Clinical trial NCT03955133: The Adverse Drug Reaction (ADRe) Profile for Polypharmacy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Keywords: medicines management
adverse drug reaction
care homes
nurses
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: Aneurin Bevan University Health Board
name: Cardiff University
First posted: 2019-05-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.
Primary purpose: SUPPORTIVE_CARE

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.

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:

* age \<18

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

Primary outcomes:
measure: Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents
timeFrame: 3 months from start of intervention
Secondary outcomes:
measure: Number of Clinical Gains Per Resident Between Baseline and 3 Months
timeFrame: Baseline, then 3 months from start of intervention
measure: Number of Medicines Prescribed: Change Between Baseline and 3 Months
timeFrame: Baseline, then 3 months from start of intervention
measure: Number of Problems Listed on Profile
timeFrame: Baseline, then 3 months from start of intervention
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
Study officials:
affiliation: Swansea University
name: sue jordan, PhD
role: STUDY_CHAIR
References:
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):102. doi: 10.3390/pharmacy6030102.
citation: 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.
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: 10.1371/journal.pone.0244519. eCollection 2021.