Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713215
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2021-01-14
Brief Title:
Thinking Outside the Box
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Thinking Outside the Box Exploring Patient and Carer Perceptions of Medication Compliance Aids MCAs
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Its 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
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 Its 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
Detailed Description:
Definitions Patient is defined as a service user in a hospitaloutpatientcommunity 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 Aids also referred to as Medication Aids 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 declineddiscontinued
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 declineddiscontinued
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 ie 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 eg 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 patients 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 participants 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
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 Aids also referred to as Medication Aids 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 declineddiscontinued
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 declineddiscontinued
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 ie 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 eg 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 patients 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2782 | OTHER_GRANT | Sir Halley Stewart Trust | None |