Reducing Intraoperative Hypothermia in Infants from the Neonatal Intensive Care Unit.

Infants from the neonatal intensive care unit (NICU) undergoing surgery in the operating room (OR) are at greater risk for hypothermia during surgery than afterward due to environmental heat loss, anesthesia, and inconsistent temperature monitoring. A multidisciplinary team aimed to reduce hypothermia (<36.1 °C) for infants at a level IV NICU at the beginning of the operation (first OR temperature) or at any time during the operation (lowest OR temperature) by 25%. Methods: The team followed preoperative, intraoperative (first, lowest, and last OR), and postoperative temperatures. It sought to reduce intraoperative hypothermia using the "Model for Improvement" by standardizing temperature monitoring, transport, and OR warming, including raising ambient OR temperatures to 74°F. Temperature monitoring was continuous, secure, and automated. The balancing metric was postoperative hyperthermia (>38 °C). Results: Over 4 years, there were 1235 operations: 455 in the baseline and 780 in the intervention period. The percentage of infants experiencing hypothermia upon OR arrival and at any point during the operation decreased from 48.7% to 6.4% and 67.5% to 37.4%, respectively. Upon return to the NICU, the percentage of infants experiencing postoperative hypothermia decreased from 5.8% to 2.1%, while postoperative hyperthermia increased from 0.8% to 2.6%. Conclusions: Intraoperative hypothermia is more prevalent than postoperative hypothermia. Standardizing temperature monitoring, transport, and OR warming reduces both; however, further reduction requires a better understanding of how and when risk factors contribute to hypothermia to avoid further increasing hyperthermia. Continuous, secure, and automated data collection improved temperature management by enhancing situational awareness and facilitating data analysis.

Efficacy and comparative effectiveness of telephone and smartphone remote continuing care interventions for alcohol use disorder: a randomized controlled trial.

BACKGROUND AND AIMS: Management of alcohol use disorder (AUD) could be enhanced by effective remote treatments. This study tested whether supplementing intensive outpatient programs (IOPs) with continuing care delivered via (1) telephone, (2) smartphone or (3) their combination improves outcomes relative to (4) IOP only. Continuing care conditions were also compared. DESIGN: Randomized controlled trial of four groups with 3-, 6-, 9-, 12- and 18-month follow-ups. SETTING: University research center in Philadelphia, PA, USA. PARTICIPANTS: Participants (n = 262) met DSM-V criteria for AUD, were largely male (71%) and African American (82%). INTERVENTIONS AND COMPARATOR: Telephone monitoring and counseling (TMC; n = 59), addiction comprehensive health enhancement support system (ACHESS; n = 68) and TMC + ACHESS (n = 70) provided for 12 months. The control condition received IOP only (TAU; n = 65). MEASUREMENT: The primary outcome was percentage of days heavy drinking (PDHD) in months 1-12. Secondary outcomes were any drinking, any drug use, drinking consequences and quality of life. FINDINGS: Mean PDHD in months 1-12 was 10.29 in TAU, 5.41 in TMC, 6.80 in ACHESS and 5.99 in TMC + ACHESS. PDHD was lower in TMC [Cohen's d = 0.35, P = 0.018, 95% confidence interval (CI) = (-1.42, -0.20)], ACHESS [d = 0.31, P = 0.031, 95% CI = (-1.27, -0.06)] and TMC + ACHESS [d = 0.36, P = 0.009, 95% CI = (-1.40, -0.20)] than in TAU. Differences between TMC + ACHESS, TMC and ACHESS were small (d ≤ 0.06) and non-significant. Findings were inconclusive as to whether or not the treatment conditions differed on PDHD at 18 months. A significant effect was obtained on any drinking, which was higher in months 1-12 in TAU than in TMC [odds ratio (OR) = 3.02, standard error (SE) = 0.43, 95% CI = (1.30, 6.99), P = 0.01] and TMC + ACHESS [OR = 2.43, SE = 0.39, 95% CI = (1.12, 5.27), P = 0.025). No other significant effects were obtained on other secondary outcomes during or after treatment. CONCLUSIONS: A telephone-delivered intervention and a smartphone-delivered intervention, alone and in combination, provided effective remote continuing care for alcohol use disorder. The combination of both interventions was not superior to either alone and effects did not persist post-treatment.

Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial.

BACKGROUND: New smartphone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. One such system is the Addiction version of the Comprehensive Health Enhancement Support System (A-CHESS), which provides a range of automated functions that support patients. A-CHESS improved drinking outcomes over standard continuing care when provided to patients leaving inpatient treatment. Effective continuing care can also be delivered via telephone calls with a counselor. Telephone Monitoring and Counseling (TMC) has demonstrated efficacy in two randomized trials with alcohol-dependent patients. A-CHESS and TMC have complementary strengths. A-CHESS provides automated 24/7 recovery support services and frequent assessment of symptoms and status, but does not involve regular contact with a counselor. TMC provides regular and sustained contact with the same counselor, but no ongoing support between calls. The future of continuing care for alcohol use disorders is likely to involve automated mobile technology and counselor contact, but little is known about how best to integrate these services. METHODS/DESIGN: To address this question, the study will feature a 2 × 2 design (A-CHESS for 12 months [yes/no] × TMC for 12 months [yes/no]), in which 280 alcohol-dependent patients in intensive outpatient programs (IOPs) will be randomized to one of the four conditions and followed for 18 months. We will determine whether adding TMC to A-CHESS produces fewer heavy drinking days than TMC or A-CHESS alone and test for TMC and A-CHESS main effects. We will determine the costs of each of the four conditions and the incremental cost-effectiveness of the three active conditions. Analyses will also examine secondary outcomes, including a biological measure of alcohol use, and hypothesized moderation and mediation effects. DISCUSSION: The results of the study will yield important information on improving patient alcohol use outcomes by integrating mobile automated recovery support and counselor contact. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02681406 . Registered on 2 September 2016.

Effect of Continuing Care for Cocaine Dependence on HIV Sex-Risk Behaviors.

Evaluate the effect of continuing care interventions for cocaine use with HIV risk-reduction components on HIV sex-risk. Explore whether cocaine use at treatment initiation interacts with the type of continuing care intervention to affect HIV sex-risk. Cocaine dependent participants (N = 321) were randomized to: (1) Treatment as usual (TAU): intensive outpatient treatment, (2) TAU and telephone monitoring and counseling (TMC), and (3) TAU and TMC plus incentives for participation in telephone contacts (TMC+). Participants in TMC and TMC+ received a brief HIV intervention, with booster sessions as needed. Generalized estimating equations analysis compared TAU, TMC and TMC+ at 6, 12, 18, 24 months post-baseline on the following outcomes: overall HIV sex-risk, number of sexual partners, condom usage, exchange of drugs for sex, exchange of sex for drugs, exchange of money for sex, exchange of sex for money, and crack house visits. Overall sex-risk decreased for all treatment conditions at follow-up, with no treatment main effects. For people with no cocaine use at baseline, TAU experienced greater sex-risk reductions than TMC (p < .01) and TMC+ (p < .001). The three treatment conditions are effective in reducing HIV sex-risk. TMC with HIV risk-reduction components is unnecessary for cocaine-dependent clients who stop using cocaine early in treatment.

Effect of patient choice in an adaptive sequential randomization trial of treatment for alcohol and cocaine dependence.

OBJECTIVE: To evaluate the effect of providing choice of treatment alternatives to patients who fail to engage in or drop out of intensive outpatient programs (IOPs) for substance dependence. METHOD: Alcohol- and/or cocaine-dependent patients (N = 500) participated in a sequential, multiple-assignment, randomized trial (SMART). Those who failed to engage in an IOP at Week 2 (N = 189) or who dropped out after engagement (N = 84) were randomized for motivational-interviewing (MI) telephone calls that focused on engagement in an IOP (MI-IOP) or provided a choice of IOP type or 3 treatment options (MI-PC, or patient choice). Those not engaged at both 2 and 8 weeks (N = 102) were re-randomized either to MI-PC or no further outreach. Outcomes were treatment attendance and measures of alcohol and cocaine use obtained at 1, 2, 3, and 6 months. RESULTS: MI-PC produced better attendance than comparison conditions in patients who dropped out after initial engagement and in those re-randomized at 8 weeks. However, contrary to study hypotheses, MI-IOP produced significantly better alcohol-use outcomes than MI-PC in alcohol-dependent patients not engaged at Week 2. There were no other significant differences between treatment conditions on other main-effect analyses with alcohol- or cocaine-outcome measures. CONCLUSION: Providing treatment options via telephone calls to patients who failed to engage in IOP did not produce better substance-use outcomes than outreach calls focused on engagement in IOP. Future researchers should investigate the potential benefits of choice at other points in treatment (e.g., at intake) as well as choice of other combinations of treatments.

Treatment choices and subsequent attendance by substance-dependent patients who disengage from intensive outpatient treatment.

In an effort to increase engagement in effective treatment, we offered a choice of alternate evidence-based treatments to 137 alcohol- or cocaine-dependent adults (110 males, 27 females) who entered an intensive outpatient program (IOP) but disengaged within the first 8 weeks. We hypothesized that disengaged patients would choose and subsequently attend alternatives to IOP when given the chance, that their choices would be consistent with their previously-stated preferences, and that demographic and clinical characteristics would be predictive of alternatives chosen. Of 96 participants reached by phone, 19% chose no treatment; 49% chose to return to IOP; 24% chose individual psychotherapy; 6% chose telephone counseling; 2% chose naltrexone with medication management. There were few relationships between participant characteristics and choices made upon disengagement. Participants who chose alternative treatments were equally likely to attend their chosen treatment as those who chose IOP. Limited interest in alternative treatments may reflect allegiance to IOP, which was initially chosen by all participants. Implications for implementation of patient-centered adaptive treatment are discussed.

Who benefits from extended continuing care for cocaine dependence?

The goal of this study was to determine which cocaine dependent patients engaged in an intensive outpatient program (IOP) were most likely to benefit from extended continuing care (24 months). Participants (N=321) were randomized to: IOP treatment as usual (TAU), TAU plus Telephone Monitoring and Counseling (TMC), or TAU plus TMC plus incentives for session attendance (TMC+). Potential moderators examined were gender, stay in a controlled environment prior to IOP, number of prior drug treatments, and seven measures of progress toward IOP goals. Outcomes were: (1) abstinence from all drugs and heavy alcohol use, and (2) cocaine urine toxicology. Follow-ups were conducted at 3, 6, 9, 12, 18, and 24 months post-baseline. Results indicated that there were significant effects favoring TMC+ over TAU on the cocaine urine toxicology outcome for participants in a controlled environment prior to IOP and for those with no days of depression early in IOP. Trends were obtained favoring TMC over TAU for those in a controlled environment (cocaine urine toxicology outcome) or with high family/social problem severity (abstinence composite outcome), and TMC+ over TAU for those with high family/social problem severity or high self-efficacy (cocaine urine toxicology outcome). None of the other potential moderator effects examined reached the level of a trend. These results generally do not suggest that patients with greater problem severity or poorer performance early in treatment on the measures considered in this report will benefit to a greater degree from extended continuing care.

An adaptive approach for identifying cocaine dependent patients who benefit from extended continuing care.

OBJECTIVE: Study tested whether cocaine dependent patients using cocaine or alcohol at intake or in the first few weeks of intensive outpatient treatment would benefit more from extended continuing care than patients abstinent during this period. The effect of incentives for continuing care attendance was also examined. METHOD: Participants (N = 321) were randomized to treatment as usual (TAU), TAU and telephone monitoring and counseling (TMC), or TAU and TMC plus incentives (TMC+). The primary outcomes were (a) abstinence from all drugs and heavy alcohol use and (b) cocaine urine toxicology. Follow-ups were at 3, 6, 9, 12, 18, and 24 months. RESULTS: Cocaine and alcohol use at intake or early in treatment predicted worse outcomes on both measures (ps ≤ .0002). Significant effects favoring TMC over TAU on the abstinence composite were obtained in participants who used cocaine (odds ratio [OR] = 1.95 [1.02, 3.73]) or alcohol (OR = 2.47 [1.28, 4.78]) at intake or early in treatment. A significant effect favoring TMC+ over TAU on cocaine urine toxicology was obtained in those using cocaine during that period (OR = 0.55 [0.31, 0.95]). Conversely, there were no treatment effects in participants abstinent at baseline and no overall treatment main effects. Incentives almost doubled the number of continuing care sessions received but did not further improve outcomes. CONCLUSION: An adaptive approach for cocaine dependence in which extended continuing care is provided only to patients who are using cocaine or alcohol at intake or early in treatment improves outcomes in this group while reducing burden and costs in lower risk patients.

Enhanced continuing care provided in parallel to intensive outpatient treatment does not improve outcomes for patients with cocaine dependence.

OBJECTIVE: This study tested whether the addition of an enhanced continuing care (ECC) intervention that combined in-person and telephone sessions and began in the first week of treatment improved outcomes for cocaine-dependent patients entering an intensive outpatient program (IOP). METHOD: Participants (N = 152) were randomized to IOP treatment as usual (TAU) or IOP plus 12 months of ECC. ECC included cognitive-behavioral therapy elements to increase coping skills, as well as monetary incentives for attendance. It was provided by counselors situated at a separate clinical research facility who did not provide IOP. The primary outcomes measured were (a) cocaine urine toxicology and (b) good clinical outcome, as indicated by abstinence from all drugs and from heavy alcohol use. Secondary outcomes were frequency of abstinent days, cocaine use days, and heavy drinking days. Follow-ups were conducted at 3, 6, 9, and 12 months after baseline. RESULTS: Patients in ECC completed a mean of 18 sessions. Contrary to the hypotheses, patients in TAU had better scores on both the cocaine urine toxicology and the good clinical outcome measures than those in ECC, as indicated by significant Group × Time interactions (cocaine urine toxicology, p = .0025; abstinence composite, p = .017). These results were not moderated by substance use before or early in treatment or by IOP attendance. Results with the secondary outcomes also did not favor ECC over TAU. CONCLUSIONS: Continuing care that is not well integrated with the primary treatment program may interfere in some way with the therapeutic process, particularly when it is implemented shortly after intake.

Factors in sustained recovery from cocaine dependence.

The goal was to identify factors that predicted sustained cocaine abstinence and transitions from cocaine use to abstinence over 24 months. Data from baseline assessments and multiple follow-ups were obtained from three studies of continuing care for patients in intensive outpatient programs (IOPs). In the combined sample, remaining cocaine abstinent and transitioning into abstinence at the next follow-up were predicted by older age, less education, and less cocaine and alcohol use at baseline, and by higher self-efficacy, commitment to abstinence, better social support, lower depression, and lower scores on other problem severity measures assessed during the follow-up. In addition, higher self-help participation, self-help beliefs, readiness to change, and coping assessed during the follow-up predicted transitions from cocaine use to abstinence. These results were stable over 24 months. Commitment to abstinence, self-help behaviors and beliefs, and self-efficacy contributed independently to the prediction of cocaine use transitions. Implications for treatment are discussed.

Extended telephone-based continuing care for alcohol dependence: 24-month outcomes and subgroup analyses.

AIMS: To determine whether 18 months of telephone continuing care improves 24-month outcomes for patients with alcohol dependence. Subgroup analyses were performed to identify patients who would benefit most from continuing care. DESIGN: Comparative effectiveness trial of continuing care that consisted of monitoring and feedback only (TM) or monitoring and feedback plus counseling (TMC). Patients were randomized to treatment as usual (TAU), TAU plus TM or TAU plus TMC, and followed quarterly for 24 months. SETTING: Publicly funded intensive out-patient programs (IOP). PARTICIPANTS: A total of 252 alcohol-dependent patients (49% with current cocaine dependence) who completed 3 weeks of IOP. MEASUREMENTS: Percentage of days drinking, any heavy drinking and a composite good clinical outcome. FINDINGS: In the intent-to-treat sample, group differences in alcohol outcomes out to 18 months favoring TMC over TAU were no longer present in months 19-24. There was also a non-significant trend for TMC to perform better than usual care on the good clinical outcome measure (60% vs. 46% good clinical outcome in months 19-24). Overall significant effects favoring TMC and TM over TAU were seen for women; and TMC was also superior to TAU for participants with social support for drinking, low readiness to change and prior alcohol treatments. Most of these effects were obtained on at least two of three outcomes. However, no effects remained significant at 24 months. CONCLUSIONS: The benefits of an extended telephone-based continuing care programme to treat alcohol dependence did not persist after the end of the intervention. A post-hoc analysis suggested that women and individuals with social support for drinking, low readiness to change or prior alcohol treatments may benefit from the intervention.

Voucher incentives increase treatment participation in telephone-based continuing care for cocaine dependence.

BACKGROUND: Telephone-based monitoring is a promising approach to continuing care of substance use disorders, but patients often do not engage or participate enough to benefit. Voucher incentives can increase retention in outpatient treatment and continuing care, but may be less effective when reinforcement is delayed, as in telephone-based care. We compared treatment utilization rates among cocaine-dependent patients enrolled in telephone continuing care with and without voucher incentives to determine whether incentives increase participation in telephone-based care. METHOD: Participants were 195 cocaine-dependent patients who completed two weeks of community-based intensive outpatient treatment for substance use disorders and were randomly assigned to receive telephone continuing care with or without voucher incentives for participation as part of a larger clinical trial. The 12-month intervention included 2 in-person orientation sessions followed by up to 30 telephone sessions. Incentivized patients could receive up to $400 worth of gift cards. RESULTS: Patients who received incentives were not more likely to complete their initial orientation to continuing care. Incentivized patients who completed orientation completed 67% of possible continuing care sessions, as compared to 39% among non-incentivized patients who completed orientation. Among all patients randomized to receive incentives, the average number of completed sessions was 15.5, versus 7.2 for patients who did not receive incentives, and average voucher earnings were $200. CONCLUSIONS: Voucher incentives can have a large effect on telephone continuing care participation, even when reinforcement is delayed. Further research will determine whether increased participation leads to better outcome among patients who received incentives.

Relationship of Mental Health and Illness in Substance Abuse Patients.

This study examined the latent structure of a number of measures of mental health (MH) and mental illness (MI) in substance use disorder outpatients to determine whether they represent two independent dimensions, as Keyes (2005) found in a community sample. Seven aspects of MI assessed were assessed - optimism, personal meaning, spirituality/religiosity, social support, positive mood, hope, and vitality. MI was assessed with two measures of negative psychological moods/states, a measure of antisociality, and the Addiction Severity Index's recent psychiatric and family-social problem scores. Correlational and exploratory factor analyses revealed that MH and MI appear to reflect two independent, but correlated, constructs. However, optimism and social support had relatively high loadings on both factors. Antisociality and the family-social problem score failed to load significantly on the MI factor. Confirmatory factor analysis supported the existence of two obliquely related, negatively correlated dimensions. Study findings, although generally supporting the independence of MH and MI, suggest that the specific answers to this question may be influenced by the constructs and assessments used to measure them.

A randomized trial of extended telephone-based continuing care for alcohol dependence: within-treatment substance use outcomes.

OBJECTIVE: The study tested whether adding up to 18 months of telephone continuing care, either as monitoring and feedback (TM) or longer contacts that included counseling (TMC), to intensive outpatient programs (IOPs) improved outcomes for alcohol-dependent patients. METHOD: Participants (N = 252) who completed 3 weeks of IOP were randomized to up to 36 sessions of TM (M = 11.5 sessions), TMC (M = 9.1 sessions), or IOP only (treatment as usual [TAU]). Quarterly assessment of alcohol use (79.9% assessed at 18 months) was corroborated with available collateral reports (N = 63 at 12 months). Participants with cocaine dependence (N = 199) also provided urine samples. RESULTS: Main effects favored TMC over TAU on any alcohol use (odds ratio [OR] = 1.88, CI [1.13, 3.14]) and any heavy alcohol use (OR = 1.74, CI [1.03, 2.94]). TMC produced fewer days of alcohol use during Months 10-18 and heavy alcohol use during Months 13-18 than TAU (ds = 0.46-0.65). TMC also produced fewer days of any alcohol use and heavy alcohol use than TM during Months 4-6 (ds = 0.39 and 0.43). TM produced lower percent days alcohol use than TAU during Months 10-12 and 13-15 (ds = 0.41 and 0.39). There were no treatment effects on rates of cocaine-positive urines. CONCLUSIONS: Adding telephone continuing care to IOP improved alcohol use outcomes relative to IOP alone. Conversely, shorter calls that provided monitoring and feedback but no counseling generally did not improve outcomes over IOP.

Measurement of mental health in substance use disorder outpatients.

Few studies have examined mental health (MH) attributes of patients with substance use disorder (SUD). This study examines the internal consistency, concurrent validity, and comparative level of MH attributes (i.e., optimism, life attitudes, spirituality/religiousness, social support, positive mood, hope, and vitality) in patients with SUD compared with the instrument development group. The internal consistency of optimism, spirituality/religiousness, positive mood, hope, and vitality were similar in both groups. Some subscales of the social support and life attitude measures had lower internal consistency than was found for the original samples, although internal consistency of more global constructs were comparable. Patients with SUD had higher positive mood, spirituality/religiousness, and hope scores, whereas social support, life attitudes, and optimism scores were lower than in the original sample. Correlations between MH attributes and recent life problems of patients with SUD generally supported the concurrent validity of the MH measures.

Moderators of response to telephone continuing care for alcoholism.

OBJECTIVES: To evaluate potential moderators of the effect of adding extended telephone monitoring (TM) and telephone monitoring and counseling (TMC) continuing care to treatment as usual (TAU) for alcoholism. Continuing care was predicted to be more effective for patients with severe substance-use histories, poor initial response to treatment, and other risk factors for relapse. METHODS: Randomized study with 18-month follow-up. Outcomes were frequency of drinking and any drinking. RESULTS: Main effects favored TMC over TAU on alcohol outcomes. However, none of the 11 variables examined moderated these effects. Conversely, main effect and moderator analyses indicated TM was more beneficial than TAU only for women and for participants with lower readiness to change. CONCLUSIONS: TMC improves drinking outcomes when added to standard care, regardless of alcohol use history, early response to treatment, or other risk factors for relapse. TM is recommended for women and less motivated patients.

Reliability and validity of the alcohol short index of problems and a newly constructed drug short index of problems.

OBJECTIVE: This study evaluated the psychometric properties of the 15-item alcohol Short Index of Problems (SIP) instrument and those of a newly constructed 15-item drug Short Index of Problems (SIP-D) instrument in 277 newly entered substance-abuse patients. METHOD: The SIP is derived from the longer, 50-item Drinker Inventory of Consequences (DrInC), which was designed to assess adverse consequences of alcohol use. The SIP-D was constructed by substituting the term "drug use" for the term "drinking" in each SIP item. A 3-month recall interval was employed. RESULTS: Factor analyses of each of the instruments revealed similar solutions, with only one main factor accounting for the majority of variance. Nonparametric item response theory methods produced the same finding. Internal consistency reliability estimates for the SIP and SIP-D total scores were .98 and .97, respectively. Concurrent validity was demonstrated by examining the correlations of the total scores for each of the instruments with the recent summary indexes of the newly revised Addiction Severity Index (ASI-Version 6): alcohol, drug, medical, economic, legal, family/social, and psychiatric problems. CONCLUSIONS: This study is the first to confirm the psychometric validity of the SIP when used as an independent instrument unembedded within the DrInC. The study also supports the use of the SIP-D as a brief measure of adverse consequences of drug use. The findings strongly support the unidimensional structure of both measures.