The Adverse Drug Reaction (ADRe) Profile for Polypharmacy (ADRe-p)

August 16, 2021 updated by: Swansea University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intervention
This is a single arm before and after study with data collection at 4 time points.
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).

What is the study measuring?

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
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.
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
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.
Baseline, then 3 months from start of intervention
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)
Baseline, then 3 months from start of intervention
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.
Baseline, then 3 months from start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swansea University

Collaborators

Cardiff University
Aneurin Bevan University Health Board

Investigators

  • Study Chair: sue jordan, PhD, Swansea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2018

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (ACTUAL)

May 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SwanseaNursing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The terms of our ethical approval would not allow this.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polypharmacy

Clinical Trials on Adverse Drug Reaction ADRe Profile for Polypharmacy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe