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The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

Not Applicable
Completed
Conditions
Polypharmacy
Interventions
Other: Adverse Drug Reaction ADRe Profile for Polypharmacy
Registration Number
NCT03955133
Lead Sponsor
Swansea University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
19
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
interventionAdverse Drug Reaction ADRe Profile for PolypharmacyThis is a single arm before and after study with data collection at 4 time points.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents3 months from start of intervention

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.

Secondary Outcome Measures
NameTimeMethod
Number of Clinical Gains Per Resident Between Baseline and 3 MonthsBaseline, then 3 months from start of intervention

Number of problems addressed or ameliorated per resident e.g. pain, falls, sedation. Number at baseline minus number at 3 months.

Number of Medicines Prescribed: Change Between Baseline and 3 MonthsBaseline, then 3 months from start of intervention

number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months)

Number of Problems Listed on ProfileBaseline, then 3 months from start of intervention

Number of problems listed on the ADRe-p profile per resident. All problems might be attributable to prescribed medicines. Change in number.

Trial Locations

Locations (1)

Swansea University

🇬🇧

Swansea, United Kingdom

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