ComorbidityCASTNCT03157999
Community Assets Supporting Transitions (CAST)
A study testing Intervention group (CAST) in people with Comorbidity and Depressive Symptoms, run by McMaster University at 4 sites in Canada.
Trial summary
The aim of this study is to test a support program for older adults with symptoms of depression and other chronic health problems after they are discharged home from hospital. The study will be conducted in three communities in Ontario (Sudbury, Burlington, and Hamilton) and the program will be implemented with input… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Comorbidity, Depressive Symptoms
- What is being tested?
- Intervention group (CAST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 4 sitesCanada
- Study dates
- 25 Jul 2017to 15 Jun 2020
- 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
- Is an adult, age 65 or older;
- Is planned for discharge from hospital to the community (this includes retirement homes and transitional care beds);
- Self-reports having a diagnosis of at least two chronic conditions;
- Is experiencing depressive symptoms, assessed using the 2-item version of the Patient Health Questionnaire (PHQ-2);
- Lives within one of the study regions (Sudbury, Burlington, or Hamilton), and is not planning to move out of the region during the trial (defined as a one-year period);
- Is capable of providing informed consent, or has a substitute decision-maker who is able to provide informed consent on his/her behalf; and
- Is competent in English, or has an interpreter who is competent in English.
Who cannot join
- Is being discharged from the hospital to a long-term care home or tertiary care.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Joseph Brant Hospital
Burlington, Ontario
Health Sciences North/Laurentian University
Greater Sudbury, Ontario
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
School of Nursing, McMaster University
Hamilton, Ontario, L8N 3Z5
About this study
Official title: A Pragmatic Effectiveness-implementation Trial to Evaluate a Hospital-to-home Transitional Care Intervention Compared to Usual Care for Older Adults With Multiple Chronic Conditions and Depression
The aim of this study is to test a support program for older adults with symptoms of depression and other chronic health problems after they are discharged home from hospital. The study will be conducted in three communities in Ontario (Sudbury, Burlington, and Hamilton) and the program will be implemented with input from community members. The program will be delivered by a Registered Nurse, who will provide support to patients via home visits and telephone calls. The nurse's role will involve linking patients and their caregivers with needed services and supports, reviewing medications that the patients are taking, assessing patients' health, building the skills of patients in problem-solving and managing their care, and providing education to patients and their caregivers.
Read the detailed description
Implementing transitional care interventions for older adults with depressive symptoms and multiple chronic conditions (MCC) is a pressing concern since older adults with depression face persistent health disparities. The Community Assets Supporting Transitions (CAST) research team seeks to address these health inequities, and improve health outcomes in this vulnerable and under-served population by developing and implementing an intervention that will improve patients' self-management ability, support their families and caregivers, and build capacity for primary care and other health and non-health providers to collaborate in delivering home and community services. The proposed study builds on our pilot study that evaluated a nurse-led intervention for older adult home care clients with MCC and depressive symptoms and demonstrated that the intervention was feasible and effective in reducing depressive symptoms.
The overall aim of the study is to improve care transitions in older adults with MCC and depressive symptoms. The project will address three research questions:
- What is the effect of a new, nurse-led hospital-to-home transitional care intervention compared to usual care on health outcomes and costs for older adults with MCC and depressive symptoms?
- How is a care transition intervention adapted and implemented in diverse settings?
- What is required to sustain and scale up the intervention? We hypothesize that the intervention will improve health outcomes and reduce use of expensive health services compared to usual care at no additional cost, from a societal perspective.
- Conditions
- Comorbidity, Depressive Symptoms
- Being tested
- Intervention group (CAST)
- Keywords
- Older Adults, Transitional Care, Caregiver, Intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group (CAST)Behavioural
Intervention duration is expected to be 6 months. A full-time registered nurse (RN) will function as a Care Transitions Coordinator (CTC) who works collaboratively with one local hospital and other health and non-health representatives to deliver the intervention, which includes:
- care coordination and system navigation (including facilitating timely primary care follow-up);
- medication management;
- assessing the needs and risk of the participants (including in-depth assessment of depressive symptoms);
- evidence-based management of depressive symptoms and other chronic conditions to prevent the onset and worsening of other chronic conditions;
- patient and caregiver education; and goal setting and problem-solving therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (CAST) | Experimental | Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care. Receives: Behavioral: Intervention group (CAST) |
| Control group (usual care) | No intervention | Participants assigned to the control group will receive usual care at discharge from hospital to home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mental functioning of the older adult study participant
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary outcomes (12)
Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Measured by the physical component summary (PCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Measured by the Veterans RAND 12 item Health Survey (VR-12).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured by the CESD-10 to determine the presence and severity of depressive symptoms.
Measured: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured by the GAD-7 (24).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable)
As measured by the Modified Caregiver Strain Index
Measured: T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization
Change in utilization of health and social services by the: 1) older adult study participant, 2) family/friend caregiver of the older adult study participant.
As measured by the Health and Social Services Utilization Inventory
Measured: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in utilization of health services by the older adult study participant
As identified through Institute for Clinical Evaluative Sciences (ICES) databases
Measured: T2 = 6 months after randomization; T3 = 12 months after randomization
Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured through the Unmet Care Needs questionnaire (developed using input from patient/caregiver co-researchers to ensure the inclusion of outcomes that are relevant and meaningful to patients and caregivers).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization
Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured through the Patient-Provider Communication (PCC) questionnaire.
Measured: T1 = Baseline data collection; T2 = 6 months after randomization
Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured through the adapted Client-Centred Care Questionnaired (CCCQ).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization
Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured through the adapted Integrated Care Patient-Reported Experience Measures (IC-PREMs).
Measured: T1 = Baseline data collection; T2 = 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start25 Jul 2017
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ComorbidityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study design is a pragmatic randomized controlled trial (RCT). A pragmatic design applies RCT methodology in actual care settings to better inform decisions on the likely benefits, harms, and costs of real world implementation. The design is further classified as a Type II hybrid effectiveness-implementation study, which assigns equal weight to assessing program effectiveness and implementation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Ontario Spor Support Unit, Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Laurentian University, The Labarge Optimal Aging Initiative
- Responsible party
- Principal investigator, Maureen Markle-Reid, McMaster University
- Investigators
- Maureen F Markle-Reid, Ph.D., Principal investigator, McMaster UniversityCarrie McAiney, Ph.D., Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157999
- Sponsor's protocol ID
- RFHSC 2000003756
- Acronym
- CAST
- Status last verified
- Mar 2023
- First submitted
- 12 Apr 2017
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Markle-Reid M, McAiney C, Forbes D, Thabane L, Gibson M, Browne G, Hoch JS, Peirce T, Busing B. An interprofessional nurse-led mental health promotion intervention for older home care clients with depressive symptoms. BMC Geriatr. 2014 May 10;14:62. doi: 10.1186/1471-2318-14-62.
PubMed 24886344Markle-Reid MF, McAiney C, Forbes D, Thabane L, Gibson M, Hoch JS, Browne G, Peirce T, Busing B. Reducing depression in older home care clients: design of a prospective study of a nurse-led interprofessional mental health promotion intervention. BMC Geriatr. 2011 Aug 25;11:50. doi: 10.1186/1471-2318-11-50.
PubMed 21867539Markle-Reid M, McAiney C, Fisher K, Ganann R, Gauthier AP, Heald-Taylor G, McElhaney JE, McMillan F, Petrie P, Ploeg J, Urajnik DJ, Whitmore C. Effectiveness of a nurse-led hospital-to-home transitional care intervention for older adults with multimorbidity and depressive symptoms: A pragmatic randomized controlled trial. PLoS One. 2021 Jul 26;16(7):e0254573. doi: 10.1371/journal.pone.0254573. eCollection 2021.
PubMed 34310640Markle-Reid M, McAiney C, Ganann R, Fisher K, Gafni A, Gauthier AP, Heald-Taylor G, McElhaney J, Ploeg J, Urajnik DJ, Valaitis R, Whitmore C. Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial. BMC Geriatr. 2020 Jul 10;20(1):240. doi: 10.1186/s12877-020-01638-0.
PubMed 32650732
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Effectiveness-implementation Trial to Evaluate a Hospital-to-home Transitional Care Intervention Compared to Usual Care for Older Adults With Multiple Chronic Conditions and Depression
- ClinicalTrials.gov ID
- NCT03157999
- Acronym / sponsor ID
- CAST / RFHSC 2000003756
- Conditions
- Comorbidity, Depressive Symptoms
- Keywords
- Older Adults, Transitional Care, Caregiver, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Ontario Spor Support Unit, Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Laurentian University, The Labarge Optimal Aging Initiative
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 17 May 2017 (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.
The aim of this study is to test a support program for older adults with symptoms of depression and other chronic health problems after they are discharged home from hospital. The study will be conducted in three communities in Ontario (Sudbury, Burlington, and Hamilton) and the program will be implemented with input from community members. The program will be delivered by a Registered Nurse, who will provide support to patients via home visits and telephone calls. The nurse's role will involve linking patients and their caregivers with needed services and supports, reviewing medications that the patients are taking, assessing patients' health, building the skills of patients in problem-solving and managing their care, and providing education to patients and their caregivers.
Detailed description
Implementing transitional care interventions for older adults with depressive symptoms and multiple chronic conditions (MCC) is a pressing concern since older adults with depression face persistent health disparities. The Community Assets Supporting Transitions (CAST) research team seeks to address these health inequities, and improve health outcomes in this vulnerable and under-served population by developing and implementing an intervention that will improve patients' self-management ability, support their families and caregivers, and build capacity for primary care and other health and non-health providers to collaborate in delivering home and community services. The proposed study builds on our pilot study that evaluated a nurse-led intervention for older adult home care clients with MCC and depressive symptoms and demonstrated that the intervention was feasible and effective in reducing depressive symptoms.
The overall aim of the study is to improve care transitions in older adults with MCC and depressive symptoms. The project will address three research questions:
- What is the effect of a new, nurse-led hospital-to-home transitional care intervention compared to usual care on health outcomes and costs for older adults with MCC and depressive symptoms?
- How is a care transition intervention adapted and implemented in diverse settings?
- What is required to sustain and scale up the intervention? We hypothesize that the intervention will improve health outcomes and reduce use of expensive health services compared to usual care at no additional cost, from a societal perspective.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed study design is a pragmatic randomized controlled trial (RCT). A pragmatic design applies RCT methodology in actual care settings to better inform decisions on the likely benefits, harms, and costs of real world implementation. The design is further classified as a Type II hybrid effectiveness-implementation study, which assigns equal weight to assessing program effectiveness and implementation.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (CAST) | Experimental | Behavioral: Intervention group (CAST)Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care. |
| Control group (usual care) | No intervention | –Participants assigned to the control group will receive usual care at discharge from hospital to home. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Is an adult, age 65 or older;
- Is planned for discharge from hospital to the community (this includes retirement homes and transitional care beds);
- Self-reports having a diagnosis of at least two chronic conditions;
- Is experiencing depressive symptoms, assessed using the 2-item version of the Patient Health Questionnaire (PHQ-2);
- Lives within one of the study regions (Sudbury, Burlington, or Hamilton), and is not planning to move out of the region during the trial (defined as a one-year period);
Key exclusion criteria (1 listed)
- Is being discharged from the hospital to a long-term care home or tertiary care.
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 |
|---|---|---|
| Intervention group (CAST)Intervention duration is expected to be 6 months. A full-time registered nurse (RN) will function as a Care Transitions Coordinator (CTC) who works collaboratively with one local hospital and other health and non-health representatives to deliver the intervention, which includes: * care coordination and system navigation (including facilitating timely primary care follow-up); * medication management; * assessing the needs and risk of the participants (including in-depth assessment of depressive symptoms); * evidence-based management of depressive symptoms and other chronic conditions to prevent the onset and worsening of other chronic conditions; * patient and caregiver education; and goal setting and problem-solving therapy. | Behavioural | Intervention group (CAST) |
Primary outcome
Change in mental functioning of the older adult study participant
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
12 secondary outcomes
Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable)
Time frame: T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization
Change in utilization of health and social services by the: 1) older adult study participant, 2) family/friend caregiver of the older adult study participant.
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Change in utilization of health services by the older adult study participant
Time frame: T2 = 6 months after randomization; T3 = 12 months after randomization
Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization
Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization
Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization
Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time frame: T1 = Baseline data collection; T2 = 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 24886344Markle-Reid M, McAiney C, Forbes D, Thabane L, Gibson M, Browne G, Hoch JS, Peirce T, Busing B. An interprofessional nurse-led mental health promotion intervention for older home care clients with depressive symptoms. BMC Geriatr. 2014 May 10;14:62. doi: 10.1186/1471-2318-14-62.
- Background: PubMed 21867539Markle-Reid MF, McAiney C, Forbes D, Thabane L, Gibson M, Hoch JS, Browne G, Peirce T, Busing B. Reducing depression in older home care clients: design of a prospective study of a nurse-led interprofessional mental health promotion intervention. BMC Geriatr. 2011 Aug 25;11:50. doi: 10.1186/1471-2318-11-50.
- Derived from this study: PubMed 34310640Markle-Reid M, McAiney C, Fisher K, Ganann R, Gauthier AP, Heald-Taylor G, McElhaney JE, McMillan F, Petrie P, Ploeg J, Urajnik DJ, Whitmore C. Effectiveness of a nurse-led hospital-to-home transitional care intervention for older adults with multimorbidity and depressive symptoms: A pragmatic randomized controlled trial. PLoS One. 2021 Jul 26;16(7):e0254573. doi: 10.1371/journal.pone.0254573. eCollection 2021.
- Derived from this study: PubMed 32650732Markle-Reid M, McAiney C, Ganann R, Fisher K, Gafni A, Gauthier AP, Heald-Taylor G, McElhaney J, Ploeg J, Urajnik DJ, Valaitis R, Whitmore C. Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial. BMC Geriatr. 2020 Jul 10;20(1):240. doi: 10.1186/s12877-020-01638-0.
- Ontario SPOR support unitLink 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.
Maureen F Markle-Reid, Ph.D. principal investigator
McMaster University
Carrie McAiney, Ph.D. principal investigator
University of Waterloo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group (CAST) in people with Comorbidity and Depressive Symptoms, run by McMaster University at 4 sites in Canada.
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 7 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: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mental functioning of the older adult study participant (time frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization). 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 NCT03157999, which also lists 4 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 23 Mar 2023.