Skip to main content
Clinical Trials/NCT03955133
NCT03955133
Completed
N/A

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

Swansea University1 site in 1 country19 target enrollmentDecember 18, 2018
ConditionsPolypharmacy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Polypharmacy
Sponsor
Swansea University
Enrollment
19
Locations
1
Primary Endpoint
Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2018
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 Sites (1)

Loading locations...

Similar Trials