Shoulder PainNCT03653455
Patient Outcomes Collection: How Can we do Better?
A study testing Email reminders, Pre- and Post-operative discussion and Incentive in people with Shoulder Pain, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Email reminders, Pre- and Post-operative discussion and Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Outcomes Collection: How Can we do Better? A Randomized Trial to Determine Factors Which May Affect Patient Compliance.
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.
Read the 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
- Being tested
- Email reminders, Pre- and Post-operative discussion, Incentive
- Keywords
- Shoulder, Arthroscopy, sub-acromial decompression, distal clavicle resection, biceps tenodesis, rotator cuff repair, Patient reported outcomes
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Email remindersBehavioural
Patients will receive email reminders until their PROs are completed.
Pre- and Post-operative discussionBehavioural
Patients will discuss with their provider the importance of PROs pre-operatively, as well as their post-operative progression in comparison to established norms.
IncentiveBehavioural
Patients will receive up to $30 in amazon gift cards upon the completion of their PROs.
| Study group | Role | What they receive |
|---|---|---|
| Pre- and post-operative discussion group | Experimental | 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. Receives: Behavioral: Email reminders; Behavioral: Pre- and Post-operative discussion |
| Incentivised group | Experimental | 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. Receives: Behavioral: Email reminders; Behavioral: Incentive |
| Control group | Experimental | Patients will only receive email reminders to complete their forms, if they haven't done so. Receives: Behavioral: Email reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in PRO compliance rate between pre-surgery and 1-year post surgery
Secondary outcomes (3)
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.
Measured: Change in PRO compliance rate between pre-surgery and 1-year post surgery
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.
Measured: Change in PRO compliance rate between pre-surgery and 1-year post surgery
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.
Measured: Change in PRO compliance rate between pre-surgery and 1-year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start30 Apr 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine
- Responsible party
- Sponsor
- Investigators
- Nikhil Verma, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653455
- Sponsor's protocol ID
- 18041709
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes Collection: How Can we do Better? A Randomized Trial to Determine Factors Which May Affect Patient Compliance.
- ClinicalTrials.gov ID
- NCT03653455
- Acronym / sponsor ID
- 18041709
- Conditions
- Shoulder Pain
- Keywords
- Shoulder, Arthroscopy, sub-acromial decompression, distal clavicle resection, biceps tenodesis, rotator cuff repair, Patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre- and post-operative discussion group | Experimental | Behavioral: Email reminders, Behavioral: Pre- and Post-operative discussionPatients 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. |
| Incentivised group | Experimental | Behavioral: Email reminders, Behavioral: IncentivePatients 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. |
| Control group | Experimental | Behavioral: Email remindersPatients will only receive email reminders to complete their forms, if they haven't done so. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Email remindersPatients will receive email reminders until their PROs are completed. | Behavioural | Control group, Incentivised group, Pre- and post-operative discussion group |
| Pre- and Post-operative discussionPatients will discuss with their provider the importance of PROs pre-operatively, as well as their post-operative progression in comparison to established norms. | Behavioural | Pre- and post-operative discussion group |
| IncentivePatients will receive up to $30 in amazon gift cards upon the completion of their PROs. | Behavioural | Incentivised group |
Primary outcome
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.
3 secondary outcomes
Effects of age on PRO compliance rate.
Time frame: Change in PRO compliance rate between pre-surgery and 1-year post surgery
Effects of technological literacy on PRO compliance rate.
Time frame: Change in PRO compliance rate between pre-surgery and 1-year post surgery
Effects of English proficiency on PRO compliance rate.
Time frame: Change in PRO compliance rate between pre-surgery and 1-year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil Verma, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Email reminders, Pre- and Post-operative discussion and Incentive in people with Shoulder Pain, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.