Condition category
Not Applicable
Date applied
12/01/2018
Date assigned
05/02/2018
Last edited
05/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This study tests a new service that aims to help older patients (aged 65 or older) living in Northern Ireland and London (England) who are prescribed several medicines. This service will be delivered in community pharmacies, by trained pharmacists. To develop this service focus group discussions were held with older patients and testing was done on how the service could work in a small study at two pharmacies and with ten patients in total. This helped identify how to improve the service for both older patients and pharmacists and some changes were made to refine the service. There are still some aspects that the researchers are not certain about (for example, how best to identify older people who could benefit from this new service) and so the aim of this study is to test the refined service in a larger group of pharmacies and patients.

Who can participate?
Patients aged 65 or older who are prescribed four or more regular medications and who have a medication adherence problem

What does the study involve?
The study involves pharmacists delivering the refined service to older patients. The previous study found that recommending a set number of sessions with a pharmacist was not ideal for this group of patients. Therefore, the number of sessions with a pharmacist that each patient attends is matched to each patient's own needs (maximum of four sessions in the pharmacy). During these sessions patients are asked about any difficulties they experience when taking several medicines. In a new approach, the pharmacist uses a handheld electronic device (an iPad) to guide these sessions and record recommendations made. Together, the patient and pharmacist choose the best solutions to help overcome any difficulties.

What are the possible benefits and risks of participating?
This study will show whether the refined service works in a larger group of people and a larger number of pharmacies. This study will also help the researchers to decide whether they should proceed to a larger study to explore if this service is better than usual care in community pharmacies. In the long-term, it is hoped that this type of service will lead to improvements in how patients take (or use) their medication and ultimately reduce the number of unplanned visits to hospital and lead to improvements in older people’s quality of life. Due to the type of the study, the risk of harm to participants is considered to be low. However, it is possible that discussions between the pharmacist and patient may lead the patient to think of upsetting or distressing aspects of their medical conditions. This risk will be lessened by having a study information sheet that clearly outlines what will happen during the service. The sessions will also be held in the community pharmacy that the patient normally attends and the service will be delivered by a pharmacist with whom the patient is likely to be familiar. There is a low risk that we may identify poor practice by healthcare professionals (e.g. pharmacists, general practitioners) during the study. In the unlikely event that poor practice is identified by the researcher, then the case will be reported to the Principal Investigator who will, in the first instance, contact the healthcare professional(s) involved and if necessary, the case will be reported to the appropriate regulatory body. The procedure for disclosing cases of poor practice will be outlined in the study information sheets received by all participants.

Where is the study run from?
1. Queen's University Belfast (UK)
2. City University of London (UK)

When is the study starting and how long is it expected to run for?
December 2017 to May 2020

Who is funding the study?
Dunhill Medical Trust (UK)

Who is the main contact?
Prof. Carmel Hughes

Trial website

Contact information

Type

Scientific

Primary contact

Prof Carmel Hughes

ORCID ID

http://orcid.org/0000-0002-4656-6021

Contact details

97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

Protocol/serial number

Version 2.0

Study information

Scientific title

A pilot study of the S-MAP (Solutions for Medication Adherence Problems) intervention in older adults prescribed polypharmacy in primary care

Acronym

S-MAP (Solutions Medication Adherence Problems)

Study hypothesis

The overall aim of this study is to pilot test a complex theory-based medication adherence intervention for older patients that has been developed in line with the United Kingdom (UK) Medical Research Council’s (MRC’s) guidance for ‘Developing and evaluating complex interventions’. The intervention (previously known as the ID-MAP intervention) has undergone initial feasibility testing in two community pharmacies in Northern Ireland (10 patients in total) (https://www.isrctn.com/ISRCTN17966504). Modifications have been made to the intervention, pharmacist training and study procedures based on the feasibility study findings. The intervention name has also been amended from ‘ID-MAP (Identification of Medication Adherence Problems) intervention’ to ‘S-MAP (Solutions for Medication Adherence Problems) intervention’ based on feedback received. It was agreed that the name change better reflects that the intervention goes beyond simply identifying adherence problems and instead, has a major focus on providing tailored (i.e. personalised) solutions for each individual patient. The findings from this study will establish whether to proceed to a definitive cluster-randomised controlled trial (c-RCT) to explore the effectiveness of the S-MAP intervention in comparison with usual care in community pharmacies.

Ethics approval

Health and Social Care Research Ethics Committee (REC) B, 30/10/2017, REC ref: 17/NI/0193

Study design

Non-randomised multi-centre pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Non-adherence to multiple medications (i.e. polypharmacy) in older adults

Intervention

The S-MAP intervention will be targeted at older patients aged 65 years or older who are prescribed multiple medications (polypharmacy) to improve their adherence to agreed recommendations. In the current pilot study the intervention will be delivered to older patients by trained pharmacists. Pharmacists will be recruited from 12 community pharmacies in the United Kingdom (UK); 6 community pharmacies in England (greater London area) and 6 community pharmacies in Northern Ireland. Pharmacist training, developed in conjunction with experts in health psychology, will consist of an interactive workshop (including role play elements and demonstrations) to equip pharmacists with the skills and knowledge required to deliver the S-MAP intervention in practice. Each pharmacy will be instructed to recruit 10 patient participants (120 patients in total).

The S-MAP intervention is a ‘personalised’ intervention whereby the content will be tailored to the individual needs of each patient. The intervention has been developed in line with the MRC Framework for complex interventions using the latest available evidence, psychological theory and feedback from both patients and pharmacists. The intervention will be targeted at patients who are identified as non-adherent (identified via a short validated self-report questionnaire). All non-adherent patients will be invited to attend an initial face-to-face adherence assessment in their usual community pharmacy. The assessment will be completed by pharmacists and guided by a novel computer-based decision support tool (application that will be available on provided iPads). Based on the findings from the adherence assessment, the pharmacist and patient will collaboratively select strategies to try and address any challenges faced by the patient with the aim of improving their adherence and health outcomes.

The S-MAP intervention package consists of a range of strategies which stem from the field of health psychology incorporating behaviour change techniques. These techniques were selected based on previous qualitative research that was carried out with older patients. This research identified a wide range of factors that older patients deemed to be important influences on their medication adherence behaviours (e.g. forgetfulness, support from others, routine, beliefs about medications). Using established methods, these important influences were then linked to techniques that could be included in the intervention to improve adherence. Techniques include self-monitoring of medication use behaviour via a daily medication diary, feedback on the behaviour, social support from others, prompts/cues (such as setting medications in a highly visible location), action planning and goal setting exercises, physical/practical changes (e.g. alternative packaging, reducing the complexity of the regimen) and providing information on the health consequences of non-adherence. In the SMAP intervention these techniques will be tailored to the needs of each patient based on the adherence assessment carried out at the first session in the pharmacy.

The prior feasibility study also identified that as well as tailoring the types of adherence support required by each patient, the number of sessions also requires individual-level tailoring. The intervention will therefore be delivered over a minimum of two face-to-face sessions in the pharmacy along with a follow-up telephone call and a maximum of four face-to-face sessions. Support sessions will take place over a period of three to four months. At each session the patient’s adherence and any previously identified barriers/challenges will be re-assessed by the pharmacist to identify if the patient could benefit from further support sessions. Decisions regarding tailoring of the number of sessions (as well as the intervention content) will be guided by the computer-based decision support tool (iPad application) to ensure consistency and replicability.

Analysis in relation to the outcome measures in this study (medication adherence, health-related quality of life and unplanned hospital admissions) will be largely descriptive as the trialists are not seeking to assess effectiveness of the intervention at this pilot phase of testing. The current study will also test the practicality of involving pharmacy support staff who will be trained in key research procedures such as patient eligibility screening and data collection procedures. A process evaluation will be embedded in the study to (a) assess if the intervention was delivered by pharmacists and received by patients as intended (i.e. intervention fidelity) and b) identify the most likely potent components of this complex intervention (i.e. the potential mechanism of action of the intervention).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Medication adherence, measured using the following two approaches:
1. Refill/dispensing data (objective): patient records held in the community pharmacy will provide details of medications dispensed in the 12 months pre-baseline and 12 months post-baseline (i.e. pre-session 1). These data will be used to calculate the Medication Possession Ratio (MPR) and Daily Polypharmacy Possession Ratio (DPPR).
2. Self-report (subjective): adherence will be measured using two validated measures (Medication Adherence Rating Scale- 5 item (MARS-5) and a 1-item self-rating of ability scale developed by Lu et al.) at baseline (eligibility screening stage), 6 months post-baseline and 12 months post-baseline.

Secondary outcome measures

1. Health-related quality of life (HRQOL) measured via self-report using the EQ-5D-5L at baseline (pre-session 1) and 6 and 12 months from baseline
2. Unplanned hospitalisations (resulting in an overnight stay in hospital) in the previous six months measured via self-report at baseline (pre-session 1) and 6 and 12 months from baseline. The feasibility of collecting data from GP surgeries on unplanned hospitalisations to verify self-report data

Overall trial start date

01/12/2017

Overall trial end date

31/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Community pharmacist participants:
1. Must be registered as a pharmacist with the Pharmaceutical Society of Northern Ireland or The General Pharmaceutical Council
2. The pharmacist must be employed and regularly work at the study pharmacy site (i.e. not a locum pharmacist)
3. The pharmacy in which they work must a registered pharmacy located in Northern Ireland or greater London area (England)
4. The pharmacy in which they work must have a private consultation room/area, access to WiFi internet and printing facilities

Pharmacy support staff participants:
1. Pharmacy support staff involved in the study must have completed an accredited Medicines Counter Assistant course or equivalent (as a minimum)

Patient participants:
1. Aged 65 years or older
2. Prescribed four or more regular medications (excluding medications prescribed to be taken only when required)
3. Living in their own home
4. Have at least 12 months of dispensing data available from the time of eligibility screening (on the pharmacy-held Patient Medication Record)
5. Only attend the study site pharmacy for regular medications
6. Have an identified adherence problem (detected using a validated self-report adherence questionnaire)

Participant type

Mixed

Age group

Senior

Gender

Both

Target number of participants

12 community pharmacies with 10 patients per pharmacy (i.e. maximum of 120 patients). No restrictions have been placed on the number of community pharmacists or pharmacy support staff recruited per community pharmacy site.

Participant exclusion criteria

Community pharmacists:
1. Not meeting the eligibility criteria
2. Not providing written informed consent
3. Previous participation in the feasibility study (conducted only in Northern Ireland; ISRCTN17966504)

Pharmacy support staff:
1. Not meeting the eligibility criteria
2. Not providing written informed consent

Patient participants:
1. Not meeting the eligibility criteria
2. Not providing written informed consent
3. Prescribed medications for the treatment or management of dementia (e.g. donepezil, galantamine, rivastigmine or memantine)
4. Unable to complete the self-report adherence screening questionnaire

Recruitment start date

01/06/2018

Recruitment end date

28/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
School of Pharmacy 97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Trial participating centre

City University of London
School of Health Sciences Northampton Square
London
EC1V 0HB
United Kingdom

Sponsor information

Organisation

Queen's University Belfast

Sponsor details

Research and Enterprise Office
University Road
Belfast
BT7 1NN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Dunhill Medical Trust

Alternative name(s)

DMT

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol and relevant appendices (study documentation e.g. Participant Information Sheets, consent form templates) are available upon request from Prof. Carmel Hughes. The trialists plan to publish the findings of the pilot study once results become available. The findings will also be presented at appropriate conferences.

IPD sharing statement
Participant level data will not be reported for this non-randomised pilot study which focuses on exploring the practical aspects of the intervention and does not seek to assess effectiveness. Results with be grouped and reported together in any research publications solely to provide a descriptive overview of the findings. The sharing of individual participant level data for this type of study would provide limited additional information. Hardcopy data will be stored in a locked fire-resistant cabinet in the School of Pharmacy at Queen's University Belfast and/or in the School of Health Sciences, City University of London. Electronic data will be securely stored on password protected computers/laptop computers (to which only the research team will have access) and backed up onto the University’s encrypted server. All hardcopy and electronic data will be securely held for a period of five years before being destroyed.

Intention to publish date

31/05/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes