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

NCT03881891 | Completed

• 2 other identifiers: A131587U18HS026135
• Study Type: interventional
• Target: 1,525
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain, Postoperative; Complication, Postoperative

Outcome Measures

Primary Outcomes (6)

• Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument

  Evaluate the pain intensity on Day 1 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.

  On day 1 post procedure for each patient.

• Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument

  Evaluate the pain intensity on Day 3 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.

  On day 3 post procedure for each patient.

• Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument

  Evaluate the pain intensity on Day 5 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.

  On day 5 post procedure for each patient.

• Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument

  Evaluate the pain intensity on Day 7 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.

  On day 7 post procedure for each patient.

• Pain experience in both arms, measured using the American Pain Society, the Patient Outcome Questionnaire (APS-POQ-R) questionnaire.

  Assess patients' 7-day post-op pain experiences. The dependent variables for our analysis will be derived from the questions: "How often were you in severe pain in the first 7 days?" A score of zero signifies that the respondent was "never in severe pain" while a score of 100 means the patient was "always in severe pain"; and 2b) "How satisfied you are with the results of your pain treatment following your dental procedure?" The patient satisfaction outcome scale ranges from 0 to 10 with low scores representing low satisfaction and higher scores representing higher satisfaction.

  The pain experience outcome will be measured 7 days post procedure.

• Provider Acceptance of FollowApp.Care

  The investigators will administer the 26-item Technology Acceptance Model (TAM2) Questionnaire to providers in the intervention group pre- and post-implementation, to assess their perceived usefulness and perceived ease of use of FollowApp.Care as predictors of their usage behavior. The control group will also be invited to complete the TAM2 questionnaire post-implementation only, to assess their acceptance of FollowApp.Care if it is made available to them.

  2nd Quarter Year 3

Secondary Outcomes (1)

• Unscheduled/emergency visits during the study period;

  through study completion, an average of 3 years

Study Arms (2)

Follow-app intervention arm

EXPERIMENTAL

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.

Behavioral: Follow-app intervention arm

Standard care arm

NO INTERVENTION

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

Interventions

Follow-app intervention arm 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

Follow-app intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• rd year pre-doctoral students
• th year pre-doctoral students
• dental hygiene students

Sponsors & Collaborators

• University of California, San Francisco: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Willamette Dental Group & Skourtes Institute

Hillsboro, Oregon, 97124, United States

Location

Related Publications (1)

• 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.

  PMID: 37933185 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Elsbeth Kalenderian, DDS, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Muhammad F Walji, PhD

  UT Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 20, 2019
• Study Start: February 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)