The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

NCT03955133 | Completed Results

• 1 other identifier: SwanseaNursing
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy

Keywords

medicines management; adverse drug reaction; care homes; nurses

Outcome Measures

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

  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 Outcomes (3)

• Number of Clinical Gains Per Resident Between Baseline and 3 Months

  Baseline, then 3 months from start of intervention

• Number of Medicines Prescribed: Change Between Baseline and 3 Months

  Baseline, then 3 months from start of intervention

• Number of Problems Listed on Profile

  Baseline, then 3 months from start of intervention

Study Arms (1)

intervention

EXPERIMENTAL

This is a single arm before and after study with data collection at 4 time points.

Other: Adverse Drug Reaction ADRe Profile for Polypharmacy

Interventions

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).

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• age \<18
• Prescribed \<4 medicines daily;
• Receiving active palliative care
• Not well enough to participate, as screened by their nurses

Sponsors & Collaborators

• Swansea University: lead
• Aneurin Bevan University Health Board: collaborator
• Cardiff University: collaborator

Study Sites (1)

Swansea University

Swansea, sa2 8pp, United Kingdom

Location

Related Publications (3)

• Jordan S, Logan PA, Panes G, Vaismoradi M, Hughes D. Adverse Drug Reactions, Power, Harm Reduction, Regulation and the ADRe Profiles. Pharmacy (Basel). 2018 Sep 18;6(3):102. doi: 10.3390/pharmacy6030102.

  PMID: 30231573 BACKGROUND

• Jordan S, Banner T, Gabe-Walters M, Mikhail JM, Round J, Snelgrove S, Storey M, Wilson D, Hughes D; Medicines Management Group. Nurse-led medicines' monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines. BMJ Open. 2018 Sep 28;8(9):e023377. doi: 10.1136/bmjopen-2018-023377.

  PMID: 30269073 BACKGROUND

• Jordan S, Prout H, Carter N, Dicomidis J, Hayes J, Round J, Carson-Stevens A. Nobody ever questions-Polypharmacy in care homes: A mixed methods evaluation of a multidisciplinary medicines optimisation initiative. PLoS One. 2021 Jan 7;16(1):e0244519. doi: 10.1371/journal.pone.0244519. eCollection 2021.

  PMID: 33411824 RESULT

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Polypharmacy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Overtreatment; Medical Overuse; Health Services Misuse; Health Services; Health Care Facilities Workforce and Services; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Professor Sue Jordan
• Organization: Swansea University

s.e.jordan@swansea.ac.uk

+44 (0) 1792518541

Study Officials

• sue jordan, PhD

  Swansea University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Use of the intervention could not be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: December 18, 2018
• Primary Completion: May 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 17, 2021
• Results First Posted: August 9, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)