Chronic Pain SyndromeNCT03119896
Supporting Self-management of Chronic Pain
A study testing The Navigator Tool Intervention in people with Chronic Pain Syndrome and Chronic Pain, run by Pain Concern at 5 sites in United Kingdom.
Trial summary
Does the Navigator Tool Intervention improve communication regarding self-management during consultations between healthcare professionals and people with chronic pain? As there is usually no cure for chronic pain, healthcare professionals are increasingly turning to methods of treatment that emphasise management of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain Syndrome, Chronic Pain, Chronic Pain Due to Injury
- What is being tested?
- The Navigator Tool Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 28 Aug 2017to 19 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Be over 18 years of age
- Have experienced pain for more than 3 months
Who cannot join
- Being unable to communicate in English
- Being unable to attend consultations with a healthcare professional for the duration of the project
- Being currently participating in another research project regarding chronic pain
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
St Margaret's Health Centre
Auchterarder, Scotland, PH3 1JH
Whitesands Medical Practice
Dunbar, Scotland, EH42 1EE
St Triduana's Medical Practice
Edinburgh, Scotland, 6RU
Milngavie Clinic
Milngavie, Scotland, G62 7AA
Muirhead Medical Centre
Muirhead, Scotland, DD2 5NH
About this study
Official title: Supporting Self-management in Chronic Pain: a Collaborative Approach Providing Relevant Tools to Healthcare Professionals and People With Pain.
Does the Navigator Tool Intervention improve communication regarding self-management during consultations between healthcare professionals and people with chronic pain?
As there is usually no cure for chronic pain, healthcare professionals are increasingly turning to methods of treatment that emphasise management of symptoms rather than elimination of pain. However, as Pain Concern's previous research has shown, there are several barriers to self-management that both healthcare professionals and people with pain face in their consultations in primary care. The Navigator Tool Intervention has been designed to overcome the majority of these barriers through improving the quality of communication regarding self-management during consultations.
Read more
In line with the House of Care Model, where care relies on engaged and informed patients, healthcare professionals committed to partnership working, and organisational processes that support this, our intervention prepares both the healthcare professionals and patients for their consultation. By providing a training session for the healthcare professionals in how supported self-management can be brought into the consultation room, and by providing the patients with a paper-based tool that allows them to organise their concerns and questions prior to the consultation, the intervention aims to steer the conversation toward the aspects that the patient needs to discuss in order to better manage their pain.
This study will launch the intervention and evaluate its effectiveness in improving self-management support through conversation. It will be launched over a 3 month period in 4 sites across Scotland; 24 patients will be using the tool with a trained healthcare professional and 24 will act as a control group, receiving standard care without the tool.
Questionnaires assessing the satisfaction with the consultation(s) and communication, as well as confidence in managing one's pain, will be analysed and compared between the two groups. Interviews will be carried out with healthcare professionals and a sample of patients having used the tool to gain a deeper understanding of the usefulness of the intervention and how it may be improved in the future.
Read the detailed description
This study will involve 4 primary care sites across Scotland, 4-8 healthcare professionals (HCPs) who will administer the intervention, and 48 patient participants (1-2 HCPs and 12 patients at each site). Half of the patient participants will act as the control group and receive no intervention.
4 sites within primary care will be recruited through Pain Concern's current network of healthcare professionals. The sites will consists of general practitioners, physiotherapists and pharmacists, to ensure that the study reflects the usefulness of the intervention across primary care. Each site will nominate 1-2 healthcare professionals who will undergo a training session to learn about supported self-management and how to use the paper-based Navigator Tool effectively. This training will be developed as a collaboration between Pain Concern and the Thistle Foundation, an organisation specializing in supporting self-management for people living with chronic conditions.
Each site will identify 12 patients from their practice who will be asked to participate in the study. With their consent, the patient's contact details will be passed to the researcher who will contact them over the phone and inform them of what the study entails. Prior to this phone call, the patients will have received a written information and a consent sheet through email, post or in person at their practice. The signed consent sheet can be returned the in same way. Once recruited, the participants will be randomly allocated to either the intervention group (24 patients) or the control group (24 patients).
Once allocated to a group, the participant will be sent a pre-intervention pack. There will be two versions of this pack, one for the intervention group and one for the control group. Both packs will contain a Pain Self-Efficacy Questionnaire (PSEQ), and the pack for the intervention group will contain a copy of the Navigator Tool. The participants will be instructed to fill out the questionnaire straight away and return it to the researcher through email or post.
During the active research period (3months), the intervention group will have 2-3 consultations using the tool with a healthcare professional who has undergone the training session. The control group will receive "standard care", i.e. they will not have access to the paper-based tool, and they will be allocated whatever healthcare professional they would have seen if they had not been in the study. There will be no regulation of how many consultations these control participants will have during the research period.
After the 3 month active research period, all patient participants be sent a post-intervention pack. The intervention and control group will be sent identical packs, consisting of a demographics questionnaire, another PSEQ, and a Consultation Quality Index -2 (CQI-2) (which includes the CARE measure).
The scores will be compared between the control and active group and indicate the effect intervention has on our outcome measures. The two most important outcome measures are improvement in communication (measured by CQI-2) and improvement in confidence of pain management (PSEQ). Other outcome measures include engagement with the intervention, perceived participation in decision making, consultations and relational satisfaction and patient-centeredness, extent to which GP was enabling to the patients and perceived efficacy for self-management, scores of which will also be derived from the above questionnaires.
A more in-depth follow-up interview will be conducted with all HCPs and a sample of patient participants (8 patients) spread out over the 4 sites. These interviews will provide a more specific, nuanced and individual understanding of the patients' and healthcare professionals' satisfaction with the intervention and quality of consultations. Possible topics include ease of use, impact on consultation length, effectiveness of communication, required changes to the intervention, and extent to which the intervention achieved aims. These interviews will take place 1-2 months after the last consultation with the tool has taken place, last for around 30-45 minutes, and will be conducted in a venue close to the primary care site the participant was recruited from.
The interviews will be recorded and the researcher will then transcribe the interviews and code them using N-vivo. Themes will be elicited and cross-compared between the participants to establish prevalent experiences, views and attitudes.
- Conditions
- Chronic Pain Syndrome, Chronic Pain, Chronic Pain Due to Injury, Chronic Pain Due to Trauma, Chronic Pain Due to Malignancy (Finding), Chronic Pain Post-Procedural
- Being tested
- The Navigator Tool Intervention
- Keywords
- chronic pain, self-management, pain management, doctor patient communication, primary care
- Medical subject headings
- Chronic Pain, Signs and Symptoms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Navigator Tool InterventionOther
The intervention consists of two parts; a training session on self-management of chronic conditions for the healthcare professionals, and a paper-based tool for the patients. Both parts aim to inform and prepare the two parties as to what self-management entails in order to facilitate a constrictive consultation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (using Navigator Tool) | Experimental | The participants will receive a copy of the Navigator Tool Intervention, a paper-based information pack including the My Pain Concerns Form, suggested questions to ask your healthcare professional, a goal setting sheet and information on common self-management strategies. They will be encouraged to fill in some of the forms before the consultation, and some during the consultation. They will have consultations with a healthcare professional who has undergone a Self-management Awareness Training with the Thistle Foundation. Receives: Other: The Navigator Tool Intervention |
| Control Group (not using Navigator Tool) | No intervention | These participants will not have access to the Navigator Tool Intervention, and will have consultations with a healthcare professional who has not undergone the Self-management Awareness Training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcripts of semi-structured interviews with healthcare professionals and patients from Intervention group
Transcripts will be analysed and coded for themes and attitudes, similar concerns and experiences regarding the experience of using the intervention.
Measured: Interviews will be carried out 1-2 months after the intervention has finished (the last consultation has taken place).
Secondary outcomes (3)
Consultation Quality Index - 2 (CQI-2)
Assesses improvement and satisfaction with the communication during consultations. (Patients only)
Measured: Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it.
Pain Self-Efficacy Questionnaire (PSEQ)
Assesses improvement to the patients ability to confidently manage their own pain.
Measured: First one distributed 1 week before the intervention starts, to be completed and submitted within 1 week. Second will be distributed 1 week after the intervention has ended, to be returned within 1-2 weeks after having received it.
CARE measure
Assesses satisfaction with the communication during consultations. (Patients only)
Measured: Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start28 Aug 2017
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups; one "active group" receiving the intervention, and one "control group" receiving standard care without the intervention.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Concern
- Sponsor type
- University, hospital or other
- Collaborators
- The Thistle Foundation, Health and Social Care Alliance Scotland (the ALLIANCE), Edinburgh and Lothians Health Foundation
- Responsible party
- Sponsor
- Investigators
- Pamela F Bell, MB FFARCSI FFPMCAI FFPMRCA, Principal investigator, Pain Concern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119896
- Sponsor's protocol ID
- 223092
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2017
- Last updated
- 5 Apr 2018
- Results posted
- 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 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Self-management in Chronic Pain: a Collaborative Approach Providing Relevant Tools to Healthcare Professionals and People With Pain.
- ClinicalTrials.gov ID
- NCT03119896
- Acronym / sponsor ID
- 223092
- Conditions
- Chronic Pain Syndrome, Chronic Pain, Chronic Pain Due to Injury, Chronic Pain Due to Trauma, Chronic Pain Due to Malignancy (Finding), Chronic Pain Post-Procedural
- Keywords
- chronic pain, self-management, pain management, doctor patient communication, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Pain ConcernUniversity, hospital or other
- Collaborators
- The Thistle Foundation, Health and Social Care Alliance Scotland (the ALLIANCE), Edinburgh and Lothians Health Foundation
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does the Navigator Tool Intervention improve communication regarding self-management during consultations between healthcare professionals and people with chronic pain?
As there is usually no cure for chronic pain, healthcare professionals are increasingly turning to methods of treatment that emphasise management of symptoms rather than elimination of pain. However, as Pain Concern's previous research has shown, there are several barriers to self-management that both healthcare professionals and people with pain face in their consultations in primary care. The Navigator Tool Intervention has been designed to overcome the majority of these barriers through improving the quality of communication regarding self-management during consultations.
In line with the House of Care Model, where care relies on engaged and informed patients, healthcare professionals committed to partnership working, and organisational processes that support this, our intervention prepares both the healthcare professionals and patients for their consultation. By providing a training session for the healthcare professionals in how supported self-management can be brought into the consultation room, and by providing the patients with a paper-based tool that allows them to organise their concerns and questions prior to the consultation, the intervention aims to steer the conversation toward the aspects that the patient needs to discuss in order to better manage their pain.
This study will launch the intervention and evaluate its effectiveness in improving self-management support through conversation. It will be launched over a 3 month period in 4 sites across Scotland; 24 patients will be using the tool with a trained healthcare professional and 24 will act as a control group, receiving standard care without the tool.
Questionnaires assessing the satisfaction with the consultation(s) and communication, as well as confidence in managing one's pain, will be analysed and compared between the two groups. Interviews will be carried out with healthcare professionals and a sample of patients having used the tool to gain a deeper understanding of the usefulness of the intervention and how it may be improved in the future.
Detailed description
This study will involve 4 primary care sites across Scotland, 4-8 healthcare professionals (HCPs) who will administer the intervention, and 48 patient participants (1-2 HCPs and 12 patients at each site). Half of the patient participants will act as the control group and receive no intervention.
4 sites within primary care will be recruited through Pain Concern's current network of healthcare professionals. The sites will consists of general practitioners, physiotherapists and pharmacists, to ensure that the study reflects the usefulness of the intervention across primary care. Each site will nominate 1-2 healthcare professionals who will undergo a training session to learn about supported self-management and how to use the paper-based Navigator Tool effectively. This training will be developed as a collaboration between Pain Concern and the Thistle Foundation, an organisation specializing in supporting self-management for people living with chronic conditions.
Each site will identify 12 patients from their practice who will be asked to participate in the study. With their consent, the patient's contact details will be passed to the researcher who will contact them over the phone and inform them of what the study entails. Prior to this phone call, the patients will have received a written information and a consent sheet through email, post or in person at their practice. The signed consent sheet can be returned the in same way. Once recruited, the participants will be randomly allocated to either the intervention group (24 patients) or the control group (24 patients).
Once allocated to a group, the participant will be sent a pre-intervention pack. There will be two versions of this pack, one for the intervention group and one for the control group. Both packs will contain a Pain Self-Efficacy Questionnaire (PSEQ), and the pack for the intervention group will contain a copy of the Navigator Tool. The participants will be instructed to fill out the questionnaire straight away and return it to the researcher through email or post.
During the active research period (3months), the intervention group will have 2-3 consultations using the tool with a healthcare professional who has undergone the training session. The control group will receive "standard care", i.e. they will not have access to the paper-based tool, and they will be allocated whatever healthcare professional they would have seen if they had not been in the study. There will be no regulation of how many consultations these control participants will have during the research period.
After the 3 month active research period, all patient participants be sent a post-intervention pack. The intervention and control group will be sent identical packs, consisting of a demographics questionnaire, another PSEQ, and a Consultation Quality Index -2 (CQI-2) (which includes the CARE measure).
The scores will be compared between the control and active group and indicate the effect intervention has on our outcome measures. The two most important outcome measures are improvement in communication (measured by CQI-2) and improvement in confidence of pain management (PSEQ). Other outcome measures include engagement with the intervention, perceived participation in decision making, consultations and relational satisfaction and patient-centeredness, extent to which GP was enabling to the patients and perceived efficacy for self-management, scores of which will also be derived from the above questionnaires.
A more in-depth follow-up interview will be conducted with all HCPs and a sample of patient participants (8 patients) spread out over the 4 sites. These interviews will provide a more specific, nuanced and individual understanding of the patients' and healthcare professionals' satisfaction with the intervention and quality of consultations. Possible topics include ease of use, impact on consultation length, effectiveness of communication, required changes to the intervention, and extent to which the intervention achieved aims. These interviews will take place 1-2 months after the last consultation with the tool has taken place, last for around 30-45 minutes, and will be conducted in a venue close to the primary care site the participant was recruited from.
The interviews will be recorded and the researcher will then transcribe the interviews and code them using N-vivo. Themes will be elicited and cross-compared between the participants to establish prevalent experiences, views and attitudes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups; one "active group" receiving the intervention, and one "control group" receiving standard care without the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (using Navigator Tool) | Experimental | Other: The Navigator Tool InterventionThe participants will receive a copy of the Navigator Tool Intervention, a paper-based information pack including the My Pain Concerns Form, suggested questions to ask your healthcare professional, a goal setting sheet and information on common self-management strategies. They will be encouraged to fill in some of the forms before the consultation, and some during the consultation. They will have consultations with a healthcare professional who has undergone a Self-management Awareness Training with the Thistle Foundation. |
| Control Group (not using Navigator Tool) | No intervention | –These participants will not have access to the Navigator Tool Intervention, and will have consultations with a healthcare professional who has not undergone the Self-management Awareness Training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be over 18 years of age
- Have experienced pain for more than 3 months
Key exclusion criteria (3 listed)
- Being unable to communicate in English
- Being unable to attend consultations with a healthcare professional for the duration of the project
- Being currently participating in another research project regarding chronic pain
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 |
|---|---|---|
| The Navigator Tool InterventionThe intervention consists of two parts; a training session on self-management of chronic conditions for the healthcare professionals, and a paper-based tool for the patients. Both parts aim to inform and prepare the two parties as to what self-management entails in order to facilitate a constrictive consultation. | Other | Intervention Group (using Navigator Tool) |
Primary outcome
Transcripts of semi-structured interviews with healthcare professionals and patients from Intervention group
Time frame: Interviews will be carried out 1-2 months after the intervention has finished (the last consultation has taken place).
Transcripts will be analysed and coded for themes and attitudes, similar concerns and experiences regarding the experience of using the intervention.
3 secondary outcomes
Consultation Quality Index - 2 (CQI-2)
Time frame: Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it.
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: First one distributed 1 week before the intervention starts, to be completed and submitted within 1 week. Second will be distributed 1 week after the intervention has ended, to be returned within 1-2 weeks after having received it.
CARE measure
Time frame: Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Pamela F Bell, MB FFARCSI FFPMCAI FFPMRCA principal investigator
Pain Concern
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Navigator Tool Intervention in people with Chronic Pain Syndrome and Chronic Pain, run by Pain Concern at 5 sites 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 2 inclusion and 3 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transcripts of semi-structured interviews with healthcare professionals and patients from Intervention group (time frame: Interviews will be carried out 1-2 months after the intervention has finished (the last consultation has taken place).). 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 5 Apr 2018.