Developing & integrating a mobile application tool into a survivorship clinic for esophageal cancer patients.

Esophageal cancer (EC) patients are living longer due to enhanced screening and novel therapeutics, however, the post-esophagectomy long-term management remains challenging for patients, caregivers, and providers. Patients experience significant morbidity and have difficulty managing symptoms. Providers struggle to manage symptoms, affecting patients' quality of life and complicating care coordination between surgical teams and primary care providers. To address these patient unique needs and create a standardized method for evaluating patient reported long-term outcomes after esophagectomy for EC, our team developed the Upper Digestive Disease Assessment tool, which evolved to become a mobile application. This mobile application is designed to monitor symptom burden, direct assessment, and quantify data for patient outcome analysis after foregut (upper digestive) surgery, including esophagectomy. It is available to the public and enables virtual and remote access to survivorship care. Patients using the Upper Digestive Disease Application (UDD App) must consent to enroll, agree to terms of use, and acknowledge use of health-related information prior to gaining access to the UDD App. The results of patients scores can be utilized for triage and assessment. Care pathways can guide management of severe symptoms in a scalable and standardized method. Here we describe the history, process, and methodology for developing a patient-centric remote monitoring program to improve survivorship after EC. Programs like this that facilitate patient-centered survivorship should be an integral part of comprehensive cancer patient care.

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial.

Objective: Music listening interventions are utilized in a wide variety of clinical settings to help patients manage stress, anxiety, pain, discomfort, as well as attendant influences on sedative exposure, delirium, and cognitive functioning. While the body of research regarding the use of music-based listening interventions continues to grow, there is a paucity of information in the literature about specific music used for listening interventions. The purpose of this secondary analysis is to examine the music that study participants identified as their preferred music and listened to during the study. Design: This secondary analysis is based on data from a parent study, which was a three-arm randomized controlled trial attesting a patient-directed music (PDM) listening protocol to manage the psychophysiological symptom of anxiety. Setting: Twelve intensive care units in a major metropolitan area in the United States. Subjects: Participants included the 126 mechanically ventilated patients enrolled and randomized to the PDM listening arm of the study. Results: Data presented in this study include playlists from the 12 genres patients self-identified as preferred with specific groups and artists requested for music listening during the study. Discographies of the playlists are also included. Conclusions: The efficacy of interventions is impacted by the design of the intervention and the selection of music utilized. Implications of this analysis further explore the role of a board-certified music therapist (MT-BC) in designing and implementing a music listening intervention. The specialized knowledge on the therapeutic use and benefits of music that an MT-BC possesses supports the development of quality study intervention and appropriate implementation. The review of the music utilized in the parent study provides detailed information about the music utilized to inform future research focused on music listening interventions to effectively build on previous studies. Clinical Trial Registration: ClinicalTrials.gov NCT00440700.

Decreasing Delirium Through Music: A Randomized Pilot Trial.

BACKGROUND: Management of delirium in intensive care units is challenging because effective therapies are lacking. Music is a promising nonpharmacological intervention. OBJECTIVES: To determine the feasibility and acceptability of personalized music (PM), slow-tempo music (STM), and attention control (AC) in patients receiving mechanical ventilation in an intensive care unit, and to estimate the effect of music on delirium. METHODS: A randomized controlled trial was performed in an academic medical-surgical intensive care unit. After particular inclusion and exclusion criteria were applied, patients were randomized to groups listening to PM, relaxing STM, or an audiobook (AC group). Sessions lasted 1 hour and were given twice daily for up to 7 days. Patients wore noise-canceling headphones and used mp3 players to listen to their music/audiobook. Delirium and delirium severity were assessed twice daily by using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the CAM-ICU-7, respectively. RESULTS: Of the 1589 patients screened, 117 (7.4%) were eligible. Of those, 52 (44.4%) were randomized, with a recruitment rate of 5 patients per month. Adherence was higher in the groups listening to music (80% in the PM and STM groups vs 30% in the AC group; P = .01), and 80% of patients surveyed rated the music as enjoyable. The median number (interquartile range) of delirium/coma-free days by day 7 was 2 (1-6) for PM, 3 (1-6) for STM, and 2 (0-3) for AC (P = .32). Median delirium severity was 5.5 (1-7) for PM, 3.5 (0-7) for STM, and 4 (1-6.5) for AC (P = .78). CONCLUSIONS: Music delivery is acceptable to patients and is feasible in intensive care units. Further research testing use of this promising intervention to reduce delirium is warranted.

The Effect of Music on Pain in the Adult Intensive Care Unit: A Systematic Review of Randomized Controlled Trials.

CONTEXT: Multimodal analgesic approaches are recommended for intensive care unit (ICU) pain management. Although music is known to reduce pain in acute and chronic care settings, less is known about its effectiveness in the adult ICU. OBJECTIVES: Determine the effects of music interventions on pain in the adult ICU, compared with standard care or noise reduction. METHODS: This review was registered on PROSPERO (CRD42018106889). Databases were searched for randomized controlled trials of music interventions in the adult ICU, with the search terms ["music*" and ("critical care" or "intensive care")]. Pain scores (i.e., self-report rating scales or behavioral scores) were the main outcomes of this review. Data were analyzed using a DerSimonian-Laird random-effects method with standardized mean difference (SMD) of pain scores. Statistical heterogeneity was determined as I2 > 50% and explored via subgroup analyses and meta-regression. RESULTS: Eighteen randomized controlled trials with a total of 1173 participants (60% males; mean age 60 years) were identified. Ten of these studies were included in the meta-analysis based on risk of bias assessment (n = 706). Music was efficacious in reducing pain (SMD -0.63 [95% CI -1.02, -0.24; n = 10]; I2 = 87%). Music interventions of 20-30 minutes were associated with a larger decrease in pain scores (SMD -0.66 [95% CI -0.94, -0.37; n = 5]; I2 = 30%) compared with interventions of less than 20 minutes (SMD 0.10 [95% CI -0.10, 0.29; n = 4]; I2 = 0%). On a 0-10 scale, 20-30 minutes of music resulted in an average decrease in pain scores of 1.06 points (95% CI -1.56, -0.56). CONCLUSION: Music interventions of 20-30 minutes are efficacious to reduce pain in adult ICU patients able to self-report.

The Impact of Urban Zen Integrative Therapy on Symptoms and Health-Related Quality of Life for Patients with Pulmonary Hypertension.

Background: Patients with pulmonary hypertension (PH) experience distressing symptoms that can undermine quality of life (QoL) and treatment adherence. Complementary health approaches are known to help manage symptoms of chronic conditions and may have therapeutic benefits in PH. Objective: To explore the impact of Urban Zen Integrative Therapy (UZIT) on PH-related symptoms. Design: A within-subjects, pre-/post-intervention, repeated-measures design. Subjects/Setting: Community-dwelling adults with PH received weekly UZIT sessions in an outpatient setting. Measurements: Participants (n = 14) rated symptoms before and after each session and before and after the six-week UZIT program. Mixed-effects modeling with repeated measures was used to estimate differences in mean symptom scores before and after individual sessions. Cohen's d effect sizes were used to evaluate the impact of the UZIT program on symptoms. Results: Mean scores for pain (F(1, 105) = 19.99, p < 0.001), anxiety (F(1, 96) = 24.64, p < 0.001), fatigue (F(1, 120) = 15.68, p < 0.001), and dyspnea (F(1, 68) = 16.69, p < 0.001) were significantly reduced after UZIT sessions. Effects were moderate to large for symptom severity (d = 0.59-1.32) and moderate for symptom burden (d = 0.56) and fatigue (d = 0.62), and small for QoL (d = 0.33) after the six-week UZIT program. Conclusions: Individualized UZIT sessions were associated with reductions in symptom severity for pain, anxiety, fatigue, and dyspnea. The six-week UZIT program was associated with improvements in symptom burden, activity limitation, and QoL. ClinicalTrial.gov no.: NCT03194438.

Intervention fidelity monitoring of Urban Zen Integrative Therapy (UZIT) for persons with pulmonary hypertension.

BACKGROUND: Systematic and consistent dose delivery is critical in intervention research. Few studies testing complementary health approach (CHA) interventions describe intervention fidelity monitoring (IFM) and measurement. OBJECTIVE: To describe methodological processes in establishing and measuring consistent dose, delivery, and duration of a multi-component CHA intervention. METHODS: Adults with pulmonary hypertension received six weekly, 1-hour Urban Zen Integrative Therapy (UZIT) sessions. A total of 78 sessions were delivered and 33% of these sessions were audited. Intervention dose (time allocated to each component), intervention consistency (protocol adherence audits), and intervention delivery (performance and sequence of components) were captured using remote video observation and review of the recorded video. IFM audits were performed at the beginning (n = 16), middle (n = 5), and end (n = 5) of the study. RESULTS: UZIT interventionists adhered to the intervention protocol (99.3%) throughout the study period. Interventionists delivered UZIT components within the prescribed timeframe: 1) Beginning: gentle body movement (18.9 ± 5.8 min.), restorative pose with guided body awareness meditation (21.3 ± 2.7 min.), and Reiki (22.8 ± 3.1 min.); 2) Middle: gentle body movement (15.9 ± 1.5 min.), pose/body awareness meditation (30.1 ± 6.5 min.), and Reiki (30.1 ± 7.0 min.); 3) End: gentle body movement (18.1 ± 3.6 min.), pose/body awareness meditation (35.3 ± 6.4 min.), and Reiki (34.5 ± 7.0 min.). Essential oil inhalation was delivered during UZIT sessions 100% of the time. Interventionists adhered to treatment delivery behaviors throughout the study period: beginning (98.86%), middle (100%), and end (100%). DISCUSSION: In this pilot study, we demonstrated that the dose, consistency, and delivery of multi-component CHA therapy can be standardized and monitored to ensure intervention fidelity.

Effects of music intervention on inflammatory markers in critically ill and post-operative patients: A systematic review of the literature.

BACKGROUND: Music listening has been shown to reduce anxiety, stress, and patient tolerance of procedures. Music may also have beneficial effects on inflammatory biomarkers in intensive care and post-operative patients, but the quality of evidence is not clear. OBJECTIVES: We conducted a systematic review to evaluate the effects of music on inflammatory biomarkers in intensive care, and post-operative patients. METHODS: A comprehensive search of the literature was performed. After screening 1570 references, full text review of 26 studies was performed. Fourteen studies were selected for inclusion. RESULTS: Seven studies showed a significant decrease in cortisol levels, but the level of evidence was low. Three studies had low risk of methodological bias, while 11 studies had high risk of bias. CONCLUSIONS: Music intervention may decrease cortisol levels, but other biomarkers remain unchanged. Given the low level of evidence, further research on music effects on inflammatory biomarkers is needed.

Economic Evaluation of a Patient-Directed Music Intervention for ICU Patients Receiving Mechanical Ventilatory Support.

OBJECTIVES: Music intervention has been shown to reduce anxiety and sedative exposure among mechanically ventilated patients. Whether music intervention reduces ICU costs is not known. The aim of this study was to examine ICU costs for patients receiving a patient-directed music intervention compared with patients who received usual ICU care. DESIGN: A cost-effectiveness analysis from the hospital perspective was conducted to determine if patient-directed music intervention was cost-effective in improving patient-reported anxiety. Cost savings were also evaluated. One-way and probabilistic sensitivity analyses determined the influence of input variation on the cost-effectiveness. SETTING: Midwestern ICUs. PATIENTS: Adult ICU patients from a parent clinical trial receiving mechanical ventilatory support. INTERVENTIONS: Patients receiving the experimental patient-directed music intervention received a MP3 player, noise-canceling headphones, and music tailored to individual preferences by a music therapist. MEASUREMENTS AND MAIN RESULTS: The base case cost-effectiveness analysis estimated patient-directed music intervention reduced anxiety by 19 points on the Visual Analogue Scale-Anxiety with a reduction in cost of $2,322/patient compared with usual ICU care, resulting in patient-directed music dominance. The probabilistic cost-effectiveness analysis found that average patient-directed music intervention costs were $2,155 less than usual ICU care and projected that cost saving is achieved in 70% of 1,000 iterations. Based on break-even analyses, cost saving is achieved if the per-patient cost of patient-directed music intervention remains below $2,651, a value eight times the base case of $329. CONCLUSIONS: Patient-directed music intervention is cost-effective for reducing anxiety in mechanically ventilated ICU patients.

Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial.

BACKGROUND: Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium. METHODS/DESIGN: The Decreasing Delirium through Music (DDM) study is a three-arm, single-blind, randomized controlled feasibility trial. Sixty patients admitted to the ICU with respiratory failure requiring mechanical ventilation will be randomized to one of three arms (20 participants per arm): (1) personalized music, (2) non-personalized relaxing music, or (3) attention-control. Music preferences will be obtained from all enrolled participants or their family caregivers. Participants will receive two 1-h audio sessions a day through noise-cancelling headphones and mp3 players. Our primary aim is to determine the feasibility of the trial design (recruitment, adherence, participant retention, design and delivery of the music intervention). Our secondary aim is to estimate the potential effect size of patient-preferred music listening in reducing delirium, as measured by the Confusion Assessment Method for the ICU (CAM-ICU). Participants will receive twice daily assessments for level of sedation and presence of delirium. Enrolled participants will be followed in the hospital until death, discharge, or up to 28 days, and seen in the Critical Care Recovery Clinic at 90 days. DISCUSSION: DDM is a feasibility trial to provide personalized and non-personalized music interventions for critically ill, mechanically ventilated patients. Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03095443 . Registered on 23 March 2017.

Predictive Associations of Music, Anxiety, and Sedative Exposure on Mechanical Ventilation Weaning Trials.

BACKGROUND: Weaning from mechanical ventilation requires increased respiratory effort, which can heighten anxiety and later prolong the need for mechanical ventilation. OBJECTIVES: To examine the predictive associations of music intervention, anxiety, sedative exposure, and patients' characteristics on time to initiation and duration of weaning trials of patients receiving mechanical ventilation. METHODS: A descriptive, correlational design was used for a secondary analysis of data from a randomized trial. Music listening was defined as self-initiated, patient-directed music via headphones. Anxiety was measured daily with a visual analog scale. Sedative exposure was operationalized as a daily sedation intensity score and a sedative dose frequency. Analyses consisted of descriptive statistics, graphing, survival analysis, Cox proportional hazards regression, and linear regression. RESULTS: Of 307 patients, 52% were women and 86% were white. Mean age was 59.3 (SD, 14.4) years, mean Acute Physiology and Chronic Health Evaluation III score was 62.9 (SD, 21.6), mean duration of ventilatory support was 8 (range, 1-52) days, and mean stay in the intensive care unit was 18 (range, 2-71) days. Music listening, anxiety levels, and sedative exposure did not influence time to initial weaning trial or duration of trials. Clinical factors of illness severity, days of weaning trials, and tracheostomy placement influenced weaning patterns in this sample. CONCLUSIONS: Prospective studies of music intervention and other psychophysiological factors during weaning from mechanical ventilation are needed to better understand factors that promote successful weaning.

Contributors to fatigue in patients receiving mechanical ventilatory support: A descriptive correlational study.

OBJECTIVES: To describe levels of fatigue and explore clinical factors that might contribute to fatigue in critically ill patients receiving mechanical ventilation. RESEARCH METHODOLOGY/DESIGN: Descriptive, correlational design. Sample was a sub-set of patients enrolled in a randomised clinical trial testing patient-directed music for anxiety self-management. Clinical factors included age, gender, length of ICU stay, length of ventilatory support, illness severity (APACHE III), and sedative exposure (sedation intensity and frequency). Descriptive statistics and mixed models were used to address the study objectives. SETTING: Medical and surgical intensive care units in the Midwestern United States. MAIN OUTCOME MEASURES: Fatigue was measured daily via a 100-mm Visual Analogue Scale, up to 25 days. RESULTS: A sample of 80 patients (50% female) receiving ventilatory support for a median 7.9 days (range 1-46) with a mean age of 61.2 years (SD 14.8) provided daily fatigue ratings. ICU admission APACHE III was 61.5 (SD 19.8). Baseline mean fatigue ratings were 60.7 (SD 27.9), with fluctuations over time indicating a general trend upward. Mixed models analysis implicated illness severity (ß(se(ß))=.27(.12)) and sedation frequency (ß(se(ß))=1.2(.52)) as significant contributors to fatigue ratings. CONCLUSION: Illness severity and more frequent sedative administration were related to higher fatigue ratings in these mechanically ventilated patients.

Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial.

IMPORTANCE: Alternatives to sedative medications, such as music, may alleviate the anxiety associated with ventilatory support. OBJECTIVE: To test whether listening to self-initiated patient-directed music (PDM) can reduce anxiety and sedative exposure during ventilatory support in critically ill patients. DESIGN, SETTING, AND PATIENTS: Randomized clinical trial that enrolled 373 patients from 12 intensive care units (ICUs) at 5 hospitals in the Minneapolis-St Paul, Minnesota, area receiving acute mechanical ventilatory support for respiratory failure between September 2006 and March 2011. Of the patients included in the study, 86% were white, 52% were female, and the mean (SD) age was 59 (14) years. The patients had a mean (SD) Acute Physiology, Age and Chronic Health Evaluation III score of 63 (21.6) and a mean (SD) of 5.7 (6.4) study days. INTERVENTIONS: Self-initiated PDM (n = 126) with preferred selections tailored by a music therapist whenever desired while receiving ventilatory support, self-initiated use of noise-canceling headphones (NCH; n = 122), or usual care (n = 125). MAIN OUTCOMES AND MEASURES: Daily assessments of anxiety (on 100-mm visual analog scale) and 2 aggregate measures of sedative exposure (intensity and frequency). RESULTS: Patients in the PDM group listened to music for a mean (SD) of 79.8 (126) (median [range], 12 [0-796]) minutes/day. Patients in the NCH group wore the noise-abating headphones for a mean (SD) of 34.0 (89.6) (median [range], 0 [0-916]) minutes/day. The mixed-models analysis showed that at any time point, patients in the PDM group had an anxiety score that was 19.5 points lower (95% CI, -32.2 to -6.8) than patients in the usual care group (P = .003). By the fifth study day, anxiety was reduced by 36.5% in PDM patients. The treatment × time interaction showed that PDM significantly reduced both measures of sedative exposure. Compared with usual care, the PDM group had reduced sedation intensity by -0.18 (95% CI, -0.36 to -0.004) points/day (P = .05) and had reduced frequency by -0.21 (95% CI, -0.37 to -0.05) points/day (P = .01). The PDM group had reduced sedation frequency by -0.18 (95% CI, -0.36 to -0.004) points/day vs the NCH group (P = .04). By the fifth study day, the PDM patients received 2 fewer sedative doses (reduction of 38%) and had a reduction of 36% in sedation intensity. CONCLUSIONS AND RELEVANCE: Among ICU patients receiving acute ventilatory support for respiratory failure, PDM resulted in greater reduction in anxiety compared with usual care, but not compared with NCH. Concurrently, PDM resulted in greater reduction in sedation frequency compared with usual care or NCH, and greater reduction in sedation intensity compared with usual care, but not compared with NCH. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00440700.

Does music influence stress in mechanically ventilated patients?

OBJECTIVES: Mechanically ventilated patients experience profound stress. Interventions are needed to ameliorate stress that does not cause adverse effects. The purpose of this study was to explore the influence of music on stress in a sample of patients over the duration of ventilatory support. RESEARCH METHODOLOGY/DESIGN: Randomised controlled trial; randomised patients (56.8+16.9 years, 61% male, APACHE III 57.2+18.3) receiving ventilatory support to: (1) patient-directed music (PDM) where patients self-initiated music listening whenever desired from a preferred collection, (2) headphones only to block ICU noise, or (3) usual ICU care. Twenty-four hour urinary cortisol samples were collected from a sub-set of subjects with intact renal function and not receiving medications known to influence cortisol levels (n=65). SETTING: 12 ICUs in the Midwestern United States. MAIN OUTCOME MEASURES: Urinary free cortisol (UFC), an integrative biomarker of stress. RESULTS: Controlling for illness severity, gender, and baseline UFC (29-45 mg/day), mixed models analysis revealed no significant differences among groups in UFC over the course of ventilatory support. CONCLUSION: While music did not significantly reduce cortisol, less profound spikes in UFC levels were observed but that, given the limitations of the research, this observation could have occurred merely by chance.

Tailoring a treatment fidelity framework for an intensive care unit clinical trial.

BACKGROUND: Treatment fidelity (TF) refers to methodological strategies and practices used to monitor and enhance the reliability and validity of behavioral interventions. Treatment fidelity monitoring enhances internal and external validity and is needed for study replication and generalizability. OBJECTIVES: The aim of this study was to describe the implementation, monitoring, and impact of TF in an intensive-care-unit-based clinical trial testing music for anxiety self-management with mechanically ventilated patients. METHOD: Development of the criteria was based on the Five-Component Treatment Fidelity Framework from the Treatment Fidelity Workgroup. Descriptive statistics were used to evaluate adherence rates to the key TF criteria and the reasons criteria were unmet. Descriptive and nonparametric statistics were used to evaluate the impact of TF on participants' use of the assigned intervention. RESULTS: The Treatment Fidelity Framework was adapted easily to fit the study interventions. After the initial implementation phase of monitoring, adherence to key criteria was maintained at the targeted level of 80%. The majority of barriers to adherence affected the research nurses' opportunity to interact with the participant and encourage use of the intervention. There was a trend toward increased use of equipment associated with the assigned condition after the initiation of TF; however, this difference was not statistically significant. DISCUSSION: Treatment fidelity monitoring is an iterative process that requires ongoing vigilance. Identification of barriers and the implementation of methods to enhance protocol adherence are needed to enhance the reliability, validity, and generalizability of clinical trials in the dynamic and challenging research environment of the intensive care unit.

Nonpharmacological interventions to manage common symptoms in patients receiving mechanical ventilation.

Patients receiving mechanical ventilation can experience symptoms such as pain, anxiety, agitation, and lack of sleep while in the intensive care unit, all of which can affect healing. Nonpharmacological complementary therapies can be used as adjuncts to sedatives and analgesics. By incorporating appropriate use of complementary therapies in conjunction with mainstream medical therapies, nurses can decrease patients' anxiety, promote sleep, and promote a healing environment to improve outcomes. Minimizing noise and providing access to natural light help promote a healing environment. Methods to promote sleep include relaxation techniques such as progressive muscle relaxation and massage and communication with patients' and their families to determine the patients' normal sleep patterns. Complementary therapies to relieve anxiety and agitation include music intervention, imagery, presence, and animal-assisted therapy.