ADRe Profile in general practice
Research type
Research Study
Full title
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
IRAS ID
292693
Contact name
Sue Jordan
Contact email
Sponsor organisation
Swansea University
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
Research Summary
The number of medicines people take is increasing (NHS Digital, 2016). Older adults are particularly at risk of adverse drug reactions due to polypharmacy (Mangoni & Jackson, 2004). 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 (NICE, 2015). 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 stages.
Stage 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.
Stage 2 (12 months)
The aim of this stage is to test whether the ADRe Profile identifies and ameliorates health problems. We will perform an ADRe consultation with a group of eligible service users and compare the number and nature of health and well-being problems we identified with a similar group of service users who receive normal care.
Stage 3 (6 months)
Finally, to further explore the impact of the ADRe Profile, we will conduct semi-structured interviews with health professionals (nurses, care assistants, GPs and pharmacists) and service users.
We 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.Summary of Results
Background Adverse drug reactions (ADRs), particularly for people using 5 or more medicines, have been responsible for ill-health and 10-16% of unplanned hospital admissions for 20 years. Interventions that identify medicine-related harms early and support their resolution can improve care quality and prevent future problems.
Objectives
The main objective of this study was to assess the effectiveness of the ADRe Profile (https://scanmail.trustwave.com/?c=261&d=l_jv5rxkXoTgvYDBFIYHa08PlmCPjEltA-Qy2xNRPA&u=https%3a%2f%2fwww%2eswansea%2eac%2euk%2fadre%2f) in UK general practices, through investigation of clinical gains, assessed as impact on the number and nature of problems identified and addressed, and changes in prescribed medicines.Methods
Following a systematic review, the ADRe Profile underwent validity, reliability and feasibility testing. A randomised controlled trial was conducted in 6 GP practices in Southwest Wales. 60 service users were enrolled, 10 from each practice. All participants were aged 65 or older and taking 5 or more regular medicines. Their primary care records were analysed before and after the intervention. The practices were randomised into control and intervention arms. The ADRe profile was completed by service users in the intervention arm. Participants' views of the intervention were sought.Results
The ADRe Profile was valid, reliable, feasible, and efficient in identification of health and wellbeing problems in older people with polypharmacy.Of the 60 service users recruited, 2 in the intervention arm withdrew before ADRe could be administered, due to death, and moving out of area. A third participant withdrew after completing ADRe when all her medicines were withdrawn. Before the intervention, the numbers of problems reported in the records were similar in the two arms. The ADRe profile identified 15 times more problems than were recorded in medical notes. The study pharmacist initiated actions for 151 of the 392 ADRe-reported problems identified, most commonly (~50%) by escalating for general practitioner (GP) review or arranging laboratory tests. Some of these problems and actions were documented in the medical notes.
Service users receiving ADRe were significantly more likely to have two or more problems addressed than control arm participants (OR 6.33, 95% CI 1.97-20.38). Twenty of 28 intervention arm participants experienced at least one substantive clinical gain, for example, resolved pain, fatigue or sleep problems; one service user had prostate cancer, and another had vitamin B12 deficiency detected and treated at an early stage. The total number of substantive clinical gains was 68, and everyone had some expected gains from GP review. In addition to the 117 expected clinical gains and 80 potential clinical gains across the 28 participants, there were 201 potentially missed opportunities. (Suggestions were made for further management.)
The ADRe Profile was effective at identifying symptom patterns, for example, eleven people displayed extrapyramidal (Parkinsonian / posture and movement) symptoms, ten of whom were not previously known to the GP. Six participants had signs and symptoms of hypothyroidism (three were not known to the practice) and nine people had symptoms of congestive heart failure (five were not known to the practice). The use of ADRe increased the number of instrument arm participants with up-do-date blood pressure measurements and blood tests. There was no statistically significant association between 'allocation arm' and 'new prescribing' and 'deprescribing'. However, instrument arm participants had more medicine adjustments than control arm participants: these included 2 dose corrections (mycophenolate and paracetamol), and discontinuation of flecainide.
All service users were grateful for the opportunity to engage with the ADRe profile, and the clinical gains that followed, but healthcare professionals indicated that it was too time consuming.
Conclusions and relevance
This study found that that the ADRe Profile is valid, reliable, and suitable for use in general practices. The ADRe intervention benefits patients and is adaptable to varied clinical contexts. ADRe identifies, and offers decision support, in addressing real-time problems. It is person-centred and welcomed by service users. ADRe complements medicine reviews and could and should be used to support medicines optimisation in primary care practice in the longer term.REC name
Wales REC 6
REC reference
21/WA/0042
Date of REC Opinion
10 Mar 2021
REC opinion
Further Information Favourable Opinion