- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03879616
Optimizing Gastrointestinal Procedure Appointments
Optimizing the Use of Reminders for Gastrointestinal Procedure Appointments
This project will address the question:
Does an "enhanced" IVR-T protocol differ in effectiveness from the standard IVR-T protocol in reducing missed appointments and late cancellations for GI endoscopy? Hypothesis: The enhanced IVR-T protocol will be more effective.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol.
Randomization: Beginning in March 8, 2019, a randomization algorithm will be used in the Structured Query Language program that manages the IVR relational database to assign each visit for a procedure at all three sites to control or intervention. Since members with multiple procedures on different days during the study period could receive control or intervention for different visits, the statistical analysis will be limited to the first randomized appointment during the project period. Randomization will be stratified by clinic site.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Colorado
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Aurora, Colorado, Vereinigte Staaten, 80014
- Kaiser Permanente
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion criteria:
- Members scheduled for any GI procedure (upper endoscopy, colonoscopy, or both), with or without anesthesia, at all three clinical sites (Franklin, Rock Creek, Lone Tree) will be included if their procedure is scheduled ≥ 2 days prior to the procedure. The IVR-T protocol will be adapted based on the wait time between appointment scheduling and the date of the procedure.
- Members with all clinical indications (screening, diagnosis, or surveillance), will be included.
Exclusion criteria:
- KPCO members who request not to participate in research or not to receive IVR-T or email outreach
- KPCO members in the "break the glass" or "code pink" protocols.
- Members whose procedure is scheduled < 2 days prior to the procedure.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: An Enhanced Reminder
Members randomized to this arm of the study will receive an enhanced reminder protocol, which will include multiple reminders, multiple modalities, and motivational messages. The timing of reminders will depend on the wait time between the date the appointment is made and the date of the appointment.
|
This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol. Data from the randomized trial, for both intervention and control participants, will be analyzed to develop a statistical prediction rule that identifies members at highest risk of missing their procedure. |
Sonstiges: Control
Members randomized to this arm of the study will receive a single text message that "rolls over" to an IVR automated phone call if the text cannot be delivered.
This message will be delivered 7 business days prior to the appointment.
This replicates the current protocol for GI procedures.
Of note, members who schedule appointments within 7 days of the procedure currently receive no reminders.
|
This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol. Data from the randomized trial, for both intervention and control participants, will be analyzed to develop a statistical prediction rule that identifies members at highest risk of missing their procedure. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Rate of Cancellation and Rate of Missed Appointments
Zeitfenster: 6 months
|
The primary outcome for the study will be "appointment loss," defined by GI leaders as the combined rate of prior day cancellations, same-day cancellations, and missed clinic appointments ("no shows").
The rationale for this outcome definition is that it is difficult to schedule new procedures within this time frame.
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6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Boston Bowel Preparation Measure
Zeitfenster: 6 months
|
A secondary outcome will be the assessment of the adequacy of the bowel preparation for colonoscopy only.
|
6 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: John Steiner, MD, MPH, Kaiser Permanente
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GI2019
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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