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

November 29, 2023 updated by: University of Aberdeen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom
        • NHS Grampian
      • Aberdeen, United Kingdom
        • University of Aberdeen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Usual care. Consultation with pharmacist with no decision aid tool.
Experimental: Digital Decision Aid Tool
Consultation with pharmacist using the digital decision aid tool.
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

Pharmacy Research UK

Investigators

  • Principal Investigator: Mandy Prof Ryan, HERU Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021UA003E-281537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any data shared with other researchers will be anonymised.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Individual participant data (after de-identification) that underlie the results of this study will be available upon reasonable requests to investigators whose proposed used of data has been approved by an independent review committee identified for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Digital Decision Aid Tool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe