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
|Condition or disease||Intervention/treatment||Phase|
|Polypharmacy||Other: Adverse Drug Reaction ADRe Profile for Polypharmacy||Not Applicable|
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).
- 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.
|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|
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).
- 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.
- 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.
- 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.
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
|Swansea, United Kingdom, sa2 8pp|
|Study Chair:||sue jordan, PhD||Swansea University|