Condition category
Signs and Symptoms
Date applied
11/12/2009
Date assigned
29/01/2010
Last edited
09/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christine Bond

ORCID ID

Contact details

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

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 measures

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

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

http://www.abdn.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0701769)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23562814

Publication citations

  1. 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.

Additional files

Editorial Notes