Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0701769; pRGF/106/09
Study information
Scientific title
A pilot randomised controlled trial of general practice-based, pharmacist-led, management of chronic pain
Acronym
PIPPC
Study hypothesis
We 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
North of Scotland Research Ethics Service, Committee 1 (NoSRES) approved on the 30th November 2009 (ref: 09/S0801/107)
Study design
Exploratory randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic pain
Intervention
There 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Information 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 measures
1. 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 trial start date
04/01/2010
Overall trial end date
01/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Patients: 216; GP practices: 6; pharmacists: 6
Participant exclusion criteria
1. 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
Recruitment start date
04/01/2010
Recruitment end date
01/11/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre of Academic Primary Care
Aberdeen
AB25 2AY
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
c/o Dr Elizabeth Rattray
Deputy Director
Research and Innovation
King's College
Aberdeen
AB24 3FX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0701769)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23562814
Publication citations
-
Results
Bruhn H, Bond CM, Elliott AM, Hannaford PC, Lee AJ, McNamee P, Smith BH, Watson MC, Holland R, Wright D, Pharmacist-led management of chronic pain in primary care: results from a randomised controlled exploratory trial., BMJ Open, 2013, 3, 4, doi: 10.1136/bmjopen-2012-002361.