Orthopedic DisorderNCT03436446
Role of Social Incentives in PRO Collection
An observational study of Orthopedic Disorder, run by Duke University at 1 site in United States.
Trial summary
Value-based healthcare is heavily dependent on the accurate measurement of patient outcomes, both immediately after treatment and at long-term intervals. Patient reported outcomes (PROs) are often the central component of any quality improvement process as they are patient centered, reflect the ultimate objective of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Interview
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 24 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study population will include post-operative orthopedic patients.
Who may be able to join
- English speaking
- Orthopedic patient
- 6-24 months post-operative
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Using Social Incentives to Increase Response Rate to Routine Patient Reported Outcome Measurement After Episodic Healthcare Interventions
Value-based healthcare is heavily dependent on the accurate measurement of patient outcomes, both immediately after treatment and at long-term intervals. Patient reported outcomes (PROs) are often the central component of any quality improvement process as they are patient centered, reflect the ultimate objective of the intervention and are endorsed by many professional societies as the preferred physician performance metric. Although high response rates are critical to producing reliable data to support value-based payment models, quality improvement, and stakeholder transparency - especially in arthroscopy in which patients often fare well over time and may be less likely to continue with follow-up - response rates to outcome surveys after initial recovery from treatment are consistently below 50%. Monetary incentives offer only minor improvements in response rates against large increases in already rising costs. Individually tailored social incentives - as grounded in current behavioral economic practice - offer a potential cost-effective solution to this problem in Sports Medicine and arthroscopy.
The investigators predict that well-constructed, personal social incentives will increase response rates for long-term follow-up of episodic care compared to control. The investigators predict these rates will vary depending on the patient demographics and other characteristics.
- Conditions
- Orthopedic Disorder
- Being tested
- Interview
- Keywords
- Patient Reported Outcomes (PRO), Social Incentives
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interviews will be conducted with orthopedic patients to review the construction and phrasing of various social incentives aimed at promoting patient reported outcome collection amongst post-operative patients.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic Patients | Orthopedic patients will undergo an interview with the research team regarding the framing of various social incentives to promote increased response rates for patient reported outcome measures post-operatively. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview feedback
The investigators will use feedback from the interviews to adjust the social incentives.
Measured: End of discussion with patient, 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start8 Feb 2018
- Primary completion24 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard C Mather III, MD, MBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436446
- Sponsor's protocol ID
- Pro00086277
- Status last verified
- May 2019
- First submitted
- 12 Feb 2018
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Social Incentives to Increase Response Rate to Routine Patient Reported Outcome Measurement After Episodic Healthcare Interventions
- ClinicalTrials.gov ID
- NCT03436446
- Acronym / sponsor ID
- Pro00086277
- Conditions
- Orthopedic Disorder
- Keywords
- Patient Reported Outcomes (PRO), Social Incentives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 19 Feb 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.
Value-based healthcare is heavily dependent on the accurate measurement of patient outcomes, both immediately after treatment and at long-term intervals. Patient reported outcomes (PROs) are often the central component of any quality improvement process as they are patient centered, reflect the ultimate objective of the intervention and are endorsed by many professional societies as the preferred physician performance metric. Although high response rates are critical to producing reliable data to support value-based payment models, quality improvement, and stakeholder transparency - especially in arthroscopy in which patients often fare well over time and may be less likely to continue with follow-up - response rates to outcome surveys after initial recovery from treatment are consistently below 50%. Monetary incentives offer only minor improvements in response rates against large increases in already rising costs. Individually tailored social incentives - as grounded in current behavioral economic practice - offer a potential cost-effective solution to this problem in Sports Medicine and arthroscopy.
The investigators predict that well-constructed, personal social incentives will increase response rates for long-term follow-up of episodic care compared to control. The investigators predict these rates will vary depending on the patient demographics and other characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopedic Patients | – | Other: InterviewOrthopedic patients will undergo an interview with the research team regarding the framing of various social incentives to promote increased response rates for patient reported outcome measures post-operatively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include post-operative orthopedic patients.
Key inclusion criteria (3 listed)
- English speaking
- Orthopedic patient
- 6-24 months post-operative
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| InterviewInterviews will be conducted with orthopedic patients to review the construction and phrasing of various social incentives aimed at promoting patient reported outcome collection amongst post-operative patients. | Other | Orthopedic Patients |
Primary outcome
Interview feedback
Time frame: End of discussion with patient, 15 minutes
The investigators will use feedback from the interviews to adjust the social incentives.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Richard C Mather III, MD, MBA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Duke University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 17 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interview feedback (time frame: End of discussion with patient, 15 minutes). 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 17 Dec 2019.