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Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.

ABSTRACT: Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods: HIV physicians and advanced practice providers (n?=?41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n?=?187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (?2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n?=?170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n?=?117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.

SUBMITTER: Lira MC

PROVIDER: S-EPMC6693587 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.

Lira Marlene C MC Tsui Judith I JI Liebschutz Jane M JM Colasanti Jonathan J Root Christin C Cheng Debbie M DM Walley Alexander Y AY Sullivan Meg M Shanahan Christopher C O'Connor Kristen K Abrams Catherine C Forman Leah S LS Chaisson Christine C Bridden Carly C Podolsky Melissa C MC Outlaw Kishna K Harris Catherine E CE Harris Catherine E CE Armstrong Wendy S WS Del Rio Carlos C Samet Jeffrey H JH

HIV research & clinical practice 20190401 2

Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods: HIV physicians and advanced ...[more]

PMID: 31303143

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Project description:BackgroundDisseminating care guidelines into clinical practice remains challenging, partly due to inadequate evidence on how best to help clinics incorporate new guidelines into routine care. This is particularly true in safety net community health centers (CHCs).MethodsThis pragmatic comparative effectiveness trial used a parallel mixed methods design. Twenty-nine CHC clinics were randomized to receive increasingly intensive implementation support (implementation toolkit (arm 1); toolkit + in-person training + training webinars (arm 2); toolkit + training + webinars + offered practice facilitation (arm 3)) targeting uptake of electronic health record (EHR) tools focused on guideline-concordant cardioprotective prescribing for patients with diabetes. Outcomes were compared across study arms, to test whether increased support yielded additive improvements, and with 137 non-study CHCs that share the same EHR as the study clinics. Quantitative data from the CHCs' EHR were used to compare the magnitude of change in guideline-concordant ACE/ARB and statin prescribing, using adjusted Poisson regressions. Qualitative data collected using diverse methods (e.g., interviews, observations) identified factors influencing the quantitative outcomes.ResultsOutcomes at CHCs receiving higher-intensity support did not improve in an additive pattern. ACE/ARB prescribing did not improve in any CHC group. Statin prescribing improved overall and was significantly greater only in the arm 1 and arm 2 CHCs compared with the non-study CHCs. Factors influencing the finding of no additive impact included: aspects of the EHR tools that reduced their utility, barriers to providing the intended implementation support, and study design elements, e.g., inability to adapt the provided support. Factors influencing overall improvements in statin outcomes likely included a secular trend in awareness of statin prescribing guidelines, selection bias where motivated clinics volunteered for the study, and study participation focusing clinic staff on the targeted outcomes.ConclusionsEfforts to implement care guidelines should: ensure adaptability when providing implementation support and conduct formative evaluations to determine the optimal form of such support for a given clinic; consider how study data collection influences adoption; and consider barriers to clinics' ability to use/accept implementation support as planned. More research is needed on supporting change implementation in under-resourced settings like CHCs.Trial registrationClinicalTrials.gov, NCT02325531. Registered 15 December 2014.

Project description:BACKGROUND:This is an updated version of the original Cochrane review published in Issue 4, 2006. Patients may control postoperative pain by self administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne et al found a strong patient preference for PCA over non-patient controlled analgesia, but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne's meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, a 2001 review by Walder et al did not find statistically significant differences in pain intensity or pain relief between PCA and groups treated with non-patient controlled analgesia. OBJECTIVES:To evaluate the efficacy and safety of patient controlled intravenous opioid analgesia (termed PCA in this review) versus non-patient controlled opioid analgesia of as-needed opioid analgesia for postoperative pain relief. SEARCH METHODS:We ran the search for the previous review in November 2004. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 12), MEDLINE (1966 to 28 January 2015), and EMBASE (1980 to 28 January 2015) for randomized controlled trials (RCTs) in any language, and reference lists of reviews and retrieved articles. SELECTION CRITERIA:We selected RCTs that assessed pain intensity as a primary or secondary outcome. These studies compared PCA without a continuous background infusion with non-patient controlled opioid analgesic regimens. We excluded studies that explicitly stated they involved patients with chronic pain. DATA COLLECTION AND ANALYSIS:Two review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence. We performed meta-analysis of outcomes that included pain intensity assessed by a 0 to 100 visual analog scale (VAS), opioid consumption, patient satisfaction, length of stay, and adverse events. MAIN RESULTS:Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay. AUTHORS' CONCLUSIONS:Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control.

Project description:IMPORTANCE:"Nudges" that influence decision making through subtle cognitive mechanisms have been shown to be highly effective in a wide range of applications, but there have been few experiments to improve clinical practice. OBJECTIVE:To investigate the use of a behavioral "nudge" based on the principle of public commitment in encouraging the judicious use of antibiotics for acute respiratory infections (ARIs). DESIGN, SETTING, AND PARTICIPANTS:Randomized clinical trial in 5 outpatient primary care clinics. A total of 954 adults had ARI visits during the study timeframe: 449 patients were treated by clinicians randomized to the posted commitment letter (335 in the baseline period, 114 in the intervention period); 505 patients were treated by clinicians randomized to standard practice control (384 baseline, 121 intervention). INTERVENTIONS:The intervention consisted of displaying poster-sized commitment letters in examination rooms for 12 weeks. These letters, featuring clinician photographs and signatures, stated their commitment to avoid inappropriate antibiotic prescribing for ARIs. MAIN OUTCOMES AND MEASURES:Antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses in baseline and intervention periods, adjusted for patient age, sex, and insurance status. RESULTS:Baseline rates were 43.5% and 42.8% for control and poster, respectively. During the intervention period, inappropriate prescribing rates increased to 52.7% for controls but decreased to 33.7% in the posted commitment letter condition. Controlling for baseline prescribing rates, we found that the posted commitment letter resulted in a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing rate relative to control (P?=?.02). There was no evidence of diagnostic coding shift, and rates of appropriate antibiotic prescriptions did not diminish over time. CONCLUSIONS AND RELEVANCE:Displaying poster-sized commitment letters in examination rooms decreased inappropriate antibiotic prescribing for ARIs. The effect of this simple, low-cost intervention is comparable in magnitude to costlier, more intensive quality-improvement efforts. TRIAL REGISTRATION:clinicaltrials.gov identifier: NCT01767064.

Project description:BackgroundSchizophrenia is associated with excess mortality and multimorbidity, which is possibly associated with difficulty in coordinating care for multiple mental and physical comorbidities. We analyzed the receipt by patients with schizophrenia of 11 types of guideline-concordant care and the association of such care with survival.MethodsGuideline-concordant care over an 8-year period (financial years 2002 to 2009) was examined in a nationwide sample of 49,173 male veterans with schizophrenia, who were aged 50 years or older. Administrative databases from the electronic medical record system of the Veterans Health Administration (VA) provided comprehensive measures of patient demographics and medical information. Relying on the 2004 American Psychiatric Association guidelines, patterns in 11 types of care were identified and cluster-analyzed. Care types included cardiovascular, metabolic, weight management, nicotine dependence, infectious diseases, vision, and mental health counseling (individual, family, drugs/alcohol, psychiatric medication, and compensated work therapy). Survival analysis estimated association of care patterns with survival, adjusting for clinical and demographic covariates.ResultsThere was an average of four chronic diseases in addition to schizophrenia in the cohort, notably hypertension (43%) and dyslipidemia (29%). Three longitudinal trajectories (clusters) were identified: 'high-consistent' (averaging 5.4 types of care annually), 'moderate-consistent' (averaging 3.8), and 'poor-decreasing' (averaging 1.9). Most veterans were receiving cardiovascular care (67 to 76%), hepatic and renal function assays (79 to 84%), individual counseling (72 to 85%) and psychiatry consults (66 to 82%), with the proportion receiving care varying by cluster group. After adjustment for age, baseline comorbidity, and other covariates, there was a greater survival rate for those with poor-decreasing care compared with high-consistent care, and for high-consistent compared with moderate-consistent care.ConclusionsRelatively low levels of guideline-concordant care were seen for older VA patients with schizophrenia, and trajectories of care over time were associated with survival in a non-intuitive pattern. The group with the lowest and decreasing levels of care was also the oldest, but nonetheless had the best age-adjusted and other covariate-adjusted survival rates, possibly because they were requiring less care relative to younger, sicker veterans, and thus their comorbidity burden was markedly lower. Notably, in the group with the sickest individuals (that is those with the highest comorbidity scores, who were very disabled), receiving guideline-concordant care was associated with improved survival in adjusted models compared with those patients receiving only moderate levels of care.

Project description:BackgroundRates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics.Methods/designThe study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study's primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study's primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics.DiscussionSystems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices.Trial registrationNCT04044521 (ClinicalTrials.gov). Registered 05 August 2019.

Dataset Information

Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.

Publications

Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.

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