Effects of Communities That Care on the Adoption and Implementation Fidelity of Evidence-Based Prevention Programs in Communities: Results from a Randomized Controlled Trial

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022

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Effectiveness of a multifaceted implementation strategy on physicians’ referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial

BMC Family Practice ◽

10.1186/1471-2296-14-70 ◽

2013 ◽

Vol 14 (1) ◽

Cited By ~ 7

Author(s):

Carola ME Döpp ◽

Maud JL Graff ◽

Steven Teerenstra ◽

Maria WG Nijhuis-van der Sanden ◽

Marcel GM Olde Rikkert ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Psychosocial Intervention ◽

Implementation Strategy ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Evidence Based ◽

Randomized Controlled ◽

Cluster Randomized ◽

Referral Behavior

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A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.748848 ◽

2021 ◽

Vol 12 ◽

Author(s):

Angelina Isabella Mellentin ◽

W. Miles Cox ◽

Javad S. Fadardi ◽

Laila Martinussen ◽

Nicolaj Mistarz ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Attentional Control ◽

Alcohol Use Disorder ◽

Controlled Trial ◽

Smartphone Application ◽

Evidence Based ◽

Randomized Controlled ◽

Alcohol Cues ◽

Group A ◽

Group B

Background: There is consistent evidence that community and clinical samples of individuals with an alcohol use disorder (AUD) have attentional biases toward alcohol cues. The alcohol attentional control training program (AACTP) has shown promise for retraining these biases and decreasing alcohol consumption in community samples of excessive drinkers. However, there is a lack of evidence regarding the effectiveness of ACTP in clinical AUD samples. The main aim of the present study is to investigate whether primary pharmacological and psychological, evidence-based alcohol treatment can be enhanced by the addition of a gamified AACTP smartphone application for patients with an AUD.Design and Methods: The study will be implemented as a randomized controlled trial. A total of 317 consecutively enrolled patients with AUD will be recruited from alcohol outpatient clinics in Denmark. Patients will be randomized to one of three groups upon initiation of primary alcohol treatment: Group A: a gamified AACTP smartphone application + treatment as usual (TAU); Group B: a gamified AACTP sham-control application + TAU; or Group C: only TAU. Treatment outcomes will be assessed at baseline, post-treatment, and at 3- and 6-month follow-ups. Repeated measures MANOVA will be used to compare the trajectories of the groups over time on alcohol attentional bias, alcohol craving, and drinking reductions. It is hypothesized that Group A will achieve better treatment outcomes than either Group B or Group C.Perspectives: Because attentional bias for alcohol cues is proportional to the amount of alcohol consumed, and these biases are not addressed within current evidence-based treatment programs, this study is expected to provide new evidence regarding the effectiveness of the gamified AACTP in a clinical population. Furthermore, due to promising results found using AACTP in community samples of excessive drinkers, there is a high probability that the AACTP treatment in this study will also be effective, thereby allowing AACTP to be readily implemented in clinical settings. Finally, we expect that this study will increase the effectiveness of evidence-based AUD treatment and introduce a new, low-cost gamified treatment targeting patients with an AUD. Overall, this study is likely to have an impact at the scientific, clinical, and societal levels.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT05102942?term=NCT05102942&draw=2&rank=1, identifier: NCT05102942.

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Augmenting Evidence-Based Care With a Texting Mobile Interventionist: A Pilot Randomized Controlled Trial

Psychiatric Services ◽

10.1176/appi.ps.202000239 ◽

2020 ◽

Vol 71 (12) ◽

pp. 1218-1224

Author(s):

Dror Ben-Zeev ◽

Benjamin Buck ◽

Suzanne Meller ◽

William J. Hudenko ◽

Kevin A. Hallgren

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Evidence Based ◽

Randomized Controlled ◽

Evidence Based Care ◽

Pilot Randomized Controlled Trial

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The Implementation of Dementia Care Mapping in a Randomized Controlled Trial in Long-Term Care: Results of a Process Evaluation

American Journal of Alzheimer s Disease & Other Dementias® ◽

10.1177/1533317519845725 ◽

2019 ◽

Vol 34 (6) ◽

pp. 390-398 ◽

Cited By ~ 5

Author(s):

Claire A. Surr ◽

Alys W. Griffiths ◽

Rachael Kelley ◽

Ivana Holloway ◽

Rebecca E. A. Walwyn ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Implementation Fidelity ◽

Dementia Care ◽

External Support ◽

Care Homes ◽

Term Care ◽

Randomized Controlled ◽

Care Mapping ◽

Dementia Care Mapping

This study explored intervention implementation within a pragmatic, cluster randomized controlled trial of Dementia Care Mapping™ (DCM) in UK care homes. DCM is a practice development tool comprised of a 5 component cycle (staff briefing, mapping observations, data analysis and reporting, staff feedback, and action planning) that supports delivery of person-centered care. Two staff from the 31 intervention care homes were trained in DCM and asked to deliver 3 cycles over a 15-month period, supported by a DCM expert during cycle 1. Implementation data were collected after each mapping cycle. There was considerable variability in DCM implementation fidelity, dose, and reach. Not all homes trained 2 mappers on schedule, and some found it difficult to retain mappers. Only 26% of homes completed more than 1 cycle. Future DCM trials in care home settings should consider additional methods to support intervention completion including intervention delivery being conducted with ongoing external support.

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