Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care

Assessing the Association Between Patients' Perceptions of Success With Post-Operative Pain Management and Overall Experience With Care

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

Study Overview

• Status: Withdrawn
• Conditions: Postoperative Pain

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • Florida
    • Jupiter, Florida, United States, 33458
      • Jupiter Medical Center
    • Tamarac, Florida, United States, 33321
      • Phoenix Clinical Research LLC
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Associates of Michigan
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Women's Hospital (UPMC)
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Baylor Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Total Hip Replacement Group; Adults who have undergone a total hip replacement
Hysterectomy Group; Adults who have undergone a hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS)	Assess the association between patients' perceptions of success with opioid post-operative pain management following total hip replacement or hysterectomy surgery as measured by a patient global assessment (PGA) at 24 hours post-op and at 48 hours post-op, and their perception of pain management while in the hospital and the hospital overall, as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) instrument two-weeks (14 days) post-discharge	24 hours - 14 days post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Pain Management Modality	Determine whether there are differences in patients' perception of pain management while in the hospital and the hospital overall with respect to post-operative pain management modality	14 days post discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome measures consisting of multiple measures	Depending on available statistical power, other relevant constructs, including pain severity and mobility, as measured by BPI, a one-item Pain Numerical Rating Scale (NRS), and mobility items from the Ease of Care (EOC) Questionnaire, as well as patient demographic characteristics and medical/medication history will be taken into account when assessing the primary and secondary objectives.	48 Hours Post Op

Collaborators and Investigators

• Sponsor: The Medicines Company
• Investigators: Study Director: Jeffrey Abraham, MSPT, MBA, The Medicines Company

Publications and helpful links

General Publications

• Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
• Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MDCO-ERA-14-01