Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05/1/110
Study information
Scientific title
Self assessment of Health And Illness: Research In Neath Gastroenterology unit
Acronym
SHAIRING
Study hypothesis
The need to involve patients more actively in decisions about their care is recognised in the NHS Plans for England and Wales. Central to this is the ability to measure a patient's progress from their own perspective. This research will give insight into the feasibility and practicality of measuring and using patient-focused outcomes routinely in outpatients.
In the context of a major, multi-centre trial, MINuET (registered with ISRCTN82765705 - http://www.controlled-trials.com/ISRCTN82765705), a simple quality of life measure for use by patients with gastrointestinal disorders, the Gastrointestinal Symptom Rating Questionnaire (GSRQ) has been developed. This is a system-specific questionnaire. It is quick and simple to complete and is applicable to the majority of patients with GI disorders. We hope it will enable the integration of patient-focused measurement into routine clinical practice.
There are three main research questions:
1. In a busy gastroenterology clinic is it feasible for patients routinely to complete electronic questionnaires about their Health-Related Quality of Life (HRQL) - both generic and GastroIntestinal (GI)-specific - and for doctors to use this information? This will be assessed by qualitative interviews of staff and a sub-sample of patients, the proportions of clinic attendees who were eligible and willing to complete electronic questionnaires, and the proportion who successfully completed them among the two groups allocated to do so.
2. Does this intervention improve process of care, notably doctor-patient communication and management decisions? This will be assessed by qualitative interviews, and clinic waiting and consultation times. Limited information on diagnosis and symptoms will be obtained from routine medical records.
3. Does this intervention improve patient outcomes? This will be assessed by a) patient-completed postal questionnaires at baseline, 1 month and 3 months and b) anonymous patient satisfaction questionnaires.
Ethics approval
South West Wales Local Research Ethics Committee, 24/03/2006, ref: 06/WMV02/4
Study design
Single-centre pragmatic randomised controlled trial with repeated measurements
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gastrointestinal disorders
Intervention
Electronic Health Related Quality of Life Questionnaire (GSRQ/EQ-VAS) - a combination of Gastrointestinal Symptom Rating Questionnaire and EQ-visual analogue scale. The intervention was carried out whenever patients attended clinic visits during the 3-month study follow-up period rather than at planned timepoints.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The Physical and Mental Component Scores from the 36-item Short Form health survey (SF-36), measured at 3 months.
Secondary outcome measures
1. SF-36 scores at 1 month
2. EuroQol (EQ-5D) quality of life questionnaire, filled at recruitment (baseline), 1 month and 3 months
3. Clinic waiting times
4. Length of consultation, taken from routine patient records
5. Patient satisfaction, measured by the Outpatient Medical Interview Satisfaction Scale (OMISS) after each visit to the clinic
Overall trial start date
29/07/2006
Overall trial end date
30/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients attending gastroenterology clinic who are fluent in English and likely to be followed up in the clinic within 3 months.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Problem is primarily non-gastrointestinal
2. Currently taking part in an HRQL study
3. Frail or seriously compromised (American Society of Anaesthesiologists [ASA] status 4+)
Recruitment start date
29/07/2006
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Gastroenterology
Port Talbot
SA12 7BX
United Kingdom
Funders
Funder type
Government
Funder name
Wales Office of Research and Development for Health and Social Care - Funding Scheme 2005 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list