StrokeNCT03177954
Developing a Patient Oriented Discharge Summary for Stroke Inpatients
A study testing Patient Oriented Discharge Summary in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Patient Oriented Discharge Summary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Participants who are unable to communicate fluently in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Stroke
- Being tested
- Patient Oriented Discharge Summary
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Oriented Discharge SummaryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Oriented Discharge Summary | Experimental | A one hour patient oriented discharge summary meeting will take place with participants. Receives: Behavioral: Patient Oriented Discharge Summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Satisfaction Survey
This quantitative scale asks patients to rate their knowledge and confidence on a Likert-scale to manage their health post-discharge.
Measured: A) PRE-PODS (baseline); B) POST-PODS (3 days day after baseline) and 3-5 DAYS POST-DISCHARGE (2 weeks after baseline).
Secondary outcomes (2)
Change in Southampton Stroke Self-Management Questionnaire (SSSMQ)
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.
Measured: 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
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.)
Measured: This interview will be completed POST-DISCHARGE (2 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start10 Sep 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sander L Hitzig, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177954
- Sponsor's protocol ID
- 180-2017
- Status last verified
- Oct 2021
- First submitted
- 2 Jun 2017
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Piloting a Patient Oriented Discharge Summary (PODS) Program to Facilitate a Successful Transition From Inpatient Stroke Rehab to Home
- ClinicalTrials.gov ID
- NCT03177954
- Acronym / sponsor ID
- 180-2017
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Oriented Discharge Summary | Experimental | Behavioral: Patient Oriented Discharge SummaryA one hour patient oriented discharge summary meeting will take place with participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Participants who are unable to communicate fluently in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Oriented Discharge SummaryParticipants 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. | Behavioural | Patient Oriented Discharge Summary |
Primary outcome
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.
2 secondary outcomes
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).
One-time Patient Feedback Interview
Time frame: This interview will be completed POST-DISCHARGE (2 weeks post baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sander L Hitzig, PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Oriented Discharge Summary in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.