Patient Oriented Discharge Summary Impact Study (PODS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02673892

Recruitment Status : Recruiting

First Posted : February 4, 2016

Last Update Posted : May 14, 2018

See Contacts and Locations

Sponsor:

Collaborators:

Baycrest

Bruyere Research Institute

Thunder Bay Regional Health Sciences Centre

Mount Sinai Hospital, Canada

Information provided by (Responsible Party):

University Health Network, Toronto

Study Description

Brief Summary:

Improving the patient experience has become a major focus of quality improvement efforts in Ontario and in health systems worldwide. However, our existing knowledge base is relatively under-developed, particularly in how patients experience care as they transition from one care setting to another and the relationship between patient experience and clinical outcomes. The Patient Oriented Discharge Summary (PODS) is a discharge instruction tool created by patients, caregivers, health-care providers and design experts. It provides a written template for providers to engage patients and caregivers when reviewing important instructions on medications, activity and diet restrictions, follow-up appointments and worrisome symptoms warranting emergency care following admission to hospital. 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. The PODS impact study will study the impact of using the PODS versus usual discharge instructions on patient experience and health outcomes in a provincial-wide randomized study across acute care and rehabilitation hospitals.

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

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	760 participants
Allocation:	Randomized
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
Estimated Primary Completion Date :	August 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: PODS 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.

Arm

Intervention/treatment

Experimental: PODS

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.

Outcome Measures

Primary Outcome Measures :

Patient Experience Measure [ Time Frame: 72 hours post-discharge ]
The primary outcome will be a binary composite of the proportion of patients who scored Yes or "Completely/Quite a Bit" to 4 out of 6 of the CIHI Patient Experience In-Patient Survey on transitions of care.

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or over
Able and willing to provide informed consent or have a substitute decision maker that can provide consent and agree to answer follow up as the patient's caregiver
Admitted to hospital with either congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), Stroke, Pneumonia, Hip Fracture, Knee Replacement or Hip Replacement
Being discharged home or to a retirement home
Have a Telephone for post-discharge follow-up

Exclusion Criteria:

Patients who have already received the PODS in the past
Being discharged to nursing home, long-term care facility, rehabilitation or other hospital.
Unable to communicate due to cognitive impairment or language barrier with no caregiver or interpreter available
Palliative patient with life expectancy <= 3 months

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Shoshana Hahn-Goldberg, PhD	416-939-1507	shoshana.hahn-goldberg@uhn.ca

Locations


Canada, Ontario
Toronto General Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2C4`

Sponsors and Collaborators

University Health Network, Toronto

Baycrest

Bruyere Research Institute

Thunder Bay Regional Health Sciences Centre

Mount Sinai Hospital, Canada

Investigators


Principal Investigator:	Karen Okrainec, MD	UHN
Principal Investigator:	Howard B Abrams, MD	UHN

More Information


Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT02673892 History of Changes
Other Study ID Numbers:	15-9735-AE
First Posted:	February 4, 2016 Key Record Dates
Last Update Posted:	May 14, 2018
Last Verified:	October 2017

Keywords provided by University Health Network, Toronto:


discharge transitions patient experience

Additional relevant MeSH terms:


Heart Failure Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Pneumonia Hip Fractures Heart Diseases Cardiovascular Diseases	Respiratory Tract Diseases Respiratory Tract Infections Femoral Fractures Fractures, Bone Wounds and Injuries Hip Injuries Leg Injuries

To Top