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

NCT05421143 | Recruiting

• 1 other identifier: 2536702
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple long term conditions entails various needs for complex medication treatment, which is a huge clinical challenge considering medication interactions and disease-medication interactions. It might affect quality of life, increase medical costs and needs, and cause patients to live several years with disabilities and reduced functional level. Multiple long term conditions is an important public health problem, since it is increasingly more common as the population is getting older. It is well documented that communication problems exist between sectors in the healthcare system and that it creates an area of risk. There are many transfers that could be associated with risk for errors, as when patients are discharged from the hospital and is being transferred to the next level of care. When patients are discharged from the hospital, there is a need for transfer of correct information regarding medications. Transition of care leads to risk for medication discrepancies for the patients. Medication discrepancies are common within primary care and studies show that up to 90% of patients have at least one medication discrepancy in their lists. Different interventions have been tested to reduce medication discrepancies, but the interventions do not eliminate the need for medication reconciliations. Higher patient satisfaction have been associated with improved patient safety, clinical effectiveness, health outcomes, adherence and lower resource utilization. According to Norwegian legislation, patients or users have a right to participate in the implementation of healthcare services, e.g. the choice between available and justifiable forms of service, examination methods and treatment methods. Person-centered care (PCC) is a concept that shifts the focus away from the traditional biomedical model to personal choice by applying shared decision-making. PCC reduce symptom burden, enhance patient activation, reduce readmission rates and improve quality of life. Obtaining knowledge about medication discrepancies and perceptions from patients, next of kin and healthcare personnel (HCP) after the patient's hospital discharge could contribute to a better success rate for future interventions and services. It is therefore of interest to investigate which factors that are of importance for a successful seamless person-centered intervention to optimize medication use across healthcare levels. To obtain knowledge about medication discrepancies and perceptions, the study will include both quantitative and qualitative methods, and be using a design thinking framework. The persons included will represent a wide selection with respect to, among other things, age, gender, socio-economic background, profession and diagnoses. The patients, next of kin and HCP will be included after written, informed consent. The aim of the project is to obtain knowledge about how the investigators can strengthen patient's self-efficacy and improve the information flow when it comes to medications, in the transition between the healthcare levels. To do so, the investigators need to identify facilitators and barriers to achieve a seamless medication treatment based on the user's needs. The results will form a basis for a new, improved intervention, which follow patients during the hospital stay and further out in the primary healthcare. The aim of this project is divided into the following parts:

• Investigate the frequency and type of medication discrepancies between the medication list in the discharge summary and medication use after hospital stay, to identify risk factors for which and why medication discrepancies occur in patients with multiple long term conditions.
• Map the perceptions of patients with multiple long term conditions and next of kin regarding medication use, shared decision-making and their opinions about previously published interventions to improve medication use.
• Evaluate HCP's perceptions regarding elements in patients with multiple long term conditions care that works well, what HCP believe do not work, with particular emphasis on the treatment with medications and transfer of care. In addition, how this care could be improved especially with the new intervention in mind.
• Using design thinking framework to create prototypes for a new intervention Overall hypothesis for the project: Knowledge about medication discrepancies and perceptions from patients, next of kin and HCP regarding barriers and facilitators for a seamless medication treatment can contribute to an improved efficacy and implementation of the new, improved intervention.

Conditions

Multimorbidity

Keywords

Person-Centered Care; Ethnography; Medications; Multiple long-term conditions; Self-efficacy; Patient preferences

Outcome Measures

Primary Outcomes (1)

• Frequency and type of medication discrepancies between the medication list in the discharge summary and medication use after hospital stay.

  To identify risk factors for which and why medication discrepancies occur in patients with multiple long term conditions.

  2 years

Secondary Outcomes (2)

• Perceptions of patients with multiple long term conditions and next of kin

  1 year

• HCP's perceptions regarding elements in patients with multiple long term conditions care

  1 year

Study Arms (3)

Quantitative study with medication reconciliation

The data collection will continue consecutively until the goal of 150 patients is reached. If it is feasible, we will try to reach 200 patients. We 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.

Qualitative semi-structured interviews with patients and next of kin

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, we will include next of kin in the interviews together with the patient. We aim to include around 20-30 patients, without counting in next of kin. 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.

Qualitative semi-structured interviews with HCP

HCP will be recruited purposively along the quantitative study to ensure the informational strength in the selection. We aim to include around 15-20 HCP. The HCP recruited are involved in the patients medication regime or management, this to ensure that they 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 they care for use.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with multiple long-term conditions, their next of kin and HCP

You may qualify if:

• Patients:
• Adult ≥ 18 years
• Gives written, informed consent to participate in the study. If the patient is not competent to consent, consent can be obtained from the patient's next of kin.
• Residential address in Oslo
• Lives at home and normally manage their medications themselves (might have help from home-care nurses or next of kin)
• Scheduled to be discharged from the wards to their home or to short-term stay in nursing homes
• Uses at least four regular medications from at least two therapy classes (Anatomical Therapeutic Chemical (ATC) at first level
• Health care personnel (HCP) and next of kin:
• Expected to be involved in the included patient's medication regime or management after hospital discharge
• Able and willing to give written, informed consent to participate in the study
• HCP should be general practitioners (GPs) or home-care nurses.

You may not qualify if:

• Patients:
• Terminal and/or isolated due to infections
• Has previously been included in the study
• Has advanced cognitive failure, in accordance with assessment from treating physician
• Will not be discharged from the included wards to their homes (for example planned transfer to another ward or long-term stay at nursing home)
• Unable to communicate in Norwegian or English
• HCP and next of kin:
• Unable to communicate in Norwegian or English
• HCP or next of kin that has previously been included in the study

Sponsors & Collaborators

• Malin Olsen Syversen: lead
• Oslo University College: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0484, Norway

RECRUITING

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Liv O Mathiesen, PhD

  University of Oslo

  STUDY DIRECTOR

• Malin O Syversen, Msc

  University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin O Syversen, Msc

CONTACT

+4748126091; m.o.syversen@farmasi.uio.no

Liv Mathiesen, PhD

CONTACT

+4797689240; livmathi@farmasi.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: September 29, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publishing and before the data is deleted.
• Access Criteria: For future research.

Locations

NO (1)