Understanding Persistent Pain Using a Decision Aid Tool in a Scottish Pharmacy Setting.

Chronic Pain Clinical Trial

— UPP  

Official title:

Understanding Persistent Pain: A Feasibility Study for the Use of a Digital Decision Aid Tool for Persistent Pain in a Pharmacy Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102578
• Other study ID #: 2021UA003E-281537
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2022
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Digital Decision Aid Tool
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 .

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen
United Kingdom	University of Aberdeen	Aberdeen

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	Pharmacy Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	EuroQol's 5D-5L	Self-administered questionnaire that records state and quality of life using EuroQol's five dimensions and 5 levels.	6 weeks
Primary	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.	6 weeks