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The LEARNING WISDOM Phase II Scale up Project

Primary Purpose

Transition, Emergencies, Health Care Utilization

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GEM nurse
pre- and post-hospitalization medication list reconciliation
systematic discharge summaries
medical follow-up appointment
follow-up phone call
Wiki-based Knowledge tools
Telemonitoring service
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Transition focused on measuring Emergency Department, Care Transition, Elderly Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligible patients will be:

  • aged ≥ 65 years
  • be discharged from the ED
  • able to understand and read French
  • able to give informed consent

Eligible caregivers will be:

  • identified by the patients themselves
  • able to understand and read French
  • able to give informed consent

Exclusion Criteria:

-

Sites / Locations

  • Centres intégrés de santé et de services sociaux (CISSS) De Chaudières-AppalachesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Phase I-A (Local project set-up)

Phase I-B (Implementation):

Phase IC (Study description)

Arm Description

An executive committee will oversee the entire project. This committee, led by the nominated PI and Director of Nursing, will meet every 4 weeks during this four-year project. The team may include, depending on the hospital site: an administrator, the ED Director, the ED Head nurse, a community and/or hospital-based geriatric nurse specialist, an ED physician, a hospitalist, a geriatrician, a family physician, a home care nurse/coordinator, an inpatient unit manager, the research coordinator, and a local patient/caregiver. Each local team will be responsible for selecting and implementing the ACE intervention(s) best suiting their milieu, and will include locally identified champions to lead the local implementation.

The investigators will implement the context-adapted ACE program with the support of administrators and local implementation teams who will have the responsibility to roll out the different elements of the intervention within their respective hospitals. It may include a series of systematic pre-discharge, post-discharge and across transitions period interventions for eligible patients: 1) a GEM nurse to support patients during the post-discharge transition period, 2) pre- and post-hospitalization medication list reconciliation, 3) systematic discharge summaries given to patients and/or caregiver, and sent to their family physician, 4) a planned follow-up appointment with their family physician, 5) a systematic follow-up phone call, 6) access to wiki-based patient-oriented KT tools, 7) access to a community-based telemonitoring service.

Results from each center will be analysed over time. Guided by previous work in healthcare governance, the investigators will analyze the impact of the sequential interventions within the context of a major health reform in Quebec aiming at implementing an integrated health system and within the PI program's overall goal of creating a Learning Health System. This will be accomplished by conducting a comparative case study across the four study sites to compare the barriers, facilitators and local solutions implemented to gain a better understanding about how the ACE program could eventually be scaled up elsewhere.

Outcomes

Primary Outcome Measures

Change of 30-day hospital readmission
Composite endpoint at each month 30-day hospital readmission
Change of 30-day ED visit rate
Composite endpoint at each month 30-day ED visit rate

Secondary Outcome Measures

1- change Hospital/ED length of stay - Hospital-level outcome
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 1) Hospital/ED length of stay
2- change ED admission rate - Hospital-level outcome
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 2) ED admission rate
3- Change Alternate level care occupation rate- Hospital-level outcome
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 3) Alternate level care occupation rate
4- Change Rate of patients returning to pre-hospital living situation- Hospital-level outcome
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 4) Rate of patients returning to pre-hospital living situation
Clinicians and decision maker outcomes (Qualitative outcome)
Individual interviews will be performed every 3 months after the beginning of the implementation of the Acute Care for Elders (ACE) program at each hospital among health professionals and decision makers participating in the ACE program. These semi-structured interviews will be based on the National Health Services (NHS) Sustainability Model. This qualitative questionnaire will serve to identify the contextual elements that influenced the successful (or failed) implementation of the (Approche adaptée à la personne âgée) AAPA / ACE program for improving care transitions. These interviews will be conducted by doctoral and/or Master students, guided by experienced qualitative researcher
1- Care Transitions Measure (CTM3) - Patient outcome
The 3-item Care Transitions Measure (CTM-3) is a 3-item questionnaire measuring the perceived quality of the transition care on a 0-3 scale (0 = fully disagree; 4 = fully agree). Mean of the 3 items are linearized to obtain 0-100 scoring scale.
2- GAI-SC-SF - Patient outcome
The Geriatric Anxiety Inventory-short form (GAI-SF) has been specifically developed to measure anxiety among seniors and it has good psychometric values. The short version comprises five questions.Each positive item/question = 1. Score range 0 to 5. Anxiety is detected 3 out of 5 and above.
3- Living situation - Patient outcome
Living situation will be collected in the medical file when available at 30 days post-discharge.
4- baseline sociodemographic data - Patient outcome
baseline sociodemographic data (age, sex, race, language, education level, family income will be collected.
Caregiver-level outcomes
The Zarit Burden Interview (ZBI) is one of the most used tools for measuring the burden of caregivers. The brief French version (12 questions) of the scale has good psychometric properties, comparable to the original version.For each question, range answer is : Never=0, Rarely= 1, Sometimes= 2, Quite frequently=3, Nearly always=4. Summation of 12 items 0 to 4 points per item range 0 to 48 as total score. Score between 0-10 = no to mild burden; score between 10-20 = mild to moderate burden; score >20 = high burden.This tool is already used by CISSS-CA staff. Mentioned in Quebec's "Alzheimer's Plan"[89], caregiver burden increases as the disease progresses and is associated with psychological distress and physical health problems. Caregivers are therefore a "risk group" within the health system.
1-Clinical-level process outcome - Proportion of patients assigned a GEM Nurse
Proportion of patients assigned a GEM Nurse
2-Clinical-level process outcome - Proportion of patients/caregiver/physician receiving discharge summary
Proportion of patients/caregiver/physician receiving discharge summary
3-Clinical-level process outcome - Proportion of medication list reconciliation
Proportion of medication list reconciliation
4-Clinical-level process outcome - Proportion of patients with physician appointment
Proportion of patients with physician appointment
5-Clinical-level process outcome - Proportion of patients using telemonitoring
Proportion of patients using telemonitoring using Télé-Surveillance Santé Chaudieres-Appalaches (TSS-CA) database

Full Information

First Posted
September 9, 2019
Last Updated
November 1, 2019
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT04093245
Brief Title
The LEARNING WISDOM Phase II Scale up Project
Official Title
Supporting the Creation of a LEARNing INteGrated Health System to Mobilize Context-adapted Knowledge With a Wiki Platform to Improve the Transitions of Frail Seniors From From Hospitals and Emergency Departments to the cOMmunity: Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Inspired by the Acute Care for Elders program at Mount Sinai Hospital, this study aims to improve care for elderly patients in four hospitals of Chaudière-Appalaches. Focusing on improving transitions between hospital and the community, this project will help professionals to adapt best practices to local context in transition of care for the elderly.
Detailed Description
Background: Elderly patients discharged from hospital currently experience fragmented care, repeated and lengthy emergency department (ED) visits, relapse into their earlier condition, and rapid cognitive and functional decline. The Acute Care for Elders (ACE) program at Mount Sinai Hospital uses innovative strategies such as transition coaches, follow-up calls and patient self-care guides to improve the care transition experiences of the frail elderly patients from hospitals to the community. The ACE program reduced lengths of hospital stay and readmissions for elderly patients, increased patient satisfaction, and saved the healthcare system over $6 million in 2014. In 2016, the ACE program was implemented at one hospital in the Centre intégré en santé et en services sociaux de Chaudière-Appalaches (CISSS CA), a large integrated healthcare organization in Quebec, with a focus on improving transitions between hospital and the community for the elderly. This project used rapid, iterative user-centered design prototyping and a "Wiki-suite" (a free online database containing evidence-based knowledge tools in all areas of healthcare and an accompanying training course) to engage multiple stakeholders including a patient partner to improve care for elderly patients. Within this one year project, the investigators developed a context-adapted ACE intervention with the support of the Mt. Sinai Hospital, the Canadian Foundation for Healthcare Improvement and the Canadian Frailty Network. The goal is to scale up the ACE program for elderly care transition to three new hospital sites within the CISSS CA, using the Wiki-suite to allow for further context-adaptation of the program in these new hospitals. Objectives: 1) Implement a context-adapted ACE program in three hospitals in the CISSS CA and measure its impact on patient, caregiver, clinical and hospital-level outcomes; 2) Identify underlying mechanisms by which the context-adapted ACE program improves care transitions for the elderly; 3) Identify underlying mechanisms by which the Wiki-suite contributes to context-adaptation and local uptake of knowledge tools. Methods: Objective 1: Staggered implementation of the ACE program across the three CISSS CA sites; interrupted time series to measure the impact on hospital-level outcomes; pre/post cohort study to measure the impact of the new program on patient, caregiver and clinical outcomes. Objectives 2 and 3: Parallel mixed-methods process evaluation study to understand the mechanisms by which the context-adapted ACE program improves care transitions for the elderly and by which the Wiki-suite contributes to adaptation, implementation and scaling up of geriatric knowledge tools. Expected results: This project will provide much needed evidence on effective Knowledge Translation (KT) strategies to adapt best practices to local context in transition of care for the elderly. It will contribute to adapting geriatric knowledge to local contexts. The knowledge generated through this project will support future scale-up of the ACE program and the wiki methodology to other settings in Canada.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transition, Emergencies, Health Care Utilization, Frailty
Keywords
Emergency Department, Care Transition, Elderly Frailty

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase I-A (Local project set-up)
Arm Type
No Intervention
Arm Description
An executive committee will oversee the entire project. This committee, led by the nominated PI and Director of Nursing, will meet every 4 weeks during this four-year project. The team may include, depending on the hospital site: an administrator, the ED Director, the ED Head nurse, a community and/or hospital-based geriatric nurse specialist, an ED physician, a hospitalist, a geriatrician, a family physician, a home care nurse/coordinator, an inpatient unit manager, the research coordinator, and a local patient/caregiver. Each local team will be responsible for selecting and implementing the ACE intervention(s) best suiting their milieu, and will include locally identified champions to lead the local implementation.
Arm Title
Phase I-B (Implementation):
Arm Type
Experimental
Arm Description
The investigators will implement the context-adapted ACE program with the support of administrators and local implementation teams who will have the responsibility to roll out the different elements of the intervention within their respective hospitals. It may include a series of systematic pre-discharge, post-discharge and across transitions period interventions for eligible patients: 1) a GEM nurse to support patients during the post-discharge transition period, 2) pre- and post-hospitalization medication list reconciliation, 3) systematic discharge summaries given to patients and/or caregiver, and sent to their family physician, 4) a planned follow-up appointment with their family physician, 5) a systematic follow-up phone call, 6) access to wiki-based patient-oriented KT tools, 7) access to a community-based telemonitoring service.
Arm Title
Phase IC (Study description)
Arm Type
Experimental
Arm Description
Results from each center will be analysed over time. Guided by previous work in healthcare governance, the investigators will analyze the impact of the sequential interventions within the context of a major health reform in Quebec aiming at implementing an integrated health system and within the PI program's overall goal of creating a Learning Health System. This will be accomplished by conducting a comparative case study across the four study sites to compare the barriers, facilitators and local solutions implemented to gain a better understanding about how the ACE program could eventually be scaled up elsewhere.
Intervention Type
Behavioral
Intervention Name(s)
GEM nurse
Intervention Description
hospital-based geriatric emergency nurse (GEM nurse) specialist to support patients during the post-discharge transition period
Intervention Type
Behavioral
Intervention Name(s)
pre- and post-hospitalization medication list reconciliation
Intervention Description
pre- and post-hospitalization medication list reconciliation for elderly
Intervention Type
Behavioral
Intervention Name(s)
systematic discharge summaries
Intervention Description
systematic discharge summaries given to patients and/or caregiver, and sent to their family physician
Intervention Type
Behavioral
Intervention Name(s)
medical follow-up appointment
Intervention Description
a planned follow-up appointment with their family physician
Intervention Type
Behavioral
Intervention Name(s)
follow-up phone call
Intervention Description
a systematic follow-up phone call for discharged patients
Intervention Type
Other
Intervention Name(s)
Wiki-based Knowledge tools
Intervention Description
access to wiki-based patient-oriented KT tools
Intervention Type
Other
Intervention Name(s)
Telemonitoring service
Intervention Description
access to a community-based telemonitoring service
Primary Outcome Measure Information:
Title
Change of 30-day hospital readmission
Description
Composite endpoint at each month 30-day hospital readmission
Time Frame
each month during 4 years (48)
Title
Change of 30-day ED visit rate
Description
Composite endpoint at each month 30-day ED visit rate
Time Frame
each month during 4 years (48)
Secondary Outcome Measure Information:
Title
1- change Hospital/ED length of stay - Hospital-level outcome
Description
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 1) Hospital/ED length of stay
Time Frame
Each month during 4 years (48)
Title
2- change ED admission rate - Hospital-level outcome
Description
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 2) ED admission rate
Time Frame
Each month during 4 years (48)
Title
3- Change Alternate level care occupation rate- Hospital-level outcome
Description
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 3) Alternate level care occupation rate
Time Frame
Each month during 4 years (48)
Title
4- Change Rate of patients returning to pre-hospital living situation- Hospital-level outcome
Description
Hospital administrative databases (e.g., MedGPS, Logibec, Montreal, Canada) will be used to calculate monthly hospital-level outcomes. Monthly data will then be analyzed to form points in time. Data from the Régie d'assurance maladie du Québec (RAMQ) physician billing database and MedECHO database (containing data on hospitalizations and health professional consultations for all institutions) will also be extracted in addition to databases available at the Institut national d'excellence en santé et services sociaux (INESSS) in order to identify all health services used prior to and after the implementation of the ACE intervention. 4) Rate of patients returning to pre-hospital living situation
Time Frame
Each month during 4 years (48)
Title
Clinicians and decision maker outcomes (Qualitative outcome)
Description
Individual interviews will be performed every 3 months after the beginning of the implementation of the Acute Care for Elders (ACE) program at each hospital among health professionals and decision makers participating in the ACE program. These semi-structured interviews will be based on the National Health Services (NHS) Sustainability Model. This qualitative questionnaire will serve to identify the contextual elements that influenced the successful (or failed) implementation of the (Approche adaptée à la personne âgée) AAPA / ACE program for improving care transitions. These interviews will be conducted by doctoral and/or Master students, guided by experienced qualitative researcher
Time Frame
each 3 months, during 4 years (12)
Title
1- Care Transitions Measure (CTM3) - Patient outcome
Description
The 3-item Care Transitions Measure (CTM-3) is a 3-item questionnaire measuring the perceived quality of the transition care on a 0-3 scale (0 = fully disagree; 4 = fully agree). Mean of the 3 items are linearized to obtain 0-100 scoring scale.
Time Frame
48-72 hours post-discharge for 3-item Care Transitions Measure (CTM3)
Title
2- GAI-SC-SF - Patient outcome
Description
The Geriatric Anxiety Inventory-short form (GAI-SF) has been specifically developed to measure anxiety among seniors and it has good psychometric values. The short version comprises five questions.Each positive item/question = 1. Score range 0 to 5. Anxiety is detected 3 out of 5 and above.
Time Frame
within 7 days after post-discharge
Title
3- Living situation - Patient outcome
Description
Living situation will be collected in the medical file when available at 30 days post-discharge.
Time Frame
30 days post-discharge
Title
4- baseline sociodemographic data - Patient outcome
Description
baseline sociodemographic data (age, sex, race, language, education level, family income will be collected.
Time Frame
within 7 days after post-discharge
Title
Caregiver-level outcomes
Description
The Zarit Burden Interview (ZBI) is one of the most used tools for measuring the burden of caregivers. The brief French version (12 questions) of the scale has good psychometric properties, comparable to the original version.For each question, range answer is : Never=0, Rarely= 1, Sometimes= 2, Quite frequently=3, Nearly always=4. Summation of 12 items 0 to 4 points per item range 0 to 48 as total score. Score between 0-10 = no to mild burden; score between 10-20 = mild to moderate burden; score >20 = high burden.This tool is already used by CISSS-CA staff. Mentioned in Quebec's "Alzheimer's Plan"[89], caregiver burden increases as the disease progresses and is associated with psychological distress and physical health problems. Caregivers are therefore a "risk group" within the health system.
Time Frame
7days patient post-discharge
Title
1-Clinical-level process outcome - Proportion of patients assigned a GEM Nurse
Description
Proportion of patients assigned a GEM Nurse
Time Frame
Process assessment with a monthly Chart audit for 4 years
Title
2-Clinical-level process outcome - Proportion of patients/caregiver/physician receiving discharge summary
Description
Proportion of patients/caregiver/physician receiving discharge summary
Time Frame
48 hours post-discharge questionnaire and family physician follow-up phone call
Title
3-Clinical-level process outcome - Proportion of medication list reconciliation
Description
Proportion of medication list reconciliation
Time Frame
monthly Chart audit for 4 years
Title
4-Clinical-level process outcome - Proportion of patients with physician appointment
Description
Proportion of patients with physician appointment
Time Frame
Family physician follow-up phone call post-discharge up to 30 days
Title
5-Clinical-level process outcome - Proportion of patients using telemonitoring
Description
Proportion of patients using telemonitoring using Télé-Surveillance Santé Chaudieres-Appalaches (TSS-CA) database
Time Frame
monthly Chart audit for 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible patients will be: aged ≥ 65 years be discharged from the ED able to understand and read French able to give informed consent Eligible caregivers will be: identified by the patients themselves able to understand and read French able to give informed consent Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick M Archambault, MD, MSc
Phone
4188357121
Ext
3905
Email
patrick.m.archambault@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Y Smith, PhD
Phone
4188357121
Ext
4548
Email
pascalysmith65@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick M Archambault, MD, MSc
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centres intégrés de santé et de services sociaux (CISSS) De Chaudières-Appalaches
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Y Smith, PhD
First Name & Middle Initial & Last Name & Degree
Patrick M Archambault, MD, Msc

12. IPD Sharing Statement

Plan to Share IPD
No
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The LEARNING WISDOM Phase II Scale up Project

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