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

ISRCTN	ISRCTN06131530
DOI	https://doi.org/10.1186/ISRCTN06131530
Protocol serial number	G0701769; pRGF/106/09
Sponsor	University of Aberdeen (UK)
Funder	Medical Research Council (MRC) (UK) (ref: G0701769)

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

Primary study design	Interventional
Study design	Exploratory randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot randomised controlled trial of general practice-based, pharmacist-led, management of chronic pain
Study acronym	PIPPC
Study objectives	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(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) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	216
Key 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
Key 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
Date of first enrolment	04/01/2010
Date of final enrolment	01/11/2010

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Centre of Academic Primary Care

Aberdeen
AB25 2AY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes