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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04244968
Other study ID # REC SUH 763
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 22, 2020
Est. completion date January 2025

Study information

Verified date September 2021
Source Health Service Executive, Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to measure the impact of musculoskeletal (MSK) complaints on the quality of life and general health of MSK Patients attending MSK triage clinics. The investigators will also record the proposed management options for patients' complaints. This will be achieved by asking patients to complete questionnaires (MSK HQ) at musculoskeletal triage clinic appointment, by undertaking a clinical assessment, by recording the proposed management plan and assessing if patients have follow up appointments for the same complaint in the following year. The investigators will also measure patient satisfaction using VSQ 9 Questionnaire. After a year the investigators will repeat the MSK HQ to assess the longterm impact of MSK Triage appointment on the MSK complaint.


Description:

At present there is no data available to describe the impact of musculoskeletal (MSK) disease on the Quality of life and General Health for patients attending Rheumatology MSK triage clinics in SUH and OHLM or in similar service around Ireland. A new questionnaire (MSK HQ) has been developed which has been validated in use with this population. This will be completed by the patient on the day of the appointment and again a year later. Their number of visits to secondary care in the year after their visit will also be captured and analysed. This information will inform the health service of the outcomes of these patients and the impact of their MSK disease on the health service. It will also help with resource allocation and planning for future services, which will ensure the best service for these patients in the future. Alongside this, Patient satisfaction and feedback is vital to ensuring service quality and quality improvement. The VSQ 9 will be used to measure Patient Satisfaction in this study to evaluate if patients are satisfied with the service they have received on the day. The repeated MSK HQ will help identify if their triage clinic appointment was beneficial to their Quality of life.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 325
Est. completion date January 2025
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years and over - Patients who attend the musculoskeletal Triage Clinic in Rheumatology. - Patients who can answer the study questionnaires independently. Exclusion Criteria: - Under 18 years - Patients who present with red flag conditions, inflammatory disease or non-musculoskeletal conditions. - Patients who cannot answer the study questionnaires independently.

Study Design


Locations

Country Name City State
Ireland Sligo University Hospital Sligo

Sponsors (1)

Lead Sponsor Collaborator
Health Service Executive, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232. Review. — View Citation

Hill JC, Kang S, Benedetto E, Myers H, Blackburn S, Smith S, Dunn KM, Hay E, Rees J, Beard D, Glyn-Jones S, Barker K, Ellis B, Fitzpatrick R, Price A. Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways. BMJ Open. 2016 Aug 5;6(8):e012331. doi: 10.1136/bmjopen-2016-012331. — View Citation

Kennedy DM, Robarts S, Woodhouse L. Patients are satisfied with advanced practice physiotherapists in a role traditionally performed by orthopaedic surgeons. Physiother Can. 2010 Fall;62(4):298-305. doi: 10.3138/physio.62.4.298. Epub 2010 Oct 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Musculoskeletal Health Questionnaire Self Reported Questionnaire measuring patients health status, Score range 0 -56, with better score indicating better health status Baseline
Secondary Visit-Specific Satisfaction Questionnaire version 9 Patient Satisfaction Questionnaire, Score range 9 - 45, with higher scores indicating lower patient satisifaction Baseline
Secondary Change in Musculoskeletal Health Questionnaire Self Reported Questionnaire measuring patients health status, Score range 0 -56, with better score indicating better health status One year post baseline
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