Pragmatic Research eXamining Inpatient Symptoms

Study Overview
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Brief Summary
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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

Official Title
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Pragmatic Randomized Controlled Trial of Adjunct Acupuncture vs Usual Care Among Hospitalized Patients

Conditions
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Postoperative Pain, Nausea, Vomiting, Anxiety, Depression

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Participants will receive usual care in the hospital. | |
| Experimental: Usual care with acupuncture<br>Participants will receive usual care with acupuncture treatments up to four days per week for the duration of their hospital stay. | Procedure: Acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported nausea and vomiting | Daily nausea and vomiting symptoms will be measured using the 2-question Postoperative Nausea and Vomiting Scale. | Participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Self-reported anxiety and depression | Every other day, anxiety and depression will be measured using the 30-item Profile of Mood States questionnaire. | Participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| 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. | Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days | 
| 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. | Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days | 
| Self-reported global well-being | Every other day, global well-being will be measured using the single item Arizona Integrated Outcomes Scale. | Participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, postoperative pain, nausea, vomiting, anxiety, depression, hospitalization, inpatient