NP-Supported Multidisciplinary Diabetes Management During Perioperative Period (NPMDM-PP)

March 14, 2022 updated by: Peking University Third Hospital

NP-Supported Multidisciplinary Diabetes Management During Perioperative Period in Patient With Diabetes Mellitus

The primary objective of this study is to determine the benefits of interventions from a Multidisciplinary Diabetes Care team involved of diabetes nurse practitioners(DNP) on glucose control, perioperative outcomes and psychosocial outcomes for patients with Diabetes Mellitus

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

About 50% of diabetic patients will undergo at least one surgical operation, and nearly 20% of surgical patients have diabetes.Compared with non-diabetic patients, diabetic patients face greater risks during the perioperative period. Stress factors such as preoperative preparation, anesthesia, surgical trauma, pain, drugs and negative emotions can induce blood glucose fluctuations, which could lead to complications such as hyperglycemia, diabetic ketosis, and hypoglycemia.Therefore, perioperative management has become an important part of diabetes management.

A multidisciplinary collaborative team led by NP can reduce the mortality of patients after inpatient surgery, help patients change their lifestyle, maintain self-management behavior, improve patient experience, and reduce hospitalization costs. This study intends to explore the application effect of NP-led multidisciplinary collaborative team in the perioperative comprehensive management of diabetic patients.

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis meets World Health Organization (WHO) (1999) Diabetes Diagnostic Standards
  • Orthopedic assessment requires elective surgery and no surgical contraindications
  • HbA1c≥8.5% or intravenous fasting blood glucose (FBG)>10mmol/l
  • Informed consent.

Exclusion Criteria:

  • Cognitive and communication disorders;
  • Pregnancy;
  • Participate in other intervention studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NP-Supported Multidisciplinary Diabetes Management
NP establishes files to evaluate and manage patients before hospital and visits patients after hospitalization. Then set blood glucose control goals with endocrinology and orthopedic doctors together, initiates consultation with endocrinologists for patients with postoperative hyperglycemia, and is responsible for post-hospital follow-up.
Other: NP-Supported Multidisciplinary Diabetes Management
NP establishes files to evaluate and manage patients before hospital and visits patients after hospitalization. Then set blood glucose control goals with endocrinology and orthopedic doctors together, initiates consultation with endocrinologists for patients with postoperative hyperglycemia, and is responsible for post-hospital follow-up.
No Intervention: Regular diabetes management
The patient would go to the endocrinology outpatient clinic before hospitalization to regulate blood glucose, and be managed by by orthopedic medical staff through hospitalization. If necessary, the endocrinologist is consulted. And after the hospital, patients would be followed up by orthopedic medical staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFFICACY: TIR（Time in Range）
Time Frame: From into the group to the first hospital day; First day in hospital to the day of discharge
Time in range
From into the group to the first hospital day; First day in hospital to the day of discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFFICACY: Glycated Serum Protein
Time Frame: baseline and 1 month after discharged
Glycated Serum Protein would be conducted to measure glucose control
baseline and 1 month after discharged
EFFICACY: Incidence of perioperative hypoglycemia
Time Frame: From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
Incidence of perioperative hypoglycemia would be conducted to measure glucose control
From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
EFFICACY: Time required for blood glucose standard before surgery
Time Frame: the first hospital day
The time from the patient's enrollment to the blood glucose reaching the blood glucose control target
the first hospital day
EFFICACY: Diabetes self-management behavior
Time Frame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
measured by Summary of Diabetes Self-Care Activities（SDSCA）. SDSCA scores from 0 to 77 and higher score means better self-management behaviors.
Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
EFFICACY: Incidence of perioperative adverse events
Time Frame: 1 month after discharge
Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.
1 month after discharge
EFFICACY: Blood pressure
Time Frame: baseline, day of hospitalization, during hospitalization and 1 month after discharge
A calibrated electronic blood pressure meter of the same brand was used to measure systolic pressure and diastolic pressure in the same arm at the same time daily
baseline, day of hospitalization, during hospitalization and 1 month after discharge
EFFICACY: Body weight
Time Frame: baseline, day of hospitalization, during hospitalization and 1 month after discharge
The same scale was used to measure after patients got up in the morning.
baseline, day of hospitalization, during hospitalization and 1 month after discharge
EFFICACY: Anxiety and depression
Time Frame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
measured by Hospital Anxiety and Depression Scale (HADS) scale. HADS contains two subscales: anxiety and depression, and each subscale have 7 items. Total scores were from 0 to 42(anxiety: 21 scores; depression: 21 scores), higher score means more severe anxiety and/or depression.
Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
QUALITY OF LIFE:living quality
Time Frame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
measured by Short Form 36 Health Survey (SF-36) which contains 8 modules with different score formula. Higher total scores mean better living quality.
Measurements were taken at baseline, day of hospitalization, and 1 month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Roche Pharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2021609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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