The Development and iMplementation Of a Multidisciplinary Medication Review and Deprescribing Intervention Among Frail Older People in primarY Care (MODIFY Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- cognition
研究概览
简要总结
A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death, with higher risk among people living with frailty. National recommendations suggest that medications taken by frail older people should be reviewed annually by GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines. Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication reviews. There are four work packages (WPs).
- Review literature to identify what makes a successful medication review and how to safely deprescribe.
- Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will investigate where medication review should take place, the role of involved parties, type of medications that could be deprescribed, staff training needs, barriers and facilitators for implementation, and strategies to address them.
- Information from WP1&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs and involving frail patients and their families in decisions about medications. This will be refined through workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in deprescribing will be developed alongside the intervention.
- Feasibility study for staff in four GP practices to be trained and to implement the intervention.(this will be subject to further amendment).
详细描述
Background A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death. These effects are higher among people living with frailty who lose their in-built reserves and become vulnerable to changes triggered by small events such as a change in medication. National recommendations suggest that medications taken by frail older people should be reviewed annually by their GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines.
Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
Aim This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication review.
Methods The study involves four work packages (WPs). The research team will review previous literature to identify what makes a successful medication review and how to safely reduce/ stop inappropriate medications (WP1).
Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will be conducted (WP2). These will discover views about where medication review should take place, the role of each of the involved parties in the process, type of medications that could be deprescribed, staff development and training needs, barriers and facilitators for implementation, and strategies to address these barriers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria for WP2
- •Inclusion criteria
- •Aged 65 and over
- •Frail, (as judged by their health care professional, if applicable)
- •Prescribed multiple medications (10+), as determined by their health care professional
- •Able to give informed consent
排除标准
- •Aged under 65
- •Severe cognitive impairment, as judged by their health care professional
- •Informal carers/ relatives eligibility criteria
- •Inclusion criteria
- •An informal carer/ relative of a frail patient (aged 65 and over) who is taking multiple medications, as identified by a health care professional
- •An informal carer/ relative of a patient (aged 65 and over) living with severe dementia who is taking multiple medications, as identified by a health care professional
- •Able to consent
- •Health care professional eligibility criteria
- •A health care professional based in GP surgeries in Wessex (eg. GPs, practice-pharmacists, advanced nurse prescriber (ANPs) who works with older people living with frailty, who are prescribed multiple medications.
研究组 & 干预措施
Patients participating in structured multidisciplinary medication review
Patients participating in structured multidisciplinary medication review
干预措施: Structured multidisciplinary medication review (Other)
结局指标
主要结局
cognition
时间窗: changes between baseline and 3 months
\- cognition using the abbreviated mental test (AMT)
depression
时间窗: changes between baseline and 3 months
\- depression using the geriatric depression scale (GDS)
Mortality rates
时间窗: 3 months
mortality rates 3 months post intervention
Feasibility of recruitment
时间窗: Baseline
proportion of staff recruited and trained in each GP practice
Rates of fractures
时间窗: changes between baseline and 3 months
number of fractures and proportion of people sustained fractures (self-reported)
Feasibility of deprescribing
时间窗: 3 months follow up
number of recommendations in the medication reviews made to each patient (stop, reduce, switch or start).
number of potentially inappropriate medications
时间窗: Change between baseline and 3 months follow up
total number of potentially inappropriate medications months using the STOPP/START criteria.
frailty status
时间窗: changes between baseline and 3 months
Frailty score using the electronic frailty index (e-FI)
rates of falls
时间窗: changes between baseline and 3 months
number of falls reported and proportion of fallers (self-reported)
function
时间窗: changes between baseline and 3 months
Activity of daily living using Barthel
Rates of adverse events
时间窗: at 3 months
rates of adverse drug events due to deprescribing (including self-reported dizziness, falls, drowsiness, confusion, hallucinations, blurred vision, constipation, diarrhoea, dry mouth or other) during 3 months follow up.
Rates of hospitalisation
时间窗: 3 months
rates of hospitalisation 3 months post intervention
healthcare utilisation
时间窗: at 3 months follow up
number of visits to GP/specialists and number of unplanned hospitalisations
Acceptability
时间窗: at 3 months follow up
Interviews or focus groups will be conducted at the end of the feasibility study with a purposive sample of (n=6-8) GPs, pharmacists, ANPs in the four GP practices who received the training and implemented the intervention, and 8-10 patients and carers who received the intervention
Number of medications
时间窗: change in scores between baseline and 3 months follow up
Total number of medications taken by each patient
次要结局
未报告次要终点