NP-Supported Multidisciplinary Diabetes Management During Perioperative Period

Not Applicable

• Conditions: Diabetes
• Interventions: Other: NP-Supported Multidisciplinary Diabetes Management

• Registration Number: NCT05293015
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-23
• Last Update Posted: 2022-03-23
• Study Start: 2022-04-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NP-Supported Multidisciplinary Diabetes Management	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.

Primary Outcome Measures

Name	Time	Method
EFFICACY: TIR（Time in Range）	From into the group to the first hospital day; First day in hospital to the day of discharge	Time in range

Secondary Outcome Measures

Name	Time	Method
EFFICACY: Glycated Serum Protein	baseline and 1 month after discharged	Glycated Serum Protein would be conducted to measure glucose control
QUALITY OF LIFE:living quality	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.
EFFICACY: Incidence of perioperative hypoglycemia	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
EFFICACY: Incidence of perioperative adverse events	1 month after discharge	Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.
EFFICACY: Blood pressure	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
EFFICACY: Anxiety and depression	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.
EFFICACY: Time required for blood glucose standard before surgery	the first hospital day	The time from the patient's enrollment to the blood glucose reaching the blood glucose control target
EFFICACY: Diabetes self-management behavior	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.
EFFICACY: Body weight	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.