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
Scientific
Centre of Academic Primary Care
Foresterhill Health Centre
Westburn Road
Aberdeen
AB25 2AY
United Kingdom
Study information
| Study design | Exploratory randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 04/01/2010 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Patients: 216; GP practices: 6; pharmacists: 6 |
| 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
- Scotland
- United Kingdom
Study participating centre
Centre of Academic Primary Care
Aberdeen
AB25 2AY
United Kingdom
AB25 2AY
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
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" |
https://ror.org/016476m91 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) (ref: G0701769)
Government organisation / National government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
