Medication Monitoring for Older Adults in Primary Care

Study Overview
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Brief Summary
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Polypharmacy has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. Many adverse drug reactions could be prevented with closer monitoring. This project will establish the effectiveness of the nurse-led intervention - the ADRe Profile - for medicines commonly prescribed in primary care and evaluate intervention implementation in general practices.

Detailed Description
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The number of medicines people take is increasing. Older adults are particularly at risk of adverse drug reactions due to polypharmacy. Adverse drug reactions cause avoidable patient harm, and around 5-8% of unplanned hospital admissions in the UK, costing the NHS £1.5-2.5bn pa. Many adverse drug reactions could be prevented with closer monitoring. The nurse-led Adverse Drug Reactions Profile (ADRe Profile) represents a unique instrument that records patients' observations and self-reported information on signs and symptoms that is likely to relate to an adverse reaction to medications. This project will establish the effectiveness of ADRe Profile in identifying patient problems possibly resulting from medicines in general practices and will be implemented in 3 phases. Phase 1 (4 months) Validity and reliability testing of the ADRe Profile will be performed with key stakeholders (patients, nurses, care assistants, GP's and pharmacists), before introducing the tool to general practices. Feasibility testing will also be undertaken. Phase 2 (12 months) The aim of this phase is to test whether the ADRe Profile identifies and ameliorates health problems. The practice nurse (or the researcher) will perform an ADRe consultation with a group of eligible service users and compare the number and nature of health and well-being problems identified with a similar group of service users who receive normal care. Phase 3 (6 months) Finally, to further explore the impact of the ADRe Profile, the researchers will conduct semi-structured interviews with health professionals (nurses, care assistants, GPs and pharmacists) and service users. The investigators hope that this study will help patients gain maximum benefits from their medicines and support nurses, pharmacists and GP's to reduce any bothersome side effects and problems that, if not addressed promptly, can lead to hospital admissions.

Official Title
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Medication Monitoring in General Practice: Clinical Impact of Implementing a Nurse-led Adverse Drug Reaction (ADRe) Profile in Older Adults With 5 or More Prescribed Medicines

Conditions
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Polypharmacy

Intervention / Treatment
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* Other: Adverse Drug Reaction (ADRe) Profile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: Patients: age > 64 years with a long-term condition prescribed > 5 medications daily. (Vitamin and nutritional supplements and moisturising skin preparations will not be counted as 'medicines'.) Willing and able to give informed, signed consent themselves, or where capacity is lacking in the opinion of their nurses, a consultee/representative accompanying the patient who is willing to give advice and assent to the service user participating and sign on their behalf. Exclusion Criteria: Patients: Age < 64 years Without any long-term conditions Prescribed < 5 medications daily Not willing to participate Unable to consent and no consultee/representative present Not fluent in English or Welsh (unless a family member can assist with translation) Receiving palliative care Expected to remain in the practice for the next 12 months

Ages Eligible for Study
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Minimum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participating GP practices will be randomised into an intervention and control arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention to be administered: Adverse Drug Reactions (ADRe) Profile. 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. | Other: Adverse Drug Reaction (ADRe) Profile<br>* ADRe 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.<br>|
| No Intervention: Control<br>Usual clinical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of completion of all items in the video call-completed ADRe Profile | Comparison of completeness of the ADRe Profile completed through a video call with ADRe Profiles previously completed in person | 4 months from the start of the study | 
| Inter-rater reliability of patient versus nurse (or nurse-researcher) completed ADRe Profile (Cohen's Kappa). | To determine how much of the potential variability of the records is due to errors in measurement, to estimate a degree to which service users accurately evaluate their symptoms when compared with a nurse researcher. Cohen's Kappa will be calculated. | 4 months from the start of the study | 
| Calculated percentage and described nature of items on the ADRe Profile that can be populated from accessing the nursing and medical notes. | Establishing the overlap of information - the number and nature of the ADRe items that have previously been collected and recorded in the patients' nursing and medical notes. | 16 months from the start of the study | 
| Clinical impact on service users, including new problems identified (number and nature) and problems addressed (number and nature) | 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. | 16 months from the start of the study | 
| Prescription changes | Number of patients with changes in prescription regimens: drug or dose. Number and nature of changes. | 16 months from the start of the study | 
| Description of stakeholder views on ADRe Profile implementation effectiveness (survey rating of the ADRe Profile - Likert scale) | A brief survey will be distributed to the main stakeholders (patients, nurses, GP's and pharmacists) following completion of Randomised Controlled Trial. | 22 months from the start of the study | 
| Description of stakeholder views on ADRe Profile implementation feasibility (eliciting interview themes) | Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on feasibility of ADRe Profile integration in GP practices. | 22 months from the start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of the average nurses', GP's and pharmacists' length of time per one ADRe Profile completion | Average length of the health professionals' time involvement with one ADRe Profile | 16 months from the start of the study | 
| Calculation of the cost of nurses', GP's and pharmacists' time, based on average national salary cost per hour. | Estimated costs of ADRe implementation in GP practices | 16 months from the start of the study | 
| Description of the main stakeholders' views on multidisciplinary collaboration (eliciting interview themes) | Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on whether and how ADRe Profile contributed to multidisciplinary collaboration between nurses, doctors and pharmacists | 22 months from the start of the study | 
| Description of the patients' views on the contribution of ADRe Profile to patient-centered care (eliciting interview themes). | Semi-structured interview with the patients to seek their views on whether and how ADRe Profile contributes to patient-centered care | 22 months from the start of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medicines management, adverse drug reaction, nurses, primary care