search
Back to results

Patient Outcomes Collection: How Can we do Better?

Primary Purpose

Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Email reminders
Pre- and Post-operative discussion
Incentive
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Shoulder Pain focused on measuring Shoulder, Arthroscopy, sub-acromial decompression, distal clavicle resection, biceps tenodesis, rotator cuff repair, Patient reported outcomes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carla M. EdwardsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Pre- and post-operative discussion group

Incentivised group

Control group

Arm Description

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.

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.

Patients will only receive email reminders to complete their forms, if they haven't done so.

Outcomes

Primary Outcome Measures

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?
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

Effects of age on PRO compliance rate.
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.
Effects of technological literacy on PRO compliance rate.
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.
Effects of English proficiency on PRO compliance rate.
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.

Full Information

First Posted
July 24, 2018
Last Updated
July 28, 2023
Sponsor
Rush University Medical Center
Collaborators
American Orthopaedic Society for Sports Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03653455
Brief Title
Patient Outcomes Collection: How Can we do Better?
Official Title
Patient Outcomes Collection: How Can we do Better? A Randomized Trial to Determine Factors Which May Affect Patient Compliance.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
American Orthopaedic Society for Sports Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder, Arthroscopy, sub-acromial decompression, distal clavicle resection, biceps tenodesis, rotator cuff repair, Patient reported outcomes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre- and post-operative discussion group
Arm Type
Experimental
Arm Description
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.
Arm Title
Incentivised group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Patients will only receive email reminders to complete their forms, if they haven't done so.
Intervention Type
Behavioral
Intervention Name(s)
Email reminders
Intervention Description
Patients will receive email reminders until their PROs are completed.
Intervention Type
Behavioral
Intervention Name(s)
Pre- and Post-operative discussion
Intervention Description
Patients will discuss with their provider the importance of PROs pre-operatively, as well as their post-operative progression in comparison to established norms.
Intervention Type
Behavioral
Intervention Name(s)
Incentive
Intervention Description
Patients will receive up to $30 in amazon gift cards upon the completion of their PROs.
Primary Outcome Measure Information:
Title
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?
Description
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.
Time Frame
Change in PRO compliance rate between pre-surgery and 1-year post surgery
Secondary Outcome Measure Information:
Title
Effects of age on PRO compliance rate.
Description
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.
Time Frame
Change in PRO compliance rate between pre-surgery and 1-year post surgery
Title
Effects of technological literacy on PRO compliance rate.
Description
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.
Time Frame
Change in PRO compliance rate between pre-surgery and 1-year post surgery
Title
Effects of English proficiency on PRO compliance rate.
Description
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.
Time Frame
Change in PRO compliance rate between pre-surgery and 1-year post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: Minors or those over the age of 80 Subjects lacking English proficiency to complete the PROs of interest. Past or current medical history that would preclude patients from undergoing surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla M. Edwards, PhD
Phone
312-563-5735
Email
carla_edwards@rush.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nikhil Verma, MD
Phone
312-432-2819
Email
verma.research@rushortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Verma, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carla M. Edwards
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla M. Edwards, PhD
Phone
312-563-5735
Email
carla_edwards@rush.edu
First Name & Middle Initial & Last Name & Degree
Brian Forsythe, MD
First Name & Middle Initial & Last Name & Degree
Brian Cole, MD, MBA
First Name & Middle Initial & Last Name & Degree
Adam Yanke, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gregory Nicholson, MD

12. IPD Sharing Statement

Learn more about this trial

Patient Outcomes Collection: How Can we do Better?

We'll reach out to this number within 24 hrs