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Standardization of Post-operative Opiate Prescriptions for Same-day Ankle and Wrist Fracture Surgeries

3 kwietnia 2022 zaktualizowane przez: Zoe Rubin, The Ottawa Hospital

The purpose of this prospective cohort study is to evaluate the opiate prescribing patterns post open reduction and internal fixation (ORIF) of wrist and ankle fractures at the Ottawa Hospital.

The primary objective would be to examine the quantity and duration of opiates consumed by the study population, as well as the participant's overall satisfaction with pain control. the investigators will assess whether there is a discrepancy between the quantity of pills prescribed and what is being consumed.

With the data collected, the secondary objective would be to create a standardized pain prescription, which the investigators would implement in the second phase of this prospective study. Opiate pills consumed, pain satisfaction and left-over narcotics would again be assessed.

The overall goal of this study is to produce an appropriate standardized post-operative prescription, where the number of opiates prescribed mirrors what is being consumed. This would cut down on the quantity of left-over narcotics, helping to reduce the incidence of opiate dependency and diversion in the Ottawa community.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a multiphase study that will begin with a retrospective review of the prescribing patterns at the Ottawa Hospital. The post-operative prescriptions of 50 wrist fracture and 50 ankle fracture patients booked for same day fracture fixation will be reviewed. The type and quantity of opiate pills prescribed, as well as the other multimodal analgesics prescribed will be collected. Phase one will provide the investigators with data regarding the recent prescribing trends at the Ottawa Hospital prior to beginning the prospective phase of the study.

Phase two and three of the study involves collecting data from two prospectively collected cohorts - the standard of care cohort (phase 2) and the standardized prescription cohort (phase 3).

In phase two, eligible wrist and ankle fracture patients booked for open reduction and internal fixation through the Walking Wounded (emergency day surgery) program will be recruited and consented via telephone prior to their surgery date. The study participants will receive a post-operative prescription at the discretion of their attending surgeon, fellow or resident, with no intervention from the researchers involved in this study. On post-operative day three and post-operative day ten, these patients will be contacted by phone by the research team and asked to respond verbally to a questionnaire that will record the following measures - quantity of opiates consumed/left-over, pain intensity, satisfaction with pain treatment and other non-opiate medications taken.

Using the data collected from phase two, a standardized pain prescription will be created. The average quantity of opiates consumed by the phase two participants will be used to guide the quantity of opiates to be prescribed on the standardized prescription. Similar to recruitment in phase two, in phase three, all eligible patients will be contacted and recruited by telephone prior to their surgery. These patients will be flagged on the day of surgery and given the standardized prescription post-operatively. They will then be asked to respond to the same questionnaires via telephone on post-op day three and post-op day ten.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Zoe Rubin, M.D.
  • Numer telefonu: 5147549514
  • E-mail: zrubin@toh.ca

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Ankle and wrist fracture patients booked for ORIF (via Walking Wounded program)
  • Opioid naïve (Opiates prescribed in emergency not included)
  • Competent to give informed consent and respond to questionnaires independently
  • English or French speaking

Exclusion Criteria:

  • Admission to hospital pre- or post-operatively
  • Chronic opioid use for pain unrelated to injury
  • Chronic pain in injured extremity, unrelated to acute injury
  • Previous fracture/surgery to injured limb
  • Revision ORIF
  • Dementia or cognitive impairment

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Standard of care cohort
Eligible wrist and ankle fracture patients booked for open reduction and internal fixation through our emergency day surgery program will be recruited and consented via telephone prior to their surgery date. The study participants will receive a post-operative prescription at the discretion of their attending surgeon, fellow or resident, with no intervention from the researchers involved in this study. On post-operative day three and post-operative day ten, these patients will be contacted by phone by the research team and asked to respond verbally to a questionnaire. Measures including quantity of opiates consumed, pain intensity and satisfaction with pain treatment will be recorded.
Eksperymentalny: Standardized prescription cohort
Using the data collected from the standard of care cohort, a standardized pain prescription will be created. The average quantity of opiates consumed by the standard of care participants will be used to guide the quantity of opiates to be prescribed on the standardized prescription. In this arm, all eligible patients will be contacted and recruited by telephone prior to their surgery. These patients will be flagged on the day of surgery and given the standardized prescription post-operatively. They will then be asked to respond to the same questionnaires as the standard of care cohort via telephone on post-op day three and post-op day ten.
Inny: Standardized opiate prescription
The standardized prescription will include a single opiate, with a fixed dose and number of tablets. It will also include non-opiate adjuncts commonly prescribed at our institution, namely acetaminophen and an anti-inflammatory medication.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Patient reported pain satisfaction
Ramy czasowe: Measures will be recorded on days 3 postoperatively
Patient reported pain satisfaction between those receiving standard of care, and those receiving the novel standardized prescription will be compared. Treatment satisfaction will be measured using the 11-point ordinal rating of pain intensity (numeric rating scale) and an 11-point ordinal rating of satisfaction with pain relief. In addition to the numerical rating scale, A verbal rating scale (VRS), will also be used to qualify pain control. The VRS consists of a list of descriptors that represent varying degrees of pain intensity. Each of these descriptors has a number associated with it (e.g., 0 = none, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = intolerable pain). Comparable to the VRS, the Likert scale will similarly be used to qualify treatment satisfaction (e.g., 0 = Very satisfied, 1 = somewhat satisfied, 2 = neither satisfied nor dissatisfied, 3 = somewhat dissatisfied, and 4 = very dissatisfied).
Measures will be recorded on days 3 postoperatively
Patient reported pain satisfaction
Ramy czasowe: Measures will be recorded on day 10 postoperatively
Patient reported pain satisfaction between those receiving standard of care, and those receiving the novel standardized prescription will be compared. Treatment satisfaction will be measured using the 11-point ordinal rating of pain intensity (numeric rating scale) and an 11-point ordinal rating of satisfaction with pain relief. In addition to the numerical rating scale, A verbal rating scale (VRS), will also be used to qualify pain control. The VRS consists of a list of descriptors that represent varying degrees of pain intensity. Each of these descriptors has a number associated with it (e.g., 0 = none, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = intolerable pain). Comparable to the VRS, the Likert scale will similarly be used to qualify treatment satisfaction (e.g., 0 = Very satisfied, 1 = somewhat satisfied, 2 = neither satisfied nor dissatisfied, 3 = somewhat dissatisfied, and 4 = very dissatisfied).
Measures will be recorded on day 10 postoperatively

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Average quantity of opioids prescribed in the standard of care cohort measured using morphine equivalents.
Ramy czasowe: Prescription information will be collected at a single point prior to post-operative day 3.
The quantity of opioids prescribed per patient will be converted to Morphine Milligram Equivalents (MME). Data on quantity and types of opiates prescribed, as well as other non-opiate adjuncts, will be collected through EPIC, our institution's electronic health records system.
Prescription information will be collected at a single point prior to post-operative day 3.
Average quantity of opioids consumed post-operatively in both cohorts
Ramy czasowe: Measures will be recorded on day 3 postoperatively
The quantity of opiates consumed per patient will be collected on post-operative day three, by asking the study participant to count the number of pills remaining in their opiate prescription bottle.
Measures will be recorded on day 3 postoperatively
Average quantity of opioids consumed post-operatively in both cohorts
Ramy czasowe: Measures will be recorded on day 10 postoperatively
The quantity of opiates consumed per patient will be collected on post-operative day ten, by asking the study participant to count the number of pills remaining in their opiate prescription bottle.
Measures will be recorded on day 10 postoperatively
Average quantity of left-over/unused opiates
Ramy czasowe: Post-operative day 10
The quantity of opiates remaining per patient will be collected on post-operative day ten, by asking the study participant to count the number of pills remaining in their opiate prescription bottle.
Post-operative day 10
Distribution of use of different opioids and non-opioid adjuncts prescribed
Ramy czasowe: Prescription information will be collected at a single point prior to post-operative day 3.
The variety of different opiate molecules and non-opiate adjuncts prescribed will be collected and the frequency that each type is being used at our institution will be analyzed.
Prescription information will be collected at a single point prior to post-operative day 3.
The difference in consumption patterns between patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Ramy czasowe: Measures will be recorded on days 3 postoperatively
Average quantity of opioids consumed post-operatively will be compared between the patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Measures will be recorded on days 3 postoperatively
The difference in consumption patterns between patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Ramy czasowe: Measures will be recorded on day 10 postoperatively
Average quantity of opioids consumed post-operatively will be compared between the patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Measures will be recorded on day 10 postoperatively

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Ottawa Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 maja 2022

Zakończenie podstawowe (Oczekiwany)

1 grudnia 2022

Ukończenie studiów (Oczekiwany)

1 grudnia 2022

Daty rejestracji na studia

Pierwszy przesłany

9 lutego 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 kwietnia 2022

Pierwszy wysłany (Rzeczywisty)

12 kwietnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 kwietnia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 kwietnia 2022

Ostatnia weryfikacja

1 kwietnia 2022

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Post-op opiate standardization

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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