Patient Oriented Discharge Summary Impact Study (PODS)
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|ClinicalTrials.gov Identifier: NCT02673892|
Recruitment Status : Terminated (Recommendation of DMC - challenges recruiting, statistical considerations)
First Posted : February 4, 2016
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure Chronic Obstructive Pulmonary Disease Pneumonia Hip Fracture Total Hip Replacement Total Knee Replacement||Other: Patient Oriented Discharge Summary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||581 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Impact of a Patient-Centered Discharge Summary (PODS) on Patient Experience and Health Outcomes Following Discharge: A Multicenter Randomized Controlled Trial|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||November 2018|
Experimental: PODS intervention
The PODS intervention is administered during the discharge process which includes discharge teaching. In the acute settings, discharge teaching is provided by a nurse navigator, resident physician, or other members of the care team. In the rehabilitation setting, discharge teaching is provided by a multi-disciplinary team. PODS is used as a useful add-on to the usual discharge teaching process. The PODS form used during the study will be a fillable pdf. Members of the healthcare team will fill it out electronically, then print it out and give the paper to the patient. After the discharge teaching is finished, patients take the completed PODS home with them as a post-discharge reference and guide.
Other: Patient Oriented Discharge Summary
The PODS provides a written template for providers to engage patients and caregivers when reviewing important discharge instructions on medications, activity and diet restrictions, follow-up appointments and worrisome symptoms warranting emergency care. The PODS also uses plain and simple wording, large fonts, pictograms, and includes white space for patients to take notes and provides the option for translation of major headings into the most common spoken languages. As this will be a pragmatic design, we may make modifications to the process involved in completing the PODS, such as using pre-filled disease-specific information, if system processes and providers involved deem it more usable and feasible.
No Intervention: Usual Care
Patients randomized to this arm will receive usual discharge care. At UHN, this involves receiving a discharge summary with information pertaining to hospital course including investigations performed and medications used, as well as follow-up care suggested. It is intended to be, unlike PODS, a document for the primary care physician seeing the patient after discharge to refer to. As to discharge instructions provided for the patient, there is no standard procedure and sometimes follow-up instructions are included for the patient. Patient education may or may not be provided to the patient verbally by their nurse, resident, physician, or pharmacist. Moreover, follow-up with the primary care physician may be set up prior to or following discharge with the nurse navigator.
- Patient experience of transition of care [ Time Frame: 72 hours post-discharge ]Count of negative responses to 6 questions, with first 5 from CIHI CPES-IC: 1.During this hospital stay, did doctors, nurses or other hospital staff talk with you about whether you would have the help you needed when you left the hospital? 2.During this hospital stay, did you get information in writing about what symptoms or health problems to look out for after you left the hospital? 3.Before you left the hospital, did you have a clear understanding about all of your prescribed medications, including those you were taking before your hospital stay? 4.Did you receive enough information from hospital staff about what to do if you were worried about your condition or treatment after you left the hospital? 5.When you left the hospital, did you have a better understanding of your condition than when you entered? 6.When you left the hospital, did you have a clear understanding about your follow-up appointments and investigations? Analysis change via DMC recommendation.
- medication adherence [ Time Frame: 30 and 90 days ]self-reported adherence to all medications
- diet adherence [ Time Frame: 30 and 90 days ]self-reported adherence to diet restrictions
- activity adherence [ Time Frame: 30 and 90 days ]self-reported adherence to activity restrictions
- appointment adherence [ Time Frame: 30 and 90 days ]self-reported adherence to scheduled appointments
- unscheduled utilization [ Time Frame: 30 and 90 days ]a binary composite outcome of any unscheduled visits to primary care physician, emergency room, readmission to hospital or death
- Patient experience measure [original primary outcome measure] [ Time Frame: 72 hours post-discharge ]Proportion of patients who responded "Yes", or "Quite a Bit" or "Completely", to 4 out of the 6 prespecified questions on patient experience of transitions of care, 72 hours following discharge from hospital as a measure of patient experience of their transition of care (original primary outcome, re-specified as secondary outcome based on DMC recommendation).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673892
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4'|
|Principal Investigator:||Karen Okrainec, MD||UHN|
|Principal Investigator:||Howard B Abrams, MD||UHN|