Pelvic Floor DisordersNCT02176330
Does Using a 'Virtual Clinic' in Urogynaecology Improve Patient Experience and Reduce Cost?
A study testing ePAQ-PF followed by a telephone consultation. and ePAQ-PF followed by a face to face consultation in people with Pelvic Floor Disorders, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- ePAQ-PF followed by a telephone consultation. and ePAQ-PF followed by a face to face consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women referred to Sheffield Teaching Hospitals urogynaecology services, aged > 18 and able to read and understand English will be eligible to enter the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Jessop Wing Hospital
Sheffield, South Yorkshire
About this study
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.
Read the detailed description
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).
- Conditions
- Pelvic Floor Disorders
- Being tested
- ePAQ-PF followed by a telephone consultation., ePAQ-PF followed by a face to face consultation
- Keywords
- Randomised Controlled Trial, Virtual Clinic, ePAQ-PF, Pelvic Floor Disorders, Economic Analysis
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePAQ-PF followed by a telephone consultation.Other
All women randomised to this arm of the study were entered onto the hospital electronic patient record system under the ePAQ clinic. They were were posted an information letter and an epaq-online voucher inviting them to complete the questionnaire on-line. The clinician used these results along with the patient's own casenotes and original referral letter to support the subsequent consultation. The research nurse (HJW) then arranged their telephone consultation. Women in this group who felt unable to complete the questionnaire online would use this telephone call with the research nurse to make arrangements to attend and complete the questionnaire at the hospital.
ePAQ-PF followed by a face to face consultationOther
All women randomised to this arm of the study were posted an appointment to attend the urogynaecology clinic. They were were posted an information letter and an epaq-online voucher inviting them to complete the questionnaire on-line. The clinician used these results along with the patient's own casenotes and original referral letter to support the subsequent consultation. Women then attended for their face to face clinic consultation as normal. Women in this group who felt unable to complete the questionnaire online were given the opportunity to complete the questionnaire at the hospital when they attended for their consultation.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | ePAQ-PF followed by a face to face consultation. Receives: Other: ePAQ-PF followed by a face to face consultation |
| Virtual Clinic | Experimental | ePAQ-PF followed by a telephone consultation. Receives: Other: ePAQ-PF followed by a telephone consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Experience Questionnaire
The primary outcome measure was the Patient Experience Questionnaire (PEQ) [1] completed after the patients first clinical consultation. The PEQ was developed and validated specifically to measure patients' experience of interaction, emotion and consultation outcome. It contains 16 items in four dimensions, including 1) communication, 2) emotions, 3) short-term outcome, and 4) barriers. Three of the scales are scored from 1-5, and the emotions scales runs from 1 to 7. A high score represents a good communication experience, positive emotions, positive consultation outcome and a lack of communication barriers.
Measured: This was posted to patients at one time point. This was posted no longer than two weeks after patients had attended for their first clinic consultation (Baseline).
Secondary outcomes (4)
The Client Satisfaction Questionnaire-8.
A modified version of the CSQ-8 was administered (Howie et al, 1997; 1998). This validated instrument contains 8 items measuring the patient's satisfaction following a consultation asking 1) how they rate the service, 2) did they get the service they wanted, 3) to what extent the service me their needs, 4) would they recommend the service to their friends, 5) how satisfied they were with the amount of help received, 6) if the services received helped then to deal more effectively with their problems, 7) overall satisfaction with the service and 8) if they would return to the services if they required help again. The CSQ-8 is a eight-item self-complete questionnaire, which generates a score with a 8 to 32 range, with a higher score indicating more patient satisfaction.
Measured: This was posted to patients at one time point. This was posted no longer than two weeks after patients had attended for their first clinic consultation (Baseline).
The Short-Form-12
The SF-12 is a standardised, multidimensional, generic measure of health related quality of life (HRQOL), and was administered to patients at baseline and 6 months post initial consultation. The results from the SF-12 can be converted into utilities using the SF-6D (Brazier \& Roberts 2004). These are a value anchored on a scale of 0 (death) to 1 (full health) which represent individuals preference for a health condition. These values are assigned to health states and combined with the number of years spent in that health state to calculate quality adjusted life years (QALY) which are needed for cost utility analyses.
Measured: A subset of patients were asked to complete the SF-12 at two time points. This was posted after their intervention i.e. first consultation (Baseline) and six months later (Time 2).
The QQ-10
The QQ-10 is a 10-item instrument specifically designed for evaluating patients views on the value and burden of using of a questionnaire as part of their healthcare (Moores et al, 2012)
Measured: This was posted to patients at one time point. This was posted no longer than two weeks after patients had attended for their first clinic consultation (Baseline).
The Number and Type of Referrals
The total number and individual type of referrals made were used to evaluate the impact of ePAQ on the referral patterns and clinical visits made within the continence care pathway. At 6-month follow-up we will measure the number and type of referrals made on behalf of that patient; i.e. primary care (community nursing, community physiotherapy, GP, district nurse, practice nurse) and secondary care (gynaecology, urology, colorectal surgery, physiotherapy). These data will be collected in both groups using a standard proforma.
Measured: Data collected at the six month follow-up (Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2008
- Primary completionSep 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Georgina Jones, University of Sheffield
- Investigators
- Georgina L Jones, D.Phil, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176330
- Sponsor's protocol ID
- STH14733
- Other IDs
- North Sheffield Ethics 07/H130
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Using ePAQ on Quality and Cost of Patient Care in Uro-gynaecology: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02176330
- Acronym / sponsor ID
- STH14733
- Conditions
- Pelvic Floor Disorders
- Keywords
- Randomised Controlled Trial, Virtual Clinic, ePAQ-PF, Pelvic Floor Disorders, Economic Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- Jun 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: ePAQ-PF followed by a face to face consultationePAQ-PF followed by a face to face consultation. |
| Virtual Clinic | Experimental | Other: ePAQ-PF followed by a telephone consultation.ePAQ-PF followed by a telephone consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women referred to Sheffield Teaching Hospitals urogynaecology services, aged > 18 and able to read and understand English will be eligible to enter the study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePAQ-PF followed by a telephone consultation.All women randomised to this arm of the study were entered onto the hospital electronic patient record system under the ePAQ clinic. They were were posted an information letter and an epaq-online voucher inviting them to complete the questionnaire on-line. The clinician used these results along with the patient's own casenotes and original referral letter to support the subsequent consultation. The research nurse (HJW) then arranged their telephone consultation. Women in this group who felt unable to complete the questionnaire online would use this telephone call with the research nurse to make arrangements to attend and complete the questionnaire at the hospital. | Other | Virtual Clinic |
| ePAQ-PF followed by a face to face consultationAll women randomised to this arm of the study were posted an appointment to attend the urogynaecology clinic. They were were posted an information letter and an epaq-online voucher inviting them to complete the questionnaire on-line. The clinician used these results along with the patient's own casenotes and original referral letter to support the subsequent consultation. Women then attended for their face to face clinic consultation as normal. Women in this group who felt unable to complete the questionnaire online were given the opportunity to complete the questionnaire at the hospital when they attended for their consultation. | Other | Usual care |
Primary outcome
The Patient Experience Questionnaire
Time frame: This was posted to patients at one time point. This was posted no longer than two weeks after patients had attended for their first clinic consultation (Baseline).
The primary outcome measure was the Patient Experience Questionnaire (PEQ) [1] completed after the patients first clinical consultation. The PEQ was developed and validated specifically to measure patients' experience of interaction, emotion and consultation outcome. It contains 16 items in four dimensions, including 1) communication, 2) emotions, 3) short-term outcome, and 4) barriers. Three of the scales are scored from 1-5, and the emotions scales runs from 1 to 7. A high score represents a good communication experience, positive emotions, positive consultation outcome and a lack of communication barriers.
4 secondary outcomes
The Client Satisfaction Questionnaire-8.
Time frame: This was posted to patients at one time point. This was posted no longer than two weeks after patients had attended for their first clinic consultation (Baseline).
The Short-Form-12
Time frame: A subset of patients were asked to complete the SF-12 at two time points. This was posted after their intervention i.e. first consultation (Baseline) and six months later (Time 2).
The QQ-10
Time frame: This was posted to patients at one time point. This was posted no longer than two weeks after patients had attended for their first clinic consultation (Baseline).
The Number and Type of Referrals
Time frame: Data collected at the six month follow-up (Time 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgina L Jones, D.Phil principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePAQ-PF followed by a telephone consultation. and ePAQ-PF followed by a face to face consultation in people with Pelvic Floor Disorders, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient Experience Questionnaire (time frame: This was posted to patients at one time point. This was posted no longer than two weeks after patients had attended for their first clinic consultation (Baseline).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.