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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 developedBiannual 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)