Patient Oriented Discharge Summary Impact Study

NCT02673892 | Terminated DMC

• 1 other identifier: 15-9735-AE
• Study Type: interventional
• Target: 581
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure; Chronic Obstructive Pulmonary Disease; Pneumonia; Hip Fracture; Total Hip Replacement; Total Knee Replacement

Keywords

discharge; transitions; patient experience

Outcome Measures

Primary Outcomes (1)

• Patient experience of transition of care

  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.

  72 hours post-discharge

Secondary Outcomes (6)

• medication adherence

  30 and 90 days

• diet adherence

  30 and 90 days

• activity adherence

  30 and 90 days

• appointment adherence

  30 and 90 days

• unscheduled utilization

  30 and 90 days

Study Arms (2)

PODS intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Patient Oriented Discharge Summary OTHER

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.

PODS intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Baycrest: collaborator
• Bruyère Health Research Institute.: collaborator
• Thunder Bay Regional Health Sciences Centre: collaborator
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4', Canada

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Pneumonia; Hip Fractures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Karen Okrainec, MD

  UHN

  PRINCIPAL INVESTIGATOR

• Howard B Abrams, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 19, 2019

Record last verified: 2019-04

Locations

CA (1)