The LEARNING WISDOM Phase II Scale up Project

Frailty Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04093245
• Other study ID #: Learning Wisdom 2018-462
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2019
• Source: Laval University
• Contact: Patrick M Archambault, MD, MSc
• Phone: 4188357121
• Email: patrick.m.archambault[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Emergencies
• Frailty
• Health Care Utilization
• Transition

Intervention

Behavioral:
• GEM nurse
hospital-based geriatric emergency nurse (GEM nurse) specialist to support patients during the post-discharge transition period
• pre- and post-hospitalization medication list reconciliation
pre- and post-hospitalization medication list reconciliation for elderly
• systematic discharge summaries
systematic discharge summaries given to patients and/or caregiver, and sent to their family physician
• medical follow-up appointment
a planned follow-up appointment with their family physician
• follow-up phone call
a systematic follow-up phone call for discharged patients

Other:
• Wiki-based Knowledge tools
access to wiki-based patient-oriented KT tools
• Telemonitoring service
access to a community-based telemonitoring service

Locations

Country	Name	City	State
Canada	Centres intégrés de santé et de services sociaux (CISSS) De Chaudières-Appalaches	Lévis	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

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* Note: There are 85 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 30-day hospital readmission	Composite endpoint at each month 30-day hospital readmission	each month during 4 years (48)
Primary	Change of 30-day ED visit rate	Composite endpoint at each month 30-day ED visit rate	each month during 4 years (48)
Secondary	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	Each month during 4 years (48)
Secondary	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	Each month during 4 years (48)
Secondary	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	Each month during 4 years (48)
Secondary	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	Each month during 4 years (48)
Secondary	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	each 3 months, during 4 years (12)
Secondary	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.	48-72 hours post-discharge for 3-item Care Transitions Measure (CTM3)
Secondary	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.	within 7 days after post-discharge
Secondary	3- Living situation - Patient outcome	Living situation will be collected in the medical file when available at 30 days post-discharge.	30 days post-discharge
Secondary	4- baseline sociodemographic data - Patient outcome	baseline sociodemographic data (age, sex, race, language, education level, family income will be collected.	within 7 days after post-discharge
Secondary	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.	7days patient post-discharge
Secondary	1-Clinical-level process outcome - Proportion of patients assigned a GEM Nurse	Proportion of patients assigned a GEM Nurse	Process assessment with a monthly Chart audit for 4 years
Secondary	2-Clinical-level process outcome - Proportion of patients/caregiver/physician receiving discharge summary	Proportion of patients/caregiver/physician receiving discharge summary	48 hours post-discharge questionnaire and family physician follow-up phone call
Secondary	3-Clinical-level process outcome - Proportion of medication list reconciliation	Proportion of medication list reconciliation	monthly Chart audit for 4 years
Secondary	4-Clinical-level process outcome - Proportion of patients with physician appointment	Proportion of patients with physician appointment	Family physician follow-up phone call post-discharge up to 30 days
Secondary	5-Clinical-level process outcome - Proportion of patients using telemonitoring	Proportion of patients using telemonitoring using Télé-Surveillance Santé Chaudieres-Appalaches (TSS-CA) database	monthly Chart audit for 4 years

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