Study of practice pharmacist-led management of long-term pain

ISRCTN ISRCTN06131530
DOI https://doi.org/10.1186/ISRCTN06131530
Secondary identifying numbers G0701769; pRGF/106/09
Submission date
11/12/2009
Registration date
29/01/2010
Last edited
09/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Christine Bond
Scientific

Centre of Academic Primary Care
Foresterhill Health Centre
Westburn Road
Aberdeen
AB25 2AY
United Kingdom

Study information

Study designExploratory randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA pilot randomised controlled trial of general practice-based, pharmacist-led, management of chronic pain
Study acronymPIPPC
Study objectivesWe wish to conduct a definitive trial that tests whether pharmacists advice or pharmacists advice and prescribing will lead to better patient functioning and/or better pain control than standard care. This exploratory randomised controlled trial (RCT) will support the development and test the feasibility of conducting a future large multi-centred RCT to evaluate practice-based, pharmacist-led management of chronic pain in primary care.
Ethics approval(s)North of Scotland Research Ethics Service, Committee 1 (NoSRES) approved on the 30th November 2009 (ref: 09/S0801/107)
Health condition(s) or problem(s) studiedChronic pain
InterventionThere are three arms in this study:
1. Pharmacist review: pharmacist medication review with recommendations for changes in pain medication made to GPs for indirect implementation
2. Pharmacist prescribing: pharmacist medication review with pain management recommendations implemented directly by pharmacist at a face-to-face consultation with the patient
3. Standard care provided by GP (control)

Total duration of treatment for pharmacist prescribing arm is 31 minutes. Follow-up may take place between 2 - 4 weeks after initial consultation and take place at maximum twice a month for the 6-month follow-up period of the study. The follow-up period for all arms is 6 months.
Intervention typeOther
Primary outcome measureInformation from this pilot RCT will be used to inform final selection of a single primary outcome measure from the following:
1. 12-item short form health survey (SF-12)
2. Health Utilities Index mark 2 and mark 3 (HUI 2/3)
Administered for self-report, postal questionnaire at baseline, three and six month follow-up.
Secondary outcome measures1. The Chronic Pain Grade (assessing severity of pain)
2. The Hospital Anxiety and Depression Scale (assessing level of anxiety and depression)
Questionnaires are administered as self-report, postal questionnaire at baseline, three and six month follow-up.
Overall study start date04/01/2010
Completion date01/11/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPatients: 216; GP practices: 6; pharmacists: 6
Key inclusion criteria1. GP practices: any general practice with an existing practice pharmacist service
2. Pharmacists: a registered prescriber with evidence of appropriate professional indemnity cover
3. Patients:
3.1. Male and female patients
3.2. Aged over 18 years old
3.3. Chronic pain (defined as pain lasting more than 13 weeks)
3.4. Receiving regular prescribed medication for pain
Key exclusion criteria1. GP practices: no existing practice pharmacists
2. Pharmacists: not a registered prescriber or does not have evidence of appropriate professional indemnity cover
3. Patients:
3.1. Under 18 years old
3.2. Not experiencing chronic pain
3.3. Concomitant severe mental health problems
3.4. Terminal illness
3.5. Recent bereavement
3.6. Known alcohol or drug addiction
3.7. Unable to give informed consent
3.8. Malignant pain
3.9. Recent participation in research
3.10. Any other reason at the discretion of the GP for whom the intervention is considered inappropriate
Date of first enrolment04/01/2010
Date of final enrolment01/11/2010

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Centre of Academic Primary Care
Aberdeen
AB25 2AY
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

c/o Dr Elizabeth Rattray
Deputy Director
Research and Innovation
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom

Website http://www.abdn.ac.uk/
ROR logo "ROR" https://ror.org/016476m91

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0701769)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/04/2013 Yes No