Co-design of a Seamless Person-centered Intervention to Optimize Medication Use Across Healthcare Levels

Our research group has previously completed the OPERA- and PERLE-studies, which explore the effect of a pharmacist intervention at the hospital and medication communication at hospital discharge from the patient perspective including the discharge process, respectively. The results from the PERLE-study gives a wider understanding of the discharge process and how patients experience medication communication at discharge. The results showed that every patient experienced a unique discharge process and that communication between healthcare personnel and patients was not sufficiently fostering patient empowerment and self-efficacy. The OPERA-study found no significant effect of the in hospital intervention on time to readmission or death within 12 months, but found a statistically significantly increased overall survival. The intervention in the OPERA-study consisted of clinical pharmacist added to the multidisciplinary treatment team working systematically according to the "Integrated Medicines Management" (IMM). IMM was originally developed in Northern Ireland and refined in Sweden. It is of importance to note that the model was used as without adaption to the Norwegian context and taking into account the traditional role for clinical pharmacists in Norwegian hospitals. This is especially related to the discharge process in which pharmacist would not normally be included.

Even though the OPERA-study showed statistically significant increased overall survival, is it desirable with a new intervention that fits better to the Norwegian context. Furthermore, a study suggest that medication reconciliation, medication review and post-discharge interventions should be performed all together as an integrated part of a multi-faceted program for better outcomes, and not isolated. This leads to a demand for a new intervention that extend beyond the hospital stay to achieve a seamless person-centered intervention to optimize medication use across healthcare levels. In designing the new intervention, the investigators need to obtain more knowledge about how to inform intervention development, study design and planning with respect to the user's needs. This is important since it is shown that patients are effective and willing contributors by supporting their own medication safety at transfers in the healthcare system. When developing a complex intervention, it is important to identify facilitators and barriers, e.g. to ensure that HCP involved in its delivery find it suitable and not in conflict with their daily tasks.

This study will use a design thinking framework based on the Three I's developed by IDEO: Inspiration, Ideation and Implementation. Inspiration focuses on learning how to better understand people to create possibilities, ideation focuses on making sense of that the investigators have heard to identify opportunities for design and generate ideas, and implementation focuses on bringing the investigators solutions to life to maximize its impact. This framework is a field guide to human-centered design as a way to apply design techniques to social service and innovation sectors, such as healthcare. This study will focus on the two first I's, namely the inspiration and ideation phase, whereas the third I, the implementation phase, will be covered in future projects.

The inspiration phase will comprise the following methods:

* Literature search to identify previously published models which might be suitable * A quantitative part that assesses the number and type of medication discrepancies after hospital discharge by medication reconciliation * A qualitative part in the form of semi-structured interviews and field notes including patients, next of kin and HCP

The investigators will focus on learning how to better understand people, and will use some of the aspects from the methodology of ethnography (38). Ethnographic research focuses on the social aspect of the research object. Ethnography is a multidimensional research approach covering a range of qualitative methods, including interviews and observations. Gathering ethnographic data is often termed doing fieldwork, with the field referring to the specific sites or locations where the data collection takes places. Using an ethnographic approach to understand aspect of medication use after newly being discharged could provide new, important insights to the field, both in theory development and to inform applied research projects.

The ideation phase will comprise the following methods:

The investigators will create personas and scenarios using the baseline understanding gathered from the inspiration phase. The created personas and scenarios will be further explored through workshops for prototyping. The workshops will aim to include relevant stakeholders, e.g. end users, comprising patients, next of kin and healthcare professionals (e.g. nurses, doctors and pharmacists), researchers and designers, together to work collectively during the prototyping.

The ideation phase will lead into the implementation phase for further planning of the future intervention.

Inspiration phase:

Literature search Before the inclusion starts, the investigators will perform a literature search through relevant research in PubMed and Medline, using search terms such as "patient-centered care", "person-centered care", "decision-making", "health communication", "self-efficacy", "medication management", "medication instructions", "patient participation", "patient preference", "patient transfer", "personal health records", "patient's drug list" and "electronic patient record". This to identify previously published models for an intervention.

Recruitment of study participants:

Participants to the quantitative and qualitative parts will be recruited simultaneously. Patients admitted to the Internal medicines ward and Geriatric ward, Oslo University Hospital (OUS), Ullevål, and a selection of their HCP and (if applicable) next of kin, will be included. Employees at the wards will ask inpatients for permission for one of the data collectors to inform and ask about participation in the study. This will take place close to the patients discharge (1-3 days ahead). Participants will be enrolled at the hospital, after written, informed consent. Consent from patients and next of kin will be obtained for medication reconciliation and interviews by use of one consent form. Consent will be obtained from HCP after their patient's enrollment in the study.

The data collection will take place face to face in the patient's home, HCP offices or other suitable location (e.g. meeting room at the hospital), approximately 1-2 weeks after the patients hospital discharge. A pilot study will be carried out during the spring 2022. The inclusion of patients, next of kin and HCP to the main study will start in the autumn 2022 and continue until the different parts have reach their goal, and for the qualitative parts; also have enough information power. The goal is to include patients, next of kin and HCP in the period from August 2022-July 2024. To further enrich the data, some patients might be selected for additional follow up interviews, after additional 3-4 weeks.

Number of persons to be included:

Quantitative study with medication reconciliation: The data collection will continue consecutively until the goal of 150 patients is reached. If it is feasible, the investigators will try to reach 200 patients. The investigators think 150-200 patients will give good insight into different types of medication discrepancies, since studies have shown that up to 90% of patients have at least one medication discrepancy in primary care. The inclusion and medication reconciliation will be done by the PhD-student together with master students in pharmacy.

Qualitative semi-structured interviews with patients and next of kin: The data collection will continue until the study have enough information power. This means that a selection of patients from the quantitative study described above will be chosen purposively and step by step along the way to ensure the informational strength in the selection. When possible, the investigators will include next of kin in the interviews together with the patient. The investigators aim to include around 20-30 patients, without counting in next of kin. For the follow-up interviews, approximately 5-8 patients will be selected. The part will be accomplished together with the quantitative part. Every new interview will be compared with previous interviews to identify similarities and differences. Characteristics it is important to ensure variability for; women and men, different ethnicities, education type, spread in age, number of medications and help from next of kin/homecare nurses or not. It is also important to ensure variability in number and type of medications and diagnoses. The inclusion and interviews of patients will be done by the PhD-student and master students in pharmacy.

Qualitative semi-structured interviews with HCP: The data collection will continue until the study have enough information power. This means that HCP will be recruited purposively along the quantitative study to ensure the informational strength in the selection. The investigators aim to include around 15-20 HCP. The HCP recruited are involved in the patients medication regime or management, this to ensure that HCP have knowledge about patients with multiple long term conditions. Every new interview will be compared with previous interviews to identify similarities and differences. Characteristics it is important to ensure variability for; woman and men, physicians and homecare nurses, spread in age, years of working experience, different ethnicities and number of medications the patients the HCP care for use. The inclusion and interviews of HCP will be done by the PhD-student.

Training and piloting:

Medication reconciliation and interviews will be done by the PhD-student and master students in pharmacy after receiving adequate training of clinical work. Training in medication reconciliation will be performed in accordance with procedures from the Hospital Pharmacies Enterprise, South-Eastern Norway, by an experienced clinical pharmacist. The procedure is based on the IMM-model for clinical pharmacists.

Both the PhD-student and master students will receive training and supervision in interviewing methodology from a researcher in the project group with strong competence in qualitative methods. During the spring 2022, the PhD-student will complete a course in qualitative research methods at the University of Oslo (UiO). The master students will complete relevant research preparatory courses during spring 2022.

The study procedures and documents will be piloted to obtain input to their finalization, e.g. the interview guide, and the practicability of the data collection tools. Inclusion of patients to the pilot will continue until sufficient feedback has been obtained. The inclusion to the pilot will follow the study criteria, as described above. If only minimal or no changes to the documents are deemed necessary, persons included to the pilot might be included in the study population described above. The pilot for all parts will start at the same time, and be finished when all details are in order. The PhD-student will have assistance from the research group for detailed design of the study during the pilot, and assistance as needed during the study. Consent to participate in the pilot study will be obtained as described above.

Instruments Quantitative study with medication reconciliation: The medication reconciliation will describe medication discrepancies between the medication list in the discharge summary and the actual medication use after hospital discharge. The medication discrepancies will be explored in conversation with the patient or, if the patient agrees to this, next of kin or other relevant information sources such as the GP or home-care nurse, to

• Perceptions of patients with multiple long term conditions and next of kin [Срок оценки: 1 year]
• HCP's perceptions regarding elements in patients with multiple long term conditions care [Срок оценки: 1 year]