- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793282
The Benefits of Telephone Follow-up (TFU) (TFU)
August 4, 2022 updated by: Alana Prejet, Brandon University
The Benefits of Telephone Follow-Up After a Mental Health Assessment in an Emergency Department
This study will investigate the impact of a brief telephone follow-up following a mental health assessment in the emergency department.
The purpose of the telephone call will be to provide psycho-education, clarify any questions and reinforce discharge planning.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a randomized controlled trial.
The experimental group will receive a phone call within 72 hours of discharge to provide psycho education, clarify any questions they may have and to reinforce discharge plans made in the ED.
The control group will not receive this phone call.
Within 30 days of discharge, both groups will receive a phone call to collect data on treatment compliance including medication and follow-up adherence and if any additional visits to the Emergency Department were necessary.
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alana E Prejet, BScPN, BA
- Phone Number: 204-999-8882
- Email: prejetae05@brandonu.ca
Study Contact Backup
- Name: Phillip Goernert, PhD
- Phone Number: 204-571-8507
- Email: goernertp@brandonu.ca
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 2A6
- Recruiting
- St. Boniface Hospital
-
Contact:
- Alana E Prejet, BScPN
- Phone Number: 204.235.3053
- Email: prejetae05@brandonu.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Discharged from the ED
- Age of majority
- Competent.
Exclusion Criteria
- Incompetent,
- Under 18
- Admitted to the hospital
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Post-test satisfaction
|
Telephone Follow-up within 72 hours to discuss psycho education, discharge planning and clarify any questions they may have.
|
Experimental: Experimental
Treatment and satisfaction
|
Telephone Follow-up within 72 hours to discuss psycho education, discharge planning and clarify any questions they may have.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency Department readmission rates
Time Frame: 30 days.
|
Does a telephone call reduce readmission rates?
|
30 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with care in the Emergency Department using a 7 point Likert Scale as a function of the telephone follow up.
Time Frame: 30 days.
|
Various measures of satisfaction in care provided in Emergency Department.
Higher scores indicate higher satisfaction.
|
30 days.
|
Adherence to pharmacological interventions and follow-up appointments.
Time Frame: 30 days.
|
Adhering to pharmacological interventions and follow-up appointments by self rating on a 7 point Likert Scale.
Higher scores indicate greater adherence to treatment adherence.
|
30 days.
|
Understanding of Treatment plan
Time Frame: 30 days.
|
Assessing if the participant believes they have a good understanding of their care plan by self rating on a 7 point Likert Scale.
Higher scores indicate greater understanding of treatment plan.
|
30 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alana E Prejet, BScPN, BA, Brandon University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2022
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
February 23, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 4, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BrandonU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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