Enhanced Pharmacy Services for Methadone Patients RCT

M Jaffray1, C Matheson1, CM Bond1, AJ Lee1, A Johnstone2, B Davidson3 L Skea4

1Centre of  Academic Primary Care, University of Aberdeen
2 STRADA, Centre for Drug Misuse Research, University of Glasgow
3  Fulton Clinic, Royal Cornhill Hospital, Grampian NHS Trust
4 NHS Grampian

Funded by CSO

Study timetable: November 2008 – March 2010

Background
Of the 1166 pharmacies in Scotland, 79.1% dispense methadone for approximately 12,500 drug misusers.  Of these, 57% visit the pharmacy daily and consume their methadone under pharmacist supervised self-administration (SSAM)1. A good relationship with the pharmacist and other staff is an important influence on DMs’ self esteem, and behavior in the pharmacy2.  The pilot study of motivational interviewing which we conducted in Grampian, demonstrated the feasibility of providing enhanced pharmacy services (EPS) for methadone patients using motivational interviewing (MI)3. The findings of this pilot study were used to inform the development of the RCT which is now underway over six areas in Scotland.

Please click on the links to view the study newsletters:

March 2009
June 2009
September 2009
January 2010

The study team
The principle investigator for the study is Dr Catriona Matheson , who has over 15 years of research experience in the area of drugs misuse and the study co-ordinator is Ms Mariesha Jaffray. The study steering group are:

Dr Catriona Matheson, Drugs Misuse research, CAPC, University of Aberdeen
Professor Christine Bond, Professor of Primary Care: Pharmacy and Head of Section, CAPC, University of Aberdeen
Professor Amanda Lee, Professor in Medical Statistics, CAPC, University of Aberdeen
Ms Lucy Skea, Specialist Pharmacist in Drugs Misuse (lucy.skea@nhs.net)
Dr Bruce Davidson, Consultant Psychiatrist, SMS, Fulton Clinic, RCH, Aberdeen
Mr Allan Johnstone, Specialist trainer in Motivational Interviewing, STRADA, Glasgow http://www.projectstrada.org/v1/

Aim
The overall aim is to identify whether pharmacists trained in MI techniques can improve the outcomes of SSAM programmes. 

Design
The study is a cluster RCT and the unit of randomisation is the pharmacy. 

Methods
Pharmacies providing SSAM  for 10 or more patients were invited to participate. Target pharmacy recruitment was 74 (37 intervention, 37 control). Target patient recruitment per pharmacy was 12 DMs in their first nine months of treatment. This was later revised to include patients in their first 24 months of treatment.

Results to date
Pharmacist Recruitment
Through working with the specialist pharmacists in substance misuse in each area, we have been able to recruit pharmacies from six areas: Tayside, Ayrshire, Forth Valley, Lanarkshire, Grampian and Fife.

The area and pharmacists are::

1. Tayside – Karen Melville (karen.melville@nhs.net)
2. Ayrshire –Francis Donachie (Frances.Donachie@aapct.scot.nhs.uk)
3. Forth Valley –Jean Logan (jean.logan@fvpc.scot.nhs.uk)
4. Lanarkshire -George Lindsay (Chief Pharmacist, George.Lindsay@lanarkshire.scot.nhs.uk)
5. Grampian – Fiona Stuart (fionastuart@nhs.net), Lucy Skea (lucy.skea@nhs.net)
6. Fife – Liz Hutchings (ElizabethHutchings@fife-pct.scot.nhs.uk)

From the six areas, 87 pharmacies with 95 pharmacists (some have more than one pharmacist involved in the study) have been recruited into the study. Twelve pharmacies subsequently withdrew from the study each with one pharmacist. This leaves 84 pharmacists from 75 pharmacies currently taking part in the study. Forty-three are intervention pharmacists and 41 are control. The spread of these by pharmacists by area can be seen in Table 1 and pharmacies by area can be seen in Table 2.

Table 1: Pharmacist Recruitment

Table 2: Pharmacies Recruitment

Patient recruitment
541 patients recruited into the study : 275 intervention and 266 control. These are shown by area in Table 3.

Table 3: Patients by area and group

Training
Training sessions have now been completed for all community pharmacists in the intervention group.

Baseline data collection
All baseline patient interviews have been completed and have been entered into the study database. Baseline questionnaires and reminders have also been sent to community pharmacists. Those returned have been entered into the study database and are being prepared for analysis.

Follow-up data collection
Six month follow-up data collection is now underway in all areas with the exception of Fife (which are not due till November). The majority of these interviews have been conducted face to face with patients. However, some patients have been missed when the researchers returned to the pharmacies or have moved to another pharmacy. We have been conducting these remaining interview where possible by phone and collecting information with regard to current methadone dose from the pharmacists. There are about 70 patients who have moved pharmacy and we have no contact number for them. As these patients have consented to be followed up, we are working with the specialist pharmacists to determine if they still remain in treatment (e.g. in another pharmacy) or not.

Final report
The final follow up data collected for the study will be completed by December 2009 and the final report will be completed by March 2010.

Study findings
Presentations on the design of the study and difficulties experienced with the recruitment of patients have already been given and an abstract published with IJPP:

1. Jaffray M, Matheson C, Bond C, Lee AJ, Johnstone A, Davidson B Recruitment challenges in drug misuse RCTS – an example from Scottish Pharmacies, EWODOR 11th International Symposium on Substance Abuse Treatment, Sweden, October 2008.

2. Jaffray M, Matheson C, Bond C, Lee AJ, Johnstone A, Davidson  Recruitment challenges in drugs misuse RCTS- an example from Scottish Pharmacies. Senior Pharmacists Conference, October 2008

3. Jaffray M, Matheson C, Bond C, Lee AJ, Johnstone A, Davidson B Recruitment challenges in drug misuse RCTS – an example from Scottish Pharmacies.  Poster presentation at the Health Services Research & Pharmacy Practice Conference, Liverpool, 2009

4. Jaffray M, Matheson C, Bond C, Lee AJ, Johnstone A, Davidson B Recruitment challenges in drug misuse RCTS – an example from Scottish Pharmacies. International Journal of Pharmacy Practice 2009

An abstract presenting some of the baseline data patient data (treatment satisfaction) is also being prepared for submission to the EWODOR 12th International Symposium on Substance Abuse Treatment, Stirling, October, 2009.

The final study results will be submitted as an abstract to the International Harm Reduction Conference (IHRC), Liverpool, 2010.