures are collected from questionnaires at discharge, 3, 12 and 24 months after discharge.
Outcome measures Primary outcome measures are length of stay, health related quality of life
measured with EQ-5D and SF-36/SF-6D. Secondary outcome measures are pain measured with a
6/point ordinal scale, disability measured with Harris Hip Score / The Danish Knee
Arthroplasty Register Score.
Side effects are collected from register data on mortality and the incidence and length of
stay be-cause of deep vein thrombosis.
Data analysis The data is analysed according to the recommendations by Sackett et al using
intention-to-treat analysis. Chi-square test is used for categorical data and parametric or
non-parametric statistics for two-sample comparison of means are used for continuous data.
The significance level is set at p<0.05.
Cost efficacy study of a perioperative intervention Efficacy is in this study defined
according to Last JM as: The extent to which a specific intervention, procedure, regimen, or
service produces a beneficial result under ideal conditions. Ideally, the determination of
efficacy is based on the results of a randomized controlled trial. The question to be
answered according to Drummond MF et al is: Can it work? To determine whether a proactive
perioperative intervention in patients undergoing total hip or knee replacement is cost
effective under ideal circumstances the study is performed alongside the RCT at one hospital.
Actual costs are sought via available data sources and patient administered diaries and
collected for a period of 24 months. The collected cost data are divided into direct costs
and benefits, indirect costs and benefits and intangible costs and benefits. Direct
healthcare costs include peripoperative operation and hospital stay costs at DRG taxes
together with changes in costs due to the perioperative intervention at actual prices. Direct
postoperative primary health care sector costs include costs from visiting general
practitioner, nurses and physiotherapist at preset prices. Direct non-healthcare costs
includes social sector costs such as professional home care and extra costs at nursery homes,
private home care costs, private rehabilitation costs, costs from visiting alternative
therapists, private help costs and transportation costs at preset prices. Indirect costs are
costs from production loss and are estimated according to the friction method with a maximum
of 3 months of absenteeism from paid work at preset salary. Intangible costs and benefits are
not collected beneath being implicit in the quality of life measures. The costs are held
against the primary outcome measures in each group. The cost efficacy of the intervention is
calculated as the differences in costs related to the differences in effects between the
intervention and control group. The cost efficacy analysis is performed according to the
recommendations by Drummond et al.
Cost effectiveness study of a perioperative intervention Effectiveness is in this study
defined according to Last JM as: The extent to which a specific intervention, procedure,
regimen, or service, when deployed in the field of routine circumstances, does what it is
intended to do for a specific population. The question to be answered according to Drum-mond
MF et al is: Does it work? To determine whether a proactive perioperative intervention in
patients undergoing total hip or knee replacement is cost effective in other units in the
county under normal circumstances the estimated cost difference from the efficacy study
together with the im-plementation time, problems and costs of the fully developed
intervention is held against the actual effect difference of all outcome measures for the
period following implementation compared the period prior to implementation. The cost
effectiveness analysis is performed according to the recommendations by Drummond et al.
