Pragmatic Research eXamining Inpatient Symptoms

Depression Clinical Trial

— PRAXIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988194
• Other study ID #: 13-11353
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Nausea
• Pain, Postoperative
• Postoperative Pain
• Vomiting

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	UCSF Medical Center at Mount Zion	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (8)

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):534-40, table of contents. — View 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. Review. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;11:CD002285. — View 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. Review. Update in: Cochrane Database Syst Rev. 2015;11:CD003281. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital costs and charges	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.	Participants will be followed for the duration of hospital stay, an expected average of 6 days
Other	Use of medications	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.	Participants will be followed for the duration of hospital stay, an expected average of 6 days
Other	Time to ambulation	Data will be extracted from the participant's medical chart to determine date of ambulation.	Participants will be followed for the duration of hospital stay, an expected average of 6 days
Other	30 day readmission	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.	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
Other	Length of hospital stay	Data will be extracted from the participant's medical chart to determine length of hospital stay.	Participants will be followed for the duration of hospital stay, an expected average of 6 days
Other	Foley catheter removal	Data will be extracted from the participant's medical chart to determine date of Foley catheter removal.	Participants will be followed for the duration of hospital stay, an expected average of 6 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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