Clinical trial NCT02389907: Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care
Official title: Assessing the Association Between Patients' Perceptions of Success With Post-Operative Pain Management and Overall Experience With Care
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Postoperative Pain
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include adults 18 years of age or older who have undergone either a total hip replacement or hysterectomy.

Brief summary: Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.

Detailed description: A study to assess the association between patients' perceptions of success with post-operative pain management following total hip replacement or hysterectomy surgery and their later perception of pain management while in the hospital and the hospital overall.

Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years of age or older
* Subject (or their legally acceptable representative) must have signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Subject is receiving a unilateral total hip replacement or a hysterectomy (total abdominal hysterectomy, total abdominal hysterectomy/bilateral salpingo-oophorectomy, total vaginal hysterectomy, or total vaginal hysterectomy/salpingo-oophorectomy)
* Subject is expected to remain hospitalized for at least 24 hours post-operatively
* Subject is expected to experience pain requiring IV PCA or non-PCA (non-patient controlled opioids via IV, IM, SC, or PO routes of administration) opioids for at least 24 hours after surgery
* Subject is classified as American Society of Anesthesiology (ASA) category I, II, or III
* Subject is willing to complete the required post-operative survey measures to be completed in the hospital
* Subject is willing to complete a post-discharge survey (including HCAHPS survey instrument) via telephone approximately two-weeks (14 days) post-discharge

Exclusion Criteria:

* Subject is having an operation other than the surgical procedures selected for inclusion (e.g., bilateral or partial hip replacement, or hip revision)
* Subject cannot read, write, and communicate in English
* Subject has a history of tolerance to opioids including those prescribed opioids in the 3 month period leading up to the perioperative period (i.e., a subject is considered to have a potential tolerance to opioids if for 4 consecutive days prior to surgery they have been taking a short acting/short acting combination opioid analgesic greater than 120 mg codein daily, 40 mg hydrocodone daily, 200 mg tramadol daily, or 40 mg oxycodone daily or if they were on any dose of strong opioid analgesic such as morphine, hydromorphone, or fentanyl)
* Subject has a history of allergy to opioids reported pre-operatively or documented in medical history
* Subject is scheduled to receive additional surgical procedures beyond those listed within 72 hours of the initial surgery

Primary outcomes:
measure: Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS)
timeFrame: 24 hours - 14 days post discharge
Secondary outcomes:
measure: Post-Operative Pain Management Modality
timeFrame: 14 days post discharge
Other outcomes:
measure: Composite outcome measures consisting of multiple measures
timeFrame: 48 Hours Post Op
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Tamarac
country: United States
facility: Phoenix Clinical Research LLC
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital (UPMC)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Fort Worth
country: United States
facility: Baylor Health Research Institute
state: Texas
Study officials:
affiliation: The Medicines Company
name: Jeffrey Abraham, MSPT, MBA
role: STUDY_DIRECTOR
References:
citation: Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
citation: Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.