Effectiveness of a Comprehensive Patient-centered Hospital Discharge Planning Intervention for Frail Older Adults

NCT ID: NCT04154917

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2025-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

HOME

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HOME

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Véronique Provencher

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Véronique Provencher

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

CIUSSS de l'Estrie CHUS

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

389430

Identifier Type: -

Identifier Source: org_study_id