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

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ClinicalTrials.gov Identifier: NCT03881891
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Complication, Postoperative Behavioral: Follow-app intervention arm Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimizing Acute Post-Operative Dental Pain Management Using New Health Information Technology
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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

No Intervention: Standard care arm
This arm will comprise of patients who receive the usual care.



Primary Outcome Measures :
  1. Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument [ Time Frame: On day 1 post procedure for each patient. ]
    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.

  2. Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument [ Time Frame: On day 3 post procedure for each patient. ]
    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.

  3. Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument [ Time Frame: On day 5 post procedure for each patient. ]
    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.

  4. Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument [ Time Frame: On day 7 post procedure for each patient. ]
    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.

  5. Pain experience in both arms, measured using the American Pain Society, the Patient Outcome Questionnaire (APS-POQ-R) questionnaire. [ Time Frame: The pain experience outcome will be measured 7 days post procedure. ]
    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.

  6. Provider Acceptance of FollowApp.Care [ Time Frame: 2nd Quarter Year 3 ]

    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.



Secondary Outcome Measures :
  1. Unscheduled/emergency visits during the study period; [ Time Frame: through study completion, an average of 3 years ]
    This measure will be compiled on a monthly basis through chart review. At the patient level, the distribution of emergency/unscheduled follow-up visits (frequency and mean) will be collected.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881891


Contacts
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Contact: Alfa Yansane, PhD 510-684-1049 alfa-ibrahim.yansane@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Elsbeth Kalenderian, DDS, PhD    415-502-6504    Elsbeth.Kalenderian@ucsf.edu   
United States, Oregon
Willamette Dental Group & Skourtes Institute Recruiting
Hillsboro, Oregon, United States, 97124
Contact: Kristen Simmons, RDH    503-952-2527    ksimmons@willamettedental.com   
Sponsors and Collaborators
University of California, San Francisco
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Elsbeth Kalenderian, DDS, PhD University of California, San Francisco
Principal Investigator: Muhammad F Walji, PhD UT Houston
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form: Patient Control  [PDF] December 27, 2019
Informed Consent Form: Provider Control  [PDF] December 27, 2019

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03881891    
Other Study ID Numbers: A131587
U18HS026135 ( U.S. AHRQ Grant/Contract )
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations