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

NCT04154917 | Active Not Recruiting

• 1 other identifier: 389430
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Older Adults

Keywords

Discharge planning; Frail older adults; Comprehensive approach; Patient-centered intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  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")

  1 and 3 months post-discharge

Secondary Outcomes (1)

• Change from baseline Goal attainment scaling (GSA) at 3 months after discharge

  from baseline to 3 months post discharge

Study Arms (2)

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.

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.

Interventions

HOME 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.

Experimental

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

CIUSSS de l'Estrie CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Study Officials

• Véronique Provencher

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 7, 2019
• Study Start: November 7, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)