Understanding Persistent Pain Using a Decision Aid Tool in a Scottish Pharmacy Setting.
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Digital Decision Aid Tool
- Registration Number
- NCT05102578
- Lead Sponsor
- University of Aberdeen
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Digital Decision Aid Tool Digital Decision Aid Tool Consultation with pharmacist using the digital decision aid tool.
- Primary Outcome Measures
Name Time Method EuroQol's 5D-5L 6 weeks Self-administered questionnaire that records state and quality of life using EuroQol's five dimensions and 5 levels.
Pain assessed using the Chronic Pain Grade 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.
Personal Well-being Scale 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
NHS Grampian
🇬🇧Aberdeen, United Kingdom
University of Aberdeen
🇬🇧Aberdeen, United Kingdom