Appointment RemindersNo ShowNCT03850431

Using Behavioral Economics to Enhance Appointment Reminders and Reduce Missed Visits

A study testing Social Norms + Behavioral Instructions, Caring + Consequences for Others + Behavioral Instructions and Caring + Consequences for Self + Behavioral Instructions in people with Appointment Reminders, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Appointment Reminders
What is being tested?: Social Norms + Behavioral Instructions, Caring + Consequences for Others + Behavioral Instructions and Caring + Consequences for Self + Behavioral Instructions
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34,516 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2019to 14 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All subjects will be a minimum of 18 years old.
All subjects will be patients with scheduled outpatient appointments (either primary care or mental health) in the VA Portland Health Care System.
Race and ethnicity will not be used in determining inclusion or exclusion of subjects.

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239

Other trials in United States

About this study

"No-shows," or missed visits are a persistent problem in all health care systems. They contribute to worsened patient access, longer wait times, and inefficient use limited health care resources. The VA's no-show rate has shown no improvement in years, resulting in a staggering 9 million ambulatory no-shows in Fiscal Year (FY) 2015. Appointment reminders are an essential and proven element to addressing no-shows but major research gaps exist. Behavioral economics (BE) and allied fields offer key insights that are relevant to developing innovation in the field of appointment reminders. Adding "nudges" informed by concepts such as social norms, behavioral intentions, clear instructions, and potential negative consequences to the Veteran and others is a novel but evidence-based way to create enhanced appointment reminders. Seemingly small changes to appointment letters can create measurable shifts in appointment attendance and no-shows. Even more, these behavioral nudges can produce large benefits when taken to scale and compounded across a population.

This project will address several aims, including: developing BE-informed messages to incorporate into enhanced appointment reminders; evaluating the effect of several versions of enhanced appointment reminders; and identifying potential barriers and facilitators to widespread implementation of enhanced appointment reminder messages.

Read the detailed description

Objectives: The overarching objective of this proposal is to test the effectiveness of simple and scalable enhancements to appointment reminders in reducing no-shows, and prepare for larger-scale implementation.

Plan: "No-shows," or missed visits are a persistent problem in all health care systems. They contribute to worsened patient access, longer wait times, and inefficient use limited health care resources. The VA's no-show rate has shown no improvement in years, resulting in a staggering 9 million ambulatory no-shows in FY2015. Appointment reminders are an essential and proven element to addressing no-shows but major research gaps exist. Behavioral economics (BE) and allied fields offer key insights that are relevant to developing innovation in the field of appointment reminders. Adding "nudges" informed by concepts such as social norms, behavioral intentions, clear instructions, and potential negative consequences to the Veteran and others is a novel but evidence-based way to create enhanced appointment reminders. Seemingly small changes to appointment letters can create measurable shifts in appointment attendance and no-shows. Even more, these behavioral nudges can produce large benefits when taken to scale and compounded across a population.

The investigators will address the following aims:

Aim 1: Develop and iteratively refine BE-informed messages based on Veterans' perceptions, and incorporate them into enhanced appointment reminders.
Aim 2: Determine the effect of four versions of enhanced appointment reminders on measures relevant to treatment access, compared with usual reminders.
Aim 3: Evaluate differences in treatment effect associated with four versions of enhanced appointment reminders.
Aim 4: Characterize potential barriers and facilitators to widespread implementation of enhanced appointment reminder messages.

Methods: The investigators will first determine the validity of a series of draft messages, which are informed by concepts and principles from BE, psychology, and related fields and will be included in the intervention; the investigators will also explore potential mechanisms of action, and measure any harms by assessing Veterans' perceptions of the messages (Aim 1). After intervention refinement, the investigators will conduct a cluster randomized controlled trial to test 4 interventions, consisting of variations in nudges included in appointment letters, and compare them to usual appointment letters (Aims 2 and 3). The trial will be conducted at VA Portland Health Care System (VAPORHCS) in primary care and mental health clinics. The investigators will evaluate changes in no-show rates, attendance and cancellation rates and appointment wait times. Finally, the investigators will conduct a qualitative assessment with key informants to inform potential barriers and facilitators to implementation of revised appointment reminders (Aim 4).

Relevance to VA's Mission: This proposal directly addresses two of the six Health Services Research and Development Service (HSR\&D) priority areas: access and mental and behavioral health. First, reducing no-shows is likely to improve efficiency of access to care and reduce wait time. Second, this proposal includes a focus on interventions in mental health settings, which have especially high no-show rates and may have more potential for improvement.

Medical Subject Heading Terms: Economics, Behavioral; Mental Health; Healthcare Quality, Access, and Evaluation

Conditions: Appointment Reminders
Being tested: Social Norms + Behavioral Instructions, Caring + Consequences for Others + Behavioral Instructions, Caring + Consequences for Self + Behavioral Instructions, Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral Instructions
Keywords: Behavioral Economics, Mental Health, Veterans, Veterans Health, Primary Care, Appointments and Schedules
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Social Norms + Behavioral InstructionsBehavioural
A letter with two types of nudges. One points out the common behavior of attending appointments. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).
Caring + Consequences for Others + Behavioral InstructionsBehavioural
A letter with three types of nudges. One suggests that the institution cares about the patient. One highlights a potential negative consequence for others if the patient no-shows. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).
Caring + Consequences for Self + Behavioral InstructionsBehavioural
A letter with three types of nudges. One suggests that the institution cares about the patients. One highlights potential negative consequences for the patient if s/he no-shows. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).
Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral InstructionsBehavioural
A letter with all types of nudges combined. One suggests that the institution cares about the patients. One highlights a potential negative consequence for others if the patient no-shows. One highlights potential negative consequences for the patient if s/he no-shows. One points out the common behavior of attending appointments. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).

Study groups in NCT03850431
Study group	Role	What they receive
Social Norms + Behavioral Instructions	Experimental	Clinics assigned a letter with two types of nudges (Social Norms + Behavioral Instructions) Receives: Behavioral: Social Norms + Behavioral Instructions
Caring + Consequences for Others + Behavioral Instructions	Experimental	Clinics assigned a letter with three types of nudges (Caring + Consequences for Others + Behavioral Instructions) Receives: Behavioral: Caring + Consequences for Others + Behavioral Instructions
Caring + Consequences for Self + Behavioral Instructions	Experimental	Clinics assigned a letter with three types of nudges (Caring + Consequences for Self + Behavioral Instructions) Receives: Behavioral: Caring + Consequences for Self + Behavioral Instructions
Combination of all Nudges	Experimental	Clinics assigned a letter with a combination of all types of nudges (Behavioral: Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral Instructions) Receives: Behavioral: Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral Instructions
Usual Care	No intervention	Clinics assigned to usual care. Usual care consisted of a letter with basic appointment information on date, location, and phone number(s) for scheduling changes

What is being measured

The primary outcome is the main question the study is designed to answer.

No-Show Rate
The percentage of total appointments that are classified as a no-show, relative to the total number of appointments scheduled. The numerator ("no-shows") consists of appointments marked as a no-show and appointments canceled by the patient or clinic after the appointment time. The denominator ("total appointments") consists of no-shows and completed appointments. For calculation of missed appointments, canceled appointments are not included in the number of units analyzed. The numerator is multiplied by 100 to arrive at a percentage.
Measured: 1 year

Secondary outcomes (1)

Cancellation Rate
The percentage of scheduled appointments that are marked as canceled.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 201914 Oct 2021

First posted21 Feb 2019
Study start17 Dec 2019
Primary completion14 Oct 2021
Study completion14 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Appointment RemindersStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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
Model description: The primary objective is to systematically develop and test the effectiveness of a series of changes to appointment letters in a cluster RCT with the goal of reducing no-shows and increasing access. First, the investigators will iteratively obtain feedback and refine messages in draft interventions (Aim 1). Then evaluate the effects of four enhanced appointment reminder interventions informed by BE and the Theory of Planned Behavior, and compare them to usual care and each other (Aims 2 and 3). Appointments will be randomly allocated to one of the four interventions or usual care at the provider-level, with providers blinded to allocation. The trial will be conducted at eight locations across VAPORHCS in both mental health and primary care. The investigators will also conduct a qualitative assessment with key informants (Aim 4) to provide data that will be useful for future implementation (if intervention is effective) or suggest modifications to the intervention (if ineffective).
Masking: None (open label)
Enrolment: 34,516 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03850431
Sponsor's protocol ID: IIR 17-134
Other IDs: HX002449
Acronym: No Show
Status last verified: Oct 2023
First submitted: 19 Feb 2019
Last updated: 19 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Teo AR, Metcalf EE, Strange W, Call AA, Tuepker A, Dobscha SK, Kaboli PJ. Enhancing Usability of Appointment Reminders: Qualitative Interviews of Patients Receiving Care in the Veterans Health Administration. J Gen Intern Med. 2021 Jan;36(1):121-128. doi: 10.1007/s11606-020-06183-5. Epub 2020 Sep 9.
PubMed 32909229
Zikmund-Fisher BJ, Tuepker A, Metcalf EE, Strange W, Teo AR. Applying user-centered design in the development of nudges for a pragmatic trial to reduce no-shows among veterans. Patient Educ Couns. 2022 Jun;105(6):1620-1627. doi: 10.1016/j.pec.2021.10.024. Epub 2021 Oct 23.
PubMed 34756639
Lafferty M, Strange W, Kaboli P, Tuepker A, Teo AR. Patient Sense of Belonging in the Veterans Health Administration: A Qualitative Study of Appointment Attendance and Patient Engagement. Med Care. 2022 Sep 1;60(9):726-732. doi: 10.1097/MLR.0000000000001749. Epub 2022 Jul 26.
PubMed 35880766
Teo AR, Niederhausen M, Handley R, Metcalf EE, Call AA, Jacob RL, Zikmund-Fisher BJ, Dobscha SK, Kaboli PJ. Using Nudges to Reduce Missed Appointments in Primary Care and Mental Health: a Pragmatic Trial. J Gen Intern Med. 2023 Jul;38(Suppl 3):894-904. doi: 10.1007/s11606-023-08131-5. Epub 2023 Jun 20.
PubMed 37340264

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Behavioral Economics to Enhance Appointment Reminders and Reduce Missed Visits
ClinicalTrials.gov ID: NCT03850431
Acronym / sponsor ID: No Show / IIR 17-134
Conditions: Appointment Reminders
Keywords: Behavioral Economics, Mental Health, Veterans, Veterans Health, Primary Care, Appointments and Schedules
Study type: Interventional
Recruitment status: Completed
Enrolment: 34,516 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Iowa City VA Health Care System, VA Salt Lake City Health Care System
Study start: 17 Dec 2019 (actual)
Primary completion: 14 Oct 2021 (actual)
Study completion: 14 Oct 2021 (actual)
First posted: 21 Feb 2019 (actual)
Results: Posted 19 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The investigators will address the following aims:

Aim 1: Develop and iteratively refine BE-informed messages based on Veterans' perceptions, and incorporate them into enhanced appointment reminders.
Aim 2: Determine the effect of four versions of enhanced appointment reminders on measures relevant to treatment access, compared with usual reminders.
Aim 3: Evaluate differences in treatment effect associated with four versions of enhanced appointment reminders.
Aim 4: Characterize potential barriers and facilitators to widespread implementation of enhanced appointment reminder messages.

Medical Subject Heading Terms: Economics, Behavioral; Mental Health; Healthcare Quality, Access, and Evaluation

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: The primary objective is to systematically develop and test the effectiveness of a series of changes to appointment letters in a cluster RCT with the goal of reducing no-shows and increasing access. First, the investigators will iteratively obtain feedback and refine messages in draft interventions (Aim 1). Then evaluate the effects of four enhanced appointment reminder interventions informed by BE and the Theory of Planned Behavior, and compare them to usual care and each other (Aims 2 and 3). Appointments will be randomly allocated to one of the four interventions or usual care at the provider-level, with providers blinded to allocation. The trial will be conducted at eight locations across VAPORHCS in both mental health and primary care. The investigators will also conduct a qualitative assessment with key informants (Aim 4) to provide data that will be useful for future implementation (if intervention is effective) or suggest modifications to the intervention (if ineffective).

Arm	Type	Receives
Social Norms + Behavioral Instructions	Experimental	Behavioral: Social Norms + Behavioral InstructionsClinics assigned a letter with two types of nudges (Social Norms + Behavioral Instructions)
Caring + Consequences for Others + Behavioral Instructions	Experimental	Behavioral: Caring + Consequences for Others + Behavioral InstructionsClinics assigned a letter with three types of nudges (Caring + Consequences for Others + Behavioral Instructions)
Caring + Consequences for Self + Behavioral Instructions	Experimental	Behavioral: Caring + Consequences for Self + Behavioral InstructionsClinics assigned a letter with three types of nudges (Caring + Consequences for Self + Behavioral Instructions)
Combination of all Nudges	Experimental	Behavioral: Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral InstructionsClinics assigned a letter with a combination of all types of nudges (Behavioral: Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral Instructions)
Usual Care	No intervention	–Clinics assigned to usual care. Usual care consisted of a letter with basic appointment information on date, location, and phone number(s) for scheduling changes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

All subjects will be a minimum of 18 years old.
All subjects will be patients with scheduled outpatient appointments (either primary care or mental health) in the VA Portland Health Care System.
Race and ethnicity will not be used in determining inclusion or exclusion of subjects.

Key exclusion criteria (1 listed)

None

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
Social Norms + Behavioral InstructionsA letter with two types of nudges. One points out the common behavior of attending appointments. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).	Behavioural	Social Norms + Behavioral Instructions
Caring + Consequences for Others + Behavioral InstructionsA letter with three types of nudges. One suggests that the institution cares about the patient. One highlights a potential negative consequence for others if the patient no-shows. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).	Behavioural	Caring + Consequences for Others + Behavioral Instructions
Caring + Consequences for Self + Behavioral InstructionsA letter with three types of nudges. One suggests that the institution cares about the patients. One highlights potential negative consequences for the patient if s/he no-shows. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).	Behavioural	Caring + Consequences for Self + Behavioral Instructions
Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral InstructionsA letter with all types of nudges combined. One suggests that the institution cares about the patients. One highlights a potential negative consequence for others if the patient no-shows. One highlights potential negative consequences for the patient if s/he no-shows. One points out the common behavior of attending appointments. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).	Behavioural	Combination of all Nudges

Primary outcome

No-Show Rate
Time frame: 1 year
The percentage of total appointments that are classified as a no-show, relative to the total number of appointments scheduled. The numerator ("no-shows") consists of appointments marked as a no-show and appointments canceled by the patient or clinic after the appointment time. The denominator ("total appointments") consists of no-shows and completed appointments. For calculation of missed appointments, canceled appointments are not included in the number of units analyzed. The numerator is multiplied by 100 to arrive at a percentage.

1 secondary outcome

Cancellation Rate
Time frame: 1 year

Results and safety

Results posted to the registry on 19 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Care Appointments: Usual Care	10,929	5,584
Primary Care Appointments: Caring + Consequences for Self + Behavioral Instructions	13,465	7,287
Primary Care Appointments: Caring + Consequences for Others + Behavioral Instructions	13,525	6,196
Primary Care Appointments: Social Norms + Behavioral Instructions	9,223	5,056
Primary Care Appointments: Combination of All Nudges	12,556	6,543
Mental Health Appointments: Usual Care	3,737	2,184
Mental Health Appointments: Caring + Consequences for Self + Behavioral Instructions	3,996	2,167
Mental Health Appointments: Caring + Consequences for Others + Behavioral Instructions	4,844	2,863
Mental Health Appointments: Social Norms + Behavioral Instructions	4,760	2,860
Mental Health Appointments: Combination of All Nudges	3,354	2,142

Primary outcome: No-Show Rate

Time frame: 1 year. Number. Unit: percentage of appointments no showed

Measure	Primary Care Appointments: Usual Care n = 5584	Primary Care Appointments: Caring + Consequences for Self + Behavioral Instructions n = 7287	Primary Care Appointments: Caring + Consequences for Others + Behavioral Instructions n = 6196	Primary Care Appointments: Social Norms + Behavioral Instructions n = 5056	Primary Care Appointments: Combination of All Nudges n = 6543	Primary Care - All 4 Primary Care Intervention Arms Combined n = 22624	Mental Health Appointments: Usual Care n = 2184	Mental Health Appointments: Caring + Consequences for Self + Behavioral Instructions n = 2167	Mental Health Appointments: Caring + Consequences for Others + Behavioral Instructions n = 2863	Mental Health Appointments: Social Norms + Behavioral Instructions n = 2860	Mental Health Appointments: Combination of All Nudges n = 2142	Mental Health - All 4 Mental Health Intervention Arms Combined n = 7779
Value	11.9	11.1	10.5	12.1	10.6	11.1	18.0	19.2	21.9	20.0	18.9	20.1

Primary Care Appointments: Usual Care vs Primary Care - All 4 Primary Care Intervention Arms Combined: Odds Ratio (OR): 1.139 (95% CI 0.956 to 1.357), p = 0.145, Regression, Logistic
Primary Care Appointments: Usual Care vs Primary Care Appointments: Caring + Consequences for Self + Behavioral Instructions: Odds Ratio (OR): 1.11 (95% CI 0.912 to 1.35), p = 0.298, Regression, Logistic
Primary Care Appointments: Usual Care vs Primary Care Appointments: Caring + Consequences for Others + Behavioral Instructions: Odds Ratio (OR): 1.178 (95% CI 0.955 to 1.452), p = 0.127, Regression, Logistic

Population analysed: The number of participants analyzed is greater than listed in Participant Flow because these results include two additional arms listed for analysis: all 4 Primary Care intervention arms, and all 4 Mental Health intervention arms. These were not individual arms to which participants were randomized but rather a combination of arms for purposes of analysis. The number of appointments analyzed is greater than the number of participants because some participants had multiple appointments.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored for one year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Usual Care	0 of 7,768 (0%)	0 of 7,768 (0%)
Caring + Consequences for Self + Behavioral Instructions	0 of 9,454 (0%)	0 of 9,454 (0%)
Caring + Consequences for Others + Behavioral Instructions	0 of 9,059 (0%)	0 of 9,059 (0%)
Social Norms + Behavioral Instructions	0 of 7,196 (0%)	1 of 7,196 (0%)
Combination of All Nudges	0 of 8,685 (0%)	0 of 8,685 (0%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32909229Teo AR, Metcalf EE, Strange W, Call AA, Tuepker A, Dobscha SK, Kaboli PJ. Enhancing Usability of Appointment Reminders: Qualitative Interviews of Patients Receiving Care in the Veterans Health Administration. J Gen Intern Med. 2021 Jan;36(1):121-128. doi: 10.1007/s11606-020-06183-5. Epub 2020 Sep 9.
Results publication: PubMed 34756639Zikmund-Fisher BJ, Tuepker A, Metcalf EE, Strange W, Teo AR. Applying user-centered design in the development of nudges for a pragmatic trial to reduce no-shows among veterans. Patient Educ Couns. 2022 Jun;105(6):1620-1627. doi: 10.1016/j.pec.2021.10.024. Epub 2021 Oct 23.
Results publication: PubMed 35880766Lafferty M, Strange W, Kaboli P, Tuepker A, Teo AR. Patient Sense of Belonging in the Veterans Health Administration: A Qualitative Study of Appointment Attendance and Patient Engagement. Med Care. 2022 Sep 1;60(9):726-732. doi: 10.1097/MLR.0000000000001749. Epub 2022 Jul 26.
Results publication: PubMed 37340264Teo AR, Niederhausen M, Handley R, Metcalf EE, Call AA, Jacob RL, Zikmund-Fisher BJ, Dobscha SK, Kaboli PJ. Using Nudges to Reduce Missed Appointments in Primary Care and Mental Health: a Pragmatic Trial. J Gen Intern Med. 2023 Jul;38(Suppl 3):894-904. doi: 10.1007/s11606-023-08131-5. Epub 2023 Jun 20.
Individual participant dataSharing planned: No

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.

Alan R. Teo, MD MS principal investigator

VA Portland Health Care System, Portland, OR

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 Apr 2024. 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?

Yes. Results are posted in the registry (first posted 19 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

No-Show Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850431, which also lists 4 linked publications.

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 19 Apr 2024.