Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04154917 |
| Other study ID # |
389430 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 7, 2019 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Université de Sherbrooke |
| Contact |
Véronique Provencher |
| Phone |
819-780-2220 |
| Email |
veronique.provencher[@]usherbrooke.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
