Pragmatic Research eXamining Inpatient Symptoms

Not Applicable

Completed

• Conditions: Vomiting; Anxiety; Postoperative Pain; Nausea; Depression
• Interventions: Procedure: Acupuncture

• Registration Number: NCT01988194
• Lead Sponsor: University of California, San Francisco

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:

1. decreased pain severity

2. higher patient satisfaction

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Self-reported pain	Participants will be followed for the duration of hospital stay, an expected average of 6 days	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

Name	Time	Method
Functionality and quality of life	Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days	Functionality and quality of life will be measured using the EQ-5D questionnaire at baseline and within 3 days of hospital discharge.
Patient satisfaction	Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days	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 nausea and vomiting	Participants will be followed for the duration of hospital stay, an expected average of 6 days	Daily nausea and vomiting symptoms will be measured using the 2-question Postoperative Nausea and Vomiting Scale.
Self-reported anxiety and depression	Participants will be followed for the duration of hospital stay, an expected average of 6 days	Every other day, anxiety and depression will be measured using the 30-item Profile of Mood States questionnaire.
Self-reported global well-being	Participants will be followed for the duration of hospital stay, an expected average of 6 days	Every other day, global well-being will be measured using the single item Arizona Integrated Outcomes Scale.
Self-reported global rating of change	Participants will be followed for the duration of hospital stay, an expected average of 6 days	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.

Trial Locations

Locations (1)

UCSF Medical Center at Mount Zion; 🇺🇸 San Francisco, California, United States