The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

Study Overview
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Brief Summary
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Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. The nurse-led intervention (The ADRe Profile) to review mental health medicines has demonstrated improved care quality by: identifying serious adverse drug reactions (ADRs); reducing prescription of mental health medicines; reducing the prevalence of pain and nausea; and, increasing non-urgent national health service (NHS) contacts. The investigators will develop ADRe to encompass medicines commonly prescribed in primary care and evaluate intervention implementation in care homes in Aneurin Bevan University Health Board.

Detailed Description
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The investigators will introduce medicines' monitoring using the PADRe Profile into up to 7 care homes, each with up to 26 residents prescribed >4 medicines (estimated  90% residents). Each home will identify a nurse lead and a deputy. Nurses will be asked to administer the PADRe Profile with all patients prescribed >4 medicines. Barriers, facilitators, and feasibility of the Profile will be explored. This will identify how, in which contexts medicines' monitoring can be integrated into routine care, relate the Profile to improved processes and outcomes of care, and inform implementation strategies (see logic model in cited papers). Data collection: Record review before and after each of 3 administrations of the intervention to identify clinical and prescription changes. Narrative accounts of problems causing moderate or severe harm will be prepared. Serial interviews and debriefs with nurses: three per nurse. Stakeholder interviews with patients, participating pharmacists and prescribers for an overview of implementation.

Official Title
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Polypharmacy and Adverse Drug Reactions: Nurse-led Intervention to Minimise Adverse Drug Reactions for Older Adults in Care Homes: a Quality Improvement Process Intervention

Conditions
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Polypharmacy

Intervention / Treatment
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* Other: Adverse Drug Reaction ADRe Profile for Polypharmacy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Resident at the care home and expected to continue to live there for 1 year Currently taking >3 prescribed medicines daily Willing and able to give informed, signed consent themselves, or where capacity is lacking, a consultee is willing to give advice and assent to the resident participating. Exclusion Criteria: age <18 Prescribed <4 medicines daily; Receiving active palliative care Not well enough to participate, as screened by their nurses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>This is a single arm before and after study with data collection at 4 time points. | Other: Adverse Drug Reaction ADRe Profile for Polypharmacy<br>* PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the British National Formulary (BNF) and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents | Number of participant with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events. | 3 months from start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Clinical Gains Per Resident Between Baseline and 3 Months | Number of problems addressed or ameliorated per resident e.g. pain, falls, sedation. Number at baseline minus number at 3 months. | Baseline, then 3 months from start of intervention | 
| Number of Medicines Prescribed: Change Between Baseline and 3 Months | number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months) | Baseline, then 3 months from start of intervention | 
| Number of Problems Listed on Profile | Number of problems listed on the ADRe-p profile per resident. All problems might be attributable to prescribed medicines. Change in number. | Baseline, then 3 months from start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medicines management, adverse drug reaction, care homes, nurses