Pelvic Floor Disorders Clinical Trial
Official title:
Assessing the Impact of Using ePAQ on Quality and Cost of Patient Care in Uro-gynaecology: a Randomised Controlled Trial
The purpose of this study is to assess the impact of using a virtual clinic which combines a web-based interactive questionnaire (ePAQ-PF) used in advance of clinic appointments in combination with a telephone consultation has on patient experience and cost compared to standard care.
ePAQ is a web-based interactive questionnaire (electronic pelvic floor assessment
questionnaire) that provides a detailed evaluation of a woman's pelvic floor symptoms and
their impact on her quality of life. Touch-screen technology has been combined with computer
programming (Dot Net & SQL Server) and existing paper-based instruments to produce an
interactive user-friendly system that facilitates immediate data entry, analysis and
storage. The instrument has evolved during several years' collaborative work with colleagues
in a range of disciplines, including Gynaecology, Medical Physics, Colorectal Surgery,
Urology and General Practice, as well as involving a women's health user-group and regular
surveys of patients' views.1 Research in primary and secondary care has established the
psychometric properties of the instrument.2 The system has won a National award for
innovation (HITEA) and was cited in Lord Warner's Annual Report on NHS Innovation.3 EPAQ
Systems Ltd is one of the first NHS spin-out technology companies to be established in the
UK (created jointly with Sheffield Teaching Hospitals NHS Trust in November 2006).
More recent development work has resulted in the creation of a website, where subjects can
securely and anonymously access and use the ePAQ system via the Internet. This potentially
allows subjects to use system in advance of clinic appointments (as opposed to the current
practice of their completing it on arrival in clinic, immediately prior to their
appointment). This study aims to evaluate the impact that using ePAQ in this way may have on
the efficiency and quality of patient care. Initial survey data suggest that many women
attending urogynaecology clinics do have access to the Internet and would be willing to use
the system on-line & in advance of clinic appointments.4 The facility is also available in
the Gynaecology Unit for women without Internet access to attend specifically for supervised
use of the system. The in-depth assessment provided by the ePAQ may then be used to support
an initial telephone consultation with a clinician, following which patients may be directed
to the most appropriate clinic, as well as being provided with information and advice and
have some forms of treatment initiated (such as behavioural therapy). The proposed
randomised study aims to compare outcomes in women who use the ePAQ system in this way with
women who undergo standard care in the Urogynaecology Unit.
The major advantage of electronic systems, when compared with paper questionnaires, relate
to the practicalities of clinical data capture. Electronic questionnaires are comparable in
terms of reliability and can be superior in terms of efficiency and response rate. In
addition, electronic touch-screen questionnaires have been shown to be acceptable to
patients, regardless of their age or educational background. Data quality is high, even in
disadvantaged and technophobic subjects and cost analysis has shown potential economic
advantages.5,6,7,8,9 Pelvic floor disorders in women, such as incontinence and prolapse,
share common aetiologies and commonly coexist. Estimates vary, though it is estimated that
approximately 20% of adult women experience regular urinary incontinence, 5% have some
incontinence of faeces and 11% suffer with prolapse.10,11,12 However, despite better
understanding of these conditions, bowel, bladder, vaginal and sexual dysfunction remain
understandably taboo subjects and many women still regard them as inevitable consequences of
childbirth and ageing. The personal cost to individuals is high, however simple and
effective treatments are increasingly available. Many disorders respond well to behavioural,
physical or medical therapy and such conservative treatments are generally recommended prior
to consideration of invasive investigations or surgery.13 In clinical practice, clinical
assessment is central to diagnosis and management and the restoration of function, with a
view to improving quality of life, is the principal aim of treatment. It is well recognised
that clinical interview data may be unreliable, being based on clinicians' rather than
patients' views of their condition. It seems appropriate therefore, to seek ways of
improving clinical assessment in order to enhance the quality of care and reliably measure
outcome. Many women with pelvic floor disorders are managed in the community by GPs, nurses,
physiotherapists or continence nurse advisors. In secondary and tertiary care, urologists,
gynaecologists, colorectal surgeons and geriatricians are likely to be involved. However, at
all levels, inconsistencies in clinical assessments represent an impediment to effective
communication and the multidisciplinary approach advocated by the DoH, who in 2000
recommended the following:
- Full assessment leading to first line treatment in the primary care setting, with
treatment & management plans agreed with individual patients.
- The provision of an integrated continence service, bringing together agreed protocols
and procedures for primary, secondary and tertiary care.
- A comprehensive continence service, at home and in homes, bringing together all
relevant health disciplines.
The further development of ePAQ has the potential to substantially augment this process by
using on-line assessments to support patients' initial management and triage. Using ePAQ in
advance of clinic appointments may provide patients and clinicians with prompt and valuable
information and assist in directing patients to the most appropriate clinics in primary and
secondary care. However, such a development warrants scrutiny in terms of patient experience
and cost.
The ePAQ is now an established part of standard care and is in routine use in the Sheffield
Urogynaecology Unit. All new patients are given the opportunity to complete the
questionnaire, online, at home and their printed results are then used to inform the
subsequent clinical consultation. The aims of this research are to measure the impact that
using a virtual clinic (ePAQ-PF in advance of clinic appointments + a telephone
consultation) has on patient care and cost compared to standard care (ePAQ-PF in advance of
clinic appointments + a face to face consultation).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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