Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05692921
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-01-11
Brief Title:
Tailoring Post Discharge The TPD Study
Sponsor:
St Boniface Hospital
Organization:
St Boniface Hospital
Study Overview
Official Title:
Tailoring Post Discharge TPD - Bridging the Gap Through Education and Community Support
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized control trial seeks to better understand the educational needs of Acute Coronary Symptom ACS patients including the optimal timing and method of delivery as well as linkages with appropriate community resources and supports are important for cardiac patients to self-manage post hospital discharge to improve outcomes While there is some literature of the learning needs of ACS patients there is a paucity of research related to the timing and preferred methods of delivery This study aims to better understand how best to tailor care for ACS patients from hospital to community Specifically the investigators propose a 2 phased approach to understand the needs of patients and then to develop and deliver a tailored approach to assess educate and support patients both in-hospital and within the community The intervention compares 1 a virtual remote home monitoring RHM platform and 2 Rapid Response Nursing RRN staff to follow educate and support ACS patients post hospital discharge for a period of no more than 30 days
The Primary Objective of this study is to safely transition low risk ACS patients from hospital to home with appropriate supports to safely self-manage in the community and to provide educational and community supports to improve post discharge outcomes of low risk ACS patients
The Primary Objective of this study is to safely transition low risk ACS patients from hospital to home with appropriate supports to safely self-manage in the community and to provide educational and community supports to improve post discharge outcomes of low risk ACS patients
Detailed Description:
Study design 2 phase single center randomized prospective pilot study
Phase 1 Evaluation of quality indicator results from discharge questionnaires from patients post ACS and a further investigation through patient engagement techniques about education community support and quality of care This process comprising of patient collaboratorspartners will contribute to the study design tool and resource development
Phase 2 Randomized trial - Intervention low risk 24-hour discharge support using Rapid Response nursing RRN vs low risk 24-hour discharge support using Remote Home Monitoring RHM Patients will be assessed using a trialed multipoint tool developed for this research study utilizing the cardiac medical community and patient risks After assessment low-risk patients will be randomized into the study The study interventions will utilize either the RRN or the RHM to deliver education and support to patients post discharge
Phase 1 - Patient Engagement Panel
Patient engagement in research involves meaningful and active collaboration between patients and researchers throughout the different phases of a research project including planning data collection data analysis and knowledge translation These collaborative meetings inform and guide study development The central tenet of patient engagement in research is that while clinicians and investigators have disease and research specific expertise patients have expertise that stems from lived experience of their health issues By sharing their experiences of the daily impact of disease and their perspectives regarding unmet needs therapeutic burdens balance of benefits and risks and types of research questions most important to them patients can transform the research process from one directed by investigators to one driven and informed by the needs of patients and their caregivers
To generate information to refine the implementation plan of the study the investigators intend to recruit individuals to our Patient engagement panel who previously had ACS care and hospitalization at the St Boniface Hospital andor caregivers for the ACS patient The investigators will construct panel members that reflect key demographic characteristics of our studys target population including age sex gender rural vs urban home location and type of ACS and other relevant selection criteria These engagement activities will look to provide valuable insight into their experiences while in-hospital and their transition back to the community to help us develop patient centered education and post-discharge support The investigators expect to generate patient and caregiver knowledge over 3 sessions within a 2-week period of time Each session will be approximately 2 hours in length and will be mediated by research staff who have extensive experience in patient engagement These sessions will either be in person or virtual which will be dependent on participant needs
From the patient engagement panel The investigators will select 2 participants to become patient collaborators with our research team These patients will provide information to help guide the refinement of study design study procedures eg recruitment methods approaches to maximize education retention use of accessible language in recruitment and study materials and usability of technology relevance of outcomes to patient concerns data analysis eg interpretation and contextualization of findings and knowledge translation eg alternate dissemination methods use of accessible language manuscript development The anticipated lifespan of this patient- collaborators participation is from study planning through to the end of study knowledge translation approximately 2 years consisting of formal and informal meetings during this time period
Phase 2 - Prospective Research
Main Study ParticipantsAfter a successful PCI and assessing patients risk criteria patients who are considered low risk will be identified by the attending cardiology staff Research staff will then be provided the names of these patients and they will then approach the patient for consent prior to hospital discharge Patients upon consenting to the study will be provided several questionnaires to complete and then randomized to one of two arms the RRN arm or the RHM arm
Low Risk Assessment Process Hybrid
The cardiology team at the St Boniface Hospital will first utilize the Zwolle STEMI or the Grace NSTEMI scores to initially assess low medical risk for ACS patients Both scores have been previously validated 3-5 As many as 30 additional factors will be considered when completing the scoring for low-risk inclusion Appendix 1 These factors include social economic cognitive mental and physical dimensions
Randomization
Utilizing an online randomization tool wwwHTTPSrandomizerorg participants who consent to the main study are assigned to either RRN intervention arm or the RHM intervention arm in a blocked 11 format
Registry Participants Patients who fit the criteria for study inclusion and choose not to participate in the main study will be provided with an opportunity to consent to the registry arm of the study The registry arm of the study is an opportunity to establish a standard of care group free from research bias Patients who enroll in the registry will only need to complete a short questionnaire before they are discharged home which will take approximately 5 minutes Additionally research staff will also complete a medical chart review to identify specific medical information related to their demographics cardiac procedure hospital stay recovery and to identify any re-admissions to hospital that may have occurred after the patient has been discharged home
Standard of Care
Currently education is delivered by several health care providers including Nursing Occupation and Physical Therapy Pharmacy Dieticians and Physicians Delivery of the education material vary based on availability of health care providers and the length of time a patient is admitted to the hospital as well as timing of discharge weekday vs weekend Patients are discharged with educational material such as Heart and Strokes Living well with Hearts Disease booklet information on Coronary angiograms and angioplastystents and medication information sheets provided by pharmacy A clinical decision is made by the health care team regarding whether the patient needs cardiology follow up While most STEMI patients are referred to a cardiologist if they dont already have one the practice is variable for NSTEMI and unstable angina patients This standard of care will continue to be provided to all ACS patients being discharged from the St Boniface Hospital
Intervention
Education Development and Implementation
Focused and adaptable educational material will be created to support the patients upon hospital discharge This education and support component will either be administered by the Rapid Response Nurses RRN who will be delivering in person or virtually or the Remote Home Monitoring RHM system delivered virtually Instead of routine education for all patients through this intervention the appropriate education will be provided at the appropriate time for patients based on their own learning needs The existing educational material will be revised to be more digestible and using multiple methods of learning including infographics education short summaries etc The education will be developed in coordination with patient and clinical teams Further work throughout the patient engagement phase 1 needs to
Provide directed and tailored education publication and access to electronic documents and community support based on patient engagement sessions and current health care directives
Evaluate all discharge resource material
understand current content and process
identify and integrate changes
Identify community supports available for post ACS patients
Create resource sheet
Engage community partners
Cardiac Rehabilitation CR facilities
Community health care support ie access centres
Rapid Response Nursing Team
The RRNs will meet with study participants on 3 occasions 1 24 hours post hospital discharge 2 5-7 days post hospital discharge and 3 2-week post hospital discharge While the initial visit will be in person the next two visits may be in person or virtual phonetabletcomputer depending on patient preference The RRN will help clientspatients to
Understand their current health conditions treatments how to manage symptoms and whenwho to ask for help Specifically they will
Help clients to understand their hospital discharge plan
Support patients during their recovery at home
Reinforce and contribute to in-hospital education about heath health and recovering safely at home
Review medications to help clients understand the purpose side effects and how to take prescribed medications correctly including assisting clients with getting prescriptions filled
Connect with their Home Clinic ensuring everyone has the necessary information for follow-up care
Connect clients with a Home Clinic if they do not have one and
Access appropriate home supports to help clients remain at home safely for as long as possible
Remote Home Monitoring Platform
The remote home monitoring platform will be utilized to help tailor the education and support for the patient
Engage patients
Providing access to and delivery of health related education and information for continued self-care within the community
Evaluating post discharge symptoms
Algorithm to define and deliver continued patient care throughout the at home recovery process - green yellow and red flag system
Accessibility by health care provider to assess the need for continued direct patient care and education
Delivery of surveys for research purposes
Patients will be provided access to this platform on their own device whether mobile phone tablet or home computer
If the patient does not have access to this technology a tablet will be provided to the patient for the purposes and duration of this research study
There is no cost to the patient for this
This system has been approved and adopted by shared health for the remote home monitoring of patients after they have been discharged home from the hospital
Phase 1 Evaluation of quality indicator results from discharge questionnaires from patients post ACS and a further investigation through patient engagement techniques about education community support and quality of care This process comprising of patient collaboratorspartners will contribute to the study design tool and resource development
Phase 2 Randomized trial - Intervention low risk 24-hour discharge support using Rapid Response nursing RRN vs low risk 24-hour discharge support using Remote Home Monitoring RHM Patients will be assessed using a trialed multipoint tool developed for this research study utilizing the cardiac medical community and patient risks After assessment low-risk patients will be randomized into the study The study interventions will utilize either the RRN or the RHM to deliver education and support to patients post discharge
Phase 1 - Patient Engagement Panel
Patient engagement in research involves meaningful and active collaboration between patients and researchers throughout the different phases of a research project including planning data collection data analysis and knowledge translation These collaborative meetings inform and guide study development The central tenet of patient engagement in research is that while clinicians and investigators have disease and research specific expertise patients have expertise that stems from lived experience of their health issues By sharing their experiences of the daily impact of disease and their perspectives regarding unmet needs therapeutic burdens balance of benefits and risks and types of research questions most important to them patients can transform the research process from one directed by investigators to one driven and informed by the needs of patients and their caregivers
To generate information to refine the implementation plan of the study the investigators intend to recruit individuals to our Patient engagement panel who previously had ACS care and hospitalization at the St Boniface Hospital andor caregivers for the ACS patient The investigators will construct panel members that reflect key demographic characteristics of our studys target population including age sex gender rural vs urban home location and type of ACS and other relevant selection criteria These engagement activities will look to provide valuable insight into their experiences while in-hospital and their transition back to the community to help us develop patient centered education and post-discharge support The investigators expect to generate patient and caregiver knowledge over 3 sessions within a 2-week period of time Each session will be approximately 2 hours in length and will be mediated by research staff who have extensive experience in patient engagement These sessions will either be in person or virtual which will be dependent on participant needs
From the patient engagement panel The investigators will select 2 participants to become patient collaborators with our research team These patients will provide information to help guide the refinement of study design study procedures eg recruitment methods approaches to maximize education retention use of accessible language in recruitment and study materials and usability of technology relevance of outcomes to patient concerns data analysis eg interpretation and contextualization of findings and knowledge translation eg alternate dissemination methods use of accessible language manuscript development The anticipated lifespan of this patient- collaborators participation is from study planning through to the end of study knowledge translation approximately 2 years consisting of formal and informal meetings during this time period
Phase 2 - Prospective Research
Main Study ParticipantsAfter a successful PCI and assessing patients risk criteria patients who are considered low risk will be identified by the attending cardiology staff Research staff will then be provided the names of these patients and they will then approach the patient for consent prior to hospital discharge Patients upon consenting to the study will be provided several questionnaires to complete and then randomized to one of two arms the RRN arm or the RHM arm
Low Risk Assessment Process Hybrid
The cardiology team at the St Boniface Hospital will first utilize the Zwolle STEMI or the Grace NSTEMI scores to initially assess low medical risk for ACS patients Both scores have been previously validated 3-5 As many as 30 additional factors will be considered when completing the scoring for low-risk inclusion Appendix 1 These factors include social economic cognitive mental and physical dimensions
Randomization
Utilizing an online randomization tool wwwHTTPSrandomizerorg participants who consent to the main study are assigned to either RRN intervention arm or the RHM intervention arm in a blocked 11 format
Registry Participants Patients who fit the criteria for study inclusion and choose not to participate in the main study will be provided with an opportunity to consent to the registry arm of the study The registry arm of the study is an opportunity to establish a standard of care group free from research bias Patients who enroll in the registry will only need to complete a short questionnaire before they are discharged home which will take approximately 5 minutes Additionally research staff will also complete a medical chart review to identify specific medical information related to their demographics cardiac procedure hospital stay recovery and to identify any re-admissions to hospital that may have occurred after the patient has been discharged home
Standard of Care
Currently education is delivered by several health care providers including Nursing Occupation and Physical Therapy Pharmacy Dieticians and Physicians Delivery of the education material vary based on availability of health care providers and the length of time a patient is admitted to the hospital as well as timing of discharge weekday vs weekend Patients are discharged with educational material such as Heart and Strokes Living well with Hearts Disease booklet information on Coronary angiograms and angioplastystents and medication information sheets provided by pharmacy A clinical decision is made by the health care team regarding whether the patient needs cardiology follow up While most STEMI patients are referred to a cardiologist if they dont already have one the practice is variable for NSTEMI and unstable angina patients This standard of care will continue to be provided to all ACS patients being discharged from the St Boniface Hospital
Intervention
Education Development and Implementation
Focused and adaptable educational material will be created to support the patients upon hospital discharge This education and support component will either be administered by the Rapid Response Nurses RRN who will be delivering in person or virtually or the Remote Home Monitoring RHM system delivered virtually Instead of routine education for all patients through this intervention the appropriate education will be provided at the appropriate time for patients based on their own learning needs The existing educational material will be revised to be more digestible and using multiple methods of learning including infographics education short summaries etc The education will be developed in coordination with patient and clinical teams Further work throughout the patient engagement phase 1 needs to
Provide directed and tailored education publication and access to electronic documents and community support based on patient engagement sessions and current health care directives
Evaluate all discharge resource material
understand current content and process
identify and integrate changes
Identify community supports available for post ACS patients
Create resource sheet
Engage community partners
Cardiac Rehabilitation CR facilities
Community health care support ie access centres
Rapid Response Nursing Team
The RRNs will meet with study participants on 3 occasions 1 24 hours post hospital discharge 2 5-7 days post hospital discharge and 3 2-week post hospital discharge While the initial visit will be in person the next two visits may be in person or virtual phonetabletcomputer depending on patient preference The RRN will help clientspatients to
Understand their current health conditions treatments how to manage symptoms and whenwho to ask for help Specifically they will
Help clients to understand their hospital discharge plan
Support patients during their recovery at home
Reinforce and contribute to in-hospital education about heath health and recovering safely at home
Review medications to help clients understand the purpose side effects and how to take prescribed medications correctly including assisting clients with getting prescriptions filled
Connect with their Home Clinic ensuring everyone has the necessary information for follow-up care
Connect clients with a Home Clinic if they do not have one and
Access appropriate home supports to help clients remain at home safely for as long as possible
Remote Home Monitoring Platform
The remote home monitoring platform will be utilized to help tailor the education and support for the patient
Engage patients
Providing access to and delivery of health related education and information for continued self-care within the community
Evaluating post discharge symptoms
Algorithm to define and deliver continued patient care throughout the at home recovery process - green yellow and red flag system
Accessibility by health care provider to assess the need for continued direct patient care and education
Delivery of surveys for research purposes
Patients will be provided access to this platform on their own device whether mobile phone tablet or home computer
If the patient does not have access to this technology a tablet will be provided to the patient for the purposes and duration of this research study
There is no cost to the patient for this
This system has been approved and adopted by shared health for the remote home monitoring of patients after they have been discharged home from the hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None