Polypharmacy
Conditions
Keywords
medicines management, adverse drug reaction, care homes, nurses
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.
Interventions
OTHERAdverse 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 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).
Sponsors
Aneurin Bevan University Health Board
Cardiff University
Swansea University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Use of the intervention could not be blinded.
Intervention model description
All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinical Gains Per Resident Between Baseline and 3 Months | Baseline, then 3 months from start of intervention | Number of problems addressed or ameliorated per resident e.g. pain, falls, sedation. Number at baseline minus number at 3 months. |
| Number of Medicines Prescribed: Change Between Baseline and 3 Months | Baseline, then 3 months from start of intervention | number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months) |
| Number of Problems Listed on Profile | Baseline, then 3 months from start of intervention | Number of problems listed on the ADRe-p profile per resident. All problems might be attributable to prescribed medicines. Change in number. |
Countries
United Kingdom
Participant flow
Pre-assignment details
There was no arm / group assignment. This was a single arm study.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 74.8 years STANDARD_DEVIATION 15.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants |
| problems identified per resident | 16 problems |
| Region of Enrollment United Kingdom | 19 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: 3 months from start of intervention
Population: care home residents
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents | 17 Participants |
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.
Time frame: Baseline, then 3 months from start of intervention
Population: problems recorded for each resident. Change between start and end of study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Number of Clinical Gains Per Resident Between Baseline and 3 Months | 3 number of problems addressed per residen |
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)
Time frame: Baseline, then 3 months from start of intervention
Population: care home residents
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Number of Medicines Prescribed: Change Between Baseline and 3 Months | 0 number of medicines per resident |
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.
Time frame: Baseline, then 3 months from start of intervention
Population: care home residents
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Number of Problems Listed on Profile | 3 number of problems per resident |