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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03850431
Other study ID # IIR 17-134
Secondary ID HX002449
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2019
Est. completion date October 14, 2021

Study information

Verified date October 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

"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.


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


Recruitment information / eligibility

Status Completed
Enrollment 34516
Est. completion date October 14, 2021
Est. primary completion date October 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Norms + Behavioral Instructions
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 Instructions
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 Instructions
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 Instructions
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).

Locations

Country Name City State
United States VA Portland Health Care System, Portland, OR Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
VA Office of Research and Development Iowa City VA Health Care System, VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (4)

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.00000000000017 — View Citation

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: — View Citation

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. do — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Secondary Cancellation Rate The percentage of scheduled appointments that are marked as canceled. 1 year
See also
  Status Clinical Trial Phase
Completed NCT00178737 - Does the Message Matter? Enhancing Adherence in Healthcare Through Persuasive Messages N/A