PolypharmacyADRe-pNCT03955133
The Adverse Drug Reaction (ADRe) Profile for Polypharmacy
A study testing Adverse Drug Reaction ADRe Profile for Polypharmacy in people with Polypharmacy, run by Swansea University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Adverse Drug Reaction ADRe Profile for Polypharmacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- age <18
- Prescribed <4 medicines daily;
- Receiving active palliative care
- Not well enough to participate, as screened by their nurses
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Polypharmacy
- Being tested
- Adverse Drug Reaction ADRe Profile for Polypharmacy
- Keywords
- medicines management, adverse drug reaction, care homes, nurses
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse Drug Reaction ADRe Profile for PolypharmacyOther
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 British National Formulary (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).
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | This is a single arm before and after study with data collection at 4 time points. Receives: Other: Adverse Drug Reaction ADRe Profile for Polypharmacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents
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.
Measured: 3 months from start of intervention
Secondary outcomes (3)
Number of Clinical Gains Per Resident Between Baseline and 3 Months
Number of problems addressed or ameliorated per resident e.g. pain, falls, sedation. Number at baseline minus number at 3 months.
Measured: Baseline, then 3 months from start of intervention
Number of Medicines Prescribed: Change Between Baseline and 3 Months
number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months)
Measured: Baseline, then 3 months from start of intervention
Number of Problems Listed on Profile
Number of problems listed on the ADRe-p profile per resident. All problems might be attributable to prescribed medicines. Change in number.
Measured: Baseline, then 3 months from start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start18 Dec 2018
- Primary completion31 May 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Aneurin Bevan University Health Board, Cardiff University
- Responsible party
- Sponsor
- Investigators
- sue jordan, PhD, Study chair, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955133
- Sponsor's protocol ID
- SwanseaNursing
- Acronym
- ADRe-p
- Status last verified
- Feb 2020
- First submitted
- 15 May 2019
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The terms of our ethical approval would not allow this.
Publications
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.
PubMed 30231573Jordan 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.
PubMed 30269073Jordan 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.
PubMed 33411824
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03955133
- Acronym / sponsor ID
- ADRe-p / SwanseaNursing
- Conditions
- Polypharmacy
- Keywords
- medicines management, adverse drug reaction, care homes, nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Aneurin Bevan University Health Board, Cardiff University
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Adverse Drug Reaction ADRe Profile for PolypharmacyThis is a single arm before and after study with data collection at 4 time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Resident at the care home and expected to continue to live there for 1 year
Key exclusion criteria (4 listed)
- age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adverse Drug Reaction ADRe Profile for PolypharmacyPADRe 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 British National Formulary (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). | Other | intervention |
Primary outcome
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.
3 secondary outcomes
Number of Clinical Gains Per Resident Between Baseline and 3 Months
Time frame: Baseline, then 3 months from start of intervention
Number of Medicines Prescribed: Change Between Baseline and 3 Months
Time frame: Baseline, then 3 months from start of intervention
Number of Problems Listed on Profile
Time frame: Baseline, then 3 months from start of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30231573Jordan 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.
- Background: PubMed 30269073Jordan 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.
- Results publication: PubMed 33411824Jordan 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.
- Individual participant dataSharing planned: No. The terms of our ethical approval would not allow this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sue jordan, PhD study chair
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adverse Drug Reaction ADRe Profile for Polypharmacy in people with Polypharmacy, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955133, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.