TransitionNCT04093245

The LEARNING WISDOM Phase II Scale up Project

A study testing GEM nurse, pre- and post-hospitalization medication list reconciliation and systematic discharge summaries in people with Transition and Emergencies, run by Laval University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Transition, Emergencies, Health Care Utilization
What is being tested?: GEM nurse, pre- and post-hospitalization medication list reconciliation and systematic discharge summaries
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,000 participants
Where: 1 siteCanada
Study dates: 21 Jan 2019to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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:

Show all 9Show fewer

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

Patrick M Archambault, MD, MSc contact

4188357121 ext. 3905

patrick.m.archambault@gmail.com

Pascal Y Smith, PhD contact

4188357121 ext. 4548

pascalysmith65@gmail.com

Canada1 site, 1 recruiting

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

Other trials in Canada

About this study

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

Read the 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.

Conditions: Transition, Emergencies, Health Care Utilization, Frailty
Being tested: GEM nurse, pre- and post-hospitalization medication list reconciliation, systematic discharge summaries, medical follow-up appointment, follow-up phone call
Keywords: Emergency Department, Care Transition, Elderly Frailty
Medical subject headings: Emergencies, Patient Acceptance of Health Care, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GEM nurseBehavioural
hospital-based geriatric emergency nurse (GEM nurse) specialist to support patients during the post-discharge transition period
pre- and post-hospitalization medication list reconciliationBehavioural
pre- and post-hospitalization medication list reconciliation for elderly
systematic discharge summariesBehavioural
systematic discharge summaries given to patients and/or caregiver, and sent to their family physician
medical follow-up appointmentBehavioural
a planned follow-up appointment with their family physician
follow-up phone callBehavioural
a systematic follow-up phone call for discharged patients
Wiki-based Knowledge toolsOther
access to wiki-based patient-oriented KT tools
Telemonitoring serviceOther
access to a community-based telemonitoring service

Study groups in NCT04093245
Study group	Role	What they receive
Phase I-A (Local project set-up)	No intervention	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.
Phase I-B (Implementation):	Experimental	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. Receives: Behavioral: GEM nurse; Behavioral: pre- and post-hospitalization medication list reconciliation; Behavioral: systematic discharge summaries; Behavioral: medical follow-up appointment; Behavioral: follow-up phone call; Other: Wiki-based Knowledge tools; Other: Telemonitoring service
Phase IC (Study description)	Experimental	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. Receives: Behavioral: GEM nurse; Behavioral: pre- and post-hospitalization medication list reconciliation; Behavioral: systematic discharge summaries; Behavioral: medical follow-up appointment; Behavioral: follow-up phone call; Other: Wiki-based Knowledge tools; Other: Telemonitoring service

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of 30-day hospital readmission
Composite endpoint at each month 30-day hospital readmission
Measured: each month during 4 years (48)
Change of 30-day ED visit rate
Composite endpoint at each month 30-day ED visit rate
Measured: each month during 4 years (48)

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 201931 Dec 2022

First posted17 Sep 2019
Study start21 Jan 2019
Primary completion31 Dec 2021 (estimated)
Study completion31 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (86)Papers the sponsor has linked to this study.
Other trials for TransitionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 4,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04093245
Sponsor's protocol ID: Learning Wisdom 2018-462
Status last verified: Nov 2019
First submitted: 9 Sep 2019
Last updated: 5 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sinha SK, Oakes SL, Chaudhry S, Suh TT. How to Use the ACE Unit to Improve Hospital Safety and Quality for Older Patients: From ACE Units to Elder-Friendly Hospitals. Acute Care for Elders. 2014. pp. 131-156. doi:10.1007/978-1-4939-1025-0_8
Sirois MJ, Emond M, Ouellet MC, Perry J, Daoust R, Morin J, Dionne C, Camden S, Moore L, Allain-Boule N. Cumulative incidence of functional decline after minor injuries in previously independent older Canadian individuals in the emergency department. J Am Geriatr Soc. 2013 Oct;61(10):1661-8. doi: 10.1111/jgs.12482.
PubMed 24117285
Reid RC, Cummings GE, Cooper SL, Abel SL, Bissell LJ, Estabrooks CA, Rowe BH, Wagg A, Norton PG, Ertel M, Cummings GG. The Older Persons' Transitions in Care (OPTIC) study: pilot testing of the transition tracking tool. BMC Health Serv Res. 2013 Dec 14;13:515. doi: 10.1186/1472-6963-13-515.
PubMed 24330805
Osborn R, Moulds D, Squires D, Doty MM, Anderson C. International survey of older adults finds shortcomings in access, coordination, and patient-centered care. Health Aff (Millwood). 2014 Dec;33(12):2247-55. doi: 10.1377/hlthaff.2014.0947. Epub 2014 Nov 19.
PubMed 25410260
Dubuc N, Dubois MF, Raiche M, Gueye NR, Hebert R. Meeting the home-care needs of disabled older persons living in the community: does integrated services delivery make a difference? BMC Geriatr. 2011 Oct 26;11:67. doi: 10.1186/1471-2318-11-67.
PubMed 22029878
Levesque JF, Pineault R, Hamel M, Roberge D, Kapetanakis C, Simard B, Prud'homme A. Emerging organisational models of primary healthcare and unmet needs for care: insights from a population-based survey in Quebec province. BMC Fam Pract. 2012 Jul 2;13:66. doi: 10.1186/1471-2296-13-66.
PubMed 22748060
van Walraven C, Taljaard M, Bell CM, Etchells E, Stiell IG, Zarnke K, Forster AJ. A prospective cohort study found that provider and information continuity was low after patient discharge from hospital. J Clin Epidemiol. 2010 Sep;63(9):1000-10. doi: 10.1016/j.jclinepi.2010.01.023.
PubMed 20656194
Haggerty JL, Reid RJ, Freeman GK, Starfield BH, Adair CE, McKendry R. Continuity of care: a multidisciplinary review. BMJ. 2003 Nov 22;327(7425):1219-21. doi: 10.1136/bmj.327.7425.1219.
PubMed 14630762
Trahan LM, Spiers JA, Cummings GG. Decisions to Transfer Nursing Home Residents to Emergency Departments: A Scoping Review of Contributing Factors and Staff Perspectives. J Am Med Dir Assoc. 2016 Nov 1;17(11):994-1005. doi: 10.1016/j.jamda.2016.05.012. Epub 2016 Jun 24.
PubMed 27349625
Dhalla IA, O'Brien T, Ko F, Laupacis A. Toward safer transitions: how can we reduce post-discharge adverse events? Healthc Q. 2012;15 Spec No:63-7. doi: 10.12927/hcq.2012.22839. No abstract available.
PubMed 22874449
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
PubMed 12558354
Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development and testing of a measure designed to assess the quality of care transitions. Int J Integr Care. 2002;2:e02. doi: 10.5334/ijic.60. Epub 2002 Jun 1.
PubMed 16896392
Harrison A, Verhoef M. Understanding coordination of care from the consumer's perspective in a regional health system. Health Serv Res. 2002 Aug;37(4):1031-54. doi: 10.1034/j.1600-0560.2002.64.x.
PubMed 12236382
Weaver FM, Perloff L, Waters T. Patients' and caregivers' transition from hospital to home: needs and recommendations. Home Health Care Serv Q. 1998;17(3):27-48. doi: 10.1300/j027v17n03_03.
PubMed 10351068
Beers MH, Sliwkowski J, Brooks J. Compliance with medication orders among the elderly after hospital discharge. Hosp Formul. 1992 Jul;27(7):720-4.
PubMed 10119187

Want to know more?

Patrick M Archambault, MD, MSc

4188357121 ext. 3905

patrick.m.archambault@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04093245
Acronym / sponsor ID: Learning Wisdom 2018-462
Conditions: Transition, Emergencies, Health Care Utilization, Frailty
Keywords: Emergency Department, Care Transition, Elderly Frailty
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 4,000 participants (estimated)
Lead sponsor: Laval UniversityUniversity, hospital or other
Study start: 21 Jan 2019 (actual)
Primary completion: 31 Dec 2021 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 17 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase I-A (Local project set-up)	No intervention	–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.
Phase I-B (Implementation):	Experimental	Behavioral: GEM nurse, Behavioral: pre- and post-hospitalization medication list reconciliation, Behavioral: systematic discharge summaries, Behavioral: medical follow-up appointment, Behavioral: follow-up phone call, Other: Wiki-based Knowledge tools, Other: Telemonitoring serviceThe 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.
Phase IC (Study description)	Experimental	Behavioral: GEM nurse, Behavioral: pre- and post-hospitalization medication list reconciliation, Behavioral: systematic discharge summaries, Behavioral: medical follow-up appointment, Behavioral: follow-up phone call, Other: Wiki-based Knowledge tools, Other: Telemonitoring serviceResults 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (9 listed)

aged ≥ 65 years
be discharged from the ED
able to understand and read French
able to give informed consent
identified by the patients themselves

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GEM nursehospital-based geriatric emergency nurse (GEM nurse) specialist to support patients during the post-discharge transition period	Behavioural	Phase I-B (Implementation):, Phase IC (Study description)
pre- and post-hospitalization medication list reconciliationpre- and post-hospitalization medication list reconciliation for elderly	Behavioural	Phase I-B (Implementation):, Phase IC (Study description)
systematic discharge summariessystematic discharge summaries given to patients and/or caregiver, and sent to their family physician	Behavioural	Phase I-B (Implementation):, Phase IC (Study description)
medical follow-up appointmenta planned follow-up appointment with their family physician	Behavioural	Phase I-B (Implementation):, Phase IC (Study description)
follow-up phone calla systematic follow-up phone call for discharged patients	Behavioural	Phase I-B (Implementation):, Phase IC (Study description)
Wiki-based Knowledge toolsaccess to wiki-based patient-oriented KT tools	Other	Phase I-B (Implementation):, Phase IC (Study description)
Telemonitoring serviceaccess to a community-based telemonitoring service	Other	Phase I-B (Implementation):, Phase IC (Study description)

Primary outcome

Change of 30-day hospital readmission
Time frame: each month during 4 years (48)
Composite endpoint at each month 30-day hospital readmission
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

15 secondary outcomes

1- change Hospital/ED length of stay - Hospital-level outcome
Time frame: Each month during 4 years (48)
2- change ED admission rate - Hospital-level outcome
Time frame: Each month during 4 years (48)
3- Change Alternate level care occupation rate- Hospital-level outcome
Time frame: 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)
Clinicians and decision maker outcomes (Qualitative outcome)
Time frame: 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)
2- GAI-SC-SF - Patient outcome
Time frame: within 7 days after post-discharge
3- Living situation - Patient outcome
Time frame: 30 days post-discharge
4- baseline sociodemographic data - Patient outcome
Time frame: within 7 days after post-discharge
Caregiver-level outcomes
Time frame: 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
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
3-Clinical-level process outcome - Proportion of medication list reconciliation
Time frame: 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
5-Clinical-level process outcome - Proportion of patients using telemonitoring
Time frame: monthly Chart audit for 4 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
BackgroundSinha SK, Oakes SL, Chaudhry S, Suh TT. How to Use the ACE Unit to Improve Hospital Safety and Quality for Older Patients: From ACE Units to Elder-Friendly Hospitals. Acute Care for Elders. 2014. pp. 131-156. doi:10.1007/978-1-4939-1025-0_8
Background: PubMed 24117285Sirois MJ, Emond M, Ouellet MC, Perry J, Daoust R, Morin J, Dionne C, Camden S, Moore L, Allain-Boule N. Cumulative incidence of functional decline after minor injuries in previously independent older Canadian individuals in the emergency department. J Am Geriatr Soc. 2013 Oct;61(10):1661-8. doi: 10.1111/jgs.12482.
Background: PubMed 24330805Reid RC, Cummings GE, Cooper SL, Abel SL, Bissell LJ, Estabrooks CA, Rowe BH, Wagg A, Norton PG, Ertel M, Cummings GG. The Older Persons' Transitions in Care (OPTIC) study: pilot testing of the transition tracking tool. BMC Health Serv Res. 2013 Dec 14;13:515. doi: 10.1186/1472-6963-13-515.
Background: PubMed 25410260Osborn R, Moulds D, Squires D, Doty MM, Anderson C. International survey of older adults finds shortcomings in access, coordination, and patient-centered care. Health Aff (Millwood). 2014 Dec;33(12):2247-55. doi: 10.1377/hlthaff.2014.0947. Epub 2014 Nov 19.
Background: PubMed 22029878Dubuc N, Dubois MF, Raiche M, Gueye NR, Hebert R. Meeting the home-care needs of disabled older persons living in the community: does integrated services delivery make a difference? BMC Geriatr. 2011 Oct 26;11:67. doi: 10.1186/1471-2318-11-67.
Background: PubMed 22748060Levesque JF, Pineault R, Hamel M, Roberge D, Kapetanakis C, Simard B, Prud'homme A. Emerging organisational models of primary healthcare and unmet needs for care: insights from a population-based survey in Quebec province. BMC Fam Pract. 2012 Jul 2;13:66. doi: 10.1186/1471-2296-13-66.
Background: PubMed 20656194van Walraven C, Taljaard M, Bell CM, Etchells E, Stiell IG, Zarnke K, Forster AJ. A prospective cohort study found that provider and information continuity was low after patient discharge from hospital. J Clin Epidemiol. 2010 Sep;63(9):1000-10. doi: 10.1016/j.jclinepi.2010.01.023.
Background: PubMed 14630762Haggerty JL, Reid RJ, Freeman GK, Starfield BH, Adair CE, McKendry R. Continuity of care: a multidisciplinary review. BMJ. 2003 Nov 22;327(7425):1219-21. doi: 10.1136/bmj.327.7425.1219.
Background: PubMed 27349625Trahan LM, Spiers JA, Cummings GG. Decisions to Transfer Nursing Home Residents to Emergency Departments: A Scoping Review of Contributing Factors and Staff Perspectives. J Am Med Dir Assoc. 2016 Nov 1;17(11):994-1005. doi: 10.1016/j.jamda.2016.05.012. Epub 2016 Jun 24.
Background: PubMed 22874449Dhalla IA, O'Brien T, Ko F, Laupacis A. Toward safer transitions: how can we reduce post-discharge adverse events? Healthc Q. 2012;15 Spec No:63-7. doi: 10.12927/hcq.2012.22839. No abstract available.
Background: PubMed 12558354Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
Background: PubMed 16896392Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development and testing of a measure designed to assess the quality of care transitions. Int J Integr Care. 2002;2:e02. doi: 10.5334/ijic.60. Epub 2002 Jun 1.
The Daily - Canada's population estimates: Age and sex, July 1, 2015 \[Internet\]. 29 Sep 2015 \[cited 5 Oct 2016\].Link provided by the sponsor.
Committee on the Learning Health Care System in America, Institute of Medicine. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America \[Internet\].Link provided by the sponsor.
Cummings GG E al. Older Persons' Transitions in Care (OPTIC): a study protocol. - PubMed - NCBI \[Internet\]. \[cited 19 Oct 2016\]Link provided by the sponsor.
Neiterman E E al. Experiences of older adults in transition from hospital to community. - PubMed - NCBI \[Internet\]. \[cited 19 Oct 2016\]Link provided by the sponsor.
Mount Sinai first in Canada to Achieve Magnet® Recognition for Nursing Excellence and Patient Care - Mount Sinai Hospital - Toronto \[Internet\]. \[cited 16 Oct 2016\]Link provided by the sponsor.
Projet de loi n°10 : Loi modifiant l'organisation et la gouvernance du réseau de la santé et des services sociaux notamment par l'abolition des agences régionales - Assemblée nationale du Québec \[Internet\]. \[cited 15 Oct 2016\]Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick M Archambault, MD, MSc contact

4188357121 ext. 3905

patrick.m.archambault@gmail.com

Pascal Y Smith, PhD contact

4188357121 ext. 4548

pascalysmith65@gmail.com

Patrick M Archambault, MD, MSc principal investigator

Laval University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick M Archambault, MD, MSc (4188357121 ext. 3905, patrick.m.archambault@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of 30-day hospital readmission (time frame: each month during 4 years (48)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04093245, which also lists 86 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.