Clinical trial NCT06610214: IMPACT-care (Improved Medication Communication and Patient Involvement at Care Transitions)
Official title: IMPACT-care (Improved Medication Communication and Patient Involvement at Care Transitions)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Continuity of Patient Care
Keywords: aged
pharmacist intervention
health communication
patient centered care
medication safety
medication information
hospital discharge
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: The Kamprad Family Foundation for Entrepreneurship, Research & Charity
name: Regional Research Council Mid Sweden
name: Uppsala University
First posted: 2024-09-24
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We plan a prospective intervention study primarily with a before-and-after design. A secondary analysis using an Interrupted Time Series (ITS) design will be conducted with an exploratory approach.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Transitions of care, especially at hospital discharge, pose significant risks to patient safety. The World Health Organization (WHO) identifies this as a critical area for improvement, particularly for older patients who frequently experience preventable adverse drug events (ADEs) post-discharge.These risks often stem from poor communication between hospitals and subsequent care providers, and inadequate communication with patients and their informal caregivers, leading to gaps in post-discharge care. In Sweden, discharge conversations between hospital physicians and patients are standard practice but often lack structure and patient-centeredness. This can result in patients being poorly prepared for self-care, especially in managing their medications.

Aim: To improve the discharge process for older patients, making them (and/or informal caregiver) more informed and involved in their overall care, particularly in medication management.

Design: Prospective intervention study with a before-and-after design, supplemented by an Interrupted Time Series (ITS) analysis using an exploratory approach.

Setting: Two surgical and one geriatric ward in Region Uppsala.

Participants: Patients aged 65 or older, managing medication independently or with assistance from an informal caregiver.

Exclusion: Late palliative stage or transition to it during hospital stay; transfer to a non-participating ward; residence outside the hospital's county; admission from or discharge to a nursing home or short-term care facility; inability to receive information and give consent independently (e.g., cognitive impairment, non-contactable); death during hospital stay; inability to communicate in Swedish; previous inclusion in the study; relocation where another department maintains care responsibility; no persistent medication change post-discharge; hospital stay on the study ward of less than 48 weekday hours.

Interventions: 1, Training of Healthcare Staff; 2, Development of Medication Summary; 3, Information Package for Patient and/or Informal Caregiver; 4, Discharge Coaching; 5, Post-Discharge follow-Up call

Primary outcome measure: Quality of medication-related discharge documentation.

Data collection and analyses: Data will be collected from patients' electronic health records (EHR), the Swedish National Board of Health and Welfare's Pharmaceutical Register, and research surveys. Analyses will follow the intention-to-treat principle, using descriptive statistics, t-tests for continuous variables, and chi-square tests for categorical variables.

Relevance: The study aims to enhance the quality of discharge documentation, improve patients\&#39; adherence to medication changes, increase their sense of participation and involvement in their overall care, and reduce healthcare consumption.

Detailed description: Background:

The global older population is increasing, with the percentage of individuals aged 65 and older expected to rise from 10% in 2022 to 16% by 2050. Older people often suffer from multiple illnesses, doubling their risk of requiring hospital care compared to younger adults. Medication is the most common treatment for various health conditions, and the prevalence of multiple illnesses increases medication usage, heightening the risk of medication-related morbidity. Up to one in five hospital admissions among the older patients is estimated to be medication-related, with most deemed avoidable. Transitions in care, particularly when patients are discharged from the hospital, pose a significant risk to patient safety, highlighted as a a focus area for healthcare improvement by the World Health Organization (WHO). Over one-third of older patients experience adverse drug reactions (ADRs) within eight weeks post-discharge, half of which are considered preventable. These risks are often due to poor communication and coordination between hospitals and subsequent care providers, as well as inadequate communication between healthcare providers and patients/informal caregivers, leading to gaps in patient care post-discharge. Most hospitalized older patients undergo changes in their medication regimens that persist after discharge. Follow-up on these medication changes by subsequent healthcare provider relies on timely and high-quality discharge notes and referrals from hospital physicians, which is not always the case. These well-documented communication issues at discharge have also been confirmed in the Uppsala and Västmanland regions.

In Sweden, it is clinical practice for physicians to have a conversation with the patient at discharge discussing what occurred during the hospital stay. However, these conversations often lack standardized structure and patient-centeredness, appearing more as a checklist item for healthcare staff to complete before discharge. Patient-centered communication at discharge is crucial for preparing patients for self-care including medication management. Involving patients in medical decisions can be part of a patient-centered approach that improves patient satisfaction with care and clinical outcomes (e.g., better glycemic control in diabetics and improved blood pressure control in hypertensives). Challenges exist in involving older patients as they may be less willing and/or able to participate in medical decisions, linked to patient factors such as multimorbidity, cognitive impairment, and hearing loss. It is also common for older patients to express a lack of sufficient medication knowledge, trusting healthcare staff and following prescriptions to the best of their ability without further discussion. Additionally, older patients often struggle to remember medication information communicated at discharge, even when it is presented in a structured manner. Physicians also tend to adopt an authoritative role in medication communication with the patients at discharge, which can reduce the older patients' initiative to engage in their care and medication management. For older patients to be involved in their care at discharge, it is important for healthcare staff to see themselves as advocates for the patient rather than adopting a paternalistic approach in their communication. Informal caregivers also play a crucial role in involving the patient and bridging the communication gap between healthcare staff and the older patients.

With this background, the investigators have initiated the research project IMPACT-care (Improved Medication Information and Patient Involvement at Care Transitions; a strengthened chain of medication information across care boundaries). Within the project, the investigators have conducted several sub-studies exploring medication communication, both oral and written, in connection with the discharge of older patients from hospitals. Based on the results from these sub-studies and the literature, the investigators now plan to conduct the following intervention study with the overall aim of improving medication communication in the discharge process for older patients.

Aim:

To improve the discharge process for older patients, making them (and/or informal caregiver) more informed and involved in their overall care, particularly in their medication management.

Primary objectives:

* Improved medication-related discharge communication.
* Increased patient (and informal caregiver) involvement and confidence in their care in general and their medication management in particular.
* Enhanced patient adherence to medication changes made during the hospital stay and that persist post-discharge.
* Reduced unplanned healthcare utilization post-discharge.

Methods:

The study will be conducted in two surgical and one geriatric ward at the Uppsala University hospital in Region Uppsala.

The study will consist of three phases, the control phase, the training phase, and the intervention phase. Patients will be recruited by the research coordinators and the intervention will be performed by existing workforce at the wards. All healthcare staff involved, i.e., doctors, nurses, and clinical pharmacists, will be trained to perform the intervention. Based on a pilot study, the control and intervention phases will last about six months each and the training phase about four months. Follow-up of included patients will continue up to four months after discharge from the hospital.

The intervention comprises five individual intervention components:

1. Training of healthcare staff: Training of healthcare staff on what a discharge should entail in terms of communication (with a focus, but not exclusively, on medication) with the patient/informal caregiver and the next healthcare provider.
2. Preparation of supporting documentation for the medication report: Documentation of medication changes and follow-up plans in the patients' EHR supporting the writing of the medication report in the discharge letter and discharge summary.
3. Information package for the patient and/or informal caregiver: An informational brochure, with a medication focus, and a supplementary informational video (3-5 minutes in length) based on the information in the brochure. The broshure will be translated into additional languages commonly spoken in Sweden and the film will have subtitles in different languages.
4. Coaching around discharge: Prompting the patient/informal caregiver to review the informational brochure and/or video. Answering questions from patient/informal caregiver about the discharge process. Facilitating the involvement of informal caregivers in the discharge conversation
5. Follow-up call after discharge. A call to review the information in the discharge letter and the medication list

Eligibility criteria: Inclusion Criteria:

* Aged 65 or older
* Manages medication independently or with assistance from a caregiver

Exclusion Criteria:

* In the late palliative phase of care before or during the hospital stay
* Transfer to a non-participating ward
* Residence outside the hospital's county
* Admission from or discharge to a nursing home or short-term care facility
* Inability to independently receive information and give consent independently (e.g., cognitive impairment, non-contactable)
* Death during hospital stay
* Inability to communicate in Swedish
* Previous inclusion in the study
* Relocation where another department maintains care responsibility
* No persistent medication change post-discharge
* Hospital stay on the study ward of fewer than 48 weekday hours (excluding holidays)

Primary outcomes:
measure: CMDD-M (Complete Medication Documentation at Discharge Measure)
timeFrame: On the 1 day of discharge
Secondary outcomes:
measure: PIMCH-Q (Patient Involvement in Medication Communication at Hospital discharge Questionnaire)
timeFrame: Two weeks post discharge
measure: Quality of medication-related discharge documentation
timeFrame: On the 1 day of discharge
measure: Adherence to medication changes made during hospitalization that persist post-discharge, checklist.
timeFrame: Four months post discharge
measure: Adherence to medication changes made during hospitalisation that persist post-discharge
timeFrame: Four months post discharge
measure: Healthcare consumption
timeFrame: 7, 30 and 90 days post-discharge
measure: Healthcare consumption
timeFrame: 7, 30, and 90 days post-discharge
measure: Healthcare consumption
timeFrame: 7, 30, and 90 days post-discharge
measure: Healthcare consumption
timeFrame: 7, 30, and 90 days post-discharge
measure: Healthcare consumption
timeFrame: 7, 30, and 90 days post-discharge
measure: Healthcare consumption
timeFrame: 7, 30, and 90 days post-discharge
measure: Healthcare consumption
timeFrame: 7, 30, and 90 days post-discharge
measure: Healthcare consumption
timeFrame: 7, 30, and 90 days post-discharge
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppland
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppland
Study officials:
affiliation: Uppsala University Hospital
name: Ulrika Gillespie, PhD
role: PRINCIPAL_INVESTIGATOR
References: