Patient Oriented Discharge Summary Impact Study (PODS)

Study Description

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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

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Study Design

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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 :	March 2018
Estimated Study Completion Date :	June 2018

Arms and Interventions

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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

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Primary Outcome Measures :

1. 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 :

1. medication adherence [ Time Frame: 30 and 90 days ]
   self-reported adherence to all medications
2. diet adherence [ Time Frame: 30 and 90 days ]
   self-reported adherence to diet restrictions
3. activity adherence [ Time Frame: 30 and 90 days ]
   self-reported adherence to activity restrictions
4. appointment adherence [ Time Frame: 30 and 90 days ]
   self-reported adherence to scheduled appointments
5. 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

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
Last Update Posted:	October 26, 2017
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