| Source of record | UK Trials |
| ISRCTN | ISRCTN08768987 |
| Date ISRCTN assigned | 14/02/2008 |
| Local reference number(s) | 05/1/110 |
| Public title | Self assessment of Health And Illness: Research In Neath Gastroenterology unit |
| Scientific title |
|
| Acronym | SHAIRING |
| Disease/condition/study domain | Gastrointestinal disorders |
| 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, one month and three months and b) anonymous patient satisfaction questionnaires. |
| Design/methodology | Single centre, pragmatic, randomised controlled trial with repeated measurements. |
| Research ethics review | South West Wales Local Research Ethics Committee, approved on 24 March 2006 (ref: 06/WMV02/4) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All patients attending gastroenterology clinic who are fluent in English and likely to be followed up in the clinic within three months. |
| Participants - 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+) |
| Patient information material |
|
| Anticipated start date | 29/07/2006 |
| Anticipated end date | 30/09/2007 |
| Status of trial | Completed |
| Target number of participants | 500 |
| Interventions | 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. |
| Primary outcome measure(s) | The Physical and Mental Component Scores from the 36-item Short Form health survey (SF-36), measured at 3 months. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Wales Office of Research and Development for Health and Social Care - Funding Scheme 2005 (UK) |
| Sponsor name | Wales Office of Research and Development for Health and Social Care (UK) |
| Sponsor details | Welsh Assembly Government
Cathays Park
Cardiff
United Kingdom
CF10 3NQ |
| Contact name | Dr Faiz Ali |
| Contact details | Department of Gastroenterology
Neath Port Talbot Hospital
Baglan Way
Port Talbot
United Kingdom
SA12 7BX |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN08768987 |
| Date last extracted from ISRCTN register | 17/04/2008 |
