Clinical trial NCT01988194: Pragmatic Research eXamining Inpatient Symptoms
Official title: Pragmatic Randomized Controlled Trial of Adjunct Acupuncture vs Usual Care Among Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Nausea
Vomiting
Anxiety
Depression
Keywords: acupuncture
postoperative pain
nausea
vomiting
anxiety
depression
hospitalization
inpatient
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Self-reported pain
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary outcomes:
measure: Self-reported nausea and vomiting
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Self-reported anxiety and depression
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Functionality and quality of life
timeFrame: Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days
measure: Patient satisfaction
timeFrame: Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days
measure: Self-reported global well-being
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Self-reported global rating of change
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Other outcomes:
measure: Hospital costs and charges
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Use of medications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Time to ambulation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: 30 day readmission
timeFrame: 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
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Foley catheter removal
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Mount Zion
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maria T Chao, DrPH, MPA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.