Condition category
Not Applicable
Date applied
01/09/2005
Date assigned
01/03/2006
Last edited
14/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sharon Straus

ORCID ID

Contact details

Toronto Western Hospital
399 Bathurst street
Toronto
M5T 2S8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

138311

Study information

Scientific title

Acronym

Study hypothesis

This project proposes to develop, implement and evaluate the model of using a discharge planner to facilitate the transition between hospital and home on a general medical in-patient unit at a university-affiliated hospital. Development of the intervention will require exploration of what behavioural and organisational factors facilitate implementation of the intervention. Evaluation will include assessment of the impact of this intervention on the quality of care including adherence to discharge plans (attendance at follow-up appointments, completion of follow-up tests), readmission, adverse events, length of stay, patient satisfaction, and mortality. While a composite endpoint reflecting quality of care will be used, the relationship between the intervention and each component outcome will be explored to assist in determining appropriate outcome(s) for further evaluation of this intervention.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Continuity of care from hospital to home

Intervention

Only patients who have been admitted as an in-patient with a diagnosis of acute coronary syndrome, congestive heart failure, pneumonia, exacerbation of chronic obstructive airways disease, falls, or confusion will be approached to participate.

During the intervention phase, patients admitted to a general medical in-patient unit at the Toronto Western Hospital with one of the six common medical diagnoses noted above will be randomly allocated either to receive care from a discharge coordinator or to usual care.

Computer generated randomisation will be used in blocks of six and randomisation will be stratified by living arrangements (e.g. from long-term care facility or independent living accommodation) and by ability to speak English. Randomisation is being used because one discharge coordinator would not be able to provide care for all eligible patients and it is unclear from the literature how this intervention should be targeted. Allocation will be concealed.

All four Clinical Teaching Units (CTUs) at this hospital will participate in this study. Letters inviting participation in this study will be sent from the General Internal Medicine Program Director to all medicine residents assigned to the CTUs during the study period. Letters of invitation will also be sent from the General Internal Medicine Division Director to all staff physicians who will be attending on the medicine CTUs during the study period. Notification of the study will be provided to all members of the health care teams on the medical wards.

The research assistant will continue to attend bullet rounds each morning to identify eligible patients. The discharge coordinator will only be present from 9 am to 5 pm on Monday to Friday. Once eligible patients are identified, a research assistant will approach them for consent to participate as outlined above. If patients agree to participate, baseline demographics will be obtained. We will also attempt to collect baseline information from patients who decline the invitation to participate in the trial and determine why they are not interested in participating in the study. Once the consent has been obtained, the patient will be randomised and the discharge coordinator will be notified by the research assistant if the patient has been allocated to that intervention.

Discharge planning should include assessment, planning, implementation and monitoring phases. Those patients assigned to the discharge coordinator will receive an assessment of their supports, financial situation, living situation, medical and functional status. Data collection forms that will be used were developed in consultation with a former case manager on a neurosurgical unit and members of the allied health care team. Functional status will be assessed using the Barthel Index. Elicitation of this information will be done in collaboration with the patient; their caregivers, physicians, social workers, physiotherapists, occupational therapists, pharmacists, nurses and home care coordinators.

The discharge coordinator will work with the patient and health care team (including the home care coordinator) to identify a discharge date, and to coordinate supports, medications, follow-up tests and appointments upon discharge. Information about the diagnosis and ongoing management of the patients will be shared with the patient and their caregivers and with their family physician who will provide ongoing care.

Colleagues with expertise in human factors engineering and the development of consumer educational materials will assist in the preparation of the patient-centred materials. Patient materials will also be translated into Cantonese and Portuguese, reflecting the multicultural mix of patients admitted to the Toronto Western Hospital. This will be done to ensure that both written and verbal information is provided to patients.

The discharge coordinator will prepare the discharge summary with the physician responsible for caring for the patient focusing on the list of medications, and a description of the management plan in hospital and after discharge. The discharge coordinator will also coordinate arrangements for homecare and will disseminate relevant information about the discharge plan to the patient, caregiver, attending physician, medical house-staff and family physician. They will also provide a follow-up telephone call to the patient 48 hours and two weeks after discharge to determine if any medical issues have arisen that need attention or if any problems with follow-up have occurred. Additional referrals to appropriate services (including home care) will be made at that time as necessary. Patients will be followed up at 4, 8 and 12 weeks by the research assistant who will contact them to assess their satisfaction and quality of life.

Patients allocated to the usual care group will receive care from the health care team without the addition of the discharge coordinator. They will be followed-up at 4, 8 and 12 weeks by the research assistant and information will be obtained on the selected outcomes.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

In this study, the primary outcome will be a composite endpoint to assess the level of discontinuity of care and will include:
1. The number of patients admitted with the target conditions who do not complete at least one recommended follow-up test
2. The number of patients admitted with the target conditions who do not attend at least one recommended follow-up appointment
3. The number of patients admitted with the target conditions who do not fill at least one medication prescribed at discharge

Secondary outcome measures

Secondary outcomes include mortality and the proportion of patients readmitted to hospital (including admissions to the Emergency Department). Reasons for readmission will be assessed to determine if a medical error had an impact on readmission. Quality of life will be assessed using the 12-item Short Form health survey (SF-12) and patient satisfaction will be assessed using the Patient Satisfaction Questionnaire which includes items on convenience of care, access to care, continuity of care, competence, explanations of care, degree of consideration shown and overall satisfaction. Outcomes will be assessed at 4, 8, and 12 weeks after the intervention has been implemented.

Overall trial start date

20/06/2005

Overall trial end date

20/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be patients who:
1. Will be in hospital for more than 48 hours
2. Who are greater than 65 years of age
3. Who have a diagnosis of acute coronary syndrome, congestive heart failure, pneumonia, exacerbation of chronic obstructive airways disease, falls, or confusion

Participants will also undergo a Short Portable Mental Status Questionnaire and must score above 5 out of 10 questions.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

160

Participant exclusion criteria

Patients will be excluded if they score less than 5 on the Short Portable Mental Status Questionnaire, or if they are transferred to another in-patient service at an acute care hospital

Recruitment start date

20/06/2005

Recruitment end date

20/06/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Toronto Western Hospital
Toronto
M5T 2S8
Canada

Sponsor information

Organisation

Premier's Research Excellence Award (Canada)

Sponsor details

8th Floor
Hearst Block
900 Bay street
Toronto
M7A 2E1
Canada

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Premier's Research Excellence Awards (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes