Development of practice-based pharmacist-led management of chronic pain in primary care for evaluation by a RCT

Lead Research Organisation: University of Aberdeen
Department Name: Biomedical Sciences

Abstract

Many people with chronic pain use prescribed medicines. It is important that the correct medicines are prescribed to ensure effective pain management. For some people, changing the medicines they take might improve their pain management. We believe that regular review of medication could be beneficial for patients with chronic pain.

Pharmacists have the knowledge and training to review patients’ medicines and identify changes that could lead to better pain control. Until recently, changes to prescriptions recommended by a pharmacist had to be made by a doctor. However many pharmacists are now registered to write prescriptions.

We want to assess the benefits of pharmacist review of pain medicines and prescribing. We will compare three types of care: 1) pharmacist medicine review (using patient notes) and pharmacist prescribing, with face-to-face patient consultations; 2) pharmacist medicine review (using patient notes) with recommendations to GP; 3) standard care.

Patients with chronic pain from six GP practices will be identified and divided into three groups. Practice pharmacists will review pain medication for groups 1) and 2) and compare this with best practice, recommending changes if necessary. Afterwards we will compare the groups for any differences in the way people feel their pain is affecting them.

Technical Summary

Chronic pain affects approximately half the population, recovery is rare and management often unsatisfactory. Most people are managed with prescribed analgesics, but sub-optimal prescribing, imperfect monitoring of repeat prescriptions and concomitant use of non-prescription medicines means that treatment is often ineffective or inefficient. Recent NHS changes have supported medication review by pharmacists, but research studies have shown conflicting results. Possible reasons for this include the use of inappropriate outcomes; failure to use an iterative development process; failure to adhere to the intervention; and, reliance upon a third party to implement prescribing changes.

Our long term aim is to conduct a definitive Phase III trial in patients with chronic pain to compare standard care with pharmacist review of a patient?s medication where recommendations are implemented by the doctor with pharmacist review of a patient?s medication where recommendations are implemented by the pharmacist at a face-to-face consultation. Our Phase I work has shown that a single pharmacist in one general practice can identify and recommend changes to patients? analgesic regimes which are accepted by GPs. We still have to test the generalisability of these findings beyond a single practice, test the feasibility, and quantify the value, of pharmacist prescribing, and assess effect on clinical outcomes. This proposal is for further Phase I work and a Phase II exploratory trial to inform a definitive RCT.

The setting will be six general practices (three English and three Scottish) and will involve their GPs and practice pharmacists. Thirty-six patients with chronic pain, identified from medication records using a computerised search strategy, will be recruited from each practice and randomised to one of the three groups. Outcomes (including quality of life, pain, depression, health care utilisation including drug costs, pharmacist costs and patient costs) will be compared across the three groups at three and six months by postal questionnaire .

We will: develop and test a training package for the pharmacists to ensure standardisation of the intervention; test recruitment methods; estimate consent and participation rates; calculate response rates and quantify and compare the effect sizes to inform future sample size calculations; confirm the most appropriate outcome measures and unit of randomisation; interview pharmacists and GPs to ascertain feasibility and acceptability and gain feedback for modifications; and determine the acceptability of the proposed intervention to participants. Findings from the work will be used to optimise the intervention for a definitive Phase III RCT.
 
Description Best Brains Exchange Canada Canadian Institute for Health Research
Geographic Reach North America 
Policy Influence Type Participation in a national consultation
 
Description National Advisory Committee on Chronic Pain (Scotland). BS and PC are members
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
URL http://www.gov.scot/Topics/Health/Services/Chronic-Pain/NACCP
 
Description Use of study materials in routine care
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description NIHR Programme grant
Amount £1,999,030 (GBP)
Funding ID RP-PG-0613-20007 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description Pharmacy Practice Research Trust Grant/Pharmacy Practice Research Trust
Amount £270,000 (GBP)
Organisation Pharmacy Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 07/2011 
End 06/2013
 
Title Algorithm and outcome measures 
Description The following documents have been shared in a Material Transfer Agreement with an American researcher based at EIRMC, Idaho Falls, ID: -the study algorithm develped to administer the intervention -the patient baseline and follow-up questionnaires (licenced instruments were removed) -the pharmaceutical care plans -the study protocol 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2011 
Provided To Others? Yes  
Impact N/A 
 
Title Computerised patient search to identify patients with chronic pain 
Description Search terms by which to identify patients with chronic pain on computerised system of general practices. 
Type Of Material Model of mechanisms or symptoms - human 
Provided To Others? No  
Impact It will be easier and more efficient search to use to find patients with chronic pain. 
 
Title Further request for treatment algorithms 
Description Algorithms to inform evidence based prescribing of of pain medication management 
Type Of Material Physiological assessment or outcome measure 
Provided To Others? No  
Impact WIder use of the treatment approach by other practitioners 
 
Title Study Standard Operational Procedure 
Description A detailed standard operating procedure has been developed to ensure this complex study is delivered consistently in accordance with the protocol and Ethical approval across two sites. 
Type Of Material Improvements to research infrastructure 
Year Produced 2010 
Provided To Others? Yes  
Impact This SOP was considered exemplary by the University of Aberdeen Research Governance Committee and will be used as a template for other studies ongoing in the University as well as for delivery of the definitive trial. 
 
Description Collaboration with Griffith University Brisbane 
Organisation Griffith University
Country Australia 
Sector Academic/University 
PI Contribution Visiting Professorship to Griffith University to share research experiences and develop similar studies in Australia, intellectual input to their programmes and staff training
Collaborator Contribution Griffith identified the need for my expertise to increase their research capacity in this area.
Impact No outputs yet- visit is September October 2017
Start Year 2017
 
Description Community pharmacy management of minor illness PPRT funding award 
Organisation University of East Anglia
Department Schools of Pharmacy and Medicine UEA
Country United Kingdom 
Sector Academic/University 
PI Contribution The University of Aberdeen is leading the collaboration and has the required expertise and subject knowledge. However working with the University of East Anglia as established partners enhances our understanding of the NHS infrastructures in England ensuring approaches and findings are relevant across the UK.
Collaborator Contribution Consolidating collaboration between our two schools
Impact Award of research funding
Start Year 2010
 
Description Conduct of defintive trial ( application to HTA primary care call) 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution The original MRC funded a feasibility/ pilot study which confirmed the proof of concept and the viability of a definitve RCT. The original team applied to HTA for the definitve study and were unsuccessful at outline stage at the first prioritisation screen (chronic pain was said not to be a priority). Subsequently, two years after this failed application, the same group of collaborators reconvened, and put in a revied proposal for a definitve RCT in response to an HTA Primary Care Call. The group wass trengthened by the addtion of researchers from the Universities of London and Huddersfield and had the support of all PCRNs. The applcation was again unsuccessful despite going through to full application and having very positive referee commnents. The reason for rejection seemed to be primarily because the panel felt the intervention itself was the wrong approach. This had not been raised in any earlier feedback. The University of Aberdeen team led the design and writing of the application.
Collaborator Contribution All collborators fully contributed according to their areas of expertise, including the Aberdeen University Service User Group
Impact none
Start Year 2011
 
Description Conduct of defintive trial ( application to HTA primary care call) 
Organisation University of Dundee
Department School of Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution The original MRC funded a feasibility/ pilot study which confirmed the proof of concept and the viability of a definitve RCT. The original team applied to HTA for the definitve study and were unsuccessful at outline stage at the first prioritisation screen (chronic pain was said not to be a priority). Subsequently, two years after this failed application, the same group of collaborators reconvened, and put in a revied proposal for a definitve RCT in response to an HTA Primary Care Call. The group wass trengthened by the addtion of researchers from the Universities of London and Huddersfield and had the support of all PCRNs. The applcation was again unsuccessful despite going through to full application and having very positive referee commnents. The reason for rejection seemed to be primarily because the panel felt the intervention itself was the wrong approach. This had not been raised in any earlier feedback. The University of Aberdeen team led the design and writing of the application.
Collaborator Contribution All collborators fully contributed according to their areas of expertise, including the Aberdeen University Service User Group
Impact none
Start Year 2011
 
Description Conduct of defintive trial ( application to HTA primary care call) 
Organisation University of East Anglia
Country United Kingdom 
Sector Academic/University 
PI Contribution The original MRC funded a feasibility/ pilot study which confirmed the proof of concept and the viability of a definitve RCT. The original team applied to HTA for the definitve study and were unsuccessful at outline stage at the first prioritisation screen (chronic pain was said not to be a priority). Subsequently, two years after this failed application, the same group of collaborators reconvened, and put in a revied proposal for a definitve RCT in response to an HTA Primary Care Call. The group wass trengthened by the addtion of researchers from the Universities of London and Huddersfield and had the support of all PCRNs. The applcation was again unsuccessful despite going through to full application and having very positive referee commnents. The reason for rejection seemed to be primarily because the panel felt the intervention itself was the wrong approach. This had not been raised in any earlier feedback. The University of Aberdeen team led the design and writing of the application.
Collaborator Contribution All collborators fully contributed according to their areas of expertise, including the Aberdeen University Service User Group
Impact none
Start Year 2011
 
Description Conduct of defintive trial ( application to HTA primary care call) 
Organisation University of Huddersfield
Department School of Applied Sciences Huddersfield
Country United Kingdom 
Sector Academic/University 
PI Contribution The original MRC funded a feasibility/ pilot study which confirmed the proof of concept and the viability of a definitve RCT. The original team applied to HTA for the definitve study and were unsuccessful at outline stage at the first prioritisation screen (chronic pain was said not to be a priority). Subsequently, two years after this failed application, the same group of collaborators reconvened, and put in a revied proposal for a definitve RCT in response to an HTA Primary Care Call. The group wass trengthened by the addtion of researchers from the Universities of London and Huddersfield and had the support of all PCRNs. The applcation was again unsuccessful despite going through to full application and having very positive referee commnents. The reason for rejection seemed to be primarily because the panel felt the intervention itself was the wrong approach. This had not been raised in any earlier feedback. The University of Aberdeen team led the design and writing of the application.
Collaborator Contribution All collborators fully contributed according to their areas of expertise, including the Aberdeen University Service User Group
Impact none
Start Year 2011
 
Description Founder member of group which developed Consort guidance for pilot studies published in BMJ 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution I was the initiator of the groups which was led by professor Sandra Eldridge QMUL
Collaborator Contribution BMJ publication of new Consort guideline and associated papers
Impact Sandra M Eldridge, Claire L Coleman, Michael J Campbell, Christine M Bond, Sally Hopewell, Lehana Thabane, Gillian A Lancaster on behalf of the PAFS consensus group. CONSORT 2010 Statement: extension to randomised pilot and feasibility trials BMJ. 2016; 355: i5239 (dual publication) Eldridge S., Chan C., Campbell M., Bond C., Hopewell S., Thabane L., Lancaster G.A. CONSORT Statement: extension to randomised pilot and feasibility trials. Pilot and Feasibility Studies 2016, 2:64. DOI 10.1186/s40814-016-0105-8 (dual publication) Lehana Thabane Sally Hopewell Gillian A Lancaster Christine M Bond Claire L Coleman, Michael J Campbell, Sandra M Eldridge, Methods and Processes for Development of a CONSORT Extension for Reporting Pilot Randomized Controlled Trials Pilot and Feasibility Studies 2016, 2:25. DOI 10.1186/s40814-016-0065-z 25. Sandra Mary Eldridge; Gillian Lancaster; Michael Campbell; Lehana Thabane; Sally Hopewell; Claire Coleman; Christine Bond Defining feasibility and pilot studies in preparation for randomised controlled trials: using consensus methods and validation to develop a conceptual framework PLOSONE 2016 DOI:10.1371/journal.pone.0150205 March 15, 2016. In top 1% of most down loaded PLOS ONE papers
Start Year 2013
 
Description HTA award 09/34/03 A pilot study of the effectiveness and cost effectiveness of Multi-compartment Medication Devices. 
Organisation University of East Anglia
Department School of Medicine UEA
Country United Kingdom 
Sector Academic/University 
PI Contribution We contributed expertise on study design and subject knowledge and will have an ongoing role in delivering the project
Collaborator Contribution By combining our expertise we have been awarded a grant by HTA for £380,936 which we might not otherwise have received.
Impact The study is due to start
Start Year 2010
 
Description Invitation to write a chapter in Volume 11 of European Observatory on Health Systems and Policies 
Organisation Technical University Berlin
Country Germany 
Sector Academic/University 
PI Contribution Invited to be co-author for chapter in increased skill mix in acute care
Collaborator Contribution They are lead editors for the book
Impact Multidisciplinary international group of chapter authors
Start Year 2018
 
Description New collaboration with University of Leicester 
Organisation University of Leeds
Department School of Healthcare
Country United Kingdom 
Sector Academic/University 
PI Contribution Invited by Leeds to be a co-applicant for an NIHR grant application looking at independent prescribing in chronic pain due to my expertise and the previous grant awarded.
Collaborator Contribution Partners are taking the lead
Impact Too early fro nay tangible outputs
Start Year 2017
 
Title Study Algorithm 
Description Evidence based study algorithm for pharmaco therapy of chronic non-cancer pain. The algorithm has been shared on request with two community pharmacists with an interest in conducting pain clinics (one in Essex, one in Highland). The algorith was developed as part of this MRC funded platform project. 
Type Support Tool - For Medical Intervention
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2010
Development Status Closed
Impact The algorithm was developed specifically for the pilot RCT of pharmacist-led management of chronic pain in primary care. This was used by practice pharmacists (n = 6) managing patients randomised to either intervention arms. 
 
Description Chair RPS Expert Advisory Panel for Science 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Chair of the EAP which looks at the science underpinning the practice of pharmacy and advises the RPS on future areas where policy is needed eg the e cigarette policy, antibiotics, personalised medicine
Year(s) Of Engagement Activity 2011,2012,2013,2014,2015
 
Description Local Pharmacy forum meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Activity to be delivered on November 26th

One of the pharmacists who delivered the interention will aslo be at the meeting. The NAtioanl Clincial Lead for pain has also agreed to come to te meeting to give a short talk and hear about our work
Year(s) Of Engagement Activity 2012
 
Description PAIN HSRPP 2011 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presentation at Health Services Research and Pharmacy Practice Conference (HSRPP) conference University of East Anglia
Bruhn H, Bond C.M, Elliott, AM., Hannaford, P.C., Lee, A.J., McNamee, P., Smith, B.H., Watson M. C., Blyth A., Holland, R., Wright, D., Pharmacist led management of chronic pain in primary care: the PIPPC study 2011 IJPP 19 (supp 1) 22-3


Considerable interest in the findings from the audience
Year(s) Of Engagement Activity 2011
 
Description PCRN pharmacy engagement day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact 37 pharmacists attended and appeared very interested and asked lots of questions. Quotes from the evaluation form included:
"Good practical examples, raised interest and enthusiasm to get involved"
"I found it very interesting and would attend again in the near future"
"Good to see the intentions of pharmacy involvement in research"


We have received the support of the Greater London PCRN for a funding bid to HTA.
Year(s) Of Engagement Activity 2010
 
Description Pain RPS Conference 2011 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Royal Pharmaceutical Sociey Annual Conference September 2011
Bond C.M, Bruhn H, Blyth A, Elliott, AM., Hannaford, P.C., Holland, R., Lee, A.J., McNamee, P., Smith, B.H., Watson M, Wright, D., Pharmacist led management of chronic pain in primary care: the experiences of patients, pharmacists and GPs 2011 IJPP 19 (supp 2) 24-5


Great interest from the audience
Year(s) Of Engagement Activity 2011
 
Description Presentation to patient usergroup 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Participants in your research and patient groups
Results and Impact As part of developing the research skills of a patient usergroup the study was presented to the usergroup.

Close links to further help develop the study materials and for volunteers to attend our training session.
Year(s) Of Engagement Activity 2009