Medication Monitoring for Older Adults in Primary Care

September 29, 2021 updated by: Swansea University

Medication Monitoring in General Practice: Clinical Impact of Implementing a Nurse-led Adverse Drug Reaction (ADRe) Profile in Older Adults With 5 or More Prescribed Medicines

Polypharmacy has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. Many adverse drug reactions could be prevented with closer monitoring. This project will establish the effectiveness of the nurse-led intervention - the ADRe Profile - for medicines commonly prescribed in primary care and evaluate intervention implementation in general practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The number of medicines people take is increasing. Older adults are particularly at risk of adverse drug reactions due to polypharmacy. Adverse drug reactions cause avoidable patient harm, and around 5-8% of unplanned hospital admissions in the UK, costing the NHS £1.5-2.5bn pa. Many adverse drug reactions could be prevented with closer monitoring. The nurse-led Adverse Drug Reactions Profile (ADRe Profile) represents a unique instrument that records patients' observations and self-reported information on signs and symptoms that is likely to relate to an adverse reaction to medications. This project will establish the effectiveness of ADRe Profile in identifying patient problems possibly resulting from medicines in general practices and will be implemented in 3 phases.

Phase 1 (4 months) Validity and reliability testing of the ADRe Profile will be performed with key stakeholders (patients, nurses, care assistants, GP's and pharmacists), before introducing the tool to general practices. Feasibility testing will also be undertaken.

Phase 2 (12 months) The aim of this phase is to test whether the ADRe Profile identifies and ameliorates health problems. The practice nurse (or the researcher) will perform an ADRe consultation with a group of eligible service users and compare the number and nature of health and well-being problems identified with a similar group of service users who receive normal care.

Phase 3 (6 months) Finally, to further explore the impact of the ADRe Profile, the researchers will conduct semi-structured interviews with health professionals (nurses, care assistants, GPs and pharmacists) and service users.

The investigators hope that this study will help patients gain maximum benefits from their medicines and support nurses, pharmacists and GP's to reduce any bothersome side effects and problems that, if not addressed promptly, can lead to hospital admissions.

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

  • United Kingdom
    • Gwent
      • Newport, Gwent, United Kingdom, NP18 3XQ
        • Aneurin Bevan Health Board

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

64 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria:

Patients:

  • age > 64 years
  • with a long-term condition
  • prescribed > 5 medications daily. (Vitamin and nutritional supplements and moisturising skin preparations will not be counted as 'medicines'.)
  • Willing and able to give informed, signed consent themselves, or where capacity is lacking in the opinion of their nurses, a consultee/representative accompanying the patient who is willing to give advice and assent to the service user participating and sign on their behalf.

Exclusion Criteria:

Patients:

  • Age < 64 years
  • Without any long-term conditions
  • Prescribed < 5 medications daily
  • Not willing to participate
  • Unable to consent and no consultee/representative present
  • Not fluent in English or Welsh (unless a family member can assist with translation)
  • Receiving palliative care
  • Expected to remain in the practice for the next 12 months

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Intervention to be administered: Adverse Drug Reactions (ADRe) Profile. 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 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.
Other: Adverse Drug Reaction (ADRe) Profile
ADRe 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 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.
NO_INTERVENTION: Control
Usual clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of completion of all items in the video call-completed ADRe Profile
Time Frame: 4 months from the start of the study
Comparison of completeness of the ADRe Profile completed through a video call with ADRe Profiles previously completed in person
4 months from the start of the study
Inter-rater reliability of patient versus nurse (or nurse-researcher) completed ADRe Profile (Cohen's Kappa).
Time Frame: 4 months from the start of the study
To determine how much of the potential variability of the records is due to errors in measurement, to estimate a degree to which service users accurately evaluate their symptoms when compared with a nurse researcher. Cohen's Kappa will be calculated.
4 months from the start of the study
Calculated percentage and described nature of items on the ADRe Profile that can be populated from accessing the nursing and medical notes.
Time Frame: 16 months from the start of the study
Establishing the overlap of information - the number and nature of the ADRe items that have previously been collected and recorded in the patients' nursing and medical notes.
16 months from the start of the study
Clinical impact on service users, including new problems identified (number and nature) and problems addressed (number and nature)
Time Frame: 16 months from the start of the study
Number of patients 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.
16 months from the start of the study
Prescription changes
Time Frame: 16 months from the start of the study
Number of patients with changes in prescription regimens: drug or dose. Number and nature of changes.
16 months from the start of the study
Description of stakeholder views on ADRe Profile implementation effectiveness (survey rating of the ADRe Profile - Likert scale)
Time Frame: 22 months from the start of the study
A brief survey will be distributed to the main stakeholders (patients, nurses, GP's and pharmacists) following completion of Randomised Controlled Trial.
22 months from the start of the study
Description of stakeholder views on ADRe Profile implementation feasibility (eliciting interview themes)
Time Frame: 22 months from the start of the study
Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on feasibility of ADRe Profile integration in GP practices.
22 months from the start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculation of the average nurses', GP's and pharmacists' length of time per one ADRe Profile completion
Time Frame: 16 months from the start of the study
Average length of the health professionals' time involvement with one ADRe Profile
16 months from the start of the study
Calculation of the cost of nurses', GP's and pharmacists' time, based on average national salary cost per hour.
Time Frame: 16 months from the start of the study
Estimated costs of ADRe implementation in GP practices
16 months from the start of the study
Description of the main stakeholders' views on multidisciplinary collaboration (eliciting interview themes)
Time Frame: 22 months from the start of the study
Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on whether and how ADRe Profile contributed to multidisciplinary collaboration between nurses, doctors and pharmacists
22 months from the start of the study
Description of the patients' views on the contribution of ADRe Profile to patient-centered care (eliciting interview themes).
Time Frame: 22 months from the start of the study
Semi-structured interview with the patients to seek their views on whether and how ADRe Profile contributes to patient-centered care
22 months from the start of the study

Collaborators and Investigators

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

Sponsor

Swansea University

Collaborators

Abertawe Bro Morgannwg University Health Board
Hywel Dda 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)

January 5, 2020

Primary Completion (ACTUAL)

May 31, 2020

Study Completion (ACTUAL)

October 4, 2020

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Swansea Nursing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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