Patient Outcomes Collection: How Can we do Better?

NCT ID: NCT03653455

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2027-08-31

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Email reminders

Intervention Type: BEHAVIORAL

Patients will receive email reminders until their PROs are completed.

Pre- and Post-operative discussion

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Email reminders

Intervention Type: BEHAVIORAL

Patients will receive email reminders until their PROs are completed.

Incentive

Intervention Type: BEHAVIORAL

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

Control group

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

Group Type: EXPERIMENTAL

Email reminders

Intervention Type: BEHAVIORAL

Patients will receive email reminders until their PROs are completed.

Interventions

Email reminders

Patients will receive email reminders until their PROs are completed.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Incentive

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

Intervention Type: BEHAVIORAL

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Orthopaedic Society for Sports Medicine

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikhil Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Carla M. Edwards

Evanston, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carla M. Edwards, PhD

Role: CONTACT

carla_edwards@rush.edu

312-563-5735

Nikhil Verma, MD

Role: CONTACT

verma.research@rushortho.com

312-432-2819

Facility Contacts

Carla M. Edwards, PhD

Role: primary

carla_edwards@rush.edu

312-563-5735

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18041709

Identifier Type: -

Identifier Source: org_study_id