NP-Supported Multidisciplinary Diabetes Management During Perioperative Period (NPMDM-PP)
14. mars 2022 oppdatert av: 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
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Forventet)
170
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Qun Wang
- Telefonnummer: 13901280942
- E-post: wq3025@sina.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
EFFICACY: TIR（Time in Range）
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
EFFICACY: Glycated Serum Protein
Tidsramme: 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
Tidsramme: 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
|
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
Tidsramme: the first hospital day
|
The time from the patient's enrollment to the blood glucose reaching the blood glucose control target
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the first hospital day
|
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EFFICACY: Diabetes self-management behavior
Tidsramme: 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.
|
Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
|
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EFFICACY: Incidence of perioperative adverse events
Tidsramme: 1 month after discharge
|
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
Tidsramme: 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
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baseline, day of hospitalization, during hospitalization and 1 month after discharge
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EFFICACY: Body weight
Tidsramme: 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
|
|
EFFICACY: Anxiety and depression
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. april 2022
Primær fullføring (Forventet)
31. mars 2023
Studiet fullført (Forventet)
31. mars 2023
Datoer for studieregistrering
Først innsendt
29. desember 2021
Først innsendt som oppfylte QC-kriteriene
14. mars 2022
Først lagt ut (Faktiske)
23. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mars 2022
Sist bekreftet
1. desember 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M2021609
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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