The Patient-Held Active Record of Medication Status (PHARMS) study: a mixed-methods feasibility analysis.

BACKGROUND: Medication errors frequently occur as patients transition between hospital and the community, and may result in patient harm. Novel methods are required to address this issue. AIM: To assess the feasibility of introducing an electronic patient-held active record of medication status device (PHARMS) at the primary-secondary care interface at the time of hospital discharge. DESIGN AND SETTING: A mixed-methods study (non-randomised controlled intervention, and a process evaluation of qualitative interviews and non-participant observation) among patients >60 years in an urban hospital and general practices in Cork, Ireland. METHOD: The number and clinical significance of errors were compared between discharge prescriptions of the intervention (issued with a PHARMS device) and control (usual care, handwritten discharge prescription) groups. Semi-structured interviews were conducted with patients, junior doctors, GPs, and IT professionals, in addition to direct observation of the implementation process. RESULTS: In all, 102 patients were included in the final analysis (intervention n = 41, control n = 61). Total error number was lower in the intervention group (median 1, interquartile range [IQR] 0-3) than in the control group (median 8, IQR (4-13.5, P<0.001), with the clinical significance score in the intervention group also being lower than the control group (median 2, IQR 0-4 versus median 11, IQR 5-20, P<0.001). The PHARMS device was found to be technically implementable using existing information technology infrastructure, and acceptable to all key stakeholders. CONCLUSION: The results suggest that using PHARMS devices within existing systems in general practice and hospitals is feasible and acceptable to both patients and doctors, and may reduce medication error.

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group.  There were no differences in patient understanding between the two methods.  Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Study within a trial (SWAT) protocol. Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

INTRODUCTION: Dissemination of results of randomised controlled trials is traditionally limited to academic and professional groups rather than clinical trial participants. While there is increasing consensus that results should be communicated to trial participants, there is a lack of evidence on the most appropriate methods of dissemination. This study within a trial (SWAT) aims to address this gap by using a public and patient involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving trial results of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial (TRUST). METHODS: An experimental (intervention) study will be conducted using mixed methods to inform the development of and evaluation of a patient-preferred method of communication of trial results. The study will involve three consecutive phases. In the first phase, focus groups of trial participants will be conducted to identify a patient-preferred method of receiving trial results. The method will be developed and then assessed and refined by a patient and public expert group. In the second phase participants will be randomly assigned to the intervention (patient-preferred method) and comparison groups (standard dissemination method as developed by the lead study site in Glasgow, Scotland). In the third phase, a quantitative questionnaire will be used to measure and compare patient understanding of trial results between the two groups. DISCUSSION: This protocol provides a template for other trialists who wish to enhance patient and public involvement and additionally, will provide empirical evidence on how trialists should best disseminate study results to their participants.