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Pragmatic Research eXamining Inpatient Symptoms (PRAXIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01988194
First received: November 5, 2013
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

Many hospitalized patients experience pain during their hospital stay, and less than half report adequate pain relief. Common treatments for pain include opioid medications, which have associated side effects and complications. Research has shown that acupuncture is effective for surgical, postoperative and cancer-related pain, nausea, and vomiting. More research is needed on the effectiveness of adding acupuncture to routine care for hospitalized patients. The objective of this study is to examine the effectiveness of acupuncture delivered in a "real-world" setting according to the principles of traditional Chinese medicine among hospitalized patients to manage pain and other symptoms. 250 hospitalized participants will be randomized in a 1 to 1 ratio to receive either 1) usual care or 2) usual care with acupuncture offered (125 in each group). The primary outcome measure will be change in daily pain intensity. Data on other symptoms, such as nausea, vomiting, anxiety, and depression, as well as functionality and quality of life will be collected in person, on a web-based survey, or via telephone follow-up. The aims of the study are to examine the effectiveness of acupuncture to manage pain and other symptoms among hospitalized patients; to evaluate the impact of acupuncture on patient satisfaction among hospitalized patients; and to estimate costs and cost-effectiveness of acupuncture among a subset of hospitalized patients.

The investigators hypothesize that compared to hospitalized patients receiving usual care alone, hospitalized patients receiving acupuncture will have:

  1. decreased pain severity
  2. higher patient satisfaction

Condition Intervention
Postoperative Pain
Nausea
Vomiting
Anxiety
Depression
Device: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic Randomized Controlled Trial of Adjunct Acupuncture vs Usual Care Among Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Self-reported pain [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Daily pain intensity will be measured on a 0-10 numeric rating scale. The APS Patient Outcome Questionnaire will also be administered each day to measure pain severity and relief; impact of pain on activity, sleep, and negative emotions; side effects of treatment; helpfulness of information about pain treatment; and ability to participate in pain treatment decisions.


Secondary Outcome Measures:
  • Self-reported nausea and vomiting [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Daily nausea and vomiting symptoms will be measured using the 2-question Postoperative Nausea and Vomiting Scale.

  • Self-reported anxiety and depression [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Every other day, anxiety and depression will be measured using the 30-item Profile of Mood States questionnaire.

  • Functionality and quality of life [ Time Frame: Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days ] [ Designated as safety issue: No ]
    Functionality and quality of life will be measured using the EQ-5D questionnaire at baseline and within 3 days of hospital discharge.

  • Patient satisfaction [ Time Frame: Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days ] [ Designated as safety issue: No ]
    Within 3 days after hospital discharge, participants will be contacted to answer questions about their recent hospital stay, including questions about communication with clinicians, responsiveness of hospital staff, cleanliness and quietness of the hospital environment, pain management, and overall experience in the hospital.

  • Self-reported global well-being [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Every other day, global well-being will be measured using the single item Arizona Integrated Outcomes Scale.

  • Self-reported global rating of change [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    On the last day of hospitalization, the patient's minimal clinically important difference in pain will be measured using the single item Patient Global Impression of Change Scale.


Other Outcome Measures:
  • Hospital costs and charges [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    After discharge from the hospital, data from the medical record will be extracted to determine the diagnosis group, length of stay, and costs of medications used for pain, anxiety, nausea/vomiting, and anesthesia.

  • Use of medications [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Data about medication use will be extracted from the participant's medical chart, including type(s) of analgesics, total dose, the number of agents, whether opioids and/or adjuncts were required, and mode of delivery.

  • Time to ambulation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Data will be extracted from the participant's medical chart to determine date of ambulation.

  • 30 day readmission [ Time Frame: Participants will be followed for the duration of hospital stay and for up to 30 days after hospital discharge, for a total expected average of 36 days ] [ Designated as safety issue: No ]
    Data will be extracted from the participant's medical chart to determine whether the participant has been readmitted to the hospital within 30 days of discharge.

  • Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Data will be extracted from the participant's medical chart to determine length of hospital stay.

  • Foley catheter removal [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
    Data will be extracted from the participant's medical chart to determine date of Foley catheter removal.


Estimated Enrollment: 250
Study Start Date: November 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Participants will receive usual care in the hospital.
Experimental: Usual care with acupuncture
Participants will receive usual care with acupuncture treatments up to four days per week for the duration of their hospital stay.
Device: Acupuncture
Acupuncture treatments will be provided in patient rooms up to four days per week for the duration of their hospital stay. Treatments will be consistent with how acupuncture is typically practiced: acupuncturists will diagnosis patients according to principles of traditional Chinese medicine (TCM); and treatments will be individualized to the patients. Duration of assessment, needle placement and retention will be 20-30 minutes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English or Spanish speaking
  • Admitted to Mt Zion Hospital for a minimum anticipated length of stay for at least 4 days
  • Aged 18 or older
  • In a ward included in the roll out of the Osher Center's acupuncture program at Mt Zion

Exclusion Criteria:

  • Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction, severe depression, patients in the intensive care unit)
  • Acupuncture contraindication (e.g., sepsis, endocarditis)
  • Inability to consent or complete surveys (e.g., cognitive or communication impairment)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988194

Contacts
Contact: Maria T Chao, DrPH, MPA 415.353.7749 chaom@ocim.ucsf.edu

Locations
United States, California
UCSF Medical Center at Mount Zion Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Maria T Chao, DrPH, MPA         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Maria T Chao, DrPH, MPA University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01988194     History of Changes
Other Study ID Numbers: 13-11353
Study First Received: November 5, 2013
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
acupuncture
postoperative pain
nausea
vomiting
anxiety
depression
hospitalization
inpatient

Additional relevant MeSH terms:
Depression
Depressive Disorder
Pain, Postoperative
Vomiting
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014