Musculoskeletal PainMSK-TrackerNCT03559205
The MSK-Tracker Study
A study testing MSK-Tracker in people with Musculoskeletal Pain, run by Keele University at 1 site in United Kingdom.
Trial summary
This study will co-design and test the feasibility and impact of implementing the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) using an e-PROM (electronic Patient Reported Outcome Measure) delivered via a digital health platform, with innovative embedded components called the MSK-Tracker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- MSK-Tracker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and above with an appointment to attend the Staffordshire Musculoskeletal Interface Service for an MSK pain problem will be invited to take part.
Who cannot join
- Patients unable to use or access the internet will be unable to take part in this research as well as patients who do not provide informed consent for study participation and data collection. The online system will only be available in English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Haywood Hospital
Stoke-on-Trent, Staffordshire, ST6 7AG
About this study
Official title: Implementing the MSK-HQ to Empower Patients and Improve Services
This study will co-design and test the feasibility and impact of implementing the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) using an e-PROM (electronic Patient Reported Outcome Measure) delivered via a digital health platform, with innovative embedded components called the MSK-Tracker. The MSK-Tracker uses the MSK-HQ as a foundation to help patients with MSK pain to:
- track the extent to which they are affected by their MSK condition across different aspects of their health,
- prepare appropriately for their clinical encounters, and
- take the right steps to making positive changes to improve their quality of life and manage their condition over the longer-term.
Read more
The Study Aims to:
- Test the ability of the MSK-Tracker to act as an empowerment tool and method of facilitating a person-centred care planning approach in routine MSK clinic consultations.
- Assess the value of the MSK-Tracker in generating aggregated outputs that inform MSK service improvement.
Study Design This study will use a before and after single Centre design with the comparator between phases 1 and 3 across a range of outcomes. Phase 2 will focus on iterative testing of the MSK-Tracker.
In addition, in Phase 1 and 3 will include qualitative research (site 1 only) using the Experience Based Co-Design (EBCD) methodology to explore the impact of the MSK-Tracker and to inform further improvement and refinement of the tool and its use within the context of an MSK service and clinical practice. The findings from the qualitative research will be triangulated with insights from the aggregated data of patient outcomes to enrich and help make sense of the study findings.
Read the detailed description
The Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) is a recently validated new MSK Patient Reported Outcome Measure (PROM) that has been co-produced with patients and clinicians to measure the holistic impact of an MSK condition on a person's health. It has been validated in both primary and secondary care populations and is appropriate for use by patients across the care pathway. It is designed for use in routine, busy, clinical practice. The MSK-HQ is freely available to the NHS, and consists of 14 health items that cover the domains that matter the most to MSK patients and helps clinicians and patients to identify the areas of life where the condition is impacting most. An electronic-PROM (e-PROM) version of the MSK-HQ is available and is being used by some early adopter MSK services to audit their clinical and patient outcome performance.
However, it is not yet known whether:
- Patients using the MSK-HQ routinely as part of their care planning, supports them to feel more involved and empowered in managing their health issues.
- Using the MSK-HQ can facilitate a more holistic care planning consultation, both in terms of the quality of patient interactions and communications with healthcare professionals.
- It is acceptable or feasible for both patients and clinicians to use the MSK-HQ as an e-PROM.
Enabling organisations to examine their aggregated MSK-HQ data at service level identifies unmet need, improvement opportunities and informs MSK service and organisational developments.
This research will optimise implementation of the MSK-HQ using a digital health platform, and evaluate its impact on both clinicians and patients. In addition to investigating benefits at the individual level, we also hypothesise that the data generated by this innovation may provide substantial organisational level insight. We plan therefore to explore how MSK-HQ data can best be aggregated, made sense of and presented as actionable outputs that identify unmet need and service improvement opportunities.
This proposal is novel because of three specific developments;
- The development of an IT innovation to support the implementation of the MSK-HQ within the individual consultation, which has the potential to bring many advantages to people with MSK conditions. The individual patient is often the only consistent connection between different service components. It therefore makes sense for patients to be able to own and access their care plan as they move between providers. For conditions such as osteoarthritis, many core treatments are initiated by patients themselves rather than by the doctor and the perspectives of patients may differ from the perspectives of healthcare professionals, with information recorded by professionals in the medical records not necessarily aligned to the patient's ideas about his or her treatment plan. ii. Making the MSK-HQ available to patients in advance as a prompt prior to their consultations, and testing if its application in this way facilitates a care planning approach. Patients want to be able to own and access their care plan as they move between providers, and the MSK-Tracker will enable them to do that. Patients can also find it difficult to raise important issues of concern in short, busy clinical interactions with different providers, which can lead to healthcare inconsistencies and inequalities in the support they receive. Although reports are limited, evidence from cancer research suggests that the use of consultation prompt lists can improve care and augment consultations when they are used proactively by clinicians. Despite growing evidence that they can make the consultation more focused and time-efficient, prompt lists are infrequently used in NHS MSK consultations. Within the UK health community, there is a national debate about how to bring about more person-centred care "How can we get better at providing patient centred care?", and "No decision about me without me". Participants in the BMJ discussion agreed that a change in culture and better use of technology could benefit patients and doctors. The potential for the MSK-Tracker to influence the consultation and help patients keep track of their health status and in control of their care resonates with the 2014 Reith Lectures by Atul Gawande, who highlighted the role of checklists and prompt questions as a stimulus for achieving better outcomes and service improvement. Problems with 'the system': the interactions between people and organisations that deliver healthcare were also highlighted. This debate is of growing relevance to the MSK community and new national policy from Arthritis Research UK is now focused on efforts to ensure that those living with arthritis and musculoskeletal conditions get the care and support they need to lead as healthy and active a life as possible in order to be "In control, independent and recognised". It is clear that to empower patients to feel well supported, informed and able to manage the effects of their condition and minimise its impact on their lives, they need to have equal voice and be at the heart of setting goals and planning their own care in partnership with their MSK clinical team. However, in order to deliver changes to the way care is delivered, innovative technological solutions such as this, are required. iii. Identifying the best ways to present and format outputs of aggregated MSK-HQ data to generate insights that inform service development and improvement. The MSK-Tracker will be an exciting new development, which, if implemented through a scalable electronic solution, has substantial potential to drive forward large scale service changes. MSK-HQ is supported nationally by Arthritis Research UK, NHS England and professional bodies including the CSP (Chartered Society of Physiotherapy) and BOA (British Orthopaedic Association). The next important step is to find a feasible way to use this outcome measure within routine clinical practice as a stimulus to drive the whole system to focus on what matters to patients and improve the care provided.
The study is using a 'before' and 'after' sequential comparison design with an iterative pilot and user testing phase in between. In addition, audio recordings of the consultation (site 1 only) (in a sub-sample, n=40 (phase 1=20 \& phase 3=20)), alongside individual clinician and patient interviews and a feedback workshop with clinicians and patients, will explore the feasibility, and impact of implementing the MSK-Tracker within routine consultations and the experiences of those who have used it.
Phase 1 ('Before' stage). Patients (n=200) who meet the eligibility criteria for having long-term MSK pain and an appointment at the relevant clinic will be consented and recruited to complete the e-PROM survey and demographic information shortly before their consultation. This phase will seek to collect patient information via the online digital health platform without using the new innovative 'MSK-Tracker' components, in order to give a baseline of what changes are observed before the MSK-Tracker intervention is used. Patients will complete data online before clinic, and then 2 weeks and 3 months after clinic and their change scores examined. Clinicians will complete a case report form (CRF) using the clinician portal to record clinical behaviours within the consultation. Audio recordings of approximately 20 patient consultations will examine consultation conversations and their content (site 1 only).
Phase 2. ('Pilot stage') (Site 1 only). The MSK-Tracker will be developed and optimised through an iterative user testing framework with patients, clinicians, software provider, and experts. The MSK-Tracker will have a number of key 'care planning' components including, pre-clinic preparation, clinic dashboard, summary action plan, personal goal setting and follow-up and progress charts.
Early pilot testing of the MSK-Tracker will mirror the processes used in phase 3, with a limited number of patients and clinicians using the Tracker. The aim is to recruit approximately 40 patients (in 2 cycles of 20) to use the MSK-Tracker. During this phase all patients and clinicians will be invited to take part in an interview about their experiences to identify further potential improvements that can be made to the Tracker before commencing phase 3. The aim is to interview up to 10 patients in each of the 2 cycles.
Phase 3 ('After' stage). Identical to phase 1, patients (n=200) who meet the eligibility criteria for having long-term MSK pain and an appointment at a relevant clinic, will complete an e-PROM shortly before their consultation and again 2 weeks and 3 months after their consultation. During phase 3 the MSK-Tracker components will be used alongside the e-PROM to support the new innovative 'care planning' approach and clinicians will be trained to use the MSK-Tracker within their clinical encounters. As in phase 1 audio recordings of approximately 20 patient consultations (site 1 only) will examine consultation conversations and their content. A descriptive content analysis will be conducted to identify differences before and after the introduction of the MSK-Tracker in clinic.
In addition, qualitative research will take place using the Experience Based Co-Design (EBCD) methodology in both phase 1 and 3 (site 1 only). This will involve interviews with approximately 10 patients and up to 10 clinicians to explore the impact of the MSK-Tracker and to inform further improvement and refinement of the tool and its use within the context of an MSK service and clinical practice. The findings from this qualitative research will be triangulated with insights from the aggregated data of patient outcomes to enrich and help make sense of the study findings.
The intervention is not a treatment per se, but involves patients and clinicians engaging with the MSK-Tracker software. It is envisaged that the MSK-Tracker will facilitate a new care planning approach with the following distinct components:
- Pre-clinic preparation. Prior to a consultation, the MSK-Tracker will help patients to set their clinic agenda by asking them to think about the ways in which their long-term MSK condition is impacting on their lives.
- Clinic dashboard. During the consultation it will enable the clinician to see the patient's health impact from their MSK condition (using MSK-HQ), and present the patient's clinic agenda to inform the consultation focus and ensure the individual's specific needs are addressed.
- Summary action plan. The Tracker will be used to record the agreed action plan from the consultation, including advice, information, referrals and investigations, which the patient can access when they want to as a reminder of what was agreed.
- Personal goal setting. To help the patient focus on what they personally seek to change (e.g. to get more fit and active) in relation to the impact of the MSK condition on their life and to help them reflect on what things are helping/hindering them to achieve goals to reduce this impact a goal setting module will be available to patients within the Tracker.
- Follow-up and monitoring. The Tracker will enable the patient to re-take the MSK-HQ at 2 weeks and 3 months and then have the opportunity to look at tracker charts that show their progress on the MSK-HQ overall score and individual domains.
- Conditions
- Musculoskeletal Pain
- Being tested
- MSK-Tracker
- Keywords
- Musculoskeletal, MSK
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSK-TrackerOther
The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
- Pre-clinic preparation.
- Clinic dashboard.
- Summary action plan.
- Personal goal setting.
- Follow-up and monitoring.
| Study group | Role | What they receive |
|---|---|---|
| MSK-Tracker (before) | No intervention | Before - (Usual care in clinic consultations) |
| MSK-Tracker (after) | Active comparator | After - (MSK-Tracker in clinic consultations) Receives: Other: MSK-Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Enablement Instrument (PEI)
A measure of patient empowerment.
Scale:
Much better / Much more = 2 Better / More = 1 Same or less = 0 Not applicable = 9
Measured: 2 weeks
Secondary outcomes (5)
Musculoskeletal Health Questionnaire (MSK-HQ)
This questionnaire is about joint, back, neck, bone and muscle symptoms such as aches, pains and/or stiffness.
Min score = 0; Max score = 56. A higher score indicates better outcome.
Measured: Baseline, 2 weeks and 3 months
Consumer Health Activation Index (CHAI)
The CHAIv1 was developed for use among diverse patients to provide a measure of patient activation.
Min score = 0, Max score = 100. A high score represents a better outcome.
"low" (CHAI score 0-79), "moderate" (CHAI score 80-94), and "high" (CHAI score 95-100).
Measured: Baseline, 2 weeks and 3 months
Valuing Patients as Individuals Scale (Short Version)
Scale 1 - Care and Respect Min score = 0, Max score = 15 Higher score indicates a better outcomes.
Scale 2 - Understanding and Engagement:
Min score = 0, Max score = 15. Higher score indicates a better outcomes.
Measured: 2 weeks
Global Rating of Change (1 Item)
The response to the question:
"With respect to your joint and muscle symptoms, how would you describe yourself now compared to how it was when you came to the Haywood clinic?"
Much better = 5 Better = 4 Same = 3 Worse = 2 Much worse = 1 Prefer not to say = 9
Measured: 2 weeks and 3 months
The Patient Enablement Scale
A measure of patient empowerment
Min score = 0, Max score = 12. Higher score indicated better outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start10 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before and after comparative study
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Collaborators
- Pro-Mapp Limited Company number 10152526, Georgina Craig Associates Limited, University of Oxford, Arthritis Research UK
- Responsible party
- Sponsor
- Investigators
- Jonathan Hill, Dr, Principal investigator, Keele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559205
- Sponsor's protocol ID
- RG-0132-16-IPCHS
- Acronym
- MSK-Tracker
- Status last verified
- Oct 2021
- First submitted
- 17 Apr 2018
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the MSK-HQ to Empower Patients and Improve Services
- ClinicalTrials.gov ID
- NCT03559205
- Acronym / sponsor ID
- MSK-Tracker / RG-0132-16-IPCHS
- Conditions
- Musculoskeletal Pain
- Keywords
- Musculoskeletal, MSK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Collaborators
- Pro-Mapp Limited Company number 10152526, Georgina Craig Associates Limited, University of Oxford, Arthritis Research UK
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will co-design and test the feasibility and impact of implementing the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) using an e-PROM (electronic Patient Reported Outcome Measure) delivered via a digital health platform, with innovative embedded components called the MSK-Tracker. The MSK-Tracker uses the MSK-HQ as a foundation to help patients with MSK pain to:
- track the extent to which they are affected by their MSK condition across different aspects of their health,
- prepare appropriately for their clinical encounters, and
- take the right steps to making positive changes to improve their quality of life and manage their condition over the longer-term.
The Study Aims to:
- Test the ability of the MSK-Tracker to act as an empowerment tool and method of facilitating a person-centred care planning approach in routine MSK clinic consultations.
- Assess the value of the MSK-Tracker in generating aggregated outputs that inform MSK service improvement.
Study Design This study will use a before and after single Centre design with the comparator between phases 1 and 3 across a range of outcomes. Phase 2 will focus on iterative testing of the MSK-Tracker.
In addition, in Phase 1 and 3 will include qualitative research (site 1 only) using the Experience Based Co-Design (EBCD) methodology to explore the impact of the MSK-Tracker and to inform further improvement and refinement of the tool and its use within the context of an MSK service and clinical practice. The findings from the qualitative research will be triangulated with insights from the aggregated data of patient outcomes to enrich and help make sense of the study findings.
Detailed description
The Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) is a recently validated new MSK Patient Reported Outcome Measure (PROM) that has been co-produced with patients and clinicians to measure the holistic impact of an MSK condition on a person's health. It has been validated in both primary and secondary care populations and is appropriate for use by patients across the care pathway. It is designed for use in routine, busy, clinical practice. The MSK-HQ is freely available to the NHS, and consists of 14 health items that cover the domains that matter the most to MSK patients and helps clinicians and patients to identify the areas of life where the condition is impacting most. An electronic-PROM (e-PROM) version of the MSK-HQ is available and is being used by some early adopter MSK services to audit their clinical and patient outcome performance.
However, it is not yet known whether:
- Patients using the MSK-HQ routinely as part of their care planning, supports them to feel more involved and empowered in managing their health issues.
- Using the MSK-HQ can facilitate a more holistic care planning consultation, both in terms of the quality of patient interactions and communications with healthcare professionals.
- It is acceptable or feasible for both patients and clinicians to use the MSK-HQ as an e-PROM.
Enabling organisations to examine their aggregated MSK-HQ data at service level identifies unmet need, improvement opportunities and informs MSK service and organisational developments.
This research will optimise implementation of the MSK-HQ using a digital health platform, and evaluate its impact on both clinicians and patients. In addition to investigating benefits at the individual level, we also hypothesise that the data generated by this innovation may provide substantial organisational level insight. We plan therefore to explore how MSK-HQ data can best be aggregated, made sense of and presented as actionable outputs that identify unmet need and service improvement opportunities.
This proposal is novel because of three specific developments;
- The development of an IT innovation to support the implementation of the MSK-HQ within the individual consultation, which has the potential to bring many advantages to people with MSK conditions. The individual patient is often the only consistent connection between different service components. It therefore makes sense for patients to be able to own and access their care plan as they move between providers. For conditions such as osteoarthritis, many core treatments are initiated by patients themselves rather than by the doctor and the perspectives of patients may differ from the perspectives of healthcare professionals, with information recorded by professionals in the medical records not necessarily aligned to the patient's ideas about his or her treatment plan. ii. Making the MSK-HQ available to patients in advance as a prompt prior to their consultations, and testing if its application in this way facilitates a care planning approach. Patients want to be able to own and access their care plan as they move between providers, and the MSK-Tracker will enable them to do that. Patients can also find it difficult to raise important issues of concern in short, busy clinical interactions with different providers, which can lead to healthcare inconsistencies and inequalities in the support they receive. Although reports are limited, evidence from cancer research suggests that the use of consultation prompt lists can improve care and augment consultations when they are used proactively by clinicians. Despite growing evidence that they can make the consultation more focused and time-efficient, prompt lists are infrequently used in NHS MSK consultations. Within the UK health community, there is a national debate about how to bring about more person-centred care "How can we get better at providing patient centred care?", and "No decision about me without me". Participants in the BMJ discussion agreed that a change in culture and better use of technology could benefit patients and doctors. The potential for the MSK-Tracker to influence the consultation and help patients keep track of their health status and in control of their care resonates with the 2014 Reith Lectures by Atul Gawande, who highlighted the role of checklists and prompt questions as a stimulus for achieving better outcomes and service improvement. Problems with 'the system': the interactions between people and organisations that deliver healthcare were also highlighted. This debate is of growing relevance to the MSK community and new national policy from Arthritis Research UK is now focused on efforts to ensure that those living with arthritis and musculoskeletal conditions get the care and support they need to lead as healthy and active a life as possible in order to be "In control, independent and recognised". It is clear that to empower patients to feel well supported, informed and able to manage the effects of their condition and minimise its impact on their lives, they need to have equal voice and be at the heart of setting goals and planning their own care in partnership with their MSK clinical team. However, in order to deliver changes to the way care is delivered, innovative technological solutions such as this, are required. iii. Identifying the best ways to present and format outputs of aggregated MSK-HQ data to generate insights that inform service development and improvement. The MSK-Tracker will be an exciting new development, which, if implemented through a scalable electronic solution, has substantial potential to drive forward large scale service changes. MSK-HQ is supported nationally by Arthritis Research UK, NHS England and professional bodies including the CSP (Chartered Society of Physiotherapy) and BOA (British Orthopaedic Association). The next important step is to find a feasible way to use this outcome measure within routine clinical practice as a stimulus to drive the whole system to focus on what matters to patients and improve the care provided.
The study is using a 'before' and 'after' sequential comparison design with an iterative pilot and user testing phase in between. In addition, audio recordings of the consultation (site 1 only) (in a sub-sample, n=40 (phase 1=20 \& phase 3=20)), alongside individual clinician and patient interviews and a feedback workshop with clinicians and patients, will explore the feasibility, and impact of implementing the MSK-Tracker within routine consultations and the experiences of those who have used it.
Phase 1 ('Before' stage). Patients (n=200) who meet the eligibility criteria for having long-term MSK pain and an appointment at the relevant clinic will be consented and recruited to complete the e-PROM survey and demographic information shortly before their consultation. This phase will seek to collect patient information via the online digital health platform without using the new innovative 'MSK-Tracker' components, in order to give a baseline of what changes are observed before the MSK-Tracker intervention is used. Patients will complete data online before clinic, and then 2 weeks and 3 months after clinic and their change scores examined. Clinicians will complete a case report form (CRF) using the clinician portal to record clinical behaviours within the consultation. Audio recordings of approximately 20 patient consultations will examine consultation conversations and their content (site 1 only).
Phase 2. ('Pilot stage') (Site 1 only). The MSK-Tracker will be developed and optimised through an iterative user testing framework with patients, clinicians, software provider, and experts. The MSK-Tracker will have a number of key 'care planning' components including, pre-clinic preparation, clinic dashboard, summary action plan, personal goal setting and follow-up and progress charts.
Early pilot testing of the MSK-Tracker will mirror the processes used in phase 3, with a limited number of patients and clinicians using the Tracker. The aim is to recruit approximately 40 patients (in 2 cycles of 20) to use the MSK-Tracker. During this phase all patients and clinicians will be invited to take part in an interview about their experiences to identify further potential improvements that can be made to the Tracker before commencing phase 3. The aim is to interview up to 10 patients in each of the 2 cycles.
Phase 3 ('After' stage). Identical to phase 1, patients (n=200) who meet the eligibility criteria for having long-term MSK pain and an appointment at a relevant clinic, will complete an e-PROM shortly before their consultation and again 2 weeks and 3 months after their consultation. During phase 3 the MSK-Tracker components will be used alongside the e-PROM to support the new innovative 'care planning' approach and clinicians will be trained to use the MSK-Tracker within their clinical encounters. As in phase 1 audio recordings of approximately 20 patient consultations (site 1 only) will examine consultation conversations and their content. A descriptive content analysis will be conducted to identify differences before and after the introduction of the MSK-Tracker in clinic.
In addition, qualitative research will take place using the Experience Based Co-Design (EBCD) methodology in both phase 1 and 3 (site 1 only). This will involve interviews with approximately 10 patients and up to 10 clinicians to explore the impact of the MSK-Tracker and to inform further improvement and refinement of the tool and its use within the context of an MSK service and clinical practice. The findings from this qualitative research will be triangulated with insights from the aggregated data of patient outcomes to enrich and help make sense of the study findings.
The intervention is not a treatment per se, but involves patients and clinicians engaging with the MSK-Tracker software. It is envisaged that the MSK-Tracker will facilitate a new care planning approach with the following distinct components:
- Pre-clinic preparation. Prior to a consultation, the MSK-Tracker will help patients to set their clinic agenda by asking them to think about the ways in which their long-term MSK condition is impacting on their lives.
- Clinic dashboard. During the consultation it will enable the clinician to see the patient's health impact from their MSK condition (using MSK-HQ), and present the patient's clinic agenda to inform the consultation focus and ensure the individual's specific needs are addressed.
- Summary action plan. The Tracker will be used to record the agreed action plan from the consultation, including advice, information, referrals and investigations, which the patient can access when they want to as a reminder of what was agreed.
- Personal goal setting. To help the patient focus on what they personally seek to change (e.g. to get more fit and active) in relation to the impact of the MSK condition on their life and to help them reflect on what things are helping/hindering them to achieve goals to reduce this impact a goal setting module will be available to patients within the Tracker.
- Follow-up and monitoring. The Tracker will enable the patient to re-take the MSK-HQ at 2 weeks and 3 months and then have the opportunity to look at tracker charts that show their progress on the MSK-HQ overall score and individual domains.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before and after comparative study
| Arm | Type | Receives |
|---|---|---|
| MSK-Tracker (before) | No intervention | –Before - (Usual care in clinic consultations) |
| MSK-Tracker (after) | Active comparator | Other: MSK-TrackerAfter - (MSK-Tracker in clinic consultations) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years and above with an appointment to attend the Staffordshire Musculoskeletal Interface Service for an MSK pain problem will be invited to take part.
Key exclusion criteria (1 listed)
- Patients unable to use or access the internet will be unable to take part in this research as well as patients who do not provide informed consent for study participation and data collection. The online system will only be available in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSK-TrackerThe intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components: * Pre-clinic preparation. * Clinic dashboard. * Summary action plan. * Personal goal setting. * Follow-up and monitoring. | Other | MSK-Tracker (after) |
Primary outcome
Patient Enablement Instrument (PEI)
Time frame: 2 weeks
A measure of patient empowerment. Scale: Much better / Much more = 2 Better / More = 1 Same or less = 0 Not applicable = 9
5 secondary outcomes
Musculoskeletal Health Questionnaire (MSK-HQ)
Time frame: Baseline, 2 weeks and 3 months
Consumer Health Activation Index (CHAI)
Time frame: Baseline, 2 weeks and 3 months
Valuing Patients as Individuals Scale (Short Version)
Time frame: 2 weeks
Global Rating of Change (1 Item)
Time frame: 2 weeks and 3 months
The Patient Enablement Scale
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Musculoskeletal Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Hill, Dr principal investigator
Keele University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSK-Tracker in people with Musculoskeletal Pain, run by Keele University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Enablement Instrument (PEI) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.