Developing a Patient Oriented Discharge Summary for Stroke Inpatients

October 6, 2021 updated by: Sunnybrook Health Sciences Centre

Developing and Piloting a Patient Oriented Discharge Summary (PODS) Program to Facilitate a Successful Transition From Inpatient Stroke Rehab to Home

There is a need to improve the discharge process for patients with stroke, which has been reported to be a particularly stressful time for patients. A Patient Oriented Discharge Summary (PODS) meeting has been shown to be an effective approach for minimizing discharge-related stress and fostering self-management skills in other patients being discharged from rehabilitation into the community. The purpose of this study is to develop and evaluate whether a PODS meeting can minimize stress around the discharge process and improve patient satisfaction with this process. There are two main hypotheses regarding the PODS program: 1) it will help in-patients with stroke understand key issues related to knowledge required once discharged and 2) it will increase levels of self-efficacy in in-patients with stroke. Potential subjects are encouraged to participate if they are a Sunnybrook - St. John's Rehab admitted in-patient with a stroke diagnosis who are 18 years or older and meet the following criteria: (a) fluent in English; (b) cognitively intact; and (c) have minimal or no aphasia.The participant will be asked to answer some surveys 8-10 days prior to discharge about their knowledge and confidence in managing their stroke.

The participant will then be asked to meet with a clinical staff member who will hold a one-hour PODS meeting. In the meeting, a discharge plan will be created and given to the patient that covers a number of topics that will be useful following their return to the community. One day following the PODS meeting, the participant will be asked to answer the same survey they completed prior to the PODS and again 3-5 days following discharge. If the participant is interested they will be asked to undergo a brief interview to get their feedback on the PODS Program. It is anticipated that about 20 people will participate in the program with all 20 patients completing the surveys with 6 being asked to complete the brief interview.

To the best of the investigators knowledge, there is little risk associated with this study. Participants may become uncomfortable during the interview while discussing their experiences. By participating in this study, patients will be provided with a chance to gather information and learn problem solving and self-management skills prior to discharge. It is the hope of this project that it can lead to a more effective approach in supporting the transition from the hospital to the community for patients with stroke

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Canada
    • Ontario
      • North York, Ontario, Canada, M2M 2G1
        • St. John's Rehabilitation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a stroke diagnosis.
  • Must be minimally aphasic.
  • Physically and cognitively be able to participate in a one-hour PODS session and are capable of undergoing the PODS meeting, as well as the study assessments in person and by phone (surveys, telephone interview).

Exclusion Criteria:

  • Participants who are unable to communicate fluently in English

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient Oriented Discharge Summary
A one hour patient oriented discharge summary meeting will take place with participants.
Behavioral: Patient Oriented Discharge Summary
Participants will undergo a Patient Oriented Discharge Summary (PODS). The PODS is a personalized summary of the discharge plan presented in an easy to understand worksheet that covers (1) medication instructions; (2) follow-up appointments with phone numbers; (3) normal expected symptoms, warning signs, and what to do if they experience a problem; (4) lifestyle changes and when to resume activities; and (5) information and resources to have handy. The meeting will take place one week prior to discharge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Patient Satisfaction Survey
Time Frame: A) PRE-PODS (baseline); B) POST-PODS (3 days day after baseline) and 3-5 DAYS POST-DISCHARGE (2 weeks after baseline).
This quantitative scale asks patients to rate their knowledge and confidence on a Likert-scale to manage their health post-discharge.
A) PRE-PODS (baseline); B) POST-PODS (3 days day after baseline) and 3-5 DAYS POST-DISCHARGE (2 weeks after baseline).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Southampton Stroke Self-Management Questionnaire (SSSMQ)
Time Frame: A) PRE-PODS (baseline); B) POST-PODS (3 days day after baseline) and 3-5 DAYS POST-DISCHARGE (2 weeks after baseline).A) PRE-PODS (baseline); B) POST-PODS (1 week and 1 day after baseline) and 3-5 DAYS POST-DISCHARGE (2 weeks and 5 days after baseline).
This quantitative scale is a valid and reliable measure of self-management competency in stroke patients. It will be used to validate the results of the Patient Satisfaction Survey.
A) PRE-PODS (baseline); B) POST-PODS (3 days day after baseline) and 3-5 DAYS POST-DISCHARGE (2 weeks after baseline).A) PRE-PODS (baseline); B) POST-PODS (1 week and 1 day after baseline) and 3-5 DAYS POST-DISCHARGE (2 weeks and 5 days after baseline).
One-time Patient Feedback Interview
Time Frame: This interview will be completed POST-DISCHARGE (2 weeks post baseline)
Participants will be asked to undergo a qualitative interview. This interview will focus on their experience with the PODS program in order to get their feedback (e.g. what they liked about the program, what could be done better, etc.)
This interview will be completed POST-DISCHARGE (2 weeks post baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sander L Hitzig, PhD, Sunnybrook Health Sciences Centre

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 180-2017

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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