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Completed

NCT Number: NCT01988194

Pragmatic Research eXamining Inpatient Symptoms

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

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Key information

Conditions

Postoperative Pain Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Medical Center at Mount Zion

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acupuncture

Procedure

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 outcomes

  1. Self-reported pain

    Time frame: 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 outcomes

  1. Self-reported nausea and vomiting

    Time frame: 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.

  2. Self-reported anxiety and depression

    Time frame: 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.

  3. 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

    Functionality and quality of life will be measured using the EQ-5D questionnaire at baseline and within 3 days of hospital discharge.

  4. 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

    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.

  5. Self-reported global well-being

    Time frame: 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.

  6. Self-reported global rating of change

    Time frame: 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.

Other outcomes

  1. Hospital costs and charges

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days

    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.

  2. Use of medications

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days

    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.

  3. Time to ambulation

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days

    Data will be extracted from the participant's medical chart to determine date of ambulation.

  4. 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

    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.

  5. Length of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days

    Data will be extracted from the participant's medical chart to determine length of hospital stay.

  6. Foley catheter removal

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days

    Data will be extracted from the participant's medical chart to determine date of Foley catheter removal.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: PRAXIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 20, 2013
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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