NP-Supported Multidisciplinary Diabetes Management During Perioperative Period

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Other: NP-Supported Multidisciplinary Diabetes Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NP-Supported Multidisciplinary Diabetes Management<br>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<br>* 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.<br>|
| No Intervention: Regular diabetes management<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY: TIR（Time in Range） | 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 | Glycated Serum Protein would be conducted to measure glucose control | baseline and 1 month after discharged | 
| EFFICACY: Incidence of perioperative hypoglycemia | 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 | 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 | 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 | Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery. | 1 month after discharge | 
| EFFICACY: Blood pressure | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nurse practitioners, Multidisciplinary Diabetes Management, perioperative period