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Pilot Randomized Trial of a Recovery Navigator Program for Survivors of Critical Illness With Problematic Alcohol Use.

ABSTRACT: Many survivors of critical illness have problematic alcohol use, associated with risk of death and hospital readmission. We tested the feasibility, acceptability, treatment fidelity, and potential efficacy of a customized alcohol intervention for patients in ICUs. The intervention was delivered by a Recovery Navigator using principles of motivational interviewing and shared decision-making. Design:Pilot randomized trial. Setting:Two urban ICUs in Denver, CO. Patients:Patients with problematic alcohol use were enrolled prior to hospital discharge. Interventions:Patients were randomly assigned to usual care, single-session motivational interviewing and shared decision-making, or multisession motivational interviewing and shared decision-making. Measurements and Main Results:We assessed feasibility via enrollment and attrition, acceptability via patient satisfaction (Client Satisfaction Questionnaire-8), fidelity via observation and questionnaires, and potential efficacy via group means and CIs on measures of alcohol use, psychiatric symptoms, cognition, and other alcohol-related problems. Over 18 months, we offered the study to 111 patients, enrolled 47, and randomized 36; refusals were mainly due to stigma or patients' desire to handle problems on their own. Groups were similar at baseline, and 67% of patients met criteria for alcohol use disorder. Average patient satisfaction was high (mean = 28/32) regardless of group assignment. Sessions were delivered with 98% adherence to motivational interviewing principles and excellent motivational interviewing spirit; patients perceived the intervention to be more autonomy supportive than usual care. Group means after 6 months suggested that patients receiving the intervention might improve on measures such as alcohol use, psychiatric symptoms, legal problems, and days of paid work; however, they did not receive more substance use treatment. All results were nonsignificant due to small sample size. Conclusions:A Recovery Navigator intervention was feasible and acceptable for delivering high-fidelity brief interventions to ICU patients. Changes in alcohol-related problems with motivational interviewing and shared decision-making were nonsignificant but clinically meaningful in size. A full-scale randomized trial of motivational interviewing and shared decision-making is warranted.

SUBMITTER: Clark BJ

PROVIDER: S-EPMC7063892 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Pilot Randomized Trial of a Recovery Navigator Program for Survivors of Critical Illness With Problematic Alcohol Use.

Clark Brendan J BJ Sorrell Tanya T Hodapp Rachel M RM Reed Kathryne K Moss Marc M Aagaard Laurra L Cook Paul F PF

Critical care explorations 20191014 10

Many survivors of critical illness have problematic alcohol use, associated with risk of death and hospital readmission. We tested the feasibility, acceptability, treatment fidelity, and potential efficacy of a customized alcohol intervention for patients in ICUs. The intervention was delivered by a Recovery Navigator using principles of motivational interviewing and shared decision-making.<h4>Design</h4>Pilot randomized trial.<h4>Setting</h4>Two urban ICUs in Denver, CO.<h4>Patients</h4>Patient ...[more]

PMID: 32166232

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Project description:ObjectiveTo determine the feasibility of conducting a longitudinal prospective study to evaluate functional recovery and predictors of impaired functional recovery in critically ill children.DesignProspective pilot study.SettingSingle-center PICU at McMaster Children's Hospital, Hamilton, Canada.PatientsChildren aged 12 months to 17 years, with at least one organ dysfunction, limited mobility or bed rest during the first 48 hours of PICU admission, and a minimum 48-hour PICU length of stay, were eligible. Patients transferred from a neonatal ICU prior to ever being discharged home, already mobilizing well or at baseline functional status at time of screening, with an English language barrier, and prior enrollment into this study, were excluded.InterventionsNone.Measurements and main resultsThe primary outcome was feasibility, as defined by the ability to screen, enroll eligible patients, and execute the study procedures and measurements on participants. Secondary outcomes included functional status at baseline, 3 and 6 months, PICU morbidity, and mortality. Functional status was measured using the Pediatric Evaluation of Disability Inventory and the Participation and Environment Measure for Children and Youth. Thirty-three patients were enrolled between October 2012 and April 2013. Consent rate was 85%, and follow-up rates were 93% at 3 months and 71% at 6 months. We were able to execute the study procedures and measurements, demonstrating feasibility of conducting a future longitudinal study. Functional status deteriorated following critical illness. Recovery appears to be influenced by baseline health or functional status and severity of illness.ConclusionLongitudinal research is needed to understand how children recover after a critical illness. Our results suggest factors that may influence the recovery trajectory and were used to inform the methodology, outcomes of interest, and appropriate sample size of a larger multicenter study evaluating functional recovery in this population.

Project description:BackgroundICU survivors suffer from impaired physical function and reduced exercise capacity, yet the underlying mechanisms are poorly understood. The goal of this exploratory pilot study was to investigate potential mechanisms of exercise limitation using cardiopulmonary exercise testing (CPET) and 6-min walk testing (6MWT).MethodsWe enrolled adults aged 18 years or older who were treated for respiratory failure or shock in medical, surgical, or trauma ICUs at Vanderbilt University Medical Center (Nashville, TN, United States). We excluded patients with pre-existing cardiac dysfunction, a contraindication to CPET, or the need for supplemental oxygen at rest. We performed CPET and 6MWT 6 months after ICU discharge. We measured standard CPET parameters in addition to two measures of oxygen utilization during exercise (VO2-work rate slope and VO2 recovery half-time).ResultsWe recruited 14 participants. Low exercise capacity (i.e., VO2Peak < 80% predicted) was present in 11 out of 14 (79%) with a median VO2Peak of 12.6 ml/kg/min [9.6-15.1] and 6MWT distance of 294 m [240-433]. In addition to low VO2Peak, CPET findings in survivors included low oxygen uptake efficiency slope, low oxygen pulse, elevated chronotropic index, low VO2-work rate slope, and prolonged VO2 recovery half-time, indicating impaired oxygen utilization with a hyperdynamic heart rate and ventilatory response, a pattern seen in non-critically ill patients with mitochondrial myopathies. Worse VO2-work rate slope and VO2 recovery half-time were strongly correlated with worse VO2Peak and 6MWT distance, suggesting that exercise capacity was potentially limited by impaired muscle oxygen utilization.ConclusionsThese exploratory data suggest ICU survivors may suffer from impaired muscular oxygen metabolism due to mitochondrial dysfunction that impairs exercise capacity long-term. These findings should be further characterized in future studies that include direct assessments of muscle mitochondrial function in ICU survivors.

Project description:The Internet has increasingly been studied as mode of delivery for interventions targeting problematic alcohol use. Most interventions have been fully automated, but some research suggests that adding counselor guidance may improve alcohol consumption outcomes.An eight-module Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help-seekers. Eighty participants with problematic alcohol use according to the Alcohol Use Disorders Identification Test (AUDIT; scores of ? 6 for women and ? 8 for men) were recruited online from an open access website and randomized into three different groups. All groups were offered the same self-help program, but participants in two of the three groups received Internet-based counselor guidance in addition to the self-help program. One of the guidance groups was given a choice between guidance via asynchronous text messages or synchronous text-based chat, while the other guidance group received counselor guidance via asynchronous text messages only.In the choice group, 65% (13 of 20 participants) chose guidance via asynchronous text messages. At the 10-week post-treatment follow-up, an intention-to-treat (ITT) analysis showed that participants in the two guidance groups (choice and messages) reported significantly lower past week alcohol consumption compared to the group without guidance; 10.8 (SD = 12.1) versus 22.6 (SD = 18.4); p = 0.001; Cohen's d = 0.77. Participants in both guidance groups reported significantly lower scores on the AUDIT at follow-up compared to the group without guidance, with a mean score of 14.4 (SD = 5.2) versus 18.2 (SD = 5.9); p = 0.003; Cohen's d = 0.68. A higher proportion of participants in the guidance groups said that they would recommend the program compared to the group without guidance (81% for choice; 93% for messages versus 47% for self-help).Self-help programs for problematic alcohol use can be more effective in reducing alcohol consumption over a 10-week period when counselor guidance is added.Clinicaltrials.gov NCT02384304.

Project description:BackgroundPatients who survive critical illness suffer from a significant physical disability. The impact of rehabilitation strategies on health-related quality of life is inconsistent, with population heterogeneity cited as one potential confounder. This secondary analysis aimed to (1) examine trajectories of functional recovery in critically ill patients to delineate sub-phenotypes and (2) to assess differences between these cohorts in both clinical characteristics and clinimetric properties of physical function assessment tools.MethodsTwo hundred ninety-one adult sepsis survivors were followed-up for 24 months by telephone interviews. Physical function was assessed using the Physical Component Score (PCS) of the Short Form-36 Questionnaire (SF-36) and Activities of Daily Living and the Extra Short Musculoskeletal Function Assessment (XSFMA-F/B). Longitudinal trajectories were clustered by factor analysis. Logistical regression analyses were applied to patient characteristics potentially determining cluster allocation. Responsiveness, floor and ceiling effects and concurrent validity were assessed within clusters.ResultsOne hundred fifty-nine patients completed 24 months of follow-up, presenting overall low PCS scores. Two distinct sub-cohorts were identified, exhibiting complete recovery or persistent impairment. A third sub-cohort could not be classified into either trajectory. Age, education level and number of co-morbidities were independent determinants of poor recovery (AUROC 0.743 ((95%CI 0.659-0.826), p < 0.001). Those with complete recovery trajectories demonstrated high levels of ceiling effects in physical function (PF) (15%), role physical (RP) (45%) and body pain (BP) (57%) domains of the SF-36. Those with persistent impairment demonstrated high levels of floor effects in the same domains: PF (21%), RP (71%) and BP (12%). The PF domain demonstrated high responsiveness between ICU discharge and at 6 months and was predictive of a persistent impairment trajectory (AUROC 0.859 (95%CI 0.804-0.914), p < 0.001).ConclusionsWithin sepsis survivors, two distinct recovery trajectories of physical recovery were demonstrated. Older patients with more co-morbidities and lower educational achievements were more likely to have a persistent physical impairment trajectory. In regard to trajectory prediction, the PF score of the SF-36 was more responsive than the PCS and could be considered for primary outcomes. Future trials should consider adaptive trial designs that can deal with non-responders or sub-cohort specific outcome measures more effectively.

Project description:ImportanceOver 50% of Acute Respiratory Failure (ARF) survivors experience cognitive, physical, and psychological impairments that negatively impact their quality of life (QOL).ObjectiveTo evaluate the efficacy of a post-intensive care unit (ICU) program, the Mobile Critical Care Recovery Program (m-CCRP) consisting of a nurse care coordinator supported by an interdisciplinary team, in improving the QOL of ARF survivors.Design, setting, and participantsThis randomized clinical trial with concealed outcome assessments among ARF survivors was conducted from March 1, 2017, to April 30, 2022, with a 12-month follow-up. Patients were admitted to the ICU services of 4 Indiana hospitals (1 community, 1 county, 2 academic), affiliated with the Indiana University School of Medicine.InterventionA 12-month nurse-led collaborative care intervention (m-CCRP) supported by an interdisciplinary group of clinicians (2 intensivists, 1 geriatrician, 1 ICU nurse, and 1 neuropsychologist) was compared with a telephone-based control. The intervention comprised longitudinal symptom monitoring coupled with nurse-delivered care protocols targeting cognition, physical function, personal care, mobility, sleep disturbances, pain, depression, anxiety, agitation or aggression, delusions or hallucinations, stress and physical health, legal and financial needs, and medication adherence.Main outcomes and measuresThe primary outcome was QOL as measured by the 36-item Medical Outcomes Study Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS), with scores on each component ranging from 0-100, and higher scores indicating better health status.ResultsIn an intention-to-treat analysis among 466 ARF survivors (mean [SD] age, 56.1 [14.4] years; 250 [53.6%] female; 233 assigned to each group), the m-CCRP intervention for 12 months did not significantly improve the QOL compared with the control group (estimated difference in change from baseline between m-CCRP and control group: 1.61 [95% CI, -1.06 to 4.29] for SF-36 PCS; -2.50 [95% CI, -5.29 to 0.30] for SF-36 MCS. Compared with the control group, the rates of hospitalization were higher in the m-CCRP group (117 [50.2%] vs 95 [40.8%]; P = .04), whereas the 12-month mortality rates were not statistically significantly lower (24 [10.3%] vs 38 [16.3%]; P = .05).Conclusions and relevanceFindings from this randomized clinical trial indicated that a nurse-led 12-month comprehensive interdisciplinary care intervention did not significantly improve the QOL of ARF survivors after ICU hospitalization. These results suggest that further research is needed to identify specific patient groups who could benefit from tailored post-ICU interventions.Trial registrationClinicalTrials.gov Identifier: NCT03053245.

Dataset Information

Pilot Randomized Trial of a Recovery Navigator Program for Survivors of Critical Illness With Problematic Alcohol Use.

Publications

Pilot Randomized Trial of a Recovery Navigator Program for Survivors of Critical Illness With Problematic Alcohol Use.

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