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02 September 2010
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| [ Print-friendly version ] |
| Study of practice pharmacist-led management of long-term pain |
| ISRCTN | ISRCTN06131530 |
| ClinicalTrials.gov identifier | |
| Public title | Study of practice pharmacist-led management of long-term pain |
| Scientific title | A pilot randomised controlled trial of general practice-based, pharmacist-led, management of chronic pain |
| Acronym | PIPPC |
| Serial number at source | G0701769; pRGF/106/09 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Chronic pain |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 04/01/2010 |
| Anticipated end date | 01/11/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Patients: 216; GP practices: 6; pharmacists: 6 |
| Interventions |
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. |
| 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. |
| 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. |
| Sources of funding | Medical Research Council (MRC) (UK) (ref: G0701769) |
| Trial website | |
| Publications | |
| Contact name | Prof Christine Bond |
| Address |
Centre of Academic Primary Care
Foresterhill Health Centre Westburn Road |
| City/town | Aberdeen |
| Zip/Postcode | AB25 2AY |
| Country | United Kingdom |
| Sponsor | University of Aberdeen (UK) |
| Address |
c/o Dr Elizabeth Rattray
Deputy Director Research and Innovation King's College |
| City/town | Aberdeen |
| Zip/Postcode | AB24 3FX |
| Country | United Kingdom |
| Sponsor website: | http://www.abdn.ac.uk/ |
| Date applied | 11/12/2009 |
| Last edited | 29/01/2010 |
| Date ISRCTN assigned | 29/01/2010 |
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