Domiciliary Intervention by Occupational Therapy to Prevent Elderly Rehospitalization

Rehospitalization Clinical Trial

Official title:

Domiciliary Intervention by Occupational Therapy After Hospital Discharge, to Prevent Rehospitalization in Elderly: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052401
• Other study ID #: SA13I20184
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2014
• Last updated: February 1, 2016
• Start date: February 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Comisión Nacional de Investigación Científica y Tecnológica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y TecnológicaChile: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a home visit by an Occupational Therapist is effective in reducing the rehospitalization rates in elderly patients after hospital discharge.

Description:

Introduction: The hospitalization of the elderly is a frequent event that is associated with complications including loss of functionality, which makes it difficult for the person to reinstate to their original context after discharge, increasing the likelihood of rehospitalization.

Objective : To describe and compare the impact of home-based intervention by Occupational Therapists (OT) in the likelihood of rehospitalization at 6 months versus usual care in persons older than 60 years after discharge.

Design : Randomized controlled trial in medical units of the Hospital Clínico de la Universidad de Chile (HCUCh) and Hospital de la Fuerza Aérea de Chile (HFACH)

Patients: Two hundred and six patients aged 60 years or older admitted for acute or decompensated chronic disease to either HCUCH or HFACH, with a life expectancy greater than 6 months, not institutionalized prior to hospitalization or discharge destination , and provided that they have a person of reference after hospital discharge .

Methods: The control group consists of the usual care regarding post discharge patients, in comparison to the experimental group, which , besides the usual discharge plan, considers a home visit from OT on 2 occasions for 6 months, who will apply the following plan of action: Compliance assessment of pharmacological and non-pharmacological indications, applying a checklist of home safety evaluation and structuring of an occupational routine, education of stimulation strategies, education in recognition of warning signs and proper use of health services. Patients will be recruited between 24 and 48 hours prior to hospital discharge where they will be invited to participate. Informed consent will be retrieved, and demographic information of patients and pre- hospitalization functional backgrounds will be collected during this period, and at discharge by means of Barthel Index (independence / dependence in basic activities of daily living (ADL)), Lawton & Brody Scale (ADL instrumental), Questionnaire Pfeffer Functional Activities ( FAQ), Confusion Assessment Method (CAM) (delirium at discharge), Pfeiffer Questionnaire (Short Portable Mental Status Questionnaire: SPMSQ ) (cognition), and Geriatrics Cumulative Illness Rating Scale disease ( CIRS -G) (comorbidity). Both groups will receive telephone follow-up at 4, 12 and 24 weeks after hospital discharge with intent to evaluate functionality and rehospitalization. Allocators, medical team giving hospital discharge, pone interviewers, and data analysts will be blind of the intervention allocation.

Expected Results: the home-based intervention after discharge with OT reduce the rate of rehospitalization in at least 40 % at 6 months in people over 60 years compared with usual care .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age 60 or older

• Living close by to domiciliary intervention occupational therapy team

• Hospitalised in Medical Unit for acute illness or complicated chronic disease

• Presence of a reference individual, over 18 years old, able to understand recommendations, with contact telephone number, and that shares SPENDS at least 20 hours with patient.

• Signed informed consent by patient

Exclusion Criteria:

• Estimated survival under 6 months

• Previous Institutionalisation or defined at discharge

• Reference individual with severe hearing problems that could interfere with telephone communication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rehospitalization

Intervention

Other:
• Domiciliary Intervention
Two time domiciliary application of an standardized protocol consisting of: a) evaluation of pharmacological and non pharmacological therapies adherence. b) application of a Checklist of home safety measures. c) development of a patient oriented occupational routine d) education in strategies for elderly global stimulation e) education strategies for identifying red flags and for correct use of health services.

Locations

Country	Name	City	State
Chile	Hospital Clinico de la Universidad de Chile	Santiago	Region Metropolitana
Chile	Hospital Fuerza Aérea de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Comisión Nacional de Investigación Científica y Tecnológica

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalization Rate		6 months	No