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Patient Outcomes Collection: How Can we do Better?

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ClinicalTrials.gov Identifier: NCT03653455
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
American Orthopaedic Society for Sports Medicine
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
Patient reported outcomes (PROs) are widely used by clinical providers as important tools to help inform their clinical and research practice, and to improve quality of care for patients. In this study, the investigators aim to investigate ways by which patient PRO completion rates may be improved.

Condition or disease Intervention/treatment Phase
Shoulder Pain Behavioral: Email reminders Behavioral: pre-operative discussion Behavioral: Pre- and Post-operative discussion Behavioral: Incentive Not Applicable

Detailed Description:

Patient reported outcomes (PROs) are widely used by clinical providers as important tools to help inform their clinical and research practice, and to improve quality of care for patients. In addition, PROs are increasingly cited as a tool in measuring surgical performance and the value of health care services being delivered. The quality of data captured by PROs is, however, largely dependent on patients' response rates, both pre- and post-operatively. For pre-operative surveys, higher response rates may be achieved as patients may be reminded to complete their surveys at an office visit or prior to surgery. However, patient non-compliance presents a major challenge post-operatively, undermining PRO data integrity.

As clinical practices have moved to using PROs for all patients, rather than just a research tool, automated systems have been developed to deliver and collect PRO electronically. However, while automation has helped streamline PRO administration and data collection, this hasn't always translated into obtaining better PRO compliance rates. In an attempt to improve response rates, efforts have been made to reduce patient burden (by reducing the number of questions asked, for example), to regularly remind patients to complete their forms (either by email or telephone), or even offer patients monetary or non-monetary incentives.

Despite these measures' variable success, however, achieving high response rates remains a challenge. This, in part, is due to the fact these platforms depend heavily on patients receiving the request and their willingness to participate in the program, often long after their care is completed. As data are increasingly used to measure physician performance and quality, as well as to determine reimbursement, low patient compliance rates remain a significant impediment and affect the validity of the data.

In this study, the invetigators hypothesize that direct patient engagement can improve patient compliance with automated PRO capture.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Patient Outcomes Collection: How Can we do Better? A Randomized Trial to Determine Factors Which May Affect Patient Compliance.
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Pre-operative discussion group
At a pre-operative visit, patients and their care provider will discuss what assigned surveys are and why they are important. In addition, patients will receive email reminders to complete their forms, if they haven't done so.
Behavioral: Email reminders
Patients will receive email reminders until their PROs are completed.

Behavioral: pre-operative discussion
Patients will discuss the importance of PROs with their provider pre-operatively.

Experimental: Pre- and post-operative discussion group
Patients will discuss with their care provider their health outcomes before and at 6-months after their surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.
Behavioral: Email reminders
Patients will receive email reminders until their PROs are completed.

Behavioral: Pre- and Post-operative discussion
Patients will discuss with their provider the importance of PROs pre-operatively, as well as their post-operative progression in comparison to established norms.

Experimental: Incentivised group
Patients will receive up to $30 in amazon gift cards as an incentive if they complete their forms before surgery, as well as at 6-months and 1-year after surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.
Behavioral: Email reminders
Patients will receive email reminders until their PROs are completed.

Behavioral: Incentive
Patients will receive up to $30 in amazon gift cards upon the completion of their PROs.

Experimental: control group
Patients will only receive email reminders to complete their forms, if they haven't done so.
Behavioral: Email reminders
Patients will receive email reminders until their PROs are completed.




Primary Outcome Measures :
  1. Does patient engagement, through education or monetary incentivization, increase PRO compliance rate at 1 year after surgery, when compared to PRO compliance rate before surgery? [ Time Frame: Change in PRO compliance rate between pre-surgery and 1-year post surgery ]
    Patients will discuss the importance of PROs and how they can be used to predict their health outcome with their care provider. Alternatively, patients may receive amazon gift cards if they complete their PROs before surgery, as well as at 6-months and 1-yr after surgery. Three established PROs [American Shoulder And Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and the Veteran Rand 12-Item and 12-Item Short Form Health Survey (VR/SF12)] will be automatically emailed to patients using an electronic platform (OBERD). Rate at which these forms are completed (compliance rate) before surgery, as well 1-year post surgery will be monitored through OBERD.


Secondary Outcome Measures :
  1. Effects of age on PRO compliance rate. [ Time Frame: Change in PRO compliance rate between pre-surgery and 1-year post surgery ]
    Assess how patients' age might change PRO compliance from baseline (before surgery) to 1-year after surgery. Three established PROs [American Shoulder And Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and the Veteran Rand 12-Item and 12-Item Short Form Health Survey (VR/SF12)] will be automatically emailed to patients using an electronic platform (OBERD). Rate at which these forms are completed (compliance rate) before surgery, as well 1-year post surgery will be monitored through OBERD.

  2. Effects of technological literacy on PRO compliance rate. [ Time Frame: Change in PRO compliance rate between pre-surgery and 1-year post surgery ]
    Assess how technological literacy might change PRO compliance from baseline (before surgery) to 1-year after surgery. Three established PROs [American Shoulder And Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and the Veteran Rand 12-Item and 12-Item Short Form Health Survey (VR/SF12)] will be automatically emailed to patients using an electronic platform (OBERD). Rate at which these forms are completed (compliance rate) before surgery, as well 1-year post surgery will be monitored through OBERD.

  3. Effects of English proficiency on PRO compliance rate. [ Time Frame: Change in PRO compliance rate between pre-surgery and 1-year post surgery ]
    Assess how English proficiency might change PRO compliance from baseline (before surgery) to 1-year after surgery. Three established PROs [American Shoulder And Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and the Veteran Rand 12-Item and 12-Item Short Form Health Survey (VR/SF12)] will be automatically emailed to patients using an electronic platform (OBERD). Rate at which these forms are completed (compliance rate) before surgery, as well 1-year post surgery will be monitored through OBERD.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo shoulder arthroscopy for rotator cuff condition (sub-acromial decompression, distal clavicle resection, biceps tenodesis, partial or full thickness rotator cuff tear repair or debridement) will be eligible for enrollment in the appropriate cohort. There will be no restrictions to this enrollment apart from that presented in the exclusions below.

Exclusion Criteria:

  1. Minors or those over the age of 80
  2. Subjects lacking English proficiency to complete the PROs of interest.
  3. Past or current medical history that would preclude patients from undergoing surgery.

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): NCT03653455


Contacts
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Contact: Paria Mirmonsef, PhD 312-432-2531 paria.mirmonsef@rushortho.com
Contact: Brandon Manderle, MD 312-432-2819 Verma.Research@rushortho.com

Locations
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United States, Illinois
Midwest Orthopedics at RUSH Recruiting
Chicago, Illinois, United States, 60612
Contact: Paria Mirmonsef, PhD         
Sub-Investigator: Brian Forsythe, MD         
Sub-Investigator: Brian Cole, MD, MBA         
Sub-Investigator: Adam Yanke, MD, PhD         
Sub-Investigator: Gregory Nicholson, MD         
Sponsors and Collaborators
Rush University Medical Center
American Orthopaedic Society for Sports Medicine
Investigators
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Principal Investigator: Nikhil Verma, MD Rush University Medical Center

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03653455     History of Changes
Other Study ID Numbers: ORA# 18041709
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rush University Medical Center:
Shoulder
Arthroscopy
sub-acromial decompression
distal clavicle resection
biceps tenodesis
rotator cuff repair
Patient reported outcomes

Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms