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Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

Primary Purpose

Type II Diabetes, Periodontal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Dental cleaning
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes focused on measuring Oral health, Diabetes, Interprofessionalism, Periodontal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has diagnosis of type 2 diabetes
  • Patient has a primary care provider of record
  • Patient is currently admitted to the house staff service of the Department of Medicine at MGH
  • Patient is "ready or nearly ready for discharge," based on the assessment of the patient's medical team.

Exclusion Criteria:

  1. History of cardiac conditions for which antibiotic prophylaxis is indicated prior to dental treatment per American Dental Association/American Heart Association guidelines:51

    1. Prosthetic cardiac valve or prosthetic material used for cardiac valve repair
    2. Previous infective endocarditis
    3. Congenital heart disease (CHD) encompassing:

    i. Unrepaired cyanotic CHD, including palliative shunts and conduits ii. Completely repaired congenital heart defect with prosthetic material or device, whether placed by surgery or by catheter intervention, during the first six months after the procedure iii. Repaired CHD with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device (which inhibit endothelialization) d. Cardiac transplantation recipients who develop cardiac valvulopathy

  2. Anticoagulated with International Normalized Ratio>2.5
  3. History of prosthetic joint replacement in the last two years
  4. Medical team declines enrollment
  5. The patient is unable to participate in the provision of dental prophylaxis due to a medical condition such as altered mental status or altered cognitive status
  6. Edentulous

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Dental Cleaning and MI Arm

MI only Arm

Control Arm

Arm Description

Subjects in this arm will receive a dental cleaning by the hygienist as well as a motivational interviewing (MI) session to explore the subject's motivations to pursue oral health treatment.

Subjects in this arm will not receive a dental cleaning but the hygienist will provide a motivational interviewing (MI) session to explore the subject's motivations to pursue oral health treatment.

Subjects in this arm of the study will not receive any oral health intervention while hospitalized. A medical record review will be completed, and patients will be contacted via telephone at 3, 6, and 12 months post-hospitalization to assess their oral health-related quality of life and oral health care-seeking behaviors.

Outcomes

Primary Outcome Measures

Dental care-seeking behavior
Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.

Secondary Outcome Measures

Healthcare costs
Subject healthcare expenditures 12 months before and after intervention.
Oral health-related quality of life
Subject-reported oral health-related quality of life assessed at 6 months after intervention.
Change from baseline Hemoglobin A1c at 3 and 6 months
Subject Hemoglobin A1c reading as noted in electronic medical record 3 and 6 months after intervention.

Full Information

First Posted
September 20, 2016
Last Updated
March 5, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Harvard School of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02914743
Brief Title
Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
Official Title
Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Harvard School of Dental Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research intervention is to assess the oral health status and periodontal health of patients with diabetes hospitalized on a general medicine service, and to assess the effect of providing dental prophylaxis and motivational interviewing to patient health-seeking behaviors and provider attitudes towards oral health, as well as on patient health outcomes.
Detailed Description
Almost 20% of all patients admitted to the hospital carry a diagnosis of diabetes. Diabetes and periodontal disease have a bi-directional relationship; people with diabetes are at higher risk of tooth loss and poor oral health may impact nutrition and inflammation. Even among those with access to medical treatment for their diabetes, access to dental care may be challenging. In spite of their higher oral health risk, diabetic adults are less likely than their peers to attend a dental visit annually. While oral hygiene measures for ventilator-dependent patients have become standard of care, the oral health of less critically ill hospitalized patients has been noted to decline over the course of their hospitalization and patients generally do not have access to dental treatment., However, invasive dental treatment (restorations, tooth extraction, and periodontal scaling) has been demonstrated to be safe even for critically ill hospitalized patients. The inpatient setting, where patients are already receiving services from multiple disciplines and patients do not need to travel to see a healthcare provider, presents a unique opportunity to make integrative oral healthcare services accessible to diabetic patients, and to increase oral health knowledge of those health professionals caring for patients on an inpatient medical ward. This study will involve provision of dental prophylaxis ("tooth cleaning") as well as motivational interviewing focused on oral health care-seeking behaviors provided by a dental hygienist to patients with a diagnosis of Type II diabetes who are hospitalized on a medicine floor of Massachusetts General Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes, Periodontal Disease
Keywords
Oral health, Diabetes, Interprofessionalism, Periodontal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dental Cleaning and MI Arm
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a dental cleaning by the hygienist as well as a motivational interviewing (MI) session to explore the subject's motivations to pursue oral health treatment.
Arm Title
MI only Arm
Arm Type
Experimental
Arm Description
Subjects in this arm will not receive a dental cleaning but the hygienist will provide a motivational interviewing (MI) session to explore the subject's motivations to pursue oral health treatment.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Subjects in this arm of the study will not receive any oral health intervention while hospitalized. A medical record review will be completed, and patients will be contacted via telephone at 3, 6, and 12 months post-hospitalization to assess their oral health-related quality of life and oral health care-seeking behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
This intervention will involve a discussion intended to explore subjects' motivations to pursue dental care and empower them to visit a dentist upon release from the hospital.
Intervention Type
Procedure
Intervention Name(s)
Dental cleaning
Other Intervention Name(s)
Dental prophylaxis
Intervention Description
This procedure will involve the removal of plaque and supragingival and subgingival calculus from the surfaces of the teeth.
Primary Outcome Measure Information:
Title
Dental care-seeking behavior
Description
Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Healthcare costs
Description
Subject healthcare expenditures 12 months before and after intervention.
Time Frame
Up to 24 months
Title
Oral health-related quality of life
Description
Subject-reported oral health-related quality of life assessed at 6 months after intervention.
Time Frame
6 months
Title
Change from baseline Hemoglobin A1c at 3 and 6 months
Description
Subject Hemoglobin A1c reading as noted in electronic medical record 3 and 6 months after intervention.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Clinician attitude towards the importance of oral health
Description
Clinician attitudes towards the importance of oral health for patient wellbeing before and after working with the study's dental hygienist as measured by a Likert-scale question.
Time Frame
12 months
Title
Clinician attitude towards the value of having a hygienist in the hospital setting
Description
Clinician attitudes towards the value of working with a hygienist in the hospital setting before and after working with the study's dental hygienist as measured by a Likert-scale question.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has diagnosis of type 2 diabetes Patient has a primary care provider of record Patient is currently admitted to the house staff service of the Department of Medicine at MGH Patient is "ready or nearly ready for discharge," based on the assessment of the patient's medical team. Exclusion Criteria: History of cardiac conditions for which antibiotic prophylaxis is indicated prior to dental treatment per American Dental Association/American Heart Association guidelines:51 Prosthetic cardiac valve or prosthetic material used for cardiac valve repair Previous infective endocarditis Congenital heart disease (CHD) encompassing: i. Unrepaired cyanotic CHD, including palliative shunts and conduits ii. Completely repaired congenital heart defect with prosthetic material or device, whether placed by surgery or by catheter intervention, during the first six months after the procedure iii. Repaired CHD with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device (which inhibit endothelialization) d. Cardiac transplantation recipients who develop cardiac valvulopathy Anticoagulated with International Normalized Ratio>2.5 History of prosthetic joint replacement in the last two years Medical team declines enrollment The patient is unable to participate in the provision of dental prophylaxis due to a medical condition such as altered mental status or altered cognitive status Edentulous
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://hsdm.harvard.edu/news/dean%E2%80%99s-innovation-fund-recipients-announced
Description
Announcement of grant funding

Learn more about this trial

Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

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