scholarly journals 147 Successful Strategies Supporting Recruitment, Intervention Delivery and Retention Targets in a Randomized Controlled Trial of a Complex Intervention

Rheumatology ◽  
2016 ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Intervention Delivery ◽  
Randomized Controlled

scholarly journals Preparing for a randomized controlled trial: Strategies to optimize the design of a cardiovascular surgical patient education intervention.

2021 ◽  
Author(s):  
Suzanne Fredericks ◽  
Terrence M. Yau
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Complex Intervention ◽  
Randomized Control Trial ◽  
Controlled Trial ◽  
Surgical Patient ◽  
Education Programs ◽  
Randomized Controlled ◽  
Clinical Methods ◽  
Randomized Control

Randomized controlled trial (RCT) designs are standardized to control for bias and allow for replication. Conducting RCTs is generally straightforward when dealing with interventions that contain a single component, such as a drug. However, interventions that do not contain single components, such as a patient education programs, are more difficult to standardize, as they contain multiple elements, which may act independently or interdependently of each other. The purpose of this discursive clinical methods paper is to describe and explain a methodology that can be used to optimize the design of a complex intervention prior to its evaluation in a randomized control trial.

scholarly journals Preparing for a randomized controlled trial: Strategies to optimize the design of a cardiovascular surgical patient education intervention.

2021 ◽  
Author(s):  
Suzanne Fredericks ◽  
Terrence M. Yau
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Complex Intervention ◽  
Randomized Control Trial ◽  
Controlled Trial ◽  
Surgical Patient ◽  
Education Programs ◽  
Randomized Controlled ◽  
Clinical Methods ◽  
Randomized Control

Randomized controlled trial (RCT) designs are standardized to control for bias and allow for replication. Conducting RCTs is generally straightforward when dealing with interventions that contain a single component, such as a drug. However, interventions that do not contain single components, such as a patient education programs, are more difficult to standardize, as they contain multiple elements, which may act independently or interdependently of each other. The purpose of this discursive clinical methods paper is to describe and explain a methodology that can be used to optimize the design of a complex intervention prior to its evaluation in a randomized control trial.

scholarly journals Posttraumatic Stress Disorder Intervention for People with Severe Mental Illness in a Low-Income Country Primary Care Setting: A Randomized Feasibility Trial Protocol

2021 ◽  
Author(s):  
Lauren Ng ◽  
Eyerusalem Getachew Serba ◽  
Benyam W. Dubale ◽  
Abebaw Fekadu ◽  
Charlotte Hanlon
Keyword(s):  
Primary Care ◽  
Posttraumatic Stress Disorder ◽  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Intervention Delivery ◽  
Randomized Controlled

Abstract BackgroundIn this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization’s guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings. MethodsSpecifically, this study includes a non-randomized pre-pilot (n=5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n=40) to assess trial procedures, acceptability and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, one-month follow-up, and three-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal. DiscussionFindings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings. Trial RegistrationRegistered with ClinicalTrials.gov (NCT04385498) first posted May 13th, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1.

Monitoring treatment fidelity in a randomized controlled trial of a complex intervention

2007 ◽  
Vol 60 (3) ◽  
pp. 343-352 ◽  
Author(s):  
Valerie Spillane ◽  
Mary C. Byrne ◽  
Molly Byrne ◽  
Claire S. Leathem ◽  
Mary O’Malley ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Randomized Controlled ◽  
Monitoring Treatment

Integrating pragmatism and rigor - impact of the pandemic on a randomized controlled trial of a complex intervention

2021 ◽  
Vol 22 (5) ◽  
pp. 586
Author(s):  
Ruth Chimenti ◽  
Andrew Post ◽  
Ebonie Rio ◽  
Emine Bayman ◽  
Mederic Hall ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Randomized Controlled

Palliative assessment and advance care planning in severe dementia: An exploratory randomized controlled trial of a complex intervention

2011 ◽  
Vol 25 (3) ◽  
pp. 197-209 ◽  
Author(s):  
Elizabeth L Sampson ◽  
Louise Jones ◽  
Ingela CV Thuné-Boyle ◽  
Riitta Kukkastenvehmas ◽  
Michael King ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Advance Care Planning ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Care Planning ◽  
Severe Dementia ◽  
Randomized Controlled ◽  
Advance Care

scholarly journals Methodological challenges and solution strategies during implementation of a midwife-led multicenter randomized controlled trial (RCT) in maternity hospitals

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sabine Striebich ◽  
Elke Mattern ◽  
Theresa Oganowski ◽  
Rainhild Schäfers ◽  
Gertrud Ayerle
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Quality Data ◽  
Solution Strategies ◽  
Randomized Controlled ◽  
Link Type ◽  
Delivery Rooms

Abstract Background Randomized controlled trials (RCTs), especially multicentric, with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (Good Clinical Practice [GCP] guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand. Few published RCTs report challenges and problems in implementing complex interventions in maternity wards. In Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials. Methods The aim is to describe the key methodological and organizational challenges in conducting a multicenter study in maternity wards and the solution strategies applied to them. In particular, project-related and process-oriented challenges for hospital staff are considered. The exemplarily presented randomized controlled trial “BE-UP” investigates the effectiveness of an alternative design of a birthing room on the rate of vaginal births and women-specific outcomes. Results The results are presented in five sectors: 1) Selection of and support for cooperating hospitals: they are to be selected according to predefined criteria, and strategies to offer continuous support in trial implementation must be mapped out. 2) Establishing a process of requesting informed consent: a quality-assured process to inform pregnant women early on must be feasible and effective. 3) Individual digital real-time randomization: In addition to instructing maternity teams, appropriate measures for technical failure must be provided. 4) The standardized birthing room: The complex intervention is to be implemented according to the study protocol yet adapted to the prevailing conditions in the delivery rooms. 5) GCP-compliant documentation: midwives and obstetricians will be instructed in high-quality data collection, supported by external monitoring throughout the trial. Conclusion Since not all potential challenges can be anticipated in the planning of a trial, study teams need to be flexible and react promptly to any problems that threaten recruitment or the implementation of the complex intervention. Thought should be given to the perspectives of midwives and obstetricians as recruiters and how clinic-intern processes could be adapted to correspond with the trial’s requirements. Trial registration The BE-UP study was registered on 07/03/ 2018 in the German Register for Clinical Trials under Reference No. DRKS00012854 and can also be found on the International Clinical Trials Registry Platform (ICTRP) (see https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS0001285).

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