NCT02176330

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

June 23, 2014

Last Update Submit

June 25, 2014

Conditions

Keywords

Randomised Controlled TrialVirtual ClinicePAQ-PFPelvic Floor DisordersEconomic Analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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

    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

    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

    Data collected at the six month follow-up (Time 2)

Other Outcomes (1)

  • Resource Use Proforma

    Data collected at the six month follow-up (Time 2).

Study Arms (2)

Usual care

ACTIVE COMPARATOR

ePAQ-PF followed by a face to face consultation.

Other: ePAQ-PF followed by a face to face consultation

Virtual Clinic

EXPERIMENTAL

ePAQ-PF followed by a telephone consultation.

Other: ePAQ-PF followed by a telephone consultation.

Interventions

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.

Virtual Clinic

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.

Usual care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jessop Wing Hospital

Sheffield, South Yorkshire, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Georgina L Jones, D.Phil

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Social Science

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 27, 2014

Study Start

June 1, 2008

Primary Completion

September 1, 2010

Study Completion

August 1, 2012

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations