Frail Older AdultsHOMENCT04154917
Effectiveness of a Comprehensive Patient-centered Hospital Discharge Planning Intervention for Frail Older Adults
A study testing HOME in people with Frail Older Adults, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
A large number of frail older adults have difficulty performing activities of daily living and resuming former roles in the months following hospital discharge. This increases the risk of unplanned hospital readmissions and emergency visits after they return home. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Older Adults
- What is being tested?
- HOME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years or older
- have mild cognitive impairment (MoCA range score: 20-26)
- are expected to return to live in the community after discharge
- are conversant in French or English
- expected hospital stay should be > or = 5 days
- should have a family member who agrees to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of a Comprehensive, Patient-centered Hospital Discharge Planning Intervention (HOME) for Frail Older Adults: Feasibility Study for a Large Mixed-method Randomized Pragmatic Trial
A large number of frail older adults have difficulty performing activities of daily living and resuming former roles in the months following hospital discharge. This increases the risk of unplanned hospital readmissions and emergency visits after they return home. Comprehensive, patient-centered discharge planning has been reported to improve older adults' ability to perform activities of daily living and to reduce readmission rates after hospital discharge. However, to our knowledge, no evidence-based discharge protocol is routinely used in Canada with the frail population. An innovative discharge planning intervention called "HOME" was recently developed in Australia, which includes: 1) hospital based partnership with patient and family to establish goal setting and problem solving; 2) pre-discharge home assessment to address safety issues and problems with patient and family; 3) post-discharge home assessment and in-home training to address unmet needs; and 4) follow-up telephone calls to provide ongoing support to patient and family. A Canadian version of HOME has been developed. This will be followed by a large trial to investigate if this intervention increases functioning in daily life activities and decreases hospital and emergency readmissions for frail patients who are discharged home. Our proposed study is a preliminary and necessary step to identify problems that may arise during this large trial and address them proactively. If proven beneficial, the Canadian version of HOME would be an appropriate, applicable and acceptable intervention to improve patients' experiences and outcomes as well as change health practice surroundings discharge planning with frail older adults.
Read the detailed description
Up to 31% of frail patients are readmitted to hospital within 30 days post-discharge. Unmet needs related to new difficulties in performing activities of daily living (ADL) upon returning home increase their risk of readmission. Comprehensive, patient-centered discharge planning has been reported to improve older adults' ability to perform ADL and to reduce readmission rates. To our knowledge, no such evidence-based discharge protocol is routinely used in Canada with the frail population.
An innovative discharge planning protocol called "HOME" was recently developed in Australia and a randomized controlled trial (RCT) was conducted in a large sample of older adults in this country. The HOME intervention includes: 1-hospital-based partnership with patient and family to establish goal setting and problem solving; 2-pre-discharge home assessment to address safety issues and problems with patient and family; 3-post-discharge home assessment training to address unmet needs; and 4-Follow-up telephone calls to provide ongoing support to patient and family. Using the HOME protocol in a real-world Canadian context is expected to yield positive functional and clinical outcomes for this population. This hypothesis needs to be verified through a full-scale pragmatic mixed-method (qualitative and quantitative) RCT. This innovative method supports the integration of research into care and increase understanding of the results. Given the changes we are making to the Australian design and the different context in which the research will be done, a feasibility study will first be conducted to help circumvent problems that may arise during the full-scale RCT. Thus this study aims to assess the feasibility of conducting a fully powered multi-site, pragmatic, mixed-method RCT that will evaluate the comparative effectiveness of a Canadian version of HOME with respect to (a) functional outcomes: independence in ADL and functional goal attainment; and (b) clinical outcomes: unplanned hospital readmissions and emergency department visits.
A pragmatic pilot RCT using a rater-blinded mixed-method design will be conducted over a 2-year period. Seventy-two frail hospitalized older adults will be consecutively recruited in Sherbrooke (Quebec). Participants will be randomly allocated to the intervention group (HOME) or the control group (customary in-hospital care). Feasibility data, including recruitment and retention rates, will be collected. Quantitative methods will be used to explore the effect of the HOME intervention on (a) functional outcomes, measured by the Functional Autonomy Measurement System and the Goal Attainment Scale, and (b) clinical outcomes based on medical chart data reviews. A qualitative method embedded in the RCT will be used to explore how the intervention is experienced by clinicians, patients and families to plan further refinements. Measures will be taken at baseline, 1 and 3 months post-discharge.
With the participation of the Australian research team and a network of patient-caregiver representatives, clinicians, and key policy makers (e.g., Quebec Ministry of Health), this study will provide clinically-relevant results to support the full-scale RCT. By providing evidence on the effectiveness, benefits and potential drawbacks in a real-world context of the two options (HOME vs customary care), findings from this RCT will help stakeholders make decisions about the best way of delivering discharge planning care for frail patients.
- Conditions
- Frail Older Adults
- Being tested
- HOME
- Keywords
- Discharge planning, Frail older adults, Comprehensive approach, Patient-centered intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMEOther
HOME's focus is on the person's functional ability, safety and transition from hospital to home. HOME will be delivered by a community-based clinician (OT who will be involved in the hospital discharge planning) trained by the PI. Training will include two sessions covering assessment of functional ability, goal setting and home safety. The clinician will keep a record of recommendations provided, length of home visit and any adverse events during the intervention. Twice over the course of the study, the PI leader will observe the clinician conducting HOME interventions to assess adherence to the study protocol using a fidelity checklist. The HOME intervention comprises 4 phases, which are described in the arms section.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HOME will be delivered by a community-based OT, who will be involved in the hospital discharge planning, trained by the PI. The HOME intervention comprises 4 phases: Phase 1 (in hospital): The clinician will focus on building a rapport with the patient and family members. Information will be gathered about the participant's home environment and functional ability. Phase 2 (± 5 days prior to expected discharge): Clinician will conduct a pre-discharge home assessment with patient and family to evaluate the environment, identify potential problems, and suggest appropriate ways to address them. Phase 3 (<1 week after discharge): Post-discharge home assessment will be conducted to provide additional in-home training and follow up on any of the patient's unmet needs. Phase 4 (2-4 weeks post-discharge): Follow-up telephone calls will be made to provide ongoing support to participant and family and encourage self-problem solving and independence. Receives: Other: HOME |
| Usual care | No intervention | Usual care group will receive the customary discharge planning assessment by a different clinician (OT). During this assessment, according to usual care, information regarding the participants' ability to perform activities of daily living and regarding their home environment is gathered and used to plan for discharge. Usual care group will not receive an OT home assessment as this is not part of usual care. If the clinician identifies a potential need for assistive equipment and home modification needs, patients will be referred to community-based homecare services as is the current practice, and a home visit may be performed following discharge, typically after an lengthy wait (weeks, months) for service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Functional autonomy measure (SMAF) at 1 and 3 months after discharge
SMAF is a 29-item scale based on the WHO Classification of Disabilities. It measures functional ability in five areas: ADL (7 items), mobility (6 items), communication (3 items), mental functions (5 items), and IADL (8 items). Each item is scored from 0 (independent) to 3 (dependent) for a maximum total score of 87. A change of ≥5 points is considered clinically significant.
Measured: in the hospital at baseline (T1); at the patient's home 1 month (T2) and 3 months (T3) after discharge
Change in Unplanned hospital readmissions at 1 and 3 months after discharge
Unplanned hospital readmissions will be collected through chart reviews via the Ariane database. Readmissions will be classified as unplanned based on the medical ICD010-OMS classification ("avoidable incidents")
Measured: 1 and 3 months post-discharge
Secondary outcomes (1)
Change from baseline Goal attainment scaling (GSA) at 3 months after discharge
GAS is a personalized outcome measure involving i) setting goals according to one's own needs prior to the start of the intervention, ii) implementing the intervention, and iii) evaluating progress following the intervention.
Measured: from baseline to 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start7 Nov 2019
- Primary completion30 Dec 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Older AdultsStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A feasibility study including a pragmatic, rater-blinded, mixed-method pilot RCT will be conducted over a 2 year-period to prepare for our large-scale planned study design. 72 frail older adults will be consecutively recruited from 2 acute care wards (geriatric and medicine units) in a hospital located in a semi-urban area (Sherbrooke, Quebec). Participants will be randomly assigned to receive HOME (experimental; n=36) or customary discharge planning (control; n=36). The number of participants is achievable within the time frame as, based the number of beds and average length of stay, approximately 1200 potential eligible patients are admitted yearly. This number (n=72) would make it possible to detect a large effect size, based on calculation for primary outcomes (α = 0.05; power = 80%) and the expected dropout rate (a ≈ 16-20%). Randomization will occur after baseline assessment using randomly generated numbers provided by a statistician not involved in data collection.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Véronique Provencher, Université de Sherbrooke
- Investigators
- Véronique Provencher, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154917
- Sponsor's protocol ID
- 389430
- Acronym
- HOME
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of a Comprehensive, Patient-centered Hospital Discharge Planning Intervention (HOME) for Frail Older Adults: Feasibility Study for a Large Mixed-method Randomized Pragmatic Trial
- ClinicalTrials.gov ID
- NCT04154917
- Acronym / sponsor ID
- HOME / 389430
- Conditions
- Frail Older Adults
- Keywords
- Discharge planning, Frail older adults, Comprehensive approach, Patient-centered intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Nov 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.
A large number of frail older adults have difficulty performing activities of daily living and resuming former roles in the months following hospital discharge. This increases the risk of unplanned hospital readmissions and emergency visits after they return home. Comprehensive, patient-centered discharge planning has been reported to improve older adults' ability to perform activities of daily living and to reduce readmission rates after hospital discharge. However, to our knowledge, no evidence-based discharge protocol is routinely used in Canada with the frail population. An innovative discharge planning intervention called "HOME" was recently developed in Australia, which includes: 1) hospital based partnership with patient and family to establish goal setting and problem solving; 2) pre-discharge home assessment to address safety issues and problems with patient and family; 3) post-discharge home assessment and in-home training to address unmet needs; and 4) follow-up telephone calls to provide ongoing support to patient and family. A Canadian version of HOME has been developed. This will be followed by a large trial to investigate if this intervention increases functioning in daily life activities and decreases hospital and emergency readmissions for frail patients who are discharged home. Our proposed study is a preliminary and necessary step to identify problems that may arise during this large trial and address them proactively. If proven beneficial, the Canadian version of HOME would be an appropriate, applicable and acceptable intervention to improve patients' experiences and outcomes as well as change health practice surroundings discharge planning with frail older adults.
Detailed description
Up to 31% of frail patients are readmitted to hospital within 30 days post-discharge. Unmet needs related to new difficulties in performing activities of daily living (ADL) upon returning home increase their risk of readmission. Comprehensive, patient-centered discharge planning has been reported to improve older adults' ability to perform ADL and to reduce readmission rates. To our knowledge, no such evidence-based discharge protocol is routinely used in Canada with the frail population.
An innovative discharge planning protocol called "HOME" was recently developed in Australia and a randomized controlled trial (RCT) was conducted in a large sample of older adults in this country. The HOME intervention includes: 1-hospital-based partnership with patient and family to establish goal setting and problem solving; 2-pre-discharge home assessment to address safety issues and problems with patient and family; 3-post-discharge home assessment training to address unmet needs; and 4-Follow-up telephone calls to provide ongoing support to patient and family. Using the HOME protocol in a real-world Canadian context is expected to yield positive functional and clinical outcomes for this population. This hypothesis needs to be verified through a full-scale pragmatic mixed-method (qualitative and quantitative) RCT. This innovative method supports the integration of research into care and increase understanding of the results. Given the changes we are making to the Australian design and the different context in which the research will be done, a feasibility study will first be conducted to help circumvent problems that may arise during the full-scale RCT. Thus this study aims to assess the feasibility of conducting a fully powered multi-site, pragmatic, mixed-method RCT that will evaluate the comparative effectiveness of a Canadian version of HOME with respect to (a) functional outcomes: independence in ADL and functional goal attainment; and (b) clinical outcomes: unplanned hospital readmissions and emergency department visits.
A pragmatic pilot RCT using a rater-blinded mixed-method design will be conducted over a 2-year period. Seventy-two frail hospitalized older adults will be consecutively recruited in Sherbrooke (Quebec). Participants will be randomly allocated to the intervention group (HOME) or the control group (customary in-hospital care). Feasibility data, including recruitment and retention rates, will be collected. Quantitative methods will be used to explore the effect of the HOME intervention on (a) functional outcomes, measured by the Functional Autonomy Measurement System and the Goal Attainment Scale, and (b) clinical outcomes based on medical chart data reviews. A qualitative method embedded in the RCT will be used to explore how the intervention is experienced by clinicians, patients and families to plan further refinements. Measures will be taken at baseline, 1 and 3 months post-discharge.
With the participation of the Australian research team and a network of patient-caregiver representatives, clinicians, and key policy makers (e.g., Quebec Ministry of Health), this study will provide clinically-relevant results to support the full-scale RCT. By providing evidence on the effectiveness, benefits and potential drawbacks in a real-world context of the two options (HOME vs customary care), findings from this RCT will help stakeholders make decisions about the best way of delivering discharge planning care for frail patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A feasibility study including a pragmatic, rater-blinded, mixed-method pilot RCT will be conducted over a 2 year-period to prepare for our large-scale planned study design. 72 frail older adults will be consecutively recruited from 2 acute care wards (geriatric and medicine units) in a hospital located in a semi-urban area (Sherbrooke, Quebec). Participants will be randomly assigned to receive HOME (experimental; n=36) or customary discharge planning (control; n=36). The number of participants is achievable within the time frame as, based the number of beds and average length of stay, approximately 1200 potential eligible patients are admitted yearly. This number (n=72) would make it possible to detect a large effect size, based on calculation for primary outcomes (α = 0.05; power = 80%) and the expected dropout rate (a ≈ 16-20%). Randomization will occur after baseline assessment using randomly generated numbers provided by a statistician not involved in data collection.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: HOMEHOME will be delivered by a community-based OT, who will be involved in the hospital discharge planning, trained by the PI. The HOME intervention comprises 4 phases: Phase 1 (in hospital): The clinician will focus on building a rapport with the patient and family members. Information will be gathered about the participant's home environment and functional ability. Phase 2 (± 5 days prior to expected discharge): Clinician will conduct a pre-discharge home assessment with patient and family to evaluate the environment, identify potential problems, and suggest appropriate ways to address them. Phase 3 (<1 week after discharge): Post-discharge home assessment will be conducted to provide additional in-home training and follow up on any of the patient's unmet needs. Phase 4 (2-4 weeks post-discharge): Follow-up telephone calls will be made to provide ongoing support to participant and family and encourage self-problem solving and independence. |
| Usual care | No intervention | –Usual care group will receive the customary discharge planning assessment by a different clinician (OT). During this assessment, according to usual care, information regarding the participants' ability to perform activities of daily living and regarding their home environment is gathered and used to plan for discharge. Usual care group will not receive an OT home assessment as this is not part of usual care. If the clinician identifies a potential need for assistive equipment and home modification needs, patients will be referred to community-based homecare services as is the current practice, and a home visit may be performed following discharge, typically after an lengthy wait (weeks, months) for service. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 70 years or older
- have mild cognitive impairment (MoCA range score: 20-26)
- are expected to return to live in the community after discharge
- are conversant in French or English
- expected hospital stay should be > or = 5 days
Key exclusion criteria (0 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 |
|---|---|---|
| HOMEHOME's focus is on the person's functional ability, safety and transition from hospital to home. HOME will be delivered by a community-based clinician (OT who will be involved in the hospital discharge planning) trained by the PI. Training will include two sessions covering assessment of functional ability, goal setting and home safety. The clinician will keep a record of recommendations provided, length of home visit and any adverse events during the intervention. Twice over the course of the study, the PI leader will observe the clinician conducting HOME interventions to assess adherence to the study protocol using a fidelity checklist. The HOME intervention comprises 4 phases, which are described in the arms section. | Other | Experimental |
Primary outcome
Change from baseline Functional autonomy measure (SMAF) at 1 and 3 months after discharge
Time frame: in the hospital at baseline (T1); at the patient's home 1 month (T2) and 3 months (T3) after discharge
SMAF is a 29-item scale based on the WHO Classification of Disabilities. It measures functional ability in five areas: ADL (7 items), mobility (6 items), communication (3 items), mental functions (5 items), and IADL (8 items). Each item is scored from 0 (independent) to 3 (dependent) for a maximum total score of 87. A change of ≥5 points is considered clinically significant.
Change in Unplanned hospital readmissions at 1 and 3 months after discharge
Time frame: 1 and 3 months post-discharge
Unplanned hospital readmissions will be collected through chart reviews via the Ariane database. Readmissions will be classified as unplanned based on the medical ICD010-OMS classification ("avoidable incidents")
1 secondary outcome
Change from baseline Goal attainment scaling (GSA) at 3 months after discharge
Time frame: from baseline to 3 months post discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Frail Older Adults
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
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.
Véronique Provencher principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOME in people with Frail Older Adults, run by Université de Sherbrooke at 1 site 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 6 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 from baseline Functional autonomy measure (SMAF) at 1 and 3 months after discharge (time frame: in the hospital at baseline (T1); at the patient's home 1 month (T2) and 3 months (T3) after discharge). 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?
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 30 Mar 2025.