Optimizing Acute Post-Operative Dental Pain Management Using New Health Information Technology

NCT ID: NCT03881891

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-06-30

Brief Summary

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The investigators seek to implement a dental patient reported outcomes system using mobile phone and text messaging to target the over-reliance on pre-emptively prescribed opioids by dental providers. If successful, this project will help dentists actively track and manage their patients' pain after hours and enhance the overall care experience.

Detailed Description

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Pain has been deemed the fifth vital sign and many describe it as an adverse event. The adequate management of pain is the bane of the dental profession and its continuous assessment is crucial to minimizing patients' pain experiences. Due to the duration of action of most commonly-used local anesthetic agents, dental patients are unable to predict their pain following dental procedures until many hours later, when the participants have already returned home and dental offices are closed. This has led to an over-reliance on pre-emptively prescribed opioids by dental providers because the participants have no means to actively track their patients' pain after hours. Innovative mobile applications and connected health technologies that allow real-time tracking of patients' symptoms, functional status and quality of life, provide healthcare professionals with data that were previously unavailable, and have fostered patient engagement, shared decision-making and adherence to treatment plans. The investigators propose an innovative solution to optimize the quality of dental pain monitoring and management by implementing mobile phone technology to monitor patients' pain during the critical acute post-operative phase. The hypothesis is that by actively tracking these symptoms using mobile phones, the investigators modify analgesic prescriptions), thereby eliminating needless suffering, reducing the occurrence and/or severity of post-op complications, and enhancing the overall care experience. The investigators' ultimate goal is to achieve the quadruple aim: improve patient experience, improve patient outcomes, improve physician experience and reduce per capita costs. The investigators will test this hypothesis using a cluster-randomized experimental study design with: (1) an intervention arm where patients receive push notifications through text messages on their mobile phones (FollowApp.Care) at designated time intervals on Days 1, 3, 5 and 7; and (2) a control arm where patients receive the usual care. This project will be conducted at two dental institutions: Willamette Dental Group (WDG) and University of California San Francisco (UCSF). In Aim 1 the investigators will customize the design features of the existing FollowApp.Care at two dental institutions (Willamette Dental Group and University of California San Francisco) and assess its capacity to accurately capture patient-reported outcomes. In Aim 2 the investigators evaluate the impact of using FollowApp.Care on patient post-op experiences and oral health outcomes. And in Aim 3, the investigators evaluate provider acceptance of FollowApp.Care and its impact on provider performance. By collecting patient reported outcomes in a timely and usable way, the investigators expect to help dentists enhance their practice performance and reduce the burden of unnecessary opioid prescriptions on society.

Conditions

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Pain, Postoperative Complication, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Follow-app intervention arm

This arm will comprise of patients who are prompted to complete the PROMIS pain intensity scale through text/Short Message Service(SMS) or email mobile device notifications at pre-defined time intervals on Days 1, 3, 5 and 7 post-operatively.

Group Type EXPERIMENTAL

Follow-app intervention arm

Intervention Type BEHAVIORAL

The intervention includes implementation and evaluation of the effectiveness of a mobile phone-based text messaging system (FollowApp.Care) to collect patients' assessments of their post-op symptoms (pain intensity) and to use that data to improve their quality of care (pain experience) in the dental office setting

Standard care arm

This arm will comprise of patients who receive the usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Follow-app intervention arm

The intervention includes implementation and evaluation of the effectiveness of a mobile phone-based text messaging system (FollowApp.Care) to collect patients' assessments of their post-op symptoms (pain intensity) and to use that data to improve their quality of care (pain experience) in the dental office setting

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients who have undergone periodontal procedures.
* Patients who have undergone endodontic procedures.
* Patients who have undergone oral surgery procedures.

Exclusion Criteria

* 3rd year pre-doctoral students
* 4th year pre-doctoral students
* dental hygiene students
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elsbeth Kalenderian, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Muhammad F Walji, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Houston

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Willamette Dental Group & Skourtes Institute

Hillsboro, Oregon, United States

Site Status

Countries

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United States

References

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Tokede B, Yansane A, Ibarra-Noriega A, Mullins J, Simmons K, Skourtes N, Mehta U, Tungare S, Holmes D, White J, Walji M, Kalenderian E. Evaluating the Impact of an mHealth Platform for Managing Acute Postoperative Dental Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 20;11:e49677. doi: 10.2196/49677.

Reference Type DERIVED
PMID: 37933185 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form: Patient Control

View Document

Document Type: Informed Consent Form: Patient Intervention

View Document

Document Type: Informed Consent Form: Provider Control

View Document

Document Type: Informed Consent Form: Povider Intervention

View Document

Other Identifiers

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U18HS026135

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

A131587

Identifier Type: -

Identifier Source: org_study_id

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