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Patient Oriented Discharge Summary Impact Study (PODS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University Health Network, Toronto
Sponsor:
Collaborators:
Baycrest
Bruyere Research Institute
Thunder Bay Regional Health Sciences Centre
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02673892
First received: February 1, 2016
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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 Intervention
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Pneumonia
Hip Fracture
Total Hip Replacement
Total Knee Replacement
Other: Patient Oriented Discharge Summary

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Patient Experience Measure [ Time Frame: 72 hours post-discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    self-reported adherence to all medications

  • diet adherence [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
    self-reported adherence to diet restrictions

  • activity adherence [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
    self-reported adherence to activity restrictions

  • appointment adherence [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
    self-reported adherence to scheduled appointments

  • unscheduled utilization [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
    a binary composite outcome of any unscheduled visits to primary care physician, emergency room, readmission to hospital or death


Estimated Enrollment: 760
Study Start Date: February 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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 
Study First Received: February 1, 2016
Last Updated: February 23, 2016
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 25, 2016