Patient Oriented Discharge Summary Impact Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— PODS  

Official title:

The Impact of a Patient-Centered Discharge Summary (PODS) on Patient Experience and Health Outcomes Following Discharge: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02673892
• Other study ID #: 15-9735-AE
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Full Title: The impact of a patient-centered discharge summary (PODS) on patient experience and health outcomes following discharge: A multicenter randomized controlled trial.

Short Title: PODS Impact Study

Primary Objective: To evaluate the impact of a patient-centered discharge instruction tool on patient experience following hospital discharge.

Primary Outcome Measure: Patient experience within 72 hours following discharge from hospital. Count of negative responses (i.e., "No", or "Not at all" or "Partly") to 6 prespecified questions on patient experience of transition of care answered 72 hours following discharge from hospital, with the first 5 questions from the CIHI Patient Experiences Survey - In-Patient Care (CPES-IC). Groups will be compared using a rate ratio (ratio of negative binomial rates).

Secondary Objectives: 1) Evaluate the impact of a patient-centered discharge instruction tool on health outcomes following hospital discharge. 2) Identify the level of patient and system engagement needed when providing discharge instructions and patient-specific characteristics that might impact the use and effectiveness of discharge instructions.

Secondary Outcome Measures: Self-reported adherence to medications, diet and activity restrictions, and scheduled visits with primary care physician and/or specialist at 30 days following discharge, and a composite of unscheduled visits to primary care physician, emergency room, readmission to hospital or death at 30 days and 3 months following 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).

Study Design: The study will use a mixed methods approach with a randomized controlled trial (RCT) and qualitative study.

Inclusion Criteria: All patients (>=18 years) admitted to inpatient units at University Health Network (UHN) (and other participating hospitals in Ontario) with a primary diagnosis of chronic obstructive pulmonary disease, pneumonia, stroke, congestive heart failure, post hip and knee replacement will be recruited for randomization to receive the PODS versus standard of discharge care. These diseases were chosen to align with the Ministry of Health and Long Term Care (MOHLTC) quality based procedures.

Exclusion Criteria: Patients who are being discharged to another facility rather than home, who have a prognosis of less than 3 months, who do not have a telephone for post-discharge follow-up or with cognitive impairment or significant language barrier for whom a family member or professional interpreter is not available will be excluded from the study.

Intervention: The patient-oriented discharge summary (PODS) is a discharge instruction tool co-created with patients which provides a written template for providers to engage patients and caregivers when reviewing discharge instructions on medications, activity and diet restrictions, follow-up appointments or outstanding investigations and worrisome symptoms warranting emergency care (Appendix A). 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.

Sample Size: We estimate that we will require at minimum 199 and at maximum 388 patients in each study arm if we want to detect a 10% minimum improvement in patient experience scores. Currently, we have study centers that would like to participate in Toronto, Ottawa and Thunder Bay.

Accrual Period: Enrollment for this study will begin once ethics approval is obtained and continue until 776 patients have been enrolled (in total across all participating sites).

Study Duration: The study is expected to run between December 1, 2015 and March 31, 2018 (approximately 3 years) following research ethics board (REB) approval. This will allow for a year of study enrollment across participating sites until sample size is achieved as well as 3 months of follow-up for primary and secondary endpoints and a year for data analysis and manuscript preparation.

Data Monitoring Committee (DMC): A DMC was established on May 4, 2018, due to challenges in recruitment and widespread implementation of the intervention across multiple hospitals in Ontario resulting in a change in the standard of discharge care in the trial's setting. In view of the challenges in recruiting future patients, resource constraints, and statistical considerations, the DMC recommended that recruitment be stopped prematurely and that the analytical approach for the primary outcome be changed, analyzing the data as count data rather than dichotomized data. Study recruitment was stopped at the end of August 2018, after a total of 526 participants had been randomized, with final follow up of participants in December 2018 (see the Document Section for full details).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 581
• Est. completion date: November 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Heart Failure
• Hip Fracture
• Hip Fractures
• Lung Diseases
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Total Hip Replacement
• Total Knee Replacement

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
University Health Network, Toronto	Baycrest, Bruyere Research Institute, Mount Sinai Hospital, Canada, Thunder Bay Regional Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	medication adherence	self-reported adherence to all medications	30 and 90 days
Secondary	diet adherence	self-reported adherence to diet restrictions	30 and 90 days
Secondary	activity adherence	self-reported adherence to activity restrictions	30 and 90 days
Secondary	appointment adherence	self-reported adherence to scheduled appointments	30 and 90 days
Secondary	unscheduled utilization	a binary composite outcome of any unscheduled visits to primary care physician, emergency room, readmission to hospital or death	30 and 90 days
Secondary	Patient experience measure [original primary outcome measure]	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).	72 hours post-discharge