IMPACT-care (Improved Medication Communication and Patient Involvement at Care Transitions)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- CMDD-M (Complete Medication Documentation at Discharge Measure)
研究概览
简要总结
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, Information package for patient and/or informal caregiver 2, Preparation of medication-related discharge documentation; 3, Facilitation of discharge communication; 4, 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 adherence to medication changes, increase their sense of participation and involvement in their overall care, and reduce healthcare consumption.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor of the primary outcome measure will be blinded.
The secondary outcome measure concerning drug related readmissions will be blinded.
The secondary outcome measure concerning medication adherence is not possible to blind since it is dependent on the patients' discharge date, and the date will reveal the allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 or older
- •Manages medication independently or with assistance from a caregiver
排除标准
- •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)
研究组 & 干预措施
Control group
No intervention
Intervention group
IMPACT-care intervention
干预措施: IMPACT-care intervention (Other)
结局指标
主要结局
CMDD-M (Complete Medication Documentation at Discharge Measure)
时间窗: On the 1 day of discharge
Score (0-9 points) on CMDD-M (Complete Medication Documentation at Discharge Measure). The CMDD-M tool is point-based and measures the accuracy and quality of medication reports in the discharge letter provided to the patient and in the discharge summary intended for the next health care provider. The medication-related discharge documentation is classified as complete if 9 points are achieved using the tool.
次要结局
- PIMCH-Q (Patient Involvement in Medication Communication at Hospital discharge Questionnaire)(Two weeks post discharge)
- Quality of medication-related discharge documentation(On the 1 day of discharge)
- Adherence to medication changes made during hospitalization that persist post-discharge, checklist.(Four months post discharge)
- Adherence to medication changes made during hospitalisation that persist post-discharge(Four months post discharge)
- Healthcare consumption(7, 30, and 90 days post-discharge)
- Healthcare consumption(7, 30 and 90 days post-discharge)
研究者
Ulrika Gillespie
Deputy Chief Pharmacist / Associate Professor
Uppsala University Hospital