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Adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study.

ABSTRACT: 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.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.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.This trial has been registered in ClinicalTrials.gov. The identifier is NCT01988194, registered on November 5, 2013.

SUBMITTER: Chao MT

PROVIDER: S-EPMC5050044 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study.

Chao Maria T MT Chang Alexandra A Reddy Sanjay S Harrison James D JD Acquah Joseph J Toveg Miria M Santana Trilce T Hecht Frederick M FM

Journal of integrative medicine 20160501 3

<h4>Background</h4>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, naus ...[more]

PMID: 27181130

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Project description:BackgroundThis nonrandomized exploratory intervention and feasibility study examines how digital assistive technology (DAT), comprising a DFree ultrasound sensor, affects nursing care for continence support and evaluates nurses' willingness to incorporate DAT into the planning and practical implementation of care processes.ObjectiveThe relief provided by DFree in the clinical care setting and the extent to which it supports nursing care for activities of daily living pertaining to "micturition" is unclear. DAT DFree is expected to reduce nurses' workload in clinical continence-care settings and was designed as a human-technology interaction that ensures a high level of usability for the subjects (ie, the nurses) and increases user acceptance by at least one level (eg, from average to slightly above average) during the study.MethodsApproximately 45 nurses from neurology, neurosurgery, and geriatric medicine clinics and polyclinics at the University Medicine Halle will be included in the 90-day (3-month) intervention on-site in the respective wards. After the wards are equipped with digital technologies, the participating nurses will be trained to use DFree and will be able to select DFree as a possible patient-care resource if the anamnesis includes bladder dysfunction among only patients who are willing to participate. The willingness of nurse participants to use DFree in planning their care process will be assessed using the Technology Usage Inventory at 3 measurement points. The primary target values include the results of the multidimensional Technology Usage Inventory assessment that will be processed using descriptive statistics. Ten participating nurses will be invited to conduct extensive guided interviews that are intended to provide information about the device's usefulness and feasibility in the specific field of continence care and possible improvements.ResultsIt is expected that the intention to use will be confirmed by nurses, and the number of nursing problems, such as bladder dysfunction-induced bedwetting, will be reduced with a high rating of DAT usability.ConclusionsFirst, this study aims to produce multilevel innovative impacts, including practical, scientific, and societal effects. The results will provide practical solutions for workload reduction in the field of nursing support for continence care, where digital assistive technologies are becoming increasingly important. The DFree ultrasonic sensor is a new technical tool for the treatment of bladder dysfunction. Generating feedback to improve technical applications can increase the user-friendliness and usefulness of the device.Trial registrationDeutsches Register Klinischer Studien DRKS00031483; https://drks.de/search/en/trial/DRKS00031483.International registered report identifier (irrid)PRR1-10.2196/47025.

Project description:IntroductionImplementation researchers could draw from participatory research to engage patients (consumers of healthcare) in implementation processes and possibly reduce healthcare disparities. There is a little consumer involvement in healthcare implementation, partially because no formal guidance exists. We will create and pilot a toolkit of methods to engage consumers from the US' Veterans Health Administration (VHA) in selecting and tailoring implementation strategies. This toolkit, Consumer Voice, will provide guidance on what, when, where, how and why an implementer might engage consumers in implementing treatments. We will pilot the toolkit by implementing Safety Planning Intervention for suicide prevention with rural veterans, a population with suicide disparities. Safety Planning Intervention is effective for reducing suicidal behaviours.Methods and analysisIn Aim 1, we will use participatory approaches and user-centred design to develop Consumer Voice and its methods. In Aim 2, we will pilot Consumer Voice by implementing the Safety Planning Intervention in two clinics serving rural VHA patients. One site will receive a current implementation strategy (Implementation Facilitation) only; the second will receive Implementation Facilitation plus Consumer Voice. We will use mixed methods to assess feasibility and acceptability of Consumer Voice. We will compare sites on preliminary implementation (reach, adoption, fidelity) and clinical outcomes (depression severity, suicidal ideation, suicidal behaviour). In Aim 3, we will evaluate Aim 2 outcomes at 20 months to assess sustained impact. We will gather qualitative data on sustainability of the Safety Planning Intervention.Ethics and disseminationThese studies are overseen by the Institutional Review Board at the Central Arkansas Veterans Healthcare System. We plan to use traditional academic modalities of dissemination (eg, conferences, publications). We plan to disseminate findings through meetings with other trainers in implementation practice so they may adopt Consumer Voice. We plan to share results with local community boards.

Project description:BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSION: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.

Project description:BackgroundA growing body of literature supports the efficacy of the health-social approach for the implementation of complex interventions to enhance self-care health management among community-dwelling older adults. However, there is little research on how interventions with this approach are implemented and disseminated in a real community setting.MethodsThis pilot study adopted an effectiveness-implementation hybrid design to 1) evaluate the effectiveness of a community-based Health-Social Partnership Program (HSPP) and 2) explore the reach, adoption, implementation, and maintenance of the HSPP in the community. Potential participants were recruited if they were aged 60 or above, owned a smartphone, and were cognitively competent. The participants received nurse-led case management with support from a social service team. Factors that hindered or facilitated the program delivery were examined to determine the implementation outcomes and sustained effects of the program. Data were collected at pre-intervention (T1), immediately post-intervention (T2), and 3 months post-intervention (T3).ResultsNinety-two older adults joined and completed the program. The recruitment rate was 76.7%. A significant interaction effect was found for the mean self-efficacy scores from T1 to T2 (Wald χ2 = 12.28, p ≤ .001). Barriers to widespread program implementation included manpower shortage, lack of experienced staff, and unpredictable environment, whereas facilitators, as suggested by the older adults, providers, and community staff members, included regular communication between the research and service teams, recruitment of participants through community centers with the support of the research team, and seamless partnership among the health-social partnership team members. Strong implementation fidelity was achieved with zero attrition rate.ConclusionMost conventional randomized controlled trials investigating the effects of community-based programs have tended to control the contextual factors rather than incorporate the program in a real setting. This pilot study was the first to use a hybrid model to test the effectiveness and outcomes of HSPP implementation. The results imply that the program has a high potential sustainability in the real-life context.Trial registrationThis study was registered at clinicaltrials.gov (NCT04442867; date of first registration 23/06/2020).

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Adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study.

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Adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study.

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