The Adverse Drug Reaction (ADRe) Profile for Polypharmacy

Polypharmacy Clinical Trial

— ADRe-p  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955133
• Other study ID #: SwanseaNursing
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Polypharmacy

Intervention

Other:
• Adverse Drug Reaction ADRe Profile for Polypharmacy
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).

Locations

Country	Name	City	State
United Kingdom	Swansea University	Swansea

Sponsors (3)

Lead Sponsor	Collaborator
Swansea University	Aneurin Bevan University Health Board, Cardiff University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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). pii: E102. doi: 10.3390/pharmacy6030102. — View Citation

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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