Patient-reported OutcomesNCT03435484
Using RCT to Increase Completion Rates of the Health Assessment Questionnaire.
A study testing Arm A and Arm B in people with Patient-reported Outcomes, run by NYU Langone Health at 1 site in United States.
Trial summary
The proposed study aims to examine several iterations of instructions/reminders that patients receive for completing the Health Assessment Questionnaire (self-reported health outcomes) for their outpatient visit at NYU Langone Orthopedic Center. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient-reported Outcomes
- What is being tested?
- Arm A and Arm B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,263 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 31 May 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who are eligible to receive the Health Assessment Questionnaire in preparation for and during their outpatient visit to the NYU Langone Orthopedic Center.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Using Rapid Cycle Randomized Controlled Trials to Increase Completion Rates of the Patient-Reported Health Assessment Questionnaire During Outpatient Visits at NYU Langone Orthopedic Center
The proposed study aims to examine several iterations of instructions/reminders that patients receive for completing the Health Assessment Questionnaire (self-reported health outcomes) for their outpatient visit at NYU Langone Orthopedic Center. The goal is to increase the completion rates of patient-reported health outcomes.
- Conditions
- Patient-reported Outcomes
- Being tested
- Arm A, Arm B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm AOther
Intervention includes various iterations of instructions for completing the Health Assessment Questionnaire. Participants in this group will receive one version (out of two) of instructions for completing the Health Assessment Questionnaire.
Arm BOther
Intervention includes various iterations of instructions for completing the Health Assessment Questionnaire. Participants in this group will receive another version (out of two) of instructions for completing the Health Assessment Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Participants in this group will receive one version (out of two) of instructions for completing the Health Assessment Questionnaire. Receives: Other: Arm A |
| Arm B | Active comparator | Participants in this group will receive another version (out of two) of instructions for completing the Health Assessment Questionnaire. Receives: Other: Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Completion Rate (number of times patients complete or partially complete the questionnaire).
Completion rate data is routinely collected by the medical center.
Measured: Duration of the study, up to 6 months.
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 start7 Feb 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-reported OutcomesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- None (open label)
- Enrolment
- 27,263 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leora Horwitz, MD, MHS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435484
- Sponsor's protocol ID
- RCT PHA Optimization
- Status last verified
- Oct 2022
- First submitted
- 23 Jan 2018
- Last updated
- 10 Oct 2022
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Rapid Cycle Randomized Controlled Trials to Increase Completion Rates of the Patient-Reported Health Assessment Questionnaire During Outpatient Visits at NYU Langone Orthopedic Center
- ClinicalTrials.gov ID
- NCT03435484
- Acronym / sponsor ID
- RCT PHA Optimization
- Conditions
- Patient-reported Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,263 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (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.
The proposed study aims to examine several iterations of instructions/reminders that patients receive for completing the Health Assessment Questionnaire (self-reported health outcomes) for their outpatient visit at NYU Langone Orthopedic Center. The goal is to increase the completion rates of patient-reported health outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Other: Arm AParticipants in this group will receive one version (out of two) of instructions for completing the Health Assessment Questionnaire. |
| Arm B | Active comparator | Other: Arm BParticipants in this group will receive another version (out of two) of instructions for completing the Health Assessment Questionnaire. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are eligible to receive the Health Assessment Questionnaire in preparation for and during their outpatient visit to the NYU Langone Orthopedic Center.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Arm AIntervention includes various iterations of instructions for completing the Health Assessment Questionnaire. Participants in this group will receive one version (out of two) of instructions for completing the Health Assessment Questionnaire. | Other | Arm A |
| Arm BIntervention includes various iterations of instructions for completing the Health Assessment Questionnaire. Participants in this group will receive another version (out of two) of instructions for completing the Health Assessment Questionnaire. | Other | Arm B |
Primary outcome
Questionnaire Completion Rate (number of times patients complete or partially complete the questionnaire).
Time frame: Duration of the study, up to 6 months.
Completion rate data is routinely collected by the medical center.
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 10 Oct 2022.
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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.
Leora Horwitz, MD, MHS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A and Arm B in people with Patient-reported Outcomes, run by NYU Langone Health 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 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 10 Oct 2022. 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?
Questionnaire Completion Rate (number of times patients complete or partially complete the questionnaire). (time frame: Duration of the study, up to 6 months.). 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 10 Oct 2022.