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Completed

NCT Number: NCT03955133

The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

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.

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Key information

Conditions

Polypharmacy Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swansea University

Swansea, sa2 8pp, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adverse Drug Reaction ADRe Profile for Polypharmacy

Other

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).

Primary outcomes

  1. Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents

    Time frame: 3 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 outcomes

  1. Number of Clinical Gains Per Resident Between Baseline and 3 Months

    Time frame: Baseline, 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.

  2. Number of Medicines Prescribed: Change Between Baseline and 3 Months

    Time frame: Baseline, 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)

  3. Number of Problems Listed on Profile

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Collaborators

  • Aneurin Bevan University Health Board
  • Cardiff University

Registry information

Official study title

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

Acronym: ADRe-p

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 17, 2019
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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