NP-Supported Multidisciplinary Diabetes Management During Perioperative Period (NPMDM-PP)
14 maart 2022 bijgewerkt door: 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
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
170
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Qun Wang
- Telefoonnummer: 13901280942
- E-mail: wq3025@sina.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
|
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.
|
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Geen tussenkomst: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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EFFICACY: TIR（Time in Range）
Tijdsspanne: From into the group to the first hospital day; First day in hospital to the day of discharge
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Time in range
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From into the group to the first hospital day; First day in hospital to the day of discharge
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
EFFICACY: Glycated Serum Protein
Tijdsspanne: baseline and 1 month after discharged
|
Glycated Serum Protein would be conducted to measure glucose control
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baseline and 1 month after discharged
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EFFICACY: Incidence of perioperative hypoglycemia
Tijdsspanne: From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
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Incidence of perioperative hypoglycemia would be conducted to measure glucose control
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From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
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EFFICACY: Time required for blood glucose standard before surgery
Tijdsspanne: 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
|
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EFFICACY: Diabetes self-management behavior
Tijdsspanne: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
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measured by Summary of Diabetes Self-Care Activities（SDSCA）.
SDSCA scores from 0 to 77 and higher score means better self-management behaviors.
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Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
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EFFICACY: Incidence of perioperative adverse events
Tijdsspanne: 1 month after discharge
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Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.
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1 month after discharge
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EFFICACY: Blood pressure
Tijdsspanne: 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
|
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EFFICACY: Body weight
Tijdsspanne: 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.
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baseline, day of hospitalization, during hospitalization and 1 month after discharge
|
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EFFICACY: Anxiety and depression
Tijdsspanne: 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.
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Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
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QUALITY OF LIFE:living quality
Tijdsspanne: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
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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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Golden SH, Peart-Vigilance C, Kao WH, Brancati FL. Perioperative glycemic control and the risk of infectious complications in a cohort of adults with diabetes. Diabetes Care. 1999 Sep;22(9):1408-14. doi: 10.2337/diacare.22.9.1408.
- Liao CC, Lin CS, Shih CC, Yeh CC, Chang YC, Lee YW, Chen TL. Increased risk of fracture and postfracture adverse events in patients with diabetes: two nationwide population-based retrospective cohort studies. Diabetes Care. 2014 Aug;37(8):2246-52. doi: 10.2337/dc13-2957. Epub 2014 May 7. Erratum In: Diabetes Care. 2017 Jun 14;:
- Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. doi: 10.2337/diacare.27.2.553. No abstract available. Erratum In: Diabetes Care. 2004 Mar;27(3):856. Hirsh, Irl B [corrected to Hirsch, Irl B]. Diabetes Care. 2004 May;27(5):1255.
- Meneghini LF. Perioperative management of diabetes: translating evidence into practice. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S53-9. doi: 10.3949/ccjm.76.s4.09.
- Sebranek JJ, Lugli AK, Coursin DB. Glycaemic control in the perioperative period. Br J Anaesth. 2013 Dec;111 Suppl 1:i18-34. doi: 10.1093/bja/aet381.
- Aminian A, Kashyap SR, Burguera B, Punchai S, Sharma G, Froylich D, Brethauer SA, Schauer PR. Incidence and Clinical Features of Diabetic Ketoacidosis After Bariatric and Metabolic Surgery. Diabetes Care. 2016 Apr;39(4):e50-3. doi: 10.2337/dc15-2647. Epub 2016 Jan 28. No abstract available.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 april 2022
Primaire voltooiing (Verwacht)
31 maart 2023
Studie voltooiing (Verwacht)
31 maart 2023
Studieregistratiedata
Eerst ingediend
29 december 2021
Eerst ingediend dat voldeed aan de QC-criteria
14 maart 2022
Eerst geplaatst (Werkelijk)
23 maart 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 maart 2022
Laatste update ingediend die voldeed aan QC-criteria
14 maart 2022
Laatst geverifieerd
1 december 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M2021609
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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