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Pragmatic Research eXamining Inpatient Symptoms (PRAXIS)

Primary Purpose

Postoperative Pain, Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring acupuncture, postoperative pain, nausea, vomiting, anxiety, depression, hospitalization, inpatient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCSF Medical Center at Mount Zion

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Usual care with acupuncture

Arm Description

Participants will receive usual care in the hospital.

Participants will receive usual care with acupuncture treatments up to four days per week for the duration of their hospital stay.

Outcomes

Primary Outcome Measures

Self-reported pain
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
Daily nausea and vomiting symptoms will be measured using the 2-question Postoperative Nausea and Vomiting Scale.
Self-reported anxiety and depression
Every other day, anxiety and depression will be measured using the 30-item Profile of Mood States questionnaire.
Functionality and quality of life
Functionality and quality of life will be measured using the EQ-5D questionnaire at baseline and within 3 days of hospital discharge.
Patient satisfaction
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
Every other day, global well-being will be measured using the single item Arizona Integrated Outcomes Scale.
Self-reported global rating of change
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.

Full Information

First Posted
November 5, 2013
Last Updated
June 4, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01988194
Brief Title
Pragmatic Research eXamining Inpatient Symptoms
Acronym
PRAXIS
Official Title
Pragmatic Randomized Controlled Trial of Adjunct Acupuncture vs Usual Care Among Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: decreased pain severity higher patient satisfaction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Nausea, Vomiting, Anxiety, Depression
Keywords
acupuncture, postoperative pain, nausea, vomiting, anxiety, depression, hospitalization, inpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants will receive usual care in the hospital.
Arm Title
Usual care with acupuncture
Arm Type
Experimental
Arm Description
Participants will receive usual care with acupuncture treatments up to four days per week for the duration of their hospital stay.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported pain
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary Outcome Measure Information:
Title
Self-reported nausea and vomiting
Description
Daily nausea and vomiting symptoms will be measured using the 2-question Postoperative Nausea and Vomiting Scale.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Self-reported anxiety and depression
Description
Every other day, anxiety and depression will be measured using the 30-item Profile of Mood States questionnaire.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Functionality and quality of life
Description
Functionality and quality of life will be measured using the EQ-5D questionnaire at baseline and within 3 days of hospital discharge.
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
Title
Patient satisfaction
Description
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.
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
Title
Self-reported global well-being
Description
Every other day, global well-being will be measured using the single item Arizona Integrated Outcomes Scale.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Self-reported global rating of change
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Other Pre-specified Outcome Measures:
Title
Hospital costs and charges
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Use of medications
Description
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 Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Time to ambulation
Description
Data will be extracted from the participant's medical chart to determine date of ambulation.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
30 day readmission
Description
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.
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
Title
Length of hospital stay
Description
Data will be extracted from the participant's medical chart to determine length of hospital stay.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Foley catheter removal
Description
Data will be extracted from the participant's medical chart to determine date of Foley catheter removal.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria T Chao, DrPH, MPA
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Medical Center at Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14722175
Citation
Dix P, Sandhar B, Murdoch J, MacIntyre PA. Pain on medical wards in a district general hospital. Br J Anaesth. 2004 Feb;92(2):235-7. doi: 10.1093/bja/aeh052.
Results Reference
background
PubMed Identifier
12873949
Citation
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
Results Reference
background
PubMed Identifier
21152463
Citation
Conway Morris A, Howie N. Pain in medical inpatients: an under-recognised problem? J R Coll Physicians Edinb. 2009 Dec;39(4):292-5. doi: 10.4997/JRCPE.2009.401.
Results Reference
background
PubMed Identifier
14744841
Citation
Whelan CT, Jin L, Meltzer D. Pain and satisfaction with pain control in hospitalized medical patients: no such thing as low risk. Arch Intern Med. 2004 Jan 26;164(2):175-80. doi: 10.1001/archinte.164.2.175.
Results Reference
background
PubMed Identifier
18443635
Citation
Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
Results Reference
background
PubMed Identifier
18522936
Citation
Sun Y, Gan TJ, Dubose JW, Habib AS. Acupuncture and related techniques for postoperative pain: a systematic review of randomized controlled trials. Br J Anaesth. 2008 Aug;101(2):151-60. doi: 10.1093/bja/aen146. Epub 2008 Jun 2.
Results Reference
background
PubMed Identifier
16625560
Citation
Ezzo JM, Richardson MA, Vickers A, Allen C, Dibble SL, Issell BF, Lao L, Pearl M, Ramirez G, Roscoe J, Shen J, Shivnan JC, Streitberger K, Treish I, Zhang G. Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD002285. doi: 10.1002/14651858.CD002285.pub2.
Results Reference
background
PubMed Identifier
19370583
Citation
Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
Results Reference
background
PubMed Identifier
27181130
Citation
Chao MT, Chang A, Reddy S, Harrison JD, Acquah J, Toveg M, Santana T, Hecht FM. Adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study. J Integr Med. 2016 May;14(3):228-38. doi: 10.1016/S2095-4964(16)60252-2.
Results Reference
derived

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Pragmatic Research eXamining Inpatient Symptoms

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