Developing a core outcome set for medicines reconciliation effectiveness trials in adults: protocol for a systematic review, patient and public involvement and a Delphi survey

Errors in the prescribing and administration of medicines are frequent, costly, and harmful. Transitions of care, as patients move between different levels and locations of care, are periods when medication error is widespread. Poor coordination of processes at transitions of care, including prescribing, is associated with adverse drug events, (re) hospitalisation, and discrepancies in medicines lists. Older people are more likely to be prescribed multiple medicines, have multiple chronic conditions, and experience a growing number of care transitions. However, multimorbidity and polypharmacy are increasingly common and not just confined to older people. With the rise in polypharmacy, problems such as unnecessary medicines and avoidable side-effects are common.

This project addresses an essential element in ensuring medicine safety at care transitions by developing a Core Outcome Set (COS) to resolve heterogeneity issues in outcome reporting in clinical trials. The production of the first core outcome set for medicines reconciliation in adults will address an unmet need in providing an integral measurement approach for researchers in this area, improving the relevance and translation of future research findings.

All medicine reconciliation intervention types (e.g., pharmacist- mediated, Information Technology-driven) in any health setting with adult populations (e.g., hospitals, primary care, social care). The Institute for Healthcare Improvement’s three-step definition of medicines reconciliation, as accepted by NICE, will be used for this study:
• Verification: a current medicines list is developed using one or more sources of information (e.g., GP medical records, patient’s supply, pharmacy records).
• Clarification: medication and dosages are checked for appropriateness of discrepancies (e.g., no unintentional changes).
• Reconciliation: newly prescribed medicines are compared to existing medications, and any changes made are documented.

Aim

To develop a COS for medicines reconciliation interventional studies using a consensus process with an international panel of experts and patients.

The project will:
(1) Update an existing systematic review to identify outcomes used in intervention studies for medicines reconciliation.
(2) Use semi-structured interviews to elicit views from patients or their carers about their care transition experiences.
(3) Use a Delphi consensus study to develop a COS for intervention studies of medicines reconciliation.

Contributors

Study team
• Dr Patrick Redmond, Principal Investigator. King’s College London, Department of Population Health, School of Population Health & Environmental Sciences, London, UK.
• Professor Carmel Hughes, Co-Applicant. Professor of Primary Care Pharmacy, Department School of Pharmacy Institution Queen's University of Belfast, Northern Ireland

Collaborators
• Professor Susan Smith, Professor of Primary Care Medicine, Royal College of Surgeons in Ireland
• Dr Tamasine Grimes, Associate Professor, Pharmacy, Trinity College Dublin, Ireland
• Dr Mariam Molokhia, Reader in Clinical Epidemiology and Primary Care, King’s College London, UK.
• Dr Lise Bjerre, Associate Professor, Clinical Research Chair in Pharmacoepidemiology and Medication Appropriateness, School of Epidemiology and Public Health, University of Ottawa, Canada.
• Dr Alice Oborne, Consultant Pharmacist for Safe Medication Practice and Trust Medication Safety Officer Guy’s and St Thomas’ NHS Foundation Trust, London, UK

Further Study Information

Current Stage: Planning
Date: January 2022 - 2023
Funding source(s): TBC


Health Area

Disease Category: Effective practice/health systems

Disease Name: N/A

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Management of care

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review

The project will be overseen by a project steering group consisting of academic general practitioners; pharmacists; health service researchers; health policy specialists; bioinformaticians; and patient research partners who have experience and interest in medicines safety. A systematic literature review will identify outcomes previously used in medicines transitions interventions. Semi-structured qualitative interviews with patients will augment previous findings from healthcare professionals and identify additional outcomes of importance. An international three-round Delphi survey, based on the findings from the literature review and interviews, will prioritise outcomes for inclusion in the COS. Finally, an international consensus meeting will endorse the COS and disseminate findings for application in future trials.

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