A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial.

Abstract:

BACKGROUND:Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance. METHODS:Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study. DISCUSSION:This study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03891368 Registered 25 March 2019, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1.

journal_name

Contemp Clin Trials

authors

Aschbrenner KA,Pratt SI,Bond GR,Zubkoff L,Naslund JA,Jue K,Williams G,Kinney A,Cohen MJ,Godfrey MM,Bartels SJ

doi

10.1016/j.cct.2019.105816

subject

Has Abstract

pub_date

2019-09-01 00:00:00

pages

105816

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(19)30247-2

journal_volume

84

pub_type

杂志文章,多中心研究,随机对照试验
  • ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol.

    abstract::Major depressive disorder (MDD) is the most common mental illness and the leading cause of disability worldwide. Electroconvulsive therapy (ECT) is the most effective treatment for MDD and the gold-standard therapy for treatment-resistant depression (TRD), yet it remains underutilized due to factors such as limited av...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2018.12.009

    authors: Mathew SJ,Wilkinson ST,Altinay M,Asghar-Ali A,Chang LC,Collins KA,Dale RM,Hu B,Krishnan K,Kellner CH,Malone DA,Murrough JW,Ostroff RB,Sanacora G,Shao M,Anand A

    更新日期:2019-02-01 00:00:00

  • A decade of trials of interferon-alpha for chronic hepatitis C. A meta-regression analysis.

    abstract::The most relevant randomized controlled trials of interferon-alpha (IFN) for naive patients with chronic hepatitis C (CHC) published in a decade, just before appearance of pegylated IFN trials in 2000, were included in this paper. Its purpose is to review the relationship between sustained biochemical response in acti...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,meta分析

    doi:10.1016/j.cct.2004.12.009

    authors: Tinè F,Attanasio M,Russo F,Pagliaro L

    更新日期:2005-04-01 00:00:00

  • Community-based intervention effects on older adults' physical activity and falls: Protocol and rationale for a randomized optimization trial (Ready Steady3.0).

    abstract::The Ready Steady 3.0 trial is designed to test the main and interactive effects of two behavior change intervention components, within an 8-week physical activity intervention, on older adults' physical activity (PA). Each component is comprised of behavior change strategies that emphasize two different evidence-based...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106238

    authors: McMahon SK,Lewis BA,Guan W,Wyman JF,Rothman AJ

    更新日期:2020-12-05 00:00:00

  • Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation.

    abstract:OBJECTIVE:Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker st...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2018.03.002

    authors: Barnhart K,Giudice L,Young S,Thomas T,Diamond MP,Segars J,Youssef WA,Krawetz S,Santoro N,Eisenberg E,Zhang H,NICHD Cooperative Reproductive Medicine Network.

    更新日期:2018-05-01 00:00:00

  • The HealthyTexts study: a randomized controlled trial to improve skin cancer prevention behaviors among young people.

    abstract::Several randomized trials have found behavior change programs delivered via text messaging to be efficacious to improve preventive health behaviors such as physical activity and stopping smoking; however few have assessed its value in skin cancer prevention or early detection. The HealthyTexts study enrolled 678 parti...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.03.009

    authors: Janda M,Youl P,Marshall AL,Soyer HP,Baade P

    更新日期:2013-05-01 00:00:00

  • The SHED-IT weight loss maintenance trial protocol: A randomised controlled trial of a weight loss maintenance program for overweight and obese men.

    abstract:UNLABELLED:Despite short-term efficacy, many weight loss studies demonstrate poor long-term results and have difficulty recruiting men. Cost-effective treatments that help men achieve long-term weight loss are required. Using a two-phase, assessor-blinded, parallel-group randomised controlled trial design this study wi...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.11.004

    authors: Young MD,Collins CE,Callister R,Plotnikoff RC,Doran CM,Morgan PJ

    更新日期:2014-01-01 00:00:00

  • Effects of exercise training programs on physical performance and quality of life in patients with metastatic lung cancer undergoing palliative chemotherapy--a study protocol.

    abstract:PURPOSE:The aims of the study protocol are to investigate different adapted physical training programs in patients with advanced lung cancer undergoing palliative chemo- or radiotherapy and to evaluate their effects on physical performance, quality of life, symptom burden, and efficacy of oncologic treatment. METHODS:...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.11.013

    authors: Jensen W,Oechsle K,Baumann HJ,Mehnert A,Klose H,Bloch W,Bokemeyer C,Baumann FT

    更新日期:2014-01-01 00:00:00

  • Evaluation of the ability of clinical research participants to comprehend informed consent form.

    abstract:BACKGROUND:The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials. METHODS:Patients who were invited to particip...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cct.2009.03.005

    authors: Bhansali S,Shafiq N,Malhotra S,Pandhi P,Singh I,Venkateshan SP,Siddhu S,Sharma YP,Talwar KK

    更新日期:2009-09-01 00:00:00

  • Group physical therapy for veterans with knee osteoarthritis: study design and methodology.

    abstract::Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this con...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.12.007

    authors: Allen KD,Bongiorni D,Walker TA,Bartle J,Bosworth HB,Coffman CJ,Datta SK,Edelman D,Hall KS,Hansen G,Jennings C,Lindquist JH,Oddone EZ,Senick MJ,Sizemore JC,St John J,Hoenig H

    更新日期:2013-03-01 00:00:00

  • Vulnerable blood in high risk vascular patients: study design and methods.

    abstract:BACKGROUND:Basic research suggests that rapid increases in circulating inflammatory and hemostatic blood markers may trigger or indicate impending plaque rupture and coronary thrombosis, resulting in acute ischemic heart disease (IHD) events. However, these associations are not established in humans. METHODS AND RESUL...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2014.03.009

    authors: McDermott MM,Greenland P,Liu K,Tian L,Green D,Shah SJ,Huffman M,Wilkins J,Kibbe M,Liao Y,Huang CC,Skelly C,Jacobs C,McCarthy W,Auerbach A,Lloyd-Jones D

    更新日期:2014-05-01 00:00:00

  • Rationale and design of Mi-CARE: The mile square colorectal cancer screening, awareness and referral and education project.

    abstract::Although colorectal cancer (CRC) is largely preventable through identification of pre-cancerous polyps through various screening modalities, morbidity and mortality rates remain a challenge, especially in African-American, Latino, low-income and uninsured/underinsured patients. Barriers to screening include cost, acce...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2016.11.009

    authors: Buscemi J,Miguel YS,Tussing-Humphreys L,Watts EA,Fitzgibbon ML,Watson K,Winn RA,Matthews KL,Molina Y

    更新日期:2017-01-01 00:00:00

  • Comparative study on the pregnancy outcomes of in vitro fertilization-embryo transfer between long-acting gonadotropin-releasing hormone agonist combined with transvaginal ultrasound-guided cyst aspiration and long-acting gonadotropin-releasing hormone ag

    abstract:OBJECTIVE:To retrospectively analyze the effects of long-acting gonadotropin-releasing hormone agonist (GnRH-a) combined with transvaginal ultrasound-guided cyst aspiration on the pregnancy outcomes of in vitro fertilization-embryo transfer (IVF-ET) in the infertile patients with ovarian endometriosis. METHODS:The 134...

    journal_title:Contemporary clinical trials

    pub_type: 临床试验,杂志文章

    doi:10.1016/j.cct.2012.07.009

    authors: Guo YH,Lu N,Zhang Y,Su YC,Wang Y,Zhang YL,Sun YP

    更新日期:2012-11-01 00:00:00

  • An online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of 'Living with Bipolar': a web-based self-management intervention for bipolar disorder: trial design and protocol.

    abstract:BACKGROUND:Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventio...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.02.011

    authors: Todd NJ,Solis-Trapala I,Jones SH,Lobban FA

    更新日期:2012-07-01 00:00:00

  • A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system.

    abstract:BACKGROUND:Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk coun...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2017.02.009

    authors: Knerr S,Wernli KJ,Leppig K,Ehrlich K,Graham AL,Farrell D,Evans C,Luta G,Schwartz MD,O'Neill SC

    更新日期:2017-05-01 00:00:00

  • Clinical trials profile: professionals and sites.

    abstract::Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: pro...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2010.06.002

    authors: Paschoale HS,Barbosa FR,Nita ME,Carrilho FJ,Ono-Nita SK

    更新日期:2010-09-01 00:00:00

  • Treatment preference and patient centered prostate cancer care: Design and rationale.

    abstract::Prostate cancer is a slow progressing cancer that affects millions of men in the US. Due to uncertainties in outcomes and treatment complications, it is important that patients engage in informed decision making to choose the "optimal treatment". Patient centered care that encompasses informed decision-making can impr...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.09.024

    authors: Jayadevappa R,Chhatre S,Gallo JJ,Wittink M,Morales KH,Bruce Malkowicz S,Lee D,Guzzo T,Caruso A,Van Arsdalen K,Wein AJ,Sanford Schwartz J

    更新日期:2015-11-01 00:00:00

  • Adaptation of a sustained care cessation intervention for smokers hospitalized for psychiatric disorders: Study protocol for a randomized controlled trial.

    abstract:BACKGROUND:Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully qui...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2019.06.001

    authors: Hecht J,Rigotti NA,Minami H,Kjome KL,Bloom EL,Kahler CW,Price LH,Levy DE,Carpenter KM,Brown RA

    更新日期:2019-08-01 00:00:00

  • Competing events in patients with malignant disease who are at risk for recurrent venous thromboembolism.

    abstract::Patients with malignant disease enrolled in trials of thrombotic disorders may experience competing events such as death. The occurrence of a competing event may prevent the thrombotic event from being observed. Standard survival analysis techniques ignore competing risks, resulting in possible bias and distorted infe...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2011.07.005

    authors: Parpia S,Julian JA,Thabane L,Lee AY,Rickles FR,Levine MN

    更新日期:2011-11-01 00:00:00

  • The use of minimization in clinical trials.

    abstract::Since its introduction in 1974 the use of the term Minimization has been broadened to include other algorithms. All algorithms use patient characteristics to determine the assignment that produces the best overall balance between treatment groups. They differ in whether or not they use all of the data from each previo...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/j.cct.2009.12.005

    authors: Taves DR

    更新日期:2010-03-01 00:00:00

  • Covid-19 pandemic research opportunity: Is the Middle East & North Africa (MENA) missing out?

    abstract:BACKGROUND:The Covid-19 pandemic has caused fear and panic worldwide, forcing healthcare systems to disregard conventional practices and adopt innovation to contain the infection and death. Globally, there has been a rapid proliferation of research studies and clinical trials assessing risks, infectivity and treatment....

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,评审

    doi:10.1016/j.cct.2020.106106

    authors: Ibrahim H,Kamour AM,Harhara T,Gaba WH,Nair SC

    更新日期:2020-09-01 00:00:00

  • Heart positive: design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/dyslipidemia.

    abstract::Dyslipidemia and insulin resistance occur in a large proportion of HIV-infected patients treated with highly active antiretroviral therapy (HAART); anthropomorphic changes, such as lipoatrophy and central obesity, occur in a subset of patients. This cluster of clinical features, which is termed HIV lipodystrophy, plac...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2006.07.002

    authors: Samson SL,Pownall HJ,Scott LW,Ballantyne CM,Smith EO,Sekhar RV,Balasubramanyam A

    更新日期:2006-12-01 00:00:00

  • Physiological, psychological and functional changes with whole body vibration exercise in the elderly: FEVER methodology and protocols.

    abstract:BACKGROUND:The FEVER (Frail Elderly Vibration Exercise Response) study aims to address a paucity of research focusing on the use of Whole Body Vibration (WBV) by frail elderly who, with the highest levels of dependence and fall-related hospitalisation/mortality, potentially stand to benefit most from such accessible ex...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2015.08.008

    authors: Lark SD,Wadsworth DP

    更新日期:2015-09-01 00:00:00

  • Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    abstract::Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Br...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2016.06.005

    authors: Lentz J,Kennett M,Perlmutter J,Forrest A

    更新日期:2016-07-01 00:00:00

  • In-home obesity prevention in low-income infants through maternal and social transmission.

    abstract:BACKGROUND:Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families. METHODS:This ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2018.12.010

    authors: de la Haye K,Fluke M,Laney PC,Goran M,Galama T,Chou CP,Salvy SJ

    更新日期:2019-02-01 00:00:00

  • Moment-by-Moment in Women's Recovery: Randomized controlled trial protocol to test the efficacy of a mindfulness-based intervention on treatment retention and relapse prevention among women in residential treatment for substance use disorder.

    abstract::Although therapeutic treatments exist for substance use disorder (SUD), about half of individuals who enter treatment leave early and relapse to substance use. Early dropout from residential treatment places individuals at risk of relapse, and women in SUD residential treatment represent a vulnerable population. Evide...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.09.004

    authors: Amaro H,Black DS

    更新日期:2017-11-01 00:00:00

  • Assessing the success probability of a Phase III clinical trial based on Phase II data.

    abstract::Assessing the probability that a Phase III clinical trial will demonstrate clinically relevant efficacy based on Phase II data is an important topic in clinical drug development. An accurate estimate of how likely a Phase III trial will succeed based on available data will inform the decision on whether to move an exp...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2010.08.008

    authors: Su Z

    更新日期:2010-11-01 00:00:00

  • Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: rationale and design of the SLAM DUNC Study.

    abstract::Depression affects 20-30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV a...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.04.002

    authors: Pence BW,Gaynes BN,Williams Q,Modi R,Adams J,Quinlivan EB,Heine A,Thielman N,Mugavero MJ

    更新日期:2012-07-01 00:00:00

  • Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation.

    abstract:INTRODUCTION:Cardiac rehabilitation (CR) programs reduce overall and cardiovascular mortality in patients with a history of acute coronary events or revascularization procedures, but only 30% of patients enroll in CR and attrition rates reach up to 60%. Tai chi, a mind-body practice based on light/moderate aerobic exer...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2015.06.020

    authors: Salmoirago-Blotcher E,Wayne P,Bock BC,Dunsiger S,Wu WC,Stabile L,Yeh G

    更新日期:2015-07-01 00:00:00

  • Design and participant characteristics of a randomized-controlled trial of telemedicine for smoking cessation among rural smokers.

    abstract:INTRODUCTION:In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiven...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2014.04.008

    authors: Mussulman L,Ellerbeck EF,Cupertino AP,Preacher KJ,Spaulding R,Catley D,Cox LS,Lambart L,Hunt JJ,Nazir N,Shireman T,Richter KP

    更新日期:2014-07-01 00:00:00

  • Can weight loss improve migraine headaches in obese women? Rationale and design of the Women's Health and Migraine (WHAM) randomized controlled trial.

    abstract:BACKGROUND:Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.03.004

    authors: Bond DS,O'Leary KC,Thomas JG,Lipton RB,Papandonatos GD,Roth J,Rathier L,Daniello R,Wing RR

    更新日期:2013-05-01 00:00:00