The LEARNING WISDOM Phase II Scale up Project

November 1, 2019 updated by: Patrick Archambault, Laval University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Recruiting
        • Centres intégrés de santé et de services sociaux (CISSS) De Chaudières-Appalaches
        • Contact:
          • Pascal Y Smith, PhD
        • Principal Investigator:
          • Patrick M Archambault, MD, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Phase I-A (Local project set-up)
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.
Experimental: Phase I-B (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.
Behavioral: GEM nurse
hospital-based geriatric emergency nurse (GEM nurse) specialist to support patients during the post-discharge transition period
Behavioral: pre- and post-hospitalization medication list reconciliation
pre- and post-hospitalization medication list reconciliation for elderly
Behavioral: systematic discharge summaries
systematic discharge summaries given to patients and/or caregiver, and sent to their family physician
Behavioral: medical follow-up appointment
a planned follow-up appointment with their family physician
Behavioral: 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
Other: Telemonitoring service
access to a community-based telemonitoring service
Experimental: Phase IC (Study 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.
Behavioral: GEM nurse
hospital-based geriatric emergency nurse (GEM nurse) specialist to support patients during the post-discharge transition period
Behavioral: pre- and post-hospitalization medication list reconciliation
pre- and post-hospitalization medication list reconciliation for elderly
Behavioral: systematic discharge summaries
systematic discharge summaries given to patients and/or caregiver, and sent to their family physician
Behavioral: medical follow-up appointment
a planned follow-up appointment with their family physician
Behavioral: 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
Other: Telemonitoring service
access to a community-based telemonitoring service

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of 30-day hospital readmission
Time Frame: each month during 4 years (48)
Composite endpoint at each month 30-day hospital readmission
each month during 4 years (48)
Change of 30-day ED visit rate
Time Frame: each month during 4 years (48)
Composite endpoint at each month 30-day ED visit rate
each month during 4 years (48)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- change Hospital/ED length of stay - Hospital-level outcome
Time Frame: Each month during 4 years (48)
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)
2- change ED admission rate - Hospital-level outcome
Time Frame: Each month during 4 years (48)
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)
3- Change Alternate level care occupation rate- Hospital-level outcome
Time Frame: Each month during 4 years (48)
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)
4- Change Rate of patients returning to pre-hospital living situation- Hospital-level outcome
Time Frame: Each month during 4 years (48)
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)
Clinicians and decision maker outcomes (Qualitative outcome)
Time Frame: each 3 months, during 4 years (12)
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)
1- Care Transitions Measure (CTM3) - Patient outcome
Time Frame: 48-72 hours post-discharge for 3-item Care Transitions Measure (CTM3)
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)
2- GAI-SC-SF - Patient outcome
Time Frame: within 7 days after post-discharge
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
3- Living situation - Patient outcome
Time Frame: 30 days post-discharge
Living situation will be collected in the medical file when available at 30 days post-discharge.
30 days post-discharge
4- baseline sociodemographic data - Patient outcome
Time Frame: within 7 days after post-discharge
baseline sociodemographic data (age, sex, race, language, education level, family income will be collected.
within 7 days after post-discharge
Caregiver-level outcomes
Time Frame: 7days patient post-discharge
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
1-Clinical-level process outcome - Proportion of patients assigned a GEM Nurse
Time Frame: Process assessment with a monthly Chart audit for 4 years
Proportion of patients assigned a GEM Nurse
Process assessment with a monthly Chart audit for 4 years
2-Clinical-level process outcome - Proportion of patients/caregiver/physician receiving discharge summary
Time Frame: 48 hours post-discharge questionnaire and family physician follow-up phone call
Proportion of patients/caregiver/physician receiving discharge summary
48 hours post-discharge questionnaire and family physician follow-up phone call
3-Clinical-level process outcome - Proportion of medication list reconciliation
Time Frame: monthly Chart audit for 4 years
Proportion of medication list reconciliation
monthly Chart audit for 4 years
4-Clinical-level process outcome - Proportion of patients with physician appointment
Time Frame: Family physician follow-up phone call post-discharge up to 30 days
Proportion of patients with physician appointment
Family physician follow-up phone call post-discharge up to 30 days
5-Clinical-level process outcome - Proportion of patients using telemonitoring
Time Frame: monthly Chart audit for 4 years
Proportion of patients using telemonitoring using Télé-Surveillance Santé Chaudieres-Appalaches (TSS-CA) database
monthly Chart audit for 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Patrick M Archambault, MD, MSc, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Learning Wisdom 2018-462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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