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Opioids & SU

The Literature Collection contains over 10,000 references for published and grey literature on the integration of behavioral health and primary care. Learn More

Use the Search feature below to find references for your terms across the entire Literature Collection, or limit your searches by Authors, Keywords, or Titles and by Year, Type, or Topic. View your search results as displayed, or use the options to: Show more references per page; Sort references by Title or Date; and Refine your search criteria. Expand an individual reference to View Details. Full-text access to the literature may be available through a link to PubMed, a DOI, or a URL. References may also be exported for use in bibliographic software (e.g., EndNote, RefWorks, Zotero).

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41
Interprofessional education: Effects on professional practice and health care outcomes
Type: Journal Article
Authors: S. Reeves, M. Zwarenstein, J. Goldman, H. Barr, D. Freeth, M. Hammick, I. Koppel
Year: 2008
Publication Place: England
Abstract: BACKGROUND: Patient care is a complex activity which demands that health and social care professionals work together in an effective manner. The evidence suggests, however, that these professionals do not collaborate well together. Interprofessional education (IPE) offers a possible way to improve collaboration and patient care. OBJECTIVES: To assess the effectiveness of IPE interventions compared to education interventions in which the same health and social care professionals learn separately from one another; and to assess the effectiveness of IPE interventions compared to no education intervention. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, MEDLINE and CINAHL, for the years 1999 to 2006. We also handsearched the Journal of Interprofessional Care (1999 to 2006), reference lists of the six included studies and leading IPE books, IPE conference proceedings, and websites of IPE organisations. SELECTION CRITERIA: Randomised controlled trials (RCTs), controlled before and after (CBA) studies and interrupted time series (ITS) studies of IPE interventions that reported objectively measured or self reported (validated instrument) patient/client and/or healthcare process outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the eligibility of potentially relevant studies, and extracted data from, and assessed study quality of, included studies. A meta-analysis of study outcomes was not possible given the small number of included studies and the heterogeneity in methodological designs and outcome measures. Consequently, the results are presented in a narrative format. MAIN RESULTS: We included six studies (four RCTs and two CBA studies). Four of these studies indicated that IPE produced positive outcomes in the following areas: emergency department culture and patient satisfaction; collaborative team behaviour and reduction of clinical error rates for emergency department teams; management of care delivered to domestic violence victims; and mental health practitioner competencies related to the delivery of patient care. In addition, two of the six studies reported mixed outcomes (positive and neutral) and two studies reported that the IPE interventions had no impact on either professional practice or patient care. AUTHORS' CONCLUSIONS: This updated review found six studies that met the inclusion criteria, in contrast to our first review that found no eligible studies. Although these studies reported some positive outcomes, due to the small number of studies, the heterogeneity of interventions, and the methodological limitations, it is not possible to draw generalisable inferences about the key elements of IPE and its effectiveness. More rigorous IPE studies (i.e. those employing RCTs, CBA or ITS designs with rigorous randomisation procedures, better allocation concealment, larger sample sizes, and more appropriate control groups) are needed to provide better evidence of the impact of IPE on professional practice and healthcare outcomes. These studies should also include data collection strategies that provide insight into how IPE affects changes in health care processes and patient outcomes.
Topic(s):
Education & Workforce See topic collection
42
Interventions on frequent attenders in primary care. A systematic literature review
Type: Journal Article
Authors: F. T. Smits, K. A. Wittkampf, A. H. Schene, P. J. Bindels, H. C. Van Weert
Year: 2008
Publication Place: Norway
Abstract: OBJECTIVE: To analyse which interventions are effective in influencing morbidity, quality of life, and healthcare utilization of frequently attending patients (FAs) in primary care. METHODS: A systematic literature search was performed for articles describing interventions on FAs in primary care (Medline, Embase, and PsycINFO). Outcomes were morbidity, quality of life (QoL), and use of healthcare. Two independent assessors selected all randomized clinical trials (RCT) and assessed the quality of the selected RCTs. Results. Five primary care based RCTs were identified. Three RCTs used frequent attendance to select patients at risk of distress, major depression, and anxiety disorders. These RCTs applied psychological and psychiatric interventions and focused on undiagnosed psychiatric morbidity of FAs. Two of them found more depression-free days and a better QoL after treating major depressive disorder in FAs. No other RCT found any positive effect on morbidity or QoL. Two RCTs studied an intervention which focused on reducing frequent attendance. No intervention significantly lowered attendance. Due to the difference in study settings and the variation in methods of selecting patients, meta-analysis of the results was not possible. CONCLUSION: No study showed convincing evidence that an intervention improves QoL or morbidity of frequent attending primary care patients, although a small effect might be possible in a subgroup of depressed frequent attenders. No evidence was found that it is possible to influence healthcare utilization of FAs.
Topic(s):
Medically Unexplained Symptoms See topic collection
43
Limiting access to psychiatric services can increase total health care costs
Type: Journal Article
Authors: S. D. Horn
Year: 2003
Publication Place: United States
Abstract: Restricted access to health care services and medication is associated with overall higher utilization and higher health care costs. Although randomized controlled trials (RCTs) are regarded as the best method of determining whether a treatment strategy does more good than harm, clinical practice improvement (CPI) methods may be a more effective way of achieving superior medical outcomes for the least cost over the course of a patient's care. The Managed Care Outcomes Project, a large-scale CPI study, tracked detailed factors regarding medical care, patients, and outcomes from different managed care settings. Results showed that cost-containment strategies employed by various health maintenance organizations were associated with poor treatment outcomes for patients and in fact increased total health care costs. Psychiatric illnesses were underdiagnosed, and care ranged from patients receiving psychiatric medications without a psychiatric diagnosis to patients with a psychiatric diagnosis receiving no psychiatric treatment at all. Cost-containment strategies appeared to limit psychiatric referrals, frequency of psychiatric visits, and use of certain antidepressants (i.e., selective serotonin reuptake inhibitors). Further, the severity of the primary physical illness in the study population was associated with greater psychiatric illness. The fact that treatment was inconsistent and frequently inappropriate shows the need for better diagnostic and management protocols.
Topic(s):
Financing & Sustainability See topic collection
44
Management of depression for people with cancer (SMaRT oncology 1):
Type: Journal Article
Authors: V. Strong, R. Waters, C. Hibberd, G. Murray, L. Wall, J. Walker, G. McHugh, A. Walker, M. Sharpe
Year: 2008
Abstract: Abstract. BACKGROUND: Major depressive disorder severely impairs the quality of life of patients with medical disorders such as cancer, but evidence to guide its management is scarce. We aimed to assess the efficacy and cost of a nurse-delivered complex intervention that was designed to treat major depressive disorder in patients who have cancer. METHODS: We did a randomised trial in a regional cancer centre in Scotland, UK. 200 outpatients who had cancer with a prognosis of greater than 6 months and major depressive disorder (identified by screening) were eligible and agreed to take part. Their mean age was 56.6 (SD 11.9) years, and 141 (71%) were women. We randomly assigned 99 of these participants to usual care, and 101 to usual care plus the intervention, with minimisation for sex, age, diagnosis, and extent of disease. The intervention was delivered by a cancer nurse at the centre over an average of seven sessions. The primary outcome was the difference in mean score on the self-reported Symptom Checklist-20 depression scale (range 0 to 4) at 3 months after randomisation. Analysis was by intention to treat. This trial is registered as ISRCTN84767225. FINDINGS: Primary outcome data were missing for four patients. For 196 patients for whom we had data at 3 months, the adjusted difference in mean Symptom Checklist-20 depression score, between those who received the intervention and those who did not, was 0.34 (95% CI 0.13-0.55). This treatment effect was sustained at 6 and 12 months. The intervention also improved anxiety and fatigue but not pain or physical functioning. It cost an additional pound sterling 5278 (US$10 556) per quality-adjusted life-year gained. INTERPRETATION: The intervention-Depression Care for People with Cancer-offers a model for the management of major depressive disorder in patients with cancer and other medical disorders who are attending specialist medical services that is feasible, acceptable, and potentially cost effective.
Topic(s):
Financing & Sustainability See topic collection
45
Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation
Type: Journal Article
Authors: M. Connock, A. Juarez-Garcia, S. Jowett, E. Frew, Z. Liu, R. J. Taylor, A. Fry-Smith, E. Day, N. Lintzeris, T. Roberts, A. Burls, R. S. Taylor
Year: 2007
Publication Place: England
Abstract: OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of buprenorphine maintenance therapy (BMT) and methadone maintenance therapy (MMT) for the management of opioid-dependent individuals. DATA SOURCES: Major electronic databases were searched from inception to August 2005. Industry submissions to the National Institute for Health and Clinical Excellence were accessed. REVIEW METHODS: The assessment of clinical effectiveness was based on a review of existing reviews plus an updated search for randomised controlled trials (RCTs). A decision tree with Monte Carlo simulation model was developed to assess the cost-effectiveness of BMT and MMT. Retention in treatment and opiate abuse parameters were sourced from the meta-analysis of RCTs directly comparing flexible MMT with flexible dose BMT. Utilities were derived from a panel representing a societal perspective. RESULTS: Most of the included systematic reviews and RCTs were of moderate to good quality, and focused on short-term (up to 1-year follow-up) outcomes of retention in treatment and the level of opiate use (self-report or urinalysis). Most studies employed a trial design that compared a fixed-dose strategy (i.e. all individuals received a standard dose) of MMT or BMT and were conducted in predominantly young men who fulfilled criteria as opiate-dependent or heroin-dependent users, without significant co-morbidities. RCT meta-analyses have shown that a fixed dose of MMT or BMT has superior levels of retention in treatment and opiate use than placebo or no treatment, with higher fixed doses being more effective than lower fixed doses. There was evidence, primarily from non-randomised observational studies, that fixed-dose MMT reduces mortality, HIV risk behaviour and levels of crime compared with no therapy and one small RCT has shown the level of mortality with fixed-dose BMT to be significantly less than with placebo. Flexible dosing (i.e. individualised doses) of MMT and BMT is more reflective of real-world practice. Retention in treatment was superior for flexible MMT than flexible BMT dosing but there was no significant difference in opiate use. Indirect comparison of data from population cross-sectional studies suggests that mortality with BMT may be lower than that with MMT. A pooled RCT analysis showed no significant difference in serious adverse events with MMT compared with BMT. Although treatment modifier evidence was limited, adjunct psychosocial and contingency interventions (e.g. financial incentives for opiate-free urine samples) appeared to enhance the effects of both MMT and BMT. Also, MMT and BMT appear to be similarly effective whether delivered in a primary care or outpatient clinic setting. Although most of the included economic evaluations were considered to be of high quality, none used all of the appropriate parameters, effectiveness data, perspective and comparators required to make their results generalisable to the NHS context. One company (Schering-Plough) submitted cost-effectiveness evidence based on an economic model that had a 1-year time horizon and sourced data from a single RCT of flexible-dose MMT compared with flexible-dose BMT and utility values obtained from the literature; the results showed that for MMT vs no drug therapy, the incremental cost-effectiveness ratio (ICER) was pound 12,584/quality-adjusted life-year (QALY), for BMT versus no drug therapy, the ICER was pound 30,048/QALY and in a direct comparison, MMT was found to be slightly more effective and less costly than BMT. The assessment group model found for MMT versus no drug therapy that the ICER was pound 13,697/QALY, for BMT versus no drug therapy that the ICER was pound 26,429/QALY and, as with the industry model, in direct comparison, MMT was slightly more effective and less costly than BMT. When considering social costs, both MMT and BMT gave more health gain and were less costly than no drug treatment. These findings were robust to deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Both flexible-dose MMT and BMT are more clinically effective and more cost-effective than no drug therapy in dependent opiate users. In direct comparison, a flexible dosing strategy with MMT was found be somewhat more effective in maintaining individuals in treatment than flexible-dose BMT and therefore associated with a slightly higher health gain and lower costs. However, this needs to be balanced by the more recent experience of clinicians in the use of buprenorphine, the possible risk of higher mortality of MMT and individual opiate-dependent users' preferences. Future research should be directed towards the safety and effectiveness of MMT and BMT; potential safety concerns regarding methadone and buprenorphine, specifically mortality and key drug interactions; efficacy of substitution medications (in particular patient subgroups, such as within the criminal justice system, or within young people); and uncertainties in cost-effectiveness identified by current economic models.
Topic(s):
Opioids & Substance Use See topic collection
46
Methadone induction in primary care (ANRS-Methaville):A phase III randomized intervention trial
Type: Journal Article
Authors: P. Roux, L. Michel, J. Cohen, M. Mora, A. Morel, J. F. Aubertin, J. C. Desenclos, B. Spire, P. M. Carrieri, ANRS Methaville Study Group
Year: 2012
Abstract: Background: In France, the rapid scale-up of buprenorphine, an opioid maintenance treatment (OMT), in primary care for drug users has led to an impressive reduction in HIV prevalence among injecting drug users (IDU) but has had no major effect on Hepatitis C incidence. To date, patients willing to start methadone can only do so in a methadone clinic (a medical centre for drug and alcohol dependence (CSAPA) or a hospital setting) and are referred to primary care physicians after dose stabilization. This study aims to assess the effectiveness of methadone in patients who initiated treatment in primary care compared with those who initiated it in a CSAPA, by measuring abstinence from street opioid use after one year of treatment. Methods/Design: The ANRS-Methaville study is a randomized multicenter non-inferiority control trial comparing methadone induction (lasting approximately 2 weeks) in primary care and in CSAPA. The model of care chosen for methadone induction in primary care was based on study-specific pre-training of all physicians, exclusion criteria and daily supervision of methadone during the initiation phase. Between January 2009 and January 2011, 10 sites each having one CSAPA and several primary care physicians, were identified to recruit patients to be randomized into two groups, one starting methadone in primary care (n = 147), the other in CSAPA (n = 48). The primary outcome of the study is the proportion of participants abstinent from street opioids after 1 year of treatment i.e. non-inferiority of primary care model in terms of the proportion of patients not using street opioids compared with the proportion observed in those starting methadone in a CSAPA. Discussion: The ANRS-Methaville study is the first in France to use an interventional trial to improve access to OMT for drug users. Once the non-inferiority results become available, the Ministry of Health and agency for the safety of health products may change the the New Drug Application (NDA) of methadone and make methadone induction by trained primary care physicians possible.The trial is registered with the French Agency of Pharmaceutical Products (AFSSAPS) under the number 2008-A0277-48, the European Union Drug Regulating Authorities Clinical Trials.Number Eudract 2008-001338-28, the ClinicalTrials.gov Identifier: NCT00657397 and the International Standard Randomised Controlled Trial Number Register ISRCTN31125511.
Topic(s):
Opioids & Substance Use See topic collection
47
Multi-centre parallel arm randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based cognitive behavioural approach to managing fatigue in people with multiple sclerosis
Type: Journal Article
Authors: P. W. Thomas, S. Thomas, P. Kersten, R. Jones, A. Nock, V. Slingsby, C. Green, R. Baker, K. Galvin, C. Hillier
Year: 2010
Publication Place: England
Abstract: BACKGROUND: Fatigue is one of the most commonly reported and debilitating symptoms of multiple sclerosis (MS); approximately two-thirds of people with MS consider it to be one of their three most troubling symptoms. It may limit or prevent participation in everyday activities, work, leisure, and social pursuits, reduce psychological well-being and is one of the key precipitants of early retirement. Energy effectiveness approaches have been shown to be effective in reducing MS-fatigue, increasing self-efficacy and improving quality of life. Cognitive behavioural approaches have been found to be effective for managing fatigue in other conditions, such as chronic fatigue syndrome, and more recently, in MS. The aim of this pragmatic trial is to evaluate the clinical and cost-effectiveness of a recently developed group-based fatigue management intervention (that blends cognitive behavioural and energy effectiveness approaches) compared with current local practice. METHODS/DESIGN: This is a multi-centre parallel arm block-randomised controlled trial (RCT) of a six session group-based fatigue management intervention, delivered by health professionals, compared with current local practice. 180 consenting adults with a confirmed diagnosis of MS and significant fatigue levels, recruited via secondary/primary care or newsletters/websites, will be randomised to receive the fatigue management intervention or current local practice. An economic evaluation will be undertaken alongside the trial. Primary outcomes are fatigue severity, self-efficacy and disease-specific quality of life. Secondary outcomes include fatigue impact, general quality of life, mood, activity patterns, and cost-effectiveness. Outcomes in those receiving the fatigue management intervention will be measured 1 week prior to, and 1, 4, and 12 months after the intervention (and at equivalent times in those receiving current local practice). A qualitative component will examine what aspects of the fatigue management intervention participants found helpful/unhelpful and barriers to change. DISCUSSION: This trial is the fourth stage of a research programme that has followed the Medical Research Council guidance for developing and evaluating complex interventions. What makes the intervention unique is that it blends cognitive behavioural and energy effectiveness approaches. A potential strength of the intervention is that it could be integrated into existing service delivery models as it has been designed to be delivered by staff already working with people with MS. Service users will be involved throughout this research. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76517470.
Topic(s):
General Literature See topic collection
48
Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines
Type: Journal Article
Authors: A. M. Trescot, S. Helm, H. Hansen, R. Benyamin, S. E. Glaser, R. Adlaka, S. Patel, L. Manchikanti
Year: 2008
Publication Place: United States
Abstract: BACKGROUND: Opioid abuse has continued to increase at an alarming rate since our last opioid guidelines were published in 2005. Available evidence suggests a continued wide variance in the use of opioids, as documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration. OBJECTIVES: The objectives of opioid guidelines by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to bring consistency in opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. DESIGN: A broadly based policy committee of recognized experts in the field evaluated the available literature regarding opioid use in managing chronic non-cancer pain. This resulted in the formulation of the review and update of the guidelines published in 2006, a series of potential evidence linkages representing conclusions, followed by statements regarding the relationships between clinical interventions and outcomes. METHODS: The elements of the guideline preparation process included literature searches, literature synthesis, consensus evaluation, open forum presentations, formal endorsement by the Board of Directors of the American Society of Interventional Pain Physicians, and peer review. Based on the criteria of the U.S. Preventive Services Task Force, the quality of evidence was designated as Level I, II, and III, with 3 subcategories in Level II, with Level I described as strong and Level III as indeterminate. The recommendations were provided from 1A to 2C, varying from strong recommendation with high quality evidence to weak recommendation with low-quality or very low-quality evidence. RESULTS: After an extensive review and analysis of the literature, which included systematic reviews and all of the available literature, the evidence for the effectiveness of long-term opioids in reducing pain and improving functional status for 6 months or longer is variable. The evidence for transdermal fentanyl and sustained-release morphine is Level II-2, whereas for oxycodone the level of evidence is II-3, and the evidence for hydrocodone and methadone is Level III. There is also significant evidence of misuse and abuse of opioids. The recommendation is 2A - weak recommendation, high-quality evidence: with benefits closely balanced with risks and burdens; with evidence derived from RCTs without important limitations or overwhelming evidence from observational studies, with the implication that with a weak recommendation, best action may differ depending on circumstances or patients' or societal values. CONCLUSION: Opioids are commonly prescribed for chronic non-cancer pain and may be effective for short-term pain relief. However, long-term effectiveness of 6 months or longer is variable with evidence ranging from moderate for transdermal fentanyl and sustained-release morphine with a Level II-2, to limited for oxycodone with a Level II-3, and indeterminate for hydrocodone and methadone with a Level III. These guidelines included the evaluation of the evidence for the use of opioids in the management of chronic non-cancer pain and the recommendations for that management. These guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Because of the changing body of evidence, this document is not intended to be a "standard of care."
Topic(s):
Opioids & Substance Use See topic collection
,
Education & Workforce See topic collection
49
Optimising the benefits of unobserved dose administration for stable opioid maintenance patients: follow-up of a randomised trial
Type: Journal Article
Authors: J. R. Bell, A. Ryan, C. Mutch, R. Batey, F. Rea
Year: 2008
Publication Place: Ireland
Abstract: BACKGROUND: The registration of combination buprenorphine/naloxone, a formulation designed to reduce risk of diversion, has led some Australian jurisdictional authorities to allow treatment without direct observation of dosing for stable, opioid-dependent patients. AIM: To compare two approaches (1) initiating treatment with observed dosing, then allowing patients who demonstrate stability to change to unobserved dosing; or (2) initiating patients with unobserved dosing, subsequently requiring those who fail to stabilize to change to observed treatment. METHODS: This study builds on an RCT comparing efficacy of observed and unobserved treatment at 3 months. At the conclusion of the RCT, clinically "stable" subjects were allocated to continue without observed dosing, while those who did not demonstrate stability were allocated to observed dosing. Subjects were followed for a further 3 months. Primary end-point was retention in treatment. RESULTS: Of 119 subjects randomised, 70 were retained in treatment to 3 months. Forty-five stable subjects were allocated to unobserved dosing, 25 to observation. Unstable subjects allocated to observed treatment were more likely to drop out thereafter (OR 2.14, 95% CI 1.09-4.19). There was a non-significant trend for people initiated with observed dosing to be better retained during the allocation phase; at 6 months, 13 subjects (22%) from the original unobserved group, and 22 (34%) from the observed group, were retained in treatment (chi2=2.10, 1 df, p=0.15). CONCLUSIONS: Withdrawal of unobserved doses led to marked attrition from treatment. If access to unobserved dosing is to be restricted to stable patients, it appears preferable to initiate dosing with observation and allow unobserved doses for people who successfully stabilize, than to initiate with unobserved doses and transfer unstable patients to observation.
Topic(s):
Opioids & Substance Use See topic collection
50
Outcomes of a primary care mental health implementation program in rural Rwanda: A quasi-experimental implementation-effectiveness study
Type: Journal Article
Authors: S. L. Smith, M. F. Franke, C. Rusangwa, H. Mukasakindi, B. Nyirandagijimana, R. Bienvenu, E. Uwimana, C. Uwamaliya, J. S. Ndikubwimana, S. Dorcas, T. Mpunga, C. N. Misago, J. D. Iyamuremye, J. D. Dusabeyezu, A. A. Mohand, S. Atwood, R. A. Osrow, R. Aldis, S. Daimyo, A. Rose, S. Coleman, A. Manzi, Y. Kayiteshonga, G. J. Raviola
Year: 2020
Publication Place: United States
Abstract: INTRODUCTION: To address the know-do gap in the integration of mental health care into primary care in resource-limited settings, a multi-faceted implementation program initially designed to integrate HIV/AIDS care into primary care was adapted for severe mental disorders and epilepsy in Burera District, Rwanda. The Mentoring and Enhanced Supervision at Health Centers (MESH MH) program supported primary care-delivered mental health service delivery scale-up from 6 to 19 government-run health centers over two years. This quasi-experimental study assessed implementation reach, fidelity, and clinical outcomes at health centers supported by MESH MH during the scale up period. METHODS: MESH MH consisted of four strategies to ensure the delivery of the priority care packages at health centers: training; supervision and mentorship; audit and feedback; and systems-based quality improvement (QI). Implementation reach (service use) across the 19 health centers supported by MESH MH during the two year scale-up period was described using routine service data. Implementation fidelity was measured at four select health centers by comparing total clinical supervisory visits and checklists to target goals, and by tracking clinical observation checklist item completion rates over a nine month period. A prospective before and after evaluation measured clinical outcomes in consecutive adults presenting to four select health centers over a nine month period. Primary outcome assessments at baseline, 2 and 6 months included symptoms and functioning, measured by the General Health Questionnaire (GHQ-12) and the World Health Organization Disability Assessment Scale (WHO-DAS Brief), respectively. Secondary outcome assessments included engagement in income generating work and caregiver burden using a quantitative scale adapted to context. RESULTS: A total of 2239 mental health service users completed 15,744 visits during the scale up period. MESH MH facilitated 70% and 76% of supervisory visit and clinical checklist utilization target goals, respectively. Checklist item completion rates significantly improved overall, and for three of five checklist item subgroups examined. 121 of 146 consecutive service users completed outcome measurements six months after entry into care. Scores improved significantly over six months on both the GHQ-12, with median score improving from 26 to 10 (mean within-person change 12.5 [95% CI: 10.9-14.0] p< 0.0001), and the WHO-DAS Brief, with median score improving from 26.5 to 7 (mean within-person change 16.9 [95% CI: 14.9-18.8] p< 0.0001). Over the same period, the percentage of surveyed service users reporting an inability to work decreased significantly (51% to 6% (p < 0.001)), and the proportion of households reporting that a caregiver had left income-generating work decreased significantly (41% to 4% (p < 0.001)). CONCLUSION: MESH MH was associated with high service use, improvements in mental health care delivery by primary care nurses, and significant improvements in clinical symptoms and functional disability of service users receiving care at health centers supported by the program. Multifaceted implementation programs such as MESH MH can reduce the evidence to practice gap for mental health care delivery by nonspecialists in resource-limited settings. The primary limitation of this study is the lack of a control condition, consistent with the implementation science approach of the study. STUDY REGISTRATION: ISRCTN #37231.
Topic(s):
Financing & Sustainability See topic collection
,
Healthcare Disparities See topic collection
51
Outcomes of a primary care mental health implementation program in rural Rwanda: A quasi-experimental implementation-effectiveness study
Type: Journal Article
Authors: S. L. Smith, M. F. Franke, C. Rusangwa, H. Mukasakindi, B. Nyirandagijimana, R. Bienvenu, E. Uwimana, C. Uwamaliya, J. S. Ndikubwimana, S. Dorcas, T. Mpunga, C. N. Misago, J. D. Iyamuremye, J. D. Dusabeyezu, A. A. Mohand, S. Atwood, R. A. Osrow, R. Aldis, S. Daimyo, A. Rose, S. Coleman, A. Manzi, Y. Kayiteshonga, G. J. Raviola
Year: 2020
Publication Place: United States
Abstract: INTRODUCTION: To address the know-do gap in the integration of mental health care into primary care in resource-limited settings, a multi-faceted implementation program initially designed to integrate HIV/AIDS care into primary care was adapted for severe mental disorders and epilepsy in Burera District, Rwanda. The Mentoring and Enhanced Supervision at Health Centers (MESH MH) program supported primary care-delivered mental health service delivery scale-up from 6 to 19 government-run health centers over two years. This quasi-experimental study assessed implementation reach, fidelity, and clinical outcomes at health centers supported by MESH MH during the scale up period. METHODS: MESH MH consisted of four strategies to ensure the delivery of the priority care packages at health centers: training; supervision and mentorship; audit and feedback; and systems-based quality improvement (QI). Implementation reach (service use) across the 19 health centers supported by MESH MH during the two year scale-up period was described using routine service data. Implementation fidelity was measured at four select health centers by comparing total clinical supervisory visits and checklists to target goals, and by tracking clinical observation checklist item completion rates over a nine month period. A prospective before and after evaluation measured clinical outcomes in consecutive adults presenting to four select health centers over a nine month period. Primary outcome assessments at baseline, 2 and 6 months included symptoms and functioning, measured by the General Health Questionnaire (GHQ-12) and the World Health Organization Disability Assessment Scale (WHO-DAS Brief), respectively. Secondary outcome assessments included engagement in income generating work and caregiver burden using a quantitative scale adapted to context. RESULTS: A total of 2239 mental health service users completed 15,744 visits during the scale up period. MESH MH facilitated 70% and 76% of supervisory visit and clinical checklist utilization target goals, respectively. Checklist item completion rates significantly improved overall, and for three of five checklist item subgroups examined. 121 of 146 consecutive service users completed outcome measurements six months after entry into care. Scores improved significantly over six months on both the GHQ-12, with median score improving from 26 to 10 (mean within-person change 12.5 [95% CI: 10.9-14.0] p< 0.0001), and the WHO-DAS Brief, with median score improving from 26.5 to 7 (mean within-person change 16.9 [95% CI: 14.9-18.8] p< 0.0001). Over the same period, the percentage of surveyed service users reporting an inability to work decreased significantly (51% to 6% (p < 0.001)), and the proportion of households reporting that a caregiver had left income-generating work decreased significantly (41% to 4% (p < 0.001)). CONCLUSION: MESH MH was associated with high service use, improvements in mental health care delivery by primary care nurses, and significant improvements in clinical symptoms and functional disability of service users receiving care at health centers supported by the program. Multifaceted implementation programs such as MESH MH can reduce the evidence to practice gap for mental health care delivery by nonspecialists in resource-limited settings. The primary limitation of this study is the lack of a control condition, consistent with the implementation science approach of the study. STUDY REGISTRATION: ISRCTN #37231.
Topic(s):
Financing & Sustainability See topic collection
,
Healthcare Disparities See topic collection
52
Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP feasibility randomised trial
Type: Journal Article
Authors: T. Kendrick, B. Stuart, G. M. Leydon, A. W. Geraghty, L. Yao, R. Ryves, S. Williams, S. Zhu, C. Dowrick, G. Lewis, M. Moore
Year: 2017
Publication Place: England
Abstract: OBJECTIVES: To determine the feasibility of a trial of patient-reported outcome measures (PROMs) for monitoring primary care patients with depression. DESIGN: Partly individually randomised, partly cluster-randomised controlled trial. SETTING: Nine general practices in Southern England. PARTICIPANTS: 47 adults with new episodes of depression: 22 intervention, 25 control. RANDOMISATION: Remote computerised sequence generation and allocation. INTERVENTIONS: Patient Health Questionnaire, Distress Thermometer Analogue Scale and PSYCHLOPS problem profile for monitoring depression, following diagnosis and at 10-35 days later. Feedback of scores to patients was determined by practitioners. BLINDING: Non-blinded, using self-completed measures. PRIMARY OUTCOME: Beck Depression Inventory (BDI-II). SECONDARY OUTCOME MEASURES: Work and Social Adjustment Scale (WSAS), EuroQol Five-item, Five-level (EQ-5D-5L) Scale for quality of life, modified Client Service Receipt Inventory for costs, Medical Informant Satisfaction Scale (MISS), qualitative interviews with 14 patients and 13 practice staff about feasibility and acceptability of trial design. RESULTS: Three practices failed to recruit the target of six patients in 12 months. Follow-up rates were intervention patients: 18 (82%) at 12 weeks and 15 (68%) at 26 weeks; controls: 18 (72%) and 15 (60%), respectively. At 12 weeks, mean BDI-II score was lower among intervention group patients than controls by 5.8 points (95% CI -11.1 to -0.5), adjusted for baseline differences and clustering. WSAS scores were not significantly different. At 26 weeks, there were no significant differences in symptoms, social functioning, quality of life or costs, but mean satisfaction score was higher among controls by 22.0 points (95% CI -40.7 to -3.29). Intervention patients liked completing PROMs, but were disappointed when practitioners did not use the results to inform management. CONCLUSIONS: PROMs may improve depression outcome in the short term, even if PROM scores do not inform practitioners' management. Challenges in recruiting and following up patients need addressing for a definitive trial of relatively brief measures which can potentially inform management. https://www.isrctn.com/search?q=97492541 TRIAL REGISTRATION NUMBER: ISRCTN 97492541; Pre-results.
Topic(s):
General Literature See topic collection
53
Perspectives and concerns of clients at primary health care facilities involved in evaluation of a national mental health training programme for primary care in Kenya
Type: Journal Article
Authors: C. Othieno, R. Jenkins, S. Okeyo, J. Aruwa, J. Wallcraft, B. Jenkins
Year: 2013
Publication Place: England
Abstract: BACKGROUND: A cluster randomised controlled trial (RCT) of a national Kenyan mental health primary care training programme demonstrated a significant impact on the health, disability and quality of life of clients, despite a severe shortage of medicines in the clinics (Jenkins et al. Submitted 2012). As focus group methodology has been found to be a useful method of obtaining a detailed understanding of client and health worker perspectives within health systems (Sharfritz and Roberts. Health Transit Rev 4:81-85, 1994), the experiences of the participating clients were explored through qualitative focus group discussions in order to better understand the potential reasons for the improved outcomes in the intervention group. METHODS: Two ninety minute focus groups were conducted in Nyanza province, a poor agricultural region of Kenya, with 10 clients from the intervention group clinics where staff had received the training programme, and 10 clients from the control group where staff had not received the training during the earlier randomised controlled trial. RESULTS: These focus group discussions suggest that the clients in the intervention group noticed and appreciated enhanced communication, diagnostic and counselling skills in their respective health workers, whereas clients in the control group were aware of the lack of these skills. Confidentiality emerged from the discussions as a significant client concern in relation to the volunteer cadre of community health workers, whose only training comes from their respective primary care health workers. CONCLUSION: Enhanced health worker skills conferred by the mental health training programme may be responsible for the significant improvement in outcomes for clients in the intervention clinics found in the randomised controlled trial, despite the general shortage of medicines and other health system weaknesses. These findings suggest that strengthening mental health training for primary care staff is worthwhile even where health systems are not strong and where the medicine supply cannot be guaranteed. TRIAL REGISTRATION: ISRCTN 53515024.
Topic(s):
Education & Workforce See topic collection
54
Pharmacokinetic Evaluation of Once-Weekly and Once-Monthly Buprenorphine Subcutaneous Injection Depots (CAM2038) Versus Intravenous and Sublingual Buprenorphine in Healthy Volunteers Under Naltrexone Blockade: An Open-Label Phase 1 Study
Type: Journal Article
Authors: M. Albayaty, M. Linden, H. Olsson, M. Johnsson, K. Strandgarden, F. Tiberg
Year: 2017
Publication Place: United States
Abstract: INTRODUCTION: CAM2038 q1w (once weekly) and q4w (once monthly) are investigational buprenorphine subcutaneous (SC) formulations based on FluidCrystal((R)) injection depot technology. These two drug products are being developed for opioid dependence treatment, with a target for once-weekly and once-monthly SC dosing. The rationale for developing two products with different dosing frequencies is that treatment strategies/routines, and hence different treatment preferences, can vary between patients, different stages of opioid maintenance treatment, and countries. This study evaluated the pharmacokinetics and safety of buprenorphine and norbuprenorphine following administration of CAM2038 q1w or q4w versus active controls. METHODS: Healthy volunteers were randomized to five treatment groups. All received a single intravenous dose of buprenorphine 600 microg, followed post-washout by a single dose of CAM2038 q4w 96 mg, a single dose of CAM2038 q4w 192 mg, or sublingual buprenorphine 8, 16, or 24 mg daily for 7 days, followed post-washout by a single dose of CAM2038 q4w 64 or 128 mg or four repeated weekly doses of CAM2038 q1w 16 mg. All subjects received daily naltrexone. RESULTS: Eighty-seven subjects were randomized. Median buprenorphine t max after CAM2038 q4w was 4-10 h (24 h for CAM2038 q1w); mean terminal half-life was 19-25 days (5 days for CAM2038 q1w). CAM2038 q4w showed dose-proportional buprenorphine release, with similar exposure to repeat-dose CAM2038 q1w at comparable monthly dose level. Both CAM2038 formulations showed complete absolute bioavailability of buprenorphine and 5.7- to 7.7-fold greater buprenorphine bioavailability versus sublingual buprenorphine. CAM2038 q1w and q4w were well tolerated; subjects' acceptance was higher for CAM2038 than for sublingual buprenorphine 1 h post-dose. CONCLUSIONS: The pharmacokinetic profiles of CAM2038 q1w and q4w versus sublingual buprenorphine support expected treatment efficacy with once-weekly and once-monthly dosing, respectively. CAM2038 formulations were safe and showed good local tolerability. TRIAL REGISTRATION: ISRCTN24987553. FUNDING: Camurus AB.
Topic(s):
Opioids & Substance Use See topic collection
55
Pharmacotherapy for Cocaine Use Disorder-a Systematic Review and Meta-analysis
Type: Journal Article
Authors: B. Chan, K. Kondo, M. Freeman, C. Ayers, J. Montgomery, D. Kansagara
Year: 2019
Abstract:

BACKGROUND: Currently, there are no accepted FDA-approved pharmacotherapies for cocaine use disorder, though numerous medications have been tested in clinical trials. We conducted a systematic review and meta-analysis to better understand the effectiveness of pharmacotherapy for cocaine use disorder. METHODS: We searched multiple data sources (MEDLINE, PsycINFO, and Cochrane Library) through November 2017 for systematic reviews and randomized controlled trials (RCTs) of pharmacological interventions in adults with cocaine use disorder. When possible, we combined the findings of trials with comparable interventions and outcome measures in random-effects meta-analyses. We assessed the risk of bias of individual trials and the strength of evidence for each outcome using standardized criteria. Outcomes included continuous abstinence (3+ consecutive weeks); cocaine use; harms; and study retention. For relapse prevention studies (participants abstinent at baseline), we examined lapse (first cocaine positive or missing UDS) and relapse (two consecutive cocaine positive or missed UDS'). RESULTS: Sixty-six different drugs or drug combinations were studied in seven systematic reviews and 48 RCTs that met inclusion criteria. Antidepressants were the most widely studied drug class (38 RCTs) but appear to have no effect on cocaine use or treatment retention. Increased abstinence was found with bupropion (2 RCTs: RR 1.63, 95% CI 1.02 to 2.59), topiramate (2 RCTs: RR 2.56, 95% CI 1.39 to 4.73), and psychostimulants (14 RCTs: RR 1.36, 95% CI 1.05 to 1.77), though the strength of evidence for these findings was low. We found moderate strength of evidence that antipsychotics improved treatment retention (8 RCTs: RR 1.33, 95% CI 1.03 to 1.75). DISCUSSION: Most of the pharmacotherapies studied were not effective for treating cocaine use disorder. Bupropion, psychostimulants, and topiramate may improve abstinence, and antipsychotics may improve retention. Contingency management and behavioral interventions along with pharmacotherapy should continue to be explored. SR REGISTRATION: Prospero CRD42018085667.

Topic(s):
Opioids & Substance Use See topic collection
56
Prevalence of comorbid anxiety disorders in primary care outpatients
Type: Journal Article
Authors: C. D. Sherbourne, C. A. Jackson, L. S. Meredith, P. Camp, K. B. Wells
Year: 1996
Abstract: Abstract. OBJECTIVE: To estimate the extent to which anxiety disorders (eg, panic disorder, phobia, and generalized anxiety disorder [GAD]) co-occur in patients with major medical and psychiatric conditions. DESIGN: Observational study. SETTING: Offices of primary care providers in three US cities, with mental health specialty providers included for comparative purposes. PATIENTS: Adult patients (N = 2494) with hypertension, diabetes, heart disease (congestive heart failure or myocardial infarction), current depressive disorder, or subthreshold depression. MEASURES: Current (past 12 months) and lifetime panic disorder, phobia, GAD, perceived need for help for emotional or family problems, and unmet need (ie, failure to get help that was needed). METHODS: Comparisons of the prevalence of anxiety comorbidity in medically ill nondepressed patients of primary care providers and in depressed patients of both primary care and mental health specialty providers. RESULTS: Among primary care patients, those with chronic medical illnesses or subthreshold depression had low rates of lifetime (1.5% to 3.5%) and current (1.0% to 1.7%) panic disorder, but those with current depressive disorder had much higher rates (10.9% lifetime and 9.4% current panic disorder). Concurrent phobia and GAD were more common (10.4% to 12.4% current GAD), especially among depressed patients (25% to 54% current GAD). Depending on the type of medical illness or depression, 14% to 66% of primary care patients had at least one concurrent anxiety disorder. Patient-perceived unmet need for care for personal or emotional problems was high among all primary care patients (54.6% to 72.9%).CONCLUSION: Primary care clinicians should be aware of the possible coexistence of anxiety disorders (especially GAD) among their patients with chronic medical conditions, but especially among those with current depressive disorder.
Topic(s):
General Literature See topic collection
57
Primary care physicians treat somatization
Type: Journal Article
Authors: R. C. Smith, J. C. Gardiner, Z. Luo, S. Schooley, L. Lamerato, K. Rost
Year: 2009
Publication Place: United States
Abstract: BACKGROUND: We hypothesized that somatizing patients managed by primary care physicians (PCP) would improve with a relationship-based intervention. METHODS: We randomized 30 adults with medically unexplained symptoms to treatment or usual care. Four PCPs were trained to intervene with cognitive-behavioral, pharmacological, and patient-centered management and deployed the intervention with seven scheduled visits over 12 months. Outcomes obtained at baseline and 12 months were: Mental component summary (MCS), the primary endpoint, and measures of physical and psychological symptoms and of satisfaction with the PCP. RESULTS: Patients averaged 52.5 years; 83.3% were female; 79.6% were black. Using a difference of differences approach, we found that the intervention produced a large effect size (ES) (0.82; CI: 0.08 to 1.57) for the MCS in the predicted direction, similar to the ES for physical (-0.80; CI: -1.55 to -0.04) and psychological (-1.06; CI: -1.83 to -0.28) improvement and for increased satisfaction with the PCP (0.94; CI: 0.15 to 1.74). Using ANCOVA in a sensitivity analysis, we found that the ES fell slightly (0.59), while other measures were unchanged. CONCLUSIONS: Moderate-large effect sizes support the hypothesis that PCPs can effectively treat somatization. This points to the importance of performing a full RCT.
Topic(s):
Medically Unexplained Symptoms See topic collection
58
Problem-solving therapy for depression and common mental disorders in Zimbabwe: piloting a task-shifting primary mental health care intervention in a population with a high prevalence of people living with HIV
Type: Journal Article
Authors: D. Chibanda, P. Mesu, L. Kajawu, F. Cowan, R. Araya, M. A. Abas
Year: 2011
Publication Place: England
Abstract: BACKGROUND: There is limited evidence that interventions for depression and other common mental disorders (CMD) can be integrated sustainably into primary health care in Africa. We aimed to pilot a low-cost multi-component 'Friendship Bench Intervention' for CMD, locally adapted from problem-solving therapy and delivered by trained and supervised female lay workers to learn if was feasible and possibly effective as well as how best to implement it on a larger scale. METHOD: We trained lay workers for 8 days in screening and monitoring CMD and in delivering the intervention. Ten lay workers screened consecutive adult attenders who either were referred or self-referred to the Friendship Bench between July and December 2007. Those scoring above the validated cut-point of the Shona Symptom Questionnaire (SSQ) for CMD were potentially eligible. Exclusions were suicide risk or very severe depression. All others were offered 6 sessions of problem-solving therapy (PST) enhanced with a component of activity scheduling. Weekly nurse-led group supervision and monthly supervision from a mental health specialist were provided. Data on SSQ scores at 6 weeks after entering the study were collected by an independent research nurse. Lay workers completed a brief evaluation on their experiences of delivering the intervention. RESULTS: Of 395 potentially eligible, 33 (8%) were excluded due to high risk. Of the 362 left, 2% (7) declined and 10% (35) were lost to follow-up leaving an 88% response rate (n = 320). Over half (n = 166, 52%) had presented with an HIV-related problem. Mean SSQ score fell from 11.3 (sd 1.4) before treatment to 6.5 (sd 2.4) after 3-6 sessions. The drop in SSQ scores was proportional to the number of sessions attended. Nine of the ten lay workers rated themselves as very able to deliver the PST intervention. CONCLUSION: We have found preliminary evidence of a clinically meaningful improvement in CMD associated with locally adapted problem-solving therapy delivered by lay health workers through routine primary health care in an African setting. There is a need to test the effectiveness of this task-shifting mental health intervention in an appropriately powered randomised controlled trial. TRIAL REGISTRATION: ISRCTN: ISRCTN25476759.
Topic(s):
Healthcare Disparities See topic collection
59
Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression
Type: Journal Article
Authors: I. Svenningsson, E. L. Petersson, C. Udo, J. Westman, C. Bjorkelund, L. Wallin
Year: 2019
Publication Place: England
Abstract: BACKGROUND: The collaborative care model with a care manager has previously generated beneficial results for patients with depression in terms of decreased burden of depression symptoms. A care manager function has been tested in Sweden in the PRIM-CARE RCT with successful results. The aim of the present study was to evaluate the process of implementing care managers in collaborative care for patients with depression in Swedish primary health care in the PRIM-CARE RCT. METHODS: The study followed UK Medical Research Council guidance for process evaluation. Field notes from the implementation of the PRIM - CARE RCT were used, as well as data collected from five focus group discussions with General Practitioners (n = 29) and three focus group discussions with care managers (n = 11). Data were analysed with content analysis. RESULTS: Training sessions, careful preparation and extensive initial support to the care manager and staff at the Primary Care Centres were important ingredients in the implementation. The close access to facilitators, the recurrent peer support meetings, and the weekly newsletter strengthened the care manager function. CONCLUSIONS: A complex intervention adapted to the Swedish primary care context focusing on a care manager function for patients with depression could be performed through a stepwise implementation process. Financial support from the health care regions included in the study helped to reduce the impact of identified barriers. This process evaluation has revealed new and important knowledge for primary care development concerning infrastructure and organization building, knowledge sharing, and facilitating factors and barriers. TRIAL REGISTRATION: NCT02378272 Care Manager - Coordinating Care for Person Centered Management of Depression in Primary Care (PRIM - CARE). Registered March 4 2015. Retrospectively registered.
Topic(s):
General Literature See topic collection
60
Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression
Type: Journal Article
Authors: I. Svenningsson, E. L. Petersson, C. Udo, J. Westman, C. Bjorkelund, L. Wallin
Year: 2019
Publication Place: England
Abstract: BACKGROUND: The collaborative care model with a care manager has previously generated beneficial results for patients with depression in terms of decreased burden of depression symptoms. A care manager function has been tested in Sweden in the PRIM-CARE RCT with successful results. The aim of the present study was to evaluate the process of implementing care managers in collaborative care for patients with depression in Swedish primary health care in the PRIM-CARE RCT. METHODS: The study followed UK Medical Research Council guidance for process evaluation. Field notes from the implementation of the PRIM - CARE RCT were used, as well as data collected from five focus group discussions with General Practitioners (n = 29) and three focus group discussions with care managers (n = 11). Data were analysed with content analysis. RESULTS: Training sessions, careful preparation and extensive initial support to the care manager and staff at the Primary Care Centres were important ingredients in the implementation. The close access to facilitators, the recurrent peer support meetings, and the weekly newsletter strengthened the care manager function. CONCLUSIONS: A complex intervention adapted to the Swedish primary care context focusing on a care manager function for patients with depression could be performed through a stepwise implementation process. Financial support from the health care regions included in the study helped to reduce the impact of identified barriers. This process evaluation has revealed new and important knowledge for primary care development concerning infrastructure and organization building, knowledge sharing, and facilitating factors and barriers. TRIAL REGISTRATION: NCT02378272 Care Manager - Coordinating Care for Person Centered Management of Depression in Primary Care (PRIM - CARE). Registered March 4 2015. Retrospectively registered.
Topic(s):
General Literature See topic collection