Satisfaction, QoL,Health Status & Clinic Outcomes for Pat... | NCT04244968

Studies
Satisfaction, QoL,Health Status & Clinic Outcomes for Patients Attending MSK Triage Clinics in Rheumatology

NCT04244968

Sponsor

Health Service Executive, Ireland

Status

Active, not recruiting

Last Update Posted

Oct 4, 2024Actual

Enrollment

325Estimated

Phase

Not provided

Conditions

Musculoskeletal Pain
Rheumatologic Disorder

Interventions

Not provided

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2023Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Jan 22, 2020

First Submission Date that Met QC Criteria

Jan 27, 2020

First Posted Date

Jan 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2024

Last Update Posted Date

Oct 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michelle Heraughty, Clinical Specialist Physiotherapist, Health Service Executive, IrelandPrincipal Investigator

Lead Sponsor

Health Service Executive, IrelandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

325Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Musculoskeletal Health Questionnaire	Self Reported Questionnaire measuring patients health status, Score range 0 -56, with better score indicating better health status	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Visit-Specific Satisfaction Questionnaire version 9	Patient Satisfaction Questionnaire, Score range 9 - 45, with higher scores indicating lower patient satisifaction	Baseline
Change in Musculoskeletal Health Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients attending MSK Triage clinics in Rheumatology who meet the inclusion criteria outlined

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michelle Heraughty, MSc	HSE Ireland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sligo University Hospital		Sligo		F91H684	Ireland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27496243	Background	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.
21886368

ID	Term
D059352	Musculoskeletal Pain
D003095	Collagen Diseases

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D010146	Pain
D009461	Neurologic Manifestations