Diabetes
Conditions
Keywords
nurse practitioners, Multidisciplinary Diabetes Management, perioperative period
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.
Interventions
OTHERNP-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.
Sponsors
Roche Pharma AG
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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: Glycated Serum Protein | baseline and 1 month after discharged | Glycated Serum Protein would be conducted to measure glucose control |
| 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. |
| 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. |
| 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: 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 |
Contacts
Primary ContactQun Wang
Outcome results
None listed