Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Attitude
  • Caregivers
  • Medication Adherence
  • Medication Compliance
Type
Observational
Design
Observational Model: Case-OnlyTime Perspective: Retrospective

Participation Requirements

Age
Between 18 years and 110 years
Gender
Both males and females

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 assist...

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: Patients (inpatient or outpatient) aged 65 or over currently using an MCA Patients (inpatient or outpatient) aged 65 or over previously offered an MCA but declined/discontinued Informal carers (aged 18 or over) of patients (aged 65 or over) using MCAs. 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 a researcher, participants (patients and informal carers) will be given a description of the study verbally (face to face or via telephone). They will then be given the option to proceed to the questionnaire or to agree a time to re-discuss. The investigators will also offer the option of a written Patient Information Sheet, followed by rediscussion. 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 Establish patient and informal carer opinions of MCAs 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 Establish patient and informal carer opinions of an MCA Explore patient and informal carers reasons for stopping an MCA 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 Explore why the MCA was declined Explore alternative ways in which patients and their informal carers organise medications without the use of an MCA 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.

Tracking Information

NCT #
NCT04713215
Collaborators
  • King's College London
  • Sir Halley Stewart Trust
Investigators
Principal Investigator: Rebekah Schiff, BSc, MBBS Guy's and St Thomas' NHS Foundation Trust