title: Adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study.
abstract: BACKGROUND
  Effective pain management among hospitalized patients is an important aspect of providing quality care and achieving optimal clinical outcomes and patient satisfaction. Common pharmacologic approaches for pain, though effective, have serious side effects and are not appropriate for all inpatients. Findings from randomized controlled trials (RCTs) support the efficacy of acupuncture for many symptoms relevant to inpatients including postoperative pain, cancer-related pain, nausea and vomiting, and withdrawal from narcotic use. However, the extent to which findings from RCTs translate to real-world implementation of acupuncture in typical hospital settings is unknown.
  
  
  METHODS
  In partnership with the launch of a clinical program offering acupuncture services to inpatients at the University of California San Francisco's Mount Zion Hospital, we are conducting a pilot study using a hybrid effectiveness-implementation design to: (1) assess the effectiveness of acupuncture to manage pain and other symptoms and improve patient satisfaction; and (2) evaluate the barriers and facilitators to implementing an on-going acupuncture service for inpatients. During a two-month pre-randomization phase, we evaluated and adapted clinical scheduling and treatment protocols with acupuncturists and hospital providers and pretested study procedures including enrollment, consent, and data collection. During a six-month randomization phase, we used a two-tiered consent process in which inpatients were first consented into a study of symptom management, randomized to be offered acupuncture, and consented for acupuncture if they accepted. We are also conducting in-depth interviews and focus groups to assess evidence, context, and facilitators of key provider and hospital administration stakeholders.
  
  
  CONCLUSIONS
  Effectiveness research in "real-world" practice settings is needed to inform clinical decision-making and guide implementation of evidence-based acupuncture practices. To successfully provide clinical acupuncture services and maintain a rigorous research design, practice-based trials of acupuncture require careful planning and attention to setting-specific, contextual factors.
  
  
  BACKGROUND
  This trial has been registered in ClinicalTrials.gov. The identifier is NCT01988194, registered on November 5, 2013.
authors.affiliation: Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California 94143, USA.|Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, California 94143, USA.
authors.forename: Maria T
authors.initials: MT
authors.lastname: Chao
authors.affiliation: Departments of Anesthesiology and Internal Medicine, Loma Linda University, Loma Linda, California 92354, USA.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Chang
authors.affiliation: Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California 94143, USA.|Division of Hospital Medicine, University of California San Francisco, San Francisco, California 94143, USA.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Reddy
authors.affiliation: Division of Hospital Medicine, University of California San Francisco, San Francisco, California 94143, USA.
authors.forename: James D
authors.initials: JD
authors.lastname: Harrison
authors.affiliation: Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California 94143, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Acquah
authors.affiliation: Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California 94143, USA.
authors.forename: Miria
authors.initials: M
authors.lastname: Toveg
authors.affiliation: Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California 94143, USA.
authors.forename: Trilce
authors.initials: T
authors.lastname: Santana
authors.affiliation: Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California 94143, USA.
authors.forename: Frederick M
authors.initials: FM
authors.lastname: Hecht
mesh_terms: D015670:Acupuncture Therapy; D002985:Clinical Protocols; D006801:Humans; D007297:Inpatients; D059408:Pain Management; D010865:Pilot Projects