Medication Monitoring for Older Adults in Primary Care

NCT04663360 | Completed

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

Brief Summary

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.

Conditions

Polypharmacy

Keywords

medicines management; adverse drug reaction; nurses; primary care

Outcome Measures

Primary Outcomes (7)

• Level of completion of all items in the video call-completed ADRe Profile

  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).

  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.

  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)

  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

  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)

  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)

  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 Outcomes (4)

• Calculation of the average nurses', GP's and pharmacists' length of time per one ADRe Profile completion

  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.

  16 months from the start of the study

• Description of the main stakeholders' views on multidisciplinary collaboration (eliciting interview themes)

  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).

  22 months from the start of the study

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual clinical care.

Interventions

Adverse Drug Reaction (ADRe) Profile OTHER

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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Swansea University: lead
• Abertawe Bro Morgannwg University Health Board: collaborator
• Hywel Dda Health Board: collaborator

Study Sites (1)

Aneurin Bevan Health Board

Newport, Gwent, NP18 3XQ, United Kingdom

Location

Related Publications (15)

• Gabe ME, Murphy F, Davies GA, Russell IT, Jordan S. Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. PLoS One. 2014 May 5;9(5):e96682. doi: 10.1371/journal.pone.0096682. eCollection 2014.

  PMID: 24798210 BACKGROUND

• Jones R, Moyle C, Jordan S. Nurse-led medicines monitoring: a study examining the effects of the West Wales Adverse Drug Reaction Profile. Nurs Stand. 2016 Nov 30;31(14):42-53. doi: 10.7748/ns.2016.e10447.

  PMID: 27902153 BACKGROUND

• Jordan S. Managing adverse drug reactions: an orphan task. J Adv Nurs. 2002 Jun;38(5):437-48. doi: 10.1046/j.1365-2648.2002.02205.x.

  PMID: 12028277 BACKGROUND

• Jordan S, Tunnicliffe C, Sykes A. Minimizing side-effects: the clinical impact of nurse-administered 'side-effect' checklists. J Adv Nurs. 2002 Jan;37(2):155-65. doi: 10.1046/j.1365-2648.2002.02064.x.

  PMID: 11851783 BACKGROUND

• Jordan S, Gabe M, Newson L, Snelgrove S, Panes G, Picek A, Russell IT, Dennis M. Medication monitoring for people with dementia in care homes: the feasibility and clinical impact of nurse-led monitoring. ScientificWorldJournal. 2014 Feb 23;2014:843621. doi: 10.1155/2014/843621. eCollection 2014.

  PMID: 24707218 BACKGROUND

• Jordan S, Gabe-Walters ME, Watkins A, Humphreys I, Newson L, Snelgrove S, Dennis MS. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. PLoS One. 2015 Oct 13;10(10):e0140203. doi: 10.1371/journal.pone.0140203. eCollection 2015.

  PMID: 26461064 BACKGROUND

• Jordan S, Banner T, Gabe-Walters M, Mikhail JM, Panes G, Round J, Snelgrove S, Storey M, Hughes D; Medicines' Management Group, Swansea University. Nurse-led medicines' monitoring in care homes, implementing the Adverse Drug Reaction (ADRe) Profile improvement initiative for mental health medicines: An observational and interview study. PLoS One. 2019 Sep 11;14(9):e0220885. doi: 10.1371/journal.pone.0220885. eCollection 2019.

  PMID: 31509537 BACKGROUND

• Mangoni AA, Jackson SH. Age-related changes in pharmacokinetics and pharmacodynamics: basic principles and practical applications. Br J Clin Pharmacol. 2004 Jan;57(1):6-14. doi: 10.1046/j.1365-2125.2003.02007.x.

  PMID: 14678335 BACKGROUND

• Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017 Oct 10;17(1):230. doi: 10.1186/s12877-017-0621-2.

  PMID: 29017448 BACKGROUND

• NHS Digital (2017). Health Survey for England 2016: Prescribed medicines. https://files.digital.nhs.uk/pdf/3/c/hse2016-pres-med.pdf

  BACKGROUND

• NICE Medicines and Prescribing Centre. (2015). Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes. NICE Guideline 5. London: NICE

  BACKGROUND

• Sirois C, Domingues NS, Laroche ML, Zongo A, Lunghi C, Guenette L, Kroger E, Emond V. Polypharmacy Definitions for Multimorbid Older Adults Need Stronger Foundations to Guide Research, Clinical Practice and Public Health. Pharmacy (Basel). 2019 Aug 29;7(3):126. doi: 10.3390/pharmacy7030126.

  PMID: 31470621 BACKGROUND

• Logan V, Hughes D, Turner A, Carter N, Jordan S. Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions. BMJ Open. 2026 Jan 27;16(1):e099627. doi: 10.1136/bmjopen-2025-099627.

  PMID: 41592836 DERIVED

• Logan V, Carter N, Hughes D, Turner A, Jordan S. Reducing Adverse Drug Reactions for Older People in the Community: Evaluating the Validity and Reliability of the ADRe Profile. J Nurs Manag. 2025 May 14;2025:9921349. doi: 10.1155/jonm/9921349. eCollection 2025.

  PMID: 40401039 DERIVED

• Logan V, Bamsey A, Carter N, Hughes D, Turner A, Jordan S. Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial. Pharmacy (Basel). 2022 Apr 28;10(3):52. doi: 10.3390/pharmacy10030052.

  PMID: 35645331 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Sue Jordan, PhD

  Swansea University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible due to cluster randomisation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participating GP practices will be randomised into an intervention and control arms.

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 11, 2020
• Study Start: January 5, 2020
• Primary Completion: May 31, 2020
• Study Completion: October 4, 2020
• Last Updated: October 7, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)