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Home News

Canadian Research: Outcomes Study Stresses Standardization

by Judith Otto
August 1, 2002
in News
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Nerrolyn Ford, CPO (Aus), PhD, British Columbia Institute of
Technology (BCIT), Vancouver, is working on a prosthetic outcomes
study that emphasizes:

  • Standardized assessment and record keeping protocols;
  • The fitting of appropriate devices based upon such
    assessment;
  • Continuity of care including assessment of outcomes; and
  • Accountability based upon performance indicators and
    utilization of database information.

Her study proposal points out that “quality improvement and
accountability are of utmost importance…and require constant
update and review of client-based activities.” A standardized
record-keeping system that is understandable and accessible to all
will allow the accumulation of a country-wide database that could
prove invaluable-not only in cases of componentry recalls, but in
identifying trends such as repair frequency and service.

Currently, she explained, it is difficult to track outcomes
because everyone keeps records differently, using their own
qualitative assessment systems in maintaining patient files. To
gain an overall picture of the progress of patients through
examination of records compiled from different parts of the country
is like comparing apples to oranges, she said. “Everybody should
use the same system, so things like fitting times can be tracked
and compared.”

The project, which has just been approved and is still in its
initial phase, will depend upon cooperative input from engineers
and experts from a variety of other backgrounds. Ford’s team is
just starting prosthetic studies and developing quality systems for
prosthetic care based on her guidelines above.

“The first step will be a pilot study on a small population of
perhaps 20 patients, handled as though we were operating a small
clinic,” Ford explained. “Our initial objective will be to develop
a system that can be easily used by all clinicians-one that can be
standardized with regards to performance indicators, replacement
times, etc., and, most importantly, documented.”

She expects the study to be ongoing for about two years; its
success will depend upon its acceptance by the professional
community.

Prosthetics Outcomes Study

The BCIT has presented a proposal for the provision of
prosthetic devices to Health Canada clients. Here is some
additional information:

Summary

The British Columbia Institute of Technology presents the
following proposal for the provision of prosthetic devices to
Health Canada clients. Key components of this proposal are;

  • Standardised assessment and record keeping protocols,
  • Provision of appropriate devices based upon and justified by a
    complete patient assessment
  • Continuity of care including formal assessment of patient
    outcomes
  • Accountability based upon performance indicators published in
    biannual reports and year-round access to data base
    information

Mission statement

To provide Health Canada clients with appropriate devices in a
transparent and accountable manner as part of developing a quality
system for the provision of prosthetic and orthotic devices.

Introduction

Prosthetics is a health care environment that is rapidly
changing as new developments are made in the areas of device
technology and patient management strategies. In the following
proposal, aimed at developing service provision protocols for
Health Canada clients, it is recognised that quality improvement
and accountability are of utmost importance. Further to this it is
recognised that these issues require constantly update and review
of client based activities. It is anticipated that the proposed
study will not only focus the administrative operations of
prosthetic service delivery for Health Canada Clients but also
contribute to the overall quality of service delivery to the
amputee.

In order to supply Health Canada clients with appropriate
prosthetic devices in a transparent and accountable manner we
propose the following Quality Loop.

Quality Loop for Prosthetic Service
Delivery

The elements of the quality loop are manifested by the
following deliverables

Deliverables

  1. Assessment Report Complete assessment of the
    amputee patient is essential to the derivation of an appropriate
    prosthetic prescription. A complete patient assessment must include
    the following: Medical history – summary of the
    diagnosis, date of onset, associated condition, concurrent
    treatment modalities and past history of prosthetic management
    Psychological profile – Including analysis of
    patient needs and manner of coping with the disability,
    psychological disorders related to the disability and unrelated
    psychological disorders Biomechanical presentation
    – Record of passive and active range of motion measurements, degree
    of structural deformities, muscle strength grading, level of
    sensation and recording of any recent trauma or open wounds. This
    should also include an assessment of gait if the patient is
    ambulatory Anthropometric data collection –
    Recording of all appropriate measurements, casts and data files
    necessary to produce a model of the extremity from which a
    prosthesis can be made. We propose to employ a standardized
    electronic form for patient assessment. The interactive electronic
    form will allow for easy clinical access to patient information,
    generation of individual patient reports that may be forwarded to
    prescribing physicians and as a means of gathering patient
    statistics for research and data analysis purposes.
  2. Device Prescription of components for
    prosthetic devices will be based upon patient assessment outcomes.
    Devices will fall under two general categories: Device
    Categories
    : Interim – Interim devices
    are prescribed for the period immediately after amputation when the
    patients’ residual limb is rapidly changing shape. It is recognised
    that a good prosthetic fit during this time is essential for rapid
    wound healing and reducing the rehabilitation time for the amputee.
    During the time proceeding surgery, when the amputees’ residual
    limb is undergoing significant changes in shape and volume, it may
    be necessary to fabricate new prosthetic sockets on a regular
    basis. The number of interim prostheses required will differ for
    each individual patient. As prosthetic fit during this stage of
    rehabilitation is vital for wound healing and patient
    rehabilitation it is proposed that the provision time for an
    interim device will be as short as possible. The componentry used
    in a prosthetic device will be determined by the outcomes of
    patient assessment and in discussion with the prescribing physician
    and rehabilitation team. When possible components will be re-used
    in each subsequent interim limb. Definitive
    Definitive devices are prescribed to amputees who have a stable
    residual limb and are unlikely to require any short-term prosthetic
    socket alterations. These prostheses are often cosmetically
    finished and with the exception of repairs it is anticipated that
    the amputee will use these prostheses for two to three years. The
    prescription of componentry for definitive prostheses is determined
    by the outcomes of patient assessment and in discussion with the
    prescribing physicians and members of the rehabilitation team.
  3. Follow-up Patient follow-up and review is
    essential in a quality system. We propose the following protocols
    for follow-up with amputee patients. Interim prosthetic
    patients
    Follow-up one week after provision of the device,
    once every two weeks for the first two months and then on a monthly
    basis until a definitive device is prescribed. Definitive
    patients
    Follow-up two weeks after device provision and
    then once every six months. Activities conducted during follow-up
    visits include the following:

    • Patient assessment – As described above and evaluated against
      prior visits
    • Minor Repairs
    • Major Repairs
  4. Other deliverablesInteractive
    database *
    The proposed
    interactive data-base would linked client assessment and follow-up
    information. In addition the data-base would include information
    pertaining to:

    • devices supplied
    • components used – including serial numbers for tracking
      purposes
    • location
    • current status

    * essential if a QA system is to be
    developed
    Biannual Report

    • Summary and analysis of previous 6 months activities including
      detailed analysis of performance indicators (see below)

    New Technology Report briefing on:

    • New prosthetic componentry and scientific data related to their
      function and usage.
    • New treatment modalities relating to amputee rehabilitation
      including scientific literature related to their success.
    • Review and update of patient assessment tools

    From the data collected in the proposed clinic additional reports
    may be generated on request. Such reports may include:

    • Reports related to biomechanical effectiveness of prescribed
      devices
    • Reports related to psychosocial effectiveness
    • Reports related to the appropriateness of various
      components

    Performance Indicators As part of a quality
    improvement process, it is recognised that the proposed research
    facility must be able to provide relevant indicators that reflect
    the consumption and use of its outputs, the relative quality of
    those outputs and essential epidemiological data on its client
    base. These indicators should be reliable, current, readily
    available and comparable between jurisdictions. Quality Indicators
    for the proposed study include the following: Completion
    Time Data
    A report which reflects the time to provide a
    prescribed prosthetic service. Separation by prosthesis type will
    be available. Ongoing monitoring of these periods is to be carried
    out to identify trends and improvement opportunities.
    Replacement Time (Useful Life of a Prosthesis)
    Period of time between acquittal of a prosthesis and acquittal of
    its replacement, further subdivided by prosthesis type.
    Repair Frequency Frequency of Major and Minor
    repairs to selected prosthesis and specific componentry. Ongoing
    monitoring of these repairs to identify trends. Service
    Outputs
    Reports by period based on acquittal data
    indicating count of services provided and sorted by type.
    Cost of services Average cost of services by
    period. Individual and summary report for prosthesis by code.
    Clinic Attendance Count of appointments by clinic
    by date and by reason. Operations It is proposed
    that this project would run under the Centre for Rehabilitation
    Engineering and Technology that Enables (CREATE). This research
    centre was developed in partnership with the Neil Squire Foundation
    (NSF) and is a facility devoted to development of devices,
    technologies and products for people with disabilities.
    Staffing Needs:

    • Prosthetist
    • Technician

    Access to:

    • Physiotherapist
    • Occupational Therapist (available through NSF)
    • Diabetic Care Specialist
    • Biomechanist (Dave Kenyon/Yvette Jones)

    Capital Equipment:

    • Biomechanical analysis lab (evtl.)
    • Clinic Setting – Private assessment and casting room and
      consultation office (initially classroom could be converted)

Related posts:

  1. Commercially Available Video Games in Prosthetic Rehabilitation
  2. O&P Education: Guiding the Transition to Client-centric Training
  3. Survey Says? Findings From the Field’s Largest Study of People With Upper-limb Amputations
  4. Economic Impact of O&P Interventions: Research and O&P Organizations Lead the Way
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