Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610214
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
IMPACT-care Improved Medication Communication and Patient Involvement at Care Transitions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IMPACT-care Improved Medication Communication and Patient Involvement at Care Transitions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT-care
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-dischargeThese 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 andor 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 hospitals county admission from or discharge to a nursing home or short-term care facility inability to receive information and give consent independently eg 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 andor 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 Welfares 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 patients39 adherence to medication changes increase their sense of participation and involvement in their overall care and reduce healthcare consumption
Aim To improve the discharge process for older patients making them andor 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 hospitals county admission from or discharge to a nursing home or short-term care facility inability to receive information and give consent independently eg 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 andor 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 Welfares 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 patients39 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 patientsinformal 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 eg better glycemic control in diabetics and improved blood pressure control in hypertensives Challenges exist in involving older patients as they may be less willing andor 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 andor 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 ie 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 patientinformal 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 andor 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 patientinformal caregiver to review the informational brochure andor video Answering questions from patientinformal 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
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 patientsinformal 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 eg better glycemic control in diabetics and improved blood pressure control in hypertensives Challenges exist in involving older patients as they may be less willing andor 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 andor 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 ie 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 patientinformal 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 andor 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 patientinformal caregiver to review the informational brochure andor video Answering questions from patientinformal 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None