Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
2. Materials and Methods
3. Phase One: Cluster-Randomised Controlled Trial
- Age ≥ 65 years;
- At least one long-term medicated condition;
- Prescribed ≥ 5 medications daily (vitamin and nutritional supplements and moisturising skin preparations will not be counted as ‘medicines’ for the purpose of this trial);
- Willing and able to give informed, signed consent themselves;
- Patients who, in the opinion of their nurses, lack capacity will be included if a consultee/representative is available and willing to confer with the patient and give consent on their behalf—a consultee may be a relative or friend who cares for the individual lacking capacity, but not professionally/for payment .
- Unable to consent and no consultee/representative available;
- Not fluent in English or Welsh (unless a family member can assist with translation)
- Receiving end-of-life care—the patient safety criteria and goals of care for patients at the end of life may be different to those of general populations  and specialist skills are needed to address these different challenges;
- Not expected to remain in the practice for the next 12 months
- Clinical impact on patients
- New problems identified not recorded in GP notes (number and nature);
- Problems addressed (number and nature);
- Number of patients with a change in signs and symptoms potentially related to prescribed medicines (calculated as a difference between first and second ADRe Profile responses for each patient).
- Outcomes related to understanding the process of ADR management in primary care:
- Number and nature of items on the ADRe Profile that can be populated from accessing the GP nursing and medical notes;
- Prescription changes (number of patients with changes in prescription regimens: drug or dose, number and nature of changes);
- Description of stakeholder views on ADRe Profile implementation effectiveness (survey rating of the ADRe Profile-Likert scale);
- Description of stakeholder views on ADRe Profile implementation feasibility (eliciting interview themes).
- The secondary objective is to estimate costs associated with ADRe implementation, and the associated secondary outcome measures are:
- Survey of the average nurses’, assistants’, doctors’ and pharmacists’ time to complete and/or action one ADRe Profile, as mean and median length of health professionals’ time spent with one ADRe Profile.
- Estimation of the cost of nurses’, GP’s and pharmacists’ time based on average national salary cost per hour .
- Description of the main stakeholders’ views on multidisciplinary collaboration (eliciting interview themes).
- Description of the patients’ views on the contribution of ADRe Profile to patient-centred care (eliciting interview themes).
3.4. List of Variables
- Sex as m/f;
- Number, doses and formulations of medicines (prescribed and bought over the counter);
- High doses of any medicine (maximum recommended therapeutic dose);
- Morbidities, as reported by Davies and colleagues ;
- Post code of GP practice;
- Involvement of a consultee y/n.
3.5. Sample Size
3.6. Assignment of Interventions
3.7. Data Collection, Management and Analysis
3.8. Data Management
3.9. Statistical Methods
3.10. Data Monitoring
3.11. Criterion for Stopping This Study Early
3.13. Ancillary and Post-Trial Care
4. Phase Two: Stakeholder Views
5. Ethics and Dissemination
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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Logan, V.; Bamsey, A.; Carter, N.; Hughes, D.; Turner, A.; Jordan, S. Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial. Pharmacy 2022, 10, 52. https://doi.org/10.3390/pharmacy10030052
Logan V, Bamsey A, Carter N, Hughes D, Turner A, Jordan S. Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial. Pharmacy. 2022; 10(3):52. https://doi.org/10.3390/pharmacy10030052Chicago/Turabian Style
Logan, Vera, Alexander Bamsey, Neil Carter, David Hughes, Adam Turner, and Sue Jordan. 2022. "Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial" Pharmacy 10, no. 3: 52. https://doi.org/10.3390/pharmacy10030052