Chronic PainUPPNCT05102578
Understanding Persistent Pain Using a Decision Aid Tool in a Scottish Pharmacy Setting.
A study testing Digital Decision Aid Tool in people with Chronic Pain, run by University of Aberdeen at 2 sites in United Kingdom.
Trial summary
Persistent pain describes long term pain that is present nearly every day. It is common and affects millions of people in the United Kingdom. The investigators want to explore people's experience of living with persistent pain and investigate how pharmacists can help people manage their pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Digital Decision Aid Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jan 2022to 31 May 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years old.
- Suffer from non-malignant persistent pain (defined as pain lasting for more than three months).
- Managed entirely within a primary care setting.
Who cannot join
- Not fluent in the English language.
- Have concomitant severe mental health problems or terminal illness.
- Suffer from pain caused by cancer or other malignancy.
- Not able to give informed consent (e.g. because of mental state)
- Takes part in another research study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Grampian
Aberdeen
University of Aberdeen
Aberdeen
About this study
Official title: Understanding Persistent Pain: A Feasibility Study for the Use of a Digital Decision Aid Tool for Persistent Pain in a Pharmacy Setting
Persistent pain describes long term pain that is present nearly every day. It is common and affects millions of people in the United Kingdom. The investigators want to explore people's experience of living with persistent pain and investigate how pharmacists can help people manage their pain. For this, the investigators will be testing a digital Decision Aid Tool (DAT) that includes a pain and lifestyle assessment as part of a pain consultation.
Read the detailed description
The study design is a randomised feasibility study. Patient participants will take part in a pain consultation with a pharmacist to discuss pain management in a shared decision making (SDM) process. The unit of randomisation will be the patient participant. Thus, pharmacists will randomise patients to one of two groups: an intervention group who will receive a digital DAT for self-completion as part of the consultation and a control group which not use the digital DAT.
How the study will be implemented will be dependent on research restrictions due to the COVID-19 pandemic. If restrictions on research are in place, all study activities will be done remotely. If research restrictions are lifted the investigators will offer both remote and in person activities, depending on the participants preference.
Registered pharmacists in National Health Service (NHS) Grampian (see Section 5.1.) will be invited to take part in the study. As part of the assessment of feasibility for a future randomised control trial (RCT), a mixture of community and General Practitioner (GP)-surgery based pharmacists will be recruited. Recruited pharmacists will identify and invite patients living with persistent pain to a pain consultation. Pharmacists and patients will discuss current lifestyle and pain history, after which the pharmacist will recommend pain management plans that follow a person centred care (PCC) approach. Patients in the intervention group will receive the digital DAT - named UPP (Understanding Persistent Pain) - for self-completion with the help of the pharmacist. The DAT will generate a personalised report on the patient's preferences that can be used to discuss different PCC management plans. Management plans will be based on strategies routinely available in clinical practice4.
Heterogeneity in pharmacist-led pain consultations means that consultations are likely to differ across pharmacists. This study will allow the researchers to characterise different types of pharmacist-led pain consultations for a future larger study. As such, having a standardised control consultation falls beyond the scope of this feasibility study. Similarly, heterogeneity in current practice will cause agreed plans to differ across pharmacists and patients. These will also depend on the prescribing qualifications of the pharmacist.
The patient's GP will be informed of the person's participation and, in some cases, the recommendations/findings of the consultation. Where a prescription only medicine is deemed beneficial, pharmacists who are qualified independent prescribers will recommend this directly. Pharmacists without this qualification will, with the agreement of the patient, suggest to patients that they should book an appointment with the GP and send a referral letter to the GP with the recommendation for the prescription only medicine. Follow up consultations with the pharmacist will be arranged according to each pharmacist's current practice.
Parallel to the study, a testing event with patients living with persistent pain will be organised. Participants will be recruited using posters in GP Practices and using local patient networks. Participants will attend a half day event where they will get to use the digital DAT with the research team and provide feedback. Informed consent will be taken by the research team prior to the start of the event.
- Conditions
- Chronic Pain
- Being tested
- Digital Decision Aid Tool
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Decision Aid ToolBehavioural
The digital DAT will ask people about their current pain levels, medications and physical activity. Following this, it will include a Discrete Choice Experiment (DCE)-like component with a series of questions that ask users to choose between different pain management packages. Similar to a standard DCE, packages (or plans) are described by attributes and levels, which include broad categories of guideline-based pain management strategies routinely available in clinical practice. The descriptors used for the attributes and levels were informed by a previous qualitative research study and based on therapeutic options that are helpful and important to people with persistent pain .
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Usual care. Consultation with pharmacist with no decision aid tool. |
| Digital Decision Aid Tool | Experimental | Consultation with pharmacist using the digital decision aid tool. Receives: Behavioral: Digital Decision Aid Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed using the Chronic Pain Grade
Self-administered questionnaire that records subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients.
Measured: 6 weeks
EuroQol's 5D-5L
Self-administered questionnaire that records state and quality of life using EuroQol's five dimensions and 5 levels.
Measured: 6 weeks
Personal Well-being Scale
Self-administered questionnaire that records personal wellbeing using the UK's Office of National Statistics (ONS) Measuring Subjective Well-being for Public Policy.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Jan 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacy Research UK
- Responsible party
- Sponsor
- Investigators
- Mandy Prof Ryan, Principal investigator, HERU Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102578
- Sponsor's protocol ID
- 2021UA003E-281537
- Acronym
- UPP
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data shared with other researchers will be anonymised.
Publications
Loria-Rebolledo LE, Ryan M, Bond C, Porteous T, Murchie P, Adam R. Using a discrete choice experiment to develop a decision aid tool to inform the management of persistent pain in pharmacy: a protocol for a randomised feasibility study. BMJ Open. 2022 Sep 22;12(9):e066379. doi: 10.1136/bmjopen-2022-066379.
PubMed 36137622
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Persistent Pain: A Feasibility Study for the Use of a Digital Decision Aid Tool for Persistent Pain in a Pharmacy Setting
- ClinicalTrials.gov ID
- NCT05102578
- Acronym / sponsor ID
- UPP / 2021UA003E-281537
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Pharmacy Research UK
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 1 Nov 2021 (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.
Persistent pain describes long term pain that is present nearly every day. It is common and affects millions of people in the United Kingdom. The investigators want to explore people's experience of living with persistent pain and investigate how pharmacists can help people manage their pain. For this, the investigators will be testing a digital Decision Aid Tool (DAT) that includes a pain and lifestyle assessment as part of a pain consultation.
Detailed description
The study design is a randomised feasibility study. Patient participants will take part in a pain consultation with a pharmacist to discuss pain management in a shared decision making (SDM) process. The unit of randomisation will be the patient participant. Thus, pharmacists will randomise patients to one of two groups: an intervention group who will receive a digital DAT for self-completion as part of the consultation and a control group which not use the digital DAT.
How the study will be implemented will be dependent on research restrictions due to the COVID-19 pandemic. If restrictions on research are in place, all study activities will be done remotely. If research restrictions are lifted the investigators will offer both remote and in person activities, depending on the participants preference.
Registered pharmacists in National Health Service (NHS) Grampian (see Section 5.1.) will be invited to take part in the study. As part of the assessment of feasibility for a future randomised control trial (RCT), a mixture of community and General Practitioner (GP)-surgery based pharmacists will be recruited. Recruited pharmacists will identify and invite patients living with persistent pain to a pain consultation. Pharmacists and patients will discuss current lifestyle and pain history, after which the pharmacist will recommend pain management plans that follow a person centred care (PCC) approach. Patients in the intervention group will receive the digital DAT - named UPP (Understanding Persistent Pain) - for self-completion with the help of the pharmacist. The DAT will generate a personalised report on the patient's preferences that can be used to discuss different PCC management plans. Management plans will be based on strategies routinely available in clinical practice4.
Heterogeneity in pharmacist-led pain consultations means that consultations are likely to differ across pharmacists. This study will allow the researchers to characterise different types of pharmacist-led pain consultations for a future larger study. As such, having a standardised control consultation falls beyond the scope of this feasibility study. Similarly, heterogeneity in current practice will cause agreed plans to differ across pharmacists and patients. These will also depend on the prescribing qualifications of the pharmacist.
The patient's GP will be informed of the person's participation and, in some cases, the recommendations/findings of the consultation. Where a prescription only medicine is deemed beneficial, pharmacists who are qualified independent prescribers will recommend this directly. Pharmacists without this qualification will, with the agreement of the patient, suggest to patients that they should book an appointment with the GP and send a referral letter to the GP with the recommendation for the prescription only medicine. Follow up consultations with the pharmacist will be arranged according to each pharmacist's current practice.
Parallel to the study, a testing event with patients living with persistent pain will be organised. Participants will be recruited using posters in GP Practices and using local patient networks. Participants will attend a half day event where they will get to use the digital DAT with the research team and provide feedback. Informed consent will be taken by the research team prior to the start of the event.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Usual care. Consultation with pharmacist with no decision aid tool. |
| Digital Decision Aid Tool | Experimental | Behavioral: Digital Decision Aid ToolConsultation with pharmacist using the digital decision aid tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years old.
- Suffer from non-malignant persistent pain (defined as pain lasting for more than three months).
- Managed entirely within a primary care setting.
Key exclusion criteria (5 listed)
- Not fluent in the English language.
- Have concomitant severe mental health problems or terminal illness.
- Suffer from pain caused by cancer or other malignancy.
- Not able to give informed consent (e.g. because of mental state)
- Takes part in another research study.
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 |
|---|---|---|
| Digital Decision Aid ToolThe digital DAT will ask people about their current pain levels, medications and physical activity. Following this, it will include a Discrete Choice Experiment (DCE)-like component with a series of questions that ask users to choose between different pain management packages. Similar to a standard DCE, packages (or plans) are described by attributes and levels, which include broad categories of guideline-based pain management strategies routinely available in clinical practice. The descriptors used for the attributes and levels were informed by a previous qualitative research study and based on therapeutic options that are helpful and important to people with persistent pain . | Behavioural | Digital Decision Aid Tool |
Primary outcome
Pain assessed using the Chronic Pain Grade
Time frame: 6 weeks
Self-administered questionnaire that records subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients.
EuroQol's 5D-5L
Time frame: 6 weeks
Self-administered questionnaire that records state and quality of life using EuroQol's five dimensions and 5 levels.
Personal Well-being Scale
Time frame: 6 weeks
Self-administered questionnaire that records personal wellbeing using the UK's Office of National Statistics (ONS) Measuring Subjective Well-being for Public Policy.
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 6 Dec 2023.
- Derived from this study: PubMed 36137622Loria-Rebolledo LE, Ryan M, Bond C, Porteous T, Murchie P, Adam R. Using a discrete choice experiment to develop a decision aid tool to inform the management of persistent pain in pharmacy: a protocol for a randomised feasibility study. BMJ Open. 2022 Sep 22;12(9):e066379. doi: 10.1136/bmjopen-2022-066379.
- Individual participant dataSharing planned: Yes. Any data shared with other researchers will be anonymised.
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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.
Mandy Prof Ryan principal investigator
HERU Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Decision Aid Tool in people with Chronic Pain, run by University of Aberdeen at 2 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 3 inclusion and 5 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Pain assessed using the Chronic Pain Grade (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05102578, which also lists 1 linked publication.
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 6 Dec 2023.