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

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ClinicalTrials.gov Identifier: NCT03955133
Recruitment Status : Active, not recruiting
First Posted : May 17, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
Aneurin Bevan University Health Board
Cardiff University
Information provided by (Responsible Party):
Swansea University

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 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.

Condition or disease Intervention/treatment Phase
Polypharmacy Other: Adverse Drug Reaction ADRe Profile for Polypharmacy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.
Masking: None (Open Label)
Masking Description: Use of the intervention could not be blinded.
Primary Purpose: Supportive Care
Official Title: Polypharmacy Adverse Drug Reactions (PADRe): Nurse-led Intervention to Minimise Adverse Drug Reactions for Older Adults in Care Homes: a Quality Improvement Process Intervention
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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 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).




Primary Outcome Measures :
  1. 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 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.


Secondary Outcome Measures :
  1. Prescription changes [ Time Frame: 3 months from start of intervention ]
    Number of patients with changes in prescription regimens: drug or dose. Number and nature of changes.

  2. Contacts with the health services e.g.referrals [ Time Frame: 3 months from start of intervention ]
    Number of patients needing admissions, urgent care, referrals to allied professionals. Number and nature of episodes, as recorded in patient notes and Profiles.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955133


Locations
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United Kingdom
Swansea University
Swansea, United Kingdom, sa2 8pp
Sponsors and Collaborators
Swansea University
Aneurin Bevan University Health Board
Cardiff University
Investigators
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Study Chair: sue jordan, PhD Swansea University

Publications:
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Responsible Party: Swansea University
ClinicalTrials.gov Identifier: NCT03955133     History of Changes
Other Study ID Numbers: SwanseaNursing
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The terms of our ethical approval would not allow this.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swansea University:
medicines management
adverse drug reaction
care homes
nurses

Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders