Non-pharmacological Care Research Articles

The implementation of a pain navigator program in the department of Veterans Affairs' (VA) health care systems: a cluster randomized pragmatic clinical trial

Abstract Objective This manuscript describes the uptake of the AIM-Back Pain Navigator Pathway (PNP) designed to encourage use of non-pharmacologic care options within the Veterans Health Administration (VHA). Design This manuscript describes the implementation of a telehealth intervention from one arm of a multisite, embedded, cluster-randomized pragmatic trial comparing the effectiveness of two novel clinical care pathways that provide access to non-pharmacologic care for Veterans with low back pain (LBP). Setting Ten VHA clinics Subjects 19 pain navigators, >200 primary care physicians, and over 1000 Veterans were involved in the PNP implementation Methods Data were generated within the VHA electronic health record (EHR) for the ongoing AIM-Back trial to describe PNP implementation for system-level findings in terms of number of visits, and type of care received Results Over a 3-year period, 9 of 10 clinics implemented the PNP within the context of the AIM-Back trial. The most frequent care recommended in the PNP included physical therapy, chiropractic, acupuncture, and yoga/tai chi. During follow-up at six-weeks, ∼50% of Veterans elected to receive a different care choice than what was initially prescribed. Notable variation across clinics was documented for PNP based on time to initiation of care and follow-up rates. Conclusions Implementation of the telehealth delivered PNP provides a nuanced understanding of the introduction of novel care programs within diverse clinical settings. These findings are most applicable to care programs that are delivered remotely and involve facilitation of existing care options.

Management of neonates exposed prenatally to opioids: Impact of a developmental care program implementation

BackgroundTraditional approaches to management of neonates prenatally exposed to opioids are based on the use of pharmacotherapy (PT), adjusted to evolution of infant symptoms. Newer approaches focused on non-pharmacological care (NPC) are emerging, but there is little evidence on the active policies to implement to ensure their widespread practice. The primary objective of the study was to assess whether the implementation of a developmental care program in our neonatal medicine department had an impact on the management of these infants during hospitalization, notably exposure to NPC. MethodObservational study in a tertiary perinatal center. Data collected during hospitalization for infants with in utero opioid exposure included admission in the parents-infant unit (PIU) of the maternity ward, exposure to NPC and PT, occurrence of neonatal opioid withdrawal syndrome (NOWS), length of hospital stay (LOS) and feeding type at discharge. The impact of the intervention was measured by comparing three 6-year periods, the first preceding the implementation of a formalized developmental care program (2003–2008); the second following implementation of the program (2009–2014); the third after consolidation of the program (2015–2020). Results258 infants prenatally exposed to opioid were recorded. From the first to the third period, admission rate in the PIU was comparable (68 % to 73 %, p = 0. 95). Exposure to NPC (37 % to 84 %, p < 0.001) increased, whereas exposure to PT (40 % to 15 %, p = 0.002) and LOS (13 [9–18] days to 8 [6–11] days, p = 0.003) decreased. NOWS occurred in 141 (55 %) infants (63 % to 47 %, p = 0.10). In these infants, decrease in PT was also observed (64 % to 34 %, p = 0.02). After adjustment for perinatal confounders, hospitalization in the PIU (OR 3.23 [1.36; 7.66]; p = 0.008), and the 2015–2020 period (OR 5.11 [2.06; 12.64]; p = 0.004) were associated with absence of PT. ConclusionsAn active policy, supporting the training and warranting the practice of NPC, is essential to reduce medication usage and length of hospitalization in infants exposed in utero to opioids.

Views and perspectives toward implementing the Global Spine Care Initiative (GSCI) model of care, and related spine care program by the people in Cross Lake, Northern Manitoba, Canada: a qualitative study using the Theoretical Domain Framework (TDF)

BackgroundBack pain is very common and a leading cause of disability worldwide. Due to health care system inequalities, Indigenous communities have a disproportionately higher prevalence of injury and acute and chronic diseases compared to the general Canadian population. Indigenous communities, particularly in northern Canada, have limited access to evidence-based spine care. Strategies established in collaboration with Indigenous peoples are needed to address unmet healthcare needs, including spine care (chiropractic and movement program) services. This study aimed to understand the views and perspectives of Cross Lake community leaders and clinicians working at Cross Lake Nursing Station (CLNS) in northern Manitoba regarding the implementation of the Global Spine Care Initiative (GSCI) model of spine care (MoC) and related implementation strategies.MethodA qualitative exploratory design using an interpretivist paradigm was used. Twenty community partners were invited to participate in semi-structured interviews underpinned by the Theoretical Domains Framework (TDF) adapted to capture pertinent information. Data were analyzed deductively and inductively, and the interpretation of findings were explored in consultation with community members and partners.ResultsCommunity leaders (n = 9) and physicians, nurses, and allied health workers (n = 11) emphasized: 1) the importance of contextualizing the MoC (triaging and care pathway) and proposed new services through in-person community engagement; 2) the need and desire for local non-pharmacological spine care approaches; and 3) streamlining patient triage and CLNS workflow. Recommendations for the streamlining included reducing managerial/administrative duties, educating new incoming clinicians, incorporating follow-up appointments for spine pain patients, and establishing an electronic medical record system along with a patient portal. Suggestions regarding how to sustain the new spine care services included providing transportation, protecting allocated clinic space, resolving insurance coverage discrepancies, addressing misconceptions about chiropractic care, instilling the value of physical activity for self-care and pain relief, and a short-term (30-day) incentivised movement program which considers a variety of movement options and offers a social component after each session.ConclusionCommunity partners were favorable to the inclusion of a refined GSCI MoC. Adapting the TDF to unique Indigenous needs may help understand how best to implement the MoC in communities with similar needs.

Evidence Map of Non-Pharmacological Dementia Care Partner Interventions Implemented in the US: Gaps and Impact Opportunities.

There are 200+ tested interventions for care partners (family, friends, and fictive kin) of people living with dementia (PLWD). But these interventions do not systematically cover relevant settings. Nor do these interventions affect all relevant outcomes that matter to people and healthcare systems. We present an evidence map of settings and outcomes from translated interventions to identify gaps. Of 190 studies identified, 31 unique interventions were retained in the evidence map. Identified setting gaps included studies set solely in hospitals/medical centers or set in multiple settings. Identified outcome gaps included interventions that improved care partner beliefs about providing care, care partner negative coping strategies, PLWD resources (e.g., social support), and PLWD coping strategies. Armed with an understanding of present gaps, we call on researchers to fill the identified gaps to ensure systematic coverage of settings and evaluation of outcomes that matter to people and healthcare systems.

Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial

Infants with neonatal opioid withdrawal syndrome (NOWS) cared for with the Eat, Sleep, Console (ESC) care approach receive less pharmacologic treatment and have shorter hospital stays compared to usual care with the Finnegan Neonatal Abstinence Scoring Tool, but the effects of these approaches on feeding and weight are unknown. To evaluate feeding practices and weight trajectories in infants cared for with ESC vs usual care. ESC-NOW is a cluster randomized trial of infants with NOWS born at 36 weeks' gestation or later at 26 US hospitals from September 2020 to March 2022. Each site transitioned from usual care to ESC (the study intervention) at a randomized time. Feeding was per site practice and not specified by the intervention. Feeding and weight outcomes were assessed at hospital discharge. ESC vs usual care. Outcomes include prospectively identified secondary end points related to feeding and weight. z Scores were used for growth to account for corrected gestational age at the time of measurement. All analyses were intention to treat and adjusted for study design. Maternal/infant characteristics were included in adjusted models. The analyses included 1305 infants (702 in usual care and 603 in ESC; mean [SD] gestational age, 38.6 [1.3] weeks; 655 [50.2%] male and 650 [49.8%] female). Baseline demographic characteristics were similar between groups. The proportion of breastfed infants was higher in the ESC group (52.7% vs 41.7%; absolute difference, 11%; 95% CI, 1.0-20.9). A higher proportion of infants cared for with ESC received exclusive breast milk (15.1% vs 6.7%; absolute difference, 8.4%; 95% CI, 0.9-5.8) or any breast milk (38.8% vs 27.4%; absolute difference, 11.4%; 95% CI, 0.2-23.1) and were directly breastfeeding at discharge (35.2% vs 19.5%; absolute difference, 15.7%; 95% CI, 4.1-27.3). There was no difference in proportion of infants with weight loss greater than 10% or maximum percentage weight loss, although infants cared for with ESC had a lower weight z score on day of life 3 (-1.08 vs -1.01; absolute difference, 0.07; 95% CI, 0.02-0.12). When pharmacologic treatment was added into the model, no breastfeeding outcomes were statistically significant. In this study, infants cared for with ESC were more likely to initiate and continue breastfeeding and had no difference in percentage weight loss. The improvement in breastfeeding with ESC may be driven by reduction in pharmacologic treatment and provision of effective nonpharmacologic care. ClinicalTrials.gov Identifier: NCT04057820.

Pendekatan Intervensi Keperawatan Jiwa untuk Mengurangi Gejala Depresi pada Lansia Demensia di Indonesia dan di Jepang

The definition of Health is a complete physical and mental condition, free of disease or disability. Feelings of uselessness, sadness, insomnia, stress, depression, anxiety, delirium, and dementia are signs of psychological regression in the elderly. Health care for depressed parents with dementia requires non-pharmacological care. Objective: This research analyzes the effects of reminiscence therapy, Brain Gym, and music therapy to relieve elderly people suffering from dementia and depression. This literature review research took the published articles from 2014 to 2024 on Google Scholar and Pubmed. The researchers collected relevant data or sources based on the keywords. The results found both in Indonesia and Japan, non-pharmacological care interventions like reminiscence therapy had a significant impact. However, the Brain Gym intervention group and music therapy performed in Japan had no significant impact on relieving depression or improving the cognitive function of dementia patients. Conclusion: Reminiscence therapy succeeded in relieving cognitive function in parents suffering from dementia in Indonesia and Japan. Therefore, reminiscence therapy is suggested to be applied in Japan.

Utilization of Reimbursed Acupuncture Therapy for Low Back Pain

Treating low back pain (LBP) often involves a combination of pharmacologic, nonpharmacologic, and interventional treatments; one approach is acupuncture therapy, which is safe, effective, and cost-effective. How acupuncture is used within pain care regimens for LBP has not been widely studied. To document trends in reimbursed acupuncture between 2010 and 2019 among a large sample of patients with LBP, focusing on demographic, socioeconomic, and clinical characteristics associated with acupuncture use and the nonpharmacologic, pharmacologic, and interventional treatments used by patients who utilize acupuncture. This cross-sectional study included insurance claims of US adults in a deidentified database. The study sample included patients diagnosed with LBP between 2010 and 2019. Data were analyzed between September 2023 and June 2024. Changes in rates of reimbursed acupuncture utilization between 2010 and 2019, including electroacupuncture use, which involves the electrical stimulation of acupuncture needles. Covariates included age, sex, race and ethnicity, income, educational attainment, region, and a chronic LBP indicator. Secondary analyses tracked other nonpharmacologic treatments (eg, physical therapy, chiropractic care), pharmacologic treatments (eg, opioids, gabapentinoids), and interventional treatments (eg, epidural steroid injections). The total sample included 6 840 497 adults with LBP (mean [SD] age, 54.6 [17.8] years; 3 916 766 female [57.3%]; 802 579 Hispanic [11.7%], 258 087 non-Hispanic Asian [3.8%], 804 975 non-Hispanic Black [11.8%], 4 974 856 non-Hispanic White [72.7%]). Overall, 106 485 (1.6%) had 1 or more acupuncture claim, while 61 503 (0.9%) had 1 or more electroacupuncture claim. The rate of acupuncture utilization increased consistently, from 0.9% in 2010 to 1.6% in 2019; electroacupuncture rates were relatively stable. Patients who were female (male: odds ratio [OR], 0.68; 99% CI, 0.67-0.70), Asian (OR, 3.26; 99% CI, 3.18-3.35), residing in the Pacific region (New England: OR, 0.26; 99% CI, 0.25-0.28), earning incomes of over $100 000 (incomes less than $40 000: OR, 0.59; 99% CI, 0.57-0.61), college educated (high school or less: OR, 0.32; 99% CI, 0.27-0.35), and with chronic LBP (OR, 2.39; 99% CI, 2.35-2.43) were more likely to utilize acupuncture. Acupuncture users were more likely to engage in other nonpharmacologic pain care like physical therapy (39.2%; 99% CI, 38.9%-39.5% vs 29.3%; 99% CI, 29.3%-29.3%) and less likely to utilize prescription drugs, including opioids (41.4%; 99% CI, 41.1%-41.8% vs 52.5%; 99% CI, 52.4%-52.5%), compared with nonusers. In this cross-sectional study, we found that acupuncture utilization among patients with LBP was rare but increased over time. Demographic, socioeconomic, and clinical characteristics were associated with acupuncture utilization, and acupuncture users were more likely to utilize other nonpharmacologic treatments and less likely to utilize pharmacologic treatments.

Rehabilitation Is Associated With Improvements in Post-COVID-19 Sequelae.

Post-COVID-19 syndrome has affected millions of people, with rehabilitation being at the center of non-pharmacologic care. However, numerous published studies show conflicting results due to, among other factors, considerable variation in subject characteristics. Currently, the effects of age, sex, time of implementation, and prior disease severity on the outcomes of a supervised rehabilitation program after COVID-19 remain unknown. This was a non-randomized case-control study. Subjects with post-COVID-19 sequelae were enrolled. Among study participants, those who could attend an 8-week, supervised rehabilitation program composed the intervention group, whereas those who couldn't the control group. Measurements were collected at baseline and 8 weeks thereafter. Study groups (N = 119) had similar baseline measurements. Participation in rehabilitation (n = 47) was associated with clinically important improvements in the 6-min walk test (6MWT) distance, adjusted (for potential confounders) odds ratio (AOR) 4.56 (95% CI 1.95-10.66); 1-min sit-to-stand test, AOR 4.64 (1.88-11.48); Short Physical Performance Battery, AOR 7.93 (2.82-22.26); health-related quality of life (HRQOL) 5-level EuroQol-5D (Visual Analog Scale), AOR 3.12 (1.37-7.08); Montreal Cognitive Assessment, AOR 6.25 (2.16-18.04); International Physical Activity Questionnaire, AOR 3.63 (1.53-8.59); Fatigue Severity Scale, AOR 4.07 (1.51-10.98); Chalder Fatigue Scale (bimodal score), AOR 3.33 (1.45-7.67); Modified Medical Research Council dyspnea scale (mMRC), AOR 4.43 (1.83-10.74); Post-COVID-19 Functional Scale (PCFS), AOR 3.46 (1.51-7.95); and COPD Assessment Test, AOR 7.40 (2.92-18.75). Time from disease onset was marginally associated only with 6MWT distance, AOR 0.99 (0.99-1.00). Prior hospitalization was associated with clinically important improvements in the mMRC dyspnea scale, AOR 3.50 (1.06-11.51); and PCFS, AOR 3.42 (1.16-10.06). Age, sex, and ICU admission were not associated with the results of any of the aforementioned tests/grading scales. In this non-randomized, case-control study, post-COVID-19 rehabilitation was associated with improvements in physical function, activity, HRQOL, respiratory symptoms, fatigue, and cognitive impairment. These associations were observed independently of timing of rehabilitation, age, sex, prior hospitalization, and ICU admission.

Nonpharmacological Interventions to Mitigate Procedural Pain in the NICU: An Integrative Review.

Small infants experience a myriad of stimuli while in the Neonatal Intensive Care Unit (NICU), with many being painful or stressful experiences, although medically necessary. To determine what is known about nonpharmacological developmental care interventions used in the NICU to mitigate procedural pain of infants born under 32weeks gestation. Five electronic databases were searched: Medline, CINAHL, Scopus, Embase and the Cochrane Library. The inclusion criteria were as follows: experimental and nonexperimental studies from all publication years with infants born at less than 32weeks gestational age; peer-reviewed research articles studying nonpharmacological interventions such as skin-to-skin care, facilitated tucking, nonnutritive sucking, hand hugs, and swaddling; and English language articles. Our search yielded 1435 articles. After the elimination of 736 duplicates, a further 570 were deemed irrelevant based on their abstract/titles. Then, 124 full-text articles were analyzed with our inclusion and exclusion criteria. Twenty-seven studies were reviewed. Sucrose, facilitated tucking, pacifier, skin-to-skin care, and human milk appeared to lessen pain experienced during heel sticks, suctioning, nasogastric tube insertions, and echocardiograms. All nonpharmacological interventions failed to prove efficacious to adequately manage pain during retinopathy of prematurity (ROP) examinations. Evidence review demonstrates that healthcare practitioners should use nonpharmacological measures to help prevent pain from day-to-day procedures in the NICU including heel sticks, nasogastric tube insertions, suctioning, echocardiograms, and subcutaneous injections. Future research is necessary to better understand and measure how pain is manifested by very small premature infants. Specific research on mitigating the pain of examinations for retinopathy of prematurity is also needed.

Effect of perioperative oral care on postoperative infections in patients with cancer: A systematic review and meta-analysis.

This systematic review aimed to assess the effect of non-pharmacologic perioperative oral hygiene care on reduced incidence of postoperative pneumonia (PP), surgical site infection (SSI), and the length of hospital stay in patients with cancer, and to describe the details of oral hygiene care. We searched seven databases. Eligibility criteria were based on perioperative oral hygiene care provided by healthcare professionals to patients aged ≥18 years who were surgically treated under general anesthesia and were evaluated for the incidence of PP and SSI. We reported risk ratios (RR) for dichotomous outcomes for PP and SSI using a fixed-effects model of meta-analysis. The search resulted in 850 articles, among which two were randomized controlled trials (RCTs) and 21 were observational studies. Most studies indicated that dentists and medical care providers performed a combination of oral cleaning, and oral hygiene instructions. In RCTs, perioperative oral hygiene care significantly reduced the incidence of PP (RR, 0.86; p = .60), while in observational studies, perioperative oral hygiene care significantly reduced the incidence of PP (RR, 0.55; p < .001) and SSI (RR, 0.47; p < .001). The length of hospital stay was also significantly reduced (p < .05). However, the effectiveness of nursing intervention was not clear. Perioperative oral hygiene care implemented by healthcare professionals prevented PP and SSI and reduced length of hospital stays for patients after cancer surgery. As daily perioperative oral hygiene care is performed by nurses, it is necessary to research the effects of oral hygiene by nurses in the future.

Quality Improvement in Neonatal Care: Successful Adoption of the Eat, Sleep, Console Protocol in a Rural Hospital Setting.

The United States faces a growing burden of neonatal opioid withdrawal syndrome in rural hospitals. Traditional treatments often extend hospital stays and medication use. The Eat, Sleep, and Console (ESC) approach offers a new management strategy but is challenging in resource-limited settings. This study aimed to apply ESC in rural hospitals to reduce neonatal intensive care unit admissions, decrease length of stay (LOS) to under 7 days, and lower medication use by more than 80% within a year. Our quality improvement initiative at rural hospitals implemented a multimodal approach for in utero opioid-exposed infants, involving staff education, electronic medical record updates, and nonpharmacological care strategies. Data from January 2020 to December 2023 assessed treatment impact, including pharmacotherapy need and hospital stay lengths, using statistical process control for analysis. After ESC implementation, the percentage of opioid-exposed infants receiving pharmacological treatment significantly decreased from 60.7% to 7.9%. The average LOS was reduced from 14.5 days to 5.25 days. These improvements persisted for 24 months, with no readmissions within 30 days of discharge. This approach also reduced hospital charges by over $5 million, demonstrating its clinical and financial effectiveness. The multidisciplinary approach successfully implemented ESC in a resource-limited setting, significantly reducing both the LOS and medication exposure for opioid-exposed infants while also saving significant healthcare costs. This successful model has been adopted by at least four regional rural hospitals, thus broadening the program's impact.

Engaging Patients to Implement Nonpharmacologic Care for Newborns With Neonatal Opioid Withdrawal Syndrome

Engaging Patients to Implement Nonpharmacologic Care for Newborns With Neonatal Opioid Withdrawal Syndrome

Short term outcomes of neonatal opioid withdrawal syndrome: a comparison of two approaches.

To evaluate outcomes in opioid exposed neonates (OENs) assessed by the Eat, Sleep, Console (ESC) tool compared to the Finnegan Neonatal Abstinence Scoring System (FNASS). Retrospective analysis of a statewide database of OENs from 2017 to 2020 with birthing hospitals classified based on the assessment tool used. Four main outcomes were examined using multivariable and Poisson logistic regression models. Of 2375 OENs, 42.1% received pharmacotherapy (PT) with a consistent decrease in PT, length of treatment (LOT), and length of stay (LOS) over the study period. There was no change in use of mother's own milk (MoM). While outcomes were significantly associated with several specific variables, there were no differences in outcomes between assessment methods. While there was a significant decrease over time in PT, LOT, and LOS, improvements were independent of the assessment tool used and likely related to the increased use of non-pharmacologic care.

My Brain Made Me Do It: The Neuroscience Behind Behavior

Behavior is communication. Although behavior is often interpreted as intentional, examining the biological reasons driving behavior allows healthcare providers to equitably address basic needs, quality of life, and create person-centered care plans. Behaviors in older adults with neurocognitive challenges have great impact on quality of life and healthcare provision. Over 75% of people with dementia experience behavioral disturbances especially as the disease progresses (Press & Alexander, 2019) The healthcare burden is unimaginable including caregiver stress, loss of function in people with neurocognitive illness, and unneeded hospital stays. Despite behavior being the primary way people with advanced neurological illness communicate, healthcare providers use subjective reasoning to assign meaning to behavior. The neurologic basis for behavior is ignored and patient-centered care diminishes. By examining neurologic foundations and connecting it to function, health care providers can apply evidence-based interventions to understand, validate, and provide interventions for behavioral disturbances. This session will provide tools for learners to examine common neurologic behavioral disturbances such as pain, aggression, impulsivity, and delusions in an objective way. By redefining behaviors health care provides can provide strength-based interventions and make informed pharmacological and nonpharmacological care plan decisions. Session will include an overview of functional neuroanatomy, clinical applications, intervention ideas, and case studies.

Decreasing the incidence of delirium via multi-sensory stimulation in patients receiving mechanical ventilation in the intensive care unit: A protocol for a randomized feasibility study

IntroductionDelirium is a common acute brain dysfunction syndrome in patients admitted to intensive care units (ICUs). Family engagement strategies, based on the theory of multi-sensory stimulation to ameliorate sensory deprivation in patients, may be an effective and scalable method to reduce the burden of delirium. Methods/design: This is a assessor-blinded, randomised controlled trial of the feasibility of multi-sensory stimulation (MS) in patients with delirium. A total of 72 mechanically ventilated patients (n = 24 in each group) admitted to the ICU will be randomised to routine non-pharmacological delirium care (control), family multi-sensory stimulation and nurse multi-sensory stimulation groups. All participants except the control group will receive multi-sensory stimulation, including visual, auditory, tactile and kinesthetic stimulation, for 5 days. Our primary aim is to determine the feasibility of the study procedure (recruitment, eligibility, retention and attrition rates, appropriateness of clinical outcome measures), feasibility, acceptability and safety of the intervention (adverse events, satisfaction and other). Our secondary objective is to assess the preliminary efficacy of the MS protocol in reducing the incidence, duration and severity of delirium. Sedation levels and delirium severity will be assessed twice daily. Enrolled participants will be followed in hospital until death, discharge or up to 28 days after treatment. Ethics and disseminationThe current study was approved by the Ethics Review Board of Huazhong University of Science and Technology Union Shenzhen Hospital, China (KY-2023-031-01). The results of this study will be presented at scientific conferences and submitted for publication in peer-reviewed journals. Trial registration numberChiCTR2300071457.

Glycopyrronium 320 μg/mL in children and adolescents with severe sialorrhoea and neurodisabilities: A randomized, double-blind, placebo-controlled trial.

To investigate the efficacy, safety, and impact on quality of life (QoL)of an oral formulation of 320 μg/mL glycopyrronium designed for children. A double-blind, placebo-controlled SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial was conducted. Children (3-17 years) with neurodisabilities and severe sialorrhoea (modified Teachers Drooling Scale ≥6) were randomized to 320 μg/mL glycopyrronium or placebo, in addition to non-pharmacological standard care. Of 87 participants, 44 were aged 10 years or under and 43 had cerebral palsy. The primary endpoint, change in total Drooling Impact Scale (DIS) score from baseline to day 84, was significantly greater (improved) with 320 μg/mL glycopyrronium versus placebo (median [quartile 1, quartile 3] -29.5 [-44.5, 0] vs -1 [-16, 5]; p < 0.001), an effect also observed at day 28 (median - 25 vs -2; p < 0.01). Significant reduction in bibs/clothes used per day was seen with glycopyrronium versus placebo at day 84 (median - 2 vs 0; p < 0.01). Glycopyrronium significantly improved DIS items 9 and 10 related to the extent that drooling affects the child's and family's life (p ≤ 0.03). Adverse events were reported by 77.3% and 69.8% of children with glycopyrronium and placebo respectively; the most common treatment-related adverse event was constipation (20.5% and 16.3%). The formulation of 320 μg/mL glycopyrronium significantly improved drooling and reduced its impact on QoL, with good tolerability in children with neurodisabilities. The formulation of 320 μg/mL glycopyrronium significantly improved Drooling Impact Scale score versus placebo at day 84. The formulation reduced the impact of drooling on the child's and family's quality of life. There were no safety or tolerability concerns with this specific formulation.

NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial

IntroductionUsing pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA.MethodsThe NONA-LISA trial (ClinicalTrials.gov, NCT05609877) is a multicentre, blinded, randomised controlled trial aiming at including 324 infants born before 30 gestational weeks, meeting the criteria for surfactant treatment by LISA. Infants will be randomised to LISA after administration of fentanyl 0.5–1 mcg/kg intravenously (fentanyl group) or isotonic saline solution intravenously (saline group). All infants will receive standardised non-pharmacological comfort care before and during the LISA procedure. Additional analgesics will be provided at the clinician’s discretion. The primary outcome is the need for invasive ventilation, meaning mechanical or manual ventilation via an endotracheal tube, for at least 30 min (cumulated) within 24 h of the procedure. Secondary outcomes include the modified COMFORTneo score during the procedure, bronchopulmonary dysplasia at 36 weeks, and mortality at 36 weeks.DiscussionThe NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice.ImpactPre-procedure analgesia is associated with apnoea and may complicate procedures that rely on regular spontaneous breathing, such as Less Invasive Surfactant Administration (LISA).This randomised controlled trial addresses the effect of analgesic premedication in LISA by comparing fentanyl with a placebo (isotonic saline) in infants undergoing the LISA procedure. All infants will receive standardised non-pharmacological comfort.The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort or pain in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice regarding analgesic treatment associated with the LISA procedure.

Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study

BackgroundConsiderable disparities in chronic pain management have been identified. Persons in rural, lower income, and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type 1 effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in ommunity health centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study.MethodsDuring a planning year for the BeatPain trial, we developed a comprehensive logic model including the five-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year: (1) conduct needs assessments for involved groups; (2) identify implementation outcomes, performance objectives, and determinants; (3) select implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes.ResultsCHC leadership/providers, patients, and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes: (1) electronic referral of patients with back pain in CHC clinics to the BeatPain team and (2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support, and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies.ConclusionsImplementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings.Trial registrationClinicalTrials.gov Identifier: NCT04923334. Registered June 11, 2021.

Integrative non-pharmacological care for individuals at risk of rheumatoid arthritis.

There is increasing knowledge in the recognition of individuals at risk for progression to rheumatoid arthritis (RA) before the clinical manifestation of the disease. This prodromal phase preceding the manifestation of RA may represent a "window of opportunity" for preventive interventions that may transform the clinical approach to this disease. However, limited evidence exists in support of effective interventions to delay the onset or even halt the manifestation of RA. Given the multifactorial nature of RA development and disease progression, the latest guidelines for established RA stress the use of integrative interventions and multidisciplinary care strategies, combining pharmacologic treatment with non-pharmacological approaches. Accordingly, individuals at risk of RA could be offered an integrative, multifactorial intervention approach. Current data point toward pharmacological intervention reverting the subclinical inflammation and delay in the disease onset. In addition, targeting life style modifiable factors (smoking cessation, dental health, physical activity, and diet) may presumably improve RA prognosis in individuals at risk, mainly by changes in epigenetics, autoantibodies, cytokines profiles, and microbiome. Nonetheless, the benefits of multidisciplinary interventions to halt the manifestation of RA in at-risk individuals remain unknown. As there is a growing knowledge of possible pharmacological intervention in the preclinical phase, this narrative review aims to provide a comprehensive overview of non-pharmacological treatments in individuals at risk of RA. Considering the mechanisms preceding the clinical manifestation of RA we explored all aspects that would be worth modifying and that would represent an integrative non-pharmacological care for individuals at risk of RA.

Telehealth delivery of physical therapist-led interventions for persons with chronic low back pain in underserved communities: lessons from pragmatic clinical trials.

In this perspective, we present our experience developing and conducting two pragmatic clinical trials investigating physical therapist-led telehealth strategies for persons with chronic low back pain. Both trials, the BeatPain Utah and AIM-Back trials, are part of pragmatic clinical trial collaboratories and are being conducted with persons from communities that experience pain management disparities. Practice guidelines recommend nonpharmacologic care, and advise against opioid therapy, for the primary care management of persons with chronic low back pain. Gaps between these recommendations and actual practice patterns are pervasive, particularly for persons from racial or ethnic minoritized communities, those with fewer economic resources, and those living in rural areas including Veterans. Access barriers to evidence-based nonpharmacologic care, which is often provided by physical therapists, have contributed to these evidence-practice gaps. Telehealth delivery has created new opportunities to overcome access barriers for nonpharmacologic pain care. As a relatively new delivery mode however, telehealth delivery of physical therapy comes with additional challenges related to technology, intervention adaptations and cultural competence. The purpose of this article is to describe the challenges encountered when implementing telehealth physical therapy programs for persons with chronic low back pain in historically underserved communities. We also discuss strategies developed to overcome barriers in an effort to improve access to telehealth physical therapy and reduce pain management disparities. Inclusion of diverse and under-represented communities in pragmatic clinical trials is a critical consideration for improving disparities, but the unique circumstances present in these communities must be considered when developing implementation strategies.