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| Name | Class |
|---|---|
| Aneurin Bevan University Health Board | OTHER |
| Cardiff University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | This is a single arm before and after study with data collection at 4 time points. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adverse Drug Reaction ADRe Profile for Polypharmacy | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months from start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, then 3 months from start of intervention |
| Number of Medicines Prescribed: Change Between Baseline and 3 Months |
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Inclusion Criteria:
• Resident at the care home and expected to continue to live there for 1 year
Exclusion Criteria:
age <18
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| Name | Affiliation | Role |
|---|---|---|
| sue jordan, PhD | Swansea University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swansea University | Swansea | sa2 8pp | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30231573 | Background | 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. | |
| 30269073 | Background | 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. |
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The terms of our ethical approval would not allow this.
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There was no arm / group assignment. This was a single arm study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | This is a single arm before and after study with data collection at 4 time points. The full range of signs and symptoms possibly related to adverse effects of commonly prescribed medicines was collected. Only the first and last data sets were analysed. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
care home residents, aged >18, receiving >3 prescribed medicines, expecting to remain in the home for at least 1 year, able to give informed consent or with a consultee willing to do this on their behalf.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | This is a single arm before and after study with data collection at 4 time points. Only the first and last results were analysed. The results comprise the full range of signs and symptoms associated with possible adverse effects of commonly prescribed medicines. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | care home residents | Posted | Count of Participants | Participants | 3 months from start of intervention |
|
5 months (throughout the study period)
Standard definitions were used. However, adverse events were unlikely to emanate from the use of a paper-based checklist.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention. This is a Single Arm Before and After Study. | There were no adverse events related to the use of the intervention. (The intervention was a paper-based checklist with supporting information.) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Sue Jordan | Swansea University | +44 (0) 1792518541 | s.e.jordan@swansea.ac.uk |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2017 | Feb 22, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D019338 | Polypharmacy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000088922 | Overtreatment |
| D000069342 | Medical Overuse |
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All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.
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Use of the intervention could not be blinded.
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|
number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months) |
| 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. | Baseline, then 3 months from start of intervention |
| 33411824 | Result | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| problems identified per resident | A problem was defined as a sign or symptom noted as an 'undesirable' effect in the Summaries of Product Characteristics (SmPCs) of prescribed medicines. These were ticked on a list shared with clinicians and researchers. Researchers counted the numbers of problems. | Median | Inter-Quartile Range | problems |
|
|
|
| Secondary | 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. | problems recorded for each resident. Change between start and end of study. | Posted | Median | Inter-Quartile Range | number of problems addressed per residen | Baseline, then 3 months from start of intervention |
|
|
|
| Secondary | 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) | care home residents | Posted | Median | Inter-Quartile Range | number of medicines per resident | Baseline, then 3 months from start of intervention |
|
|
|
| Secondary | 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. | care home residents | Posted | Median | Inter-Quartile Range | number of problems per resident | Baseline, then 3 months from start of intervention |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D006300 |
| Health Services Misuse |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001294 | Attitude to Health |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |