Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04713215 |
| Other study ID # |
289976 |
| Secondary ID |
2782 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 7, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
Guy's and St Thomas' NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Medication adherence - the extent to which a patient takes their medications as prescribed -
is a global problem. Half of all medicines given to patients with long-term health problems
are not taken properly by the patient. Older adults are also more at risk of harm from their
medications as they tend to take more medicines than young people, and are less able to cope
with their effects.
There has been research into how to address these problems. One way has been through
providing patients with a medication compliance aid (MCA), to help with taking their
medications on time. MCAs are pre-packaged boxes containing tablets, grouped together
according to the day and time the medication needs to be taken. Some patients buy the MCA and
fill it themselves, other patients collect a MCA that their pharmacy makes for them.
There is not much proof that pharmacy-filled MCAs help patients, and some research suggests
they may cause harm. The views of patients on MCA use have not yet been fully explored - it
is not clear why some patients choose to stop using an MCA or refuse one when offered. Many
patients with MCAs also have a family member or friend who helps them with their medication.
No research has recognised the role of informal carers in helping patients with MCAs or asked
them their thoughts.
This study aims to understand what patients, aged 65 and older, and their informal carers
think about MCAs and how they affect their lives. It is a questionnaire study which will take
place within a National Health Service (NHS) hospital. It's designed to take approximately 20
minutes, either face to face or by phone. The investigators hope that the results from this
study will help to inform how healthcare professionals use MCAs to the benefit of patients
and their carers.
Description:
Definitions Patient is defined as a service user in a hospital/outpatient/community setting,
who may or may not have used an MCA in the past.
Informal Carer is a person who, in an unpaid capacity, supports a Patient in some aspect of
their care - for the scope of this study, this must include assistance with medication. They
will also be referred to as a Carer. It must be noted that paid carers are outside the scope
of this study. A paid carer is someone in formal employment in a caring capacity.
Participant is defined as either a Patient or Informal Carer who consents to be part of the
study, and have their data stored and used for the purposes outlined in this protocol.
Medication Compliance Aid(s), also referred to as Medication Aid(s) or MCAs, are pre-packaged
boxes containing tablets correctly grouped together according to the day and time the
medication needs to be taken, assembled by a pharmacist.
Research participants for this study will belong to the following 4 groups:
1. Patients (inpatient or outpatient) aged 65 or over currently using an MCA
2. Patients (inpatient or outpatient) aged 65 or over previously offered an MCA but
declined/discontinued
3. Informal carers (aged 18 or over) of patients (aged 65 or over) using MCAs.
4. Informal carers (aged 18 or over) of patients (aged 65 or over) who were previously
offered an MCA but it was declined/discontinued
All participants must be able to speak English and have sufficient cognitive function to
provide informed consent.
Patients and informal carers will not be recruited in pairs (i.e patient and their informal
carer). The investigators will be recruiting informal carers of patients that have cognitive
impairment and some of the patients with cognitive impairment will not have sufficient
capacity to partake in the survey themselves. However, their informal carers are an important
and large group of those supporting patients with their medications and therefore need to be
included in this study.
Setting:
Data collection for this single-centre study will be taken from participants identified
through various means including outpatient attendees (telephone and face to face), inpatient
wards and community settings e.g. a hospital @home team. The hospital @home team involves a
"community ward", involving doctors, nurses, pharmacists and therapy teams employed by the
same NHS Foundation Trust, where clinicians assess and treat patients in their homes.
Informal carers who assist with medications are identified in these settings as part of
normal clinical practice on hospital admission, clinic or @home review and also in discharge
planning activities.
The investigators will also place posters in an outpatient clinic waiting room within the
older persons assessment unit, to advertise the study to patients and informal carers.
Identification of participants:
Potential participants will be approached and screened by their clinical care team during the
course of routine clinical activity. A member of the direct clinical team will approach
potential participants, confirm eligibility using a standardised set of screening questions,
describe the study briefly and ask for verbal consent for their name and phone number to be
passed to the research team. Informal carers are commonly identified by clinical teams as
part of routine admission questions when a patient is admitted to hospital, as formal (paid)
care arrangements need to be distinguished from informal arrangements for the purpose of
discharge assessment and onward care at home. Identification of who assists with the
patient's medications is also identified as part of routine care by pharmacy staff. The
investigators will encourage members of the direct clinical care team to ask informal carers
the screening questions during routine care discussions and whether they would be interested
in taking part. If yes, the clinical team member will pass on their contact details.
If a patient lacks capacity to give informed consent for inclusion in the study, they will
not be approached for participation. Informal carers of these patients who meet the informal
carer inclusion criteria will still be eligible to be approached and will be contacted by the
clinical team looking after the patient in the first instance to check eligibility and
inquire regarding whether they are interested in taking part. This contact will be during a
routine clinical activity such as obtaining a collateral history from an informal carer.
Recruitment: On approach by researcher, participants will be given a description of the study
verbally (face to face or via phone). All potential participants will be given a copy of the
written participant information sheet prior to completing the questionnaire.
Verbal consent to proceed with the questionnaire will be sought. Optional consent will also
be sought to record a participant's email or postal address to disseminate a lay summary of
results on completion of the study.
Questionnaire:
Participants will complete a short questionnaire containing a mix of quantitative and
qualitative questions with scope to include free-text comments.
The questions will vary according to whether the participant is a patient or carer, and
whether they are currently using a pharmacy-filled MCA, previously discontinued a
pharmacy-filled MCA or have previously declined a pharmacy-filled MCA. The questions will
explore the following;
For patients, and the informal carers of patients, who use MCAs
1. Establish patient and informal carer opinions of MCAs
2. Determine whether those who use MCAs would consider switching to taking medicines in
their original packaging
For patients, and the informal carers of patients, who have used an MCA in the past but no
longer do so
1. Establish patient and informal carer opinions of an MCA
2. Explore patient and informal carers reasons for stopping an MCA
3. Explore alternative ways in which patients and informal carers organise medications
without the use of an MCA
For patients and their informal carers who have been offered an MCA but declined
1. Explore why the MCA was declined
2. Explore alternative ways in which patients and their informal carers organise
medications without the use of an MCA
3. To explore what further support they would like to help them adhere to their medications
The researchers will administer the questionnaire in all settings including face to face and
phone call. This will broaden participation to those who have difficulty reading and writing.
Close of interaction:
The participant will be thanked for their time and any further questions will be answered. No
further interactions will occur.
