Effectiveness of a Comprehensive Patient-centered Hospital Discharge Planning Intervention for Frail Older Adults (HOME)
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|ClinicalTrials.gov Identifier: NCT04154917|
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Frail Older Adults||Other: HOME||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||November 7, 2019|
|Estimated Primary Completion Date :||November 6, 2020|
|Estimated Study Completion Date :||April 30, 2021|
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.
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.
No Intervention: Usual care
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.
- 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")
- Change from baseline Goal attainment scaling (GSA) at 3 months after discharge [ Time Frame: from baseline to 3 months post 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154917
|Contact: Véronique Provencher||819-780-2220 ext firstname.lastname@example.org|
|Principal Investigator:||Véronique Provencher||Université de Sherbrooke|