Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study by Xinyu Huang, Max Geraedts, Elke Kalbe, Carsten Eggers, David José Pedrosa, Ann-Kristin Folkerts, Marcin Grzegorzek, Marlena van Munster, Johanne Stümpel, Natalie Altschuck, Ingmar Wellach, Hannes Boebinger, Anna Pedrosa, Kati Niemand, Dirk Becker, Nicole Pohlschmidt, Isabel Doblinger, Kristina Schmidt, Daniel Wolferts, Marius Nisslmueller, Gennet Beer, Mohammad Osman Ashraf, Florian Eberhardt, Rebecca Wichartz, Birgit Samans, Volker Gross, Keywan Sohrabi, Linda Kerkemeyer, Uemran Seven, Paulina Olgemoeller, Artur Piet, Mona Irsfeld, Marlena van Munster

“…This study protocol describes the process evaluation within a randomised clinical trial to assess the implementation and its impact on patient health outcomes of ParkProReakt—a proactive, multidisciplinary, digitally supported care model for community-dwelling PwPD.Methods and analysis The hybrid efficacy-implementation study will assess key implementation outcomes using the Medical Research Council framework for complex interventions alongside a randomised controlled trial. …”
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Implementation strategies to integrate HIV and hypertension care in Kampala and Wakiso districts, Uganda: study protocol for a stepped wedge cluster randomized trial (PULESA-Uganda... by Chris T. Longenecker, John Baptist Kiggundu, Florence Ayebare, Martin Muddu, James Kayima, Gerald Mutungi, Isaac Ssinabulya, Jeremy I. Schwartz, Donna Spiegelman, Guangyu Tong, Rachel Nugent, Angela Aifah, Faith Kagoya, Drew B. Cameron, Brian Hutchinson, Moses R. Kamya, Anne R. Katahoire, Fred C. Semitala

“…Cost-effective strategies to implement evidence-based hypertension care for this population are urgently needed to preserve the life-expectancy gains of antiretroviral therapy. …”
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Implementation of a nurse-delivered, community-based liver screening and assessment program for people with metabolic dysfunction-associated steatotic liver disease (LOCATE-NAFLD t... by Michelle J. Allen, Ruth Tulleners, David Brain, James O’Beirne, Elizabeth E. Powell, Adrian Barnett, Patricia C. Valery, Sanjeewa Kularatna, Ingrid J. Hickman

“…This study evaluates the implementation strategy of the LOCATE model. Methods The evaluation used mixed methods (quantitative trial data and qualitative framework analysis of semi-structured interviews) to explore the general practitioner (GP) and patient perspectives of acceptability (Acceptability Framework), and factors associated with reach, effectiveness, adoption, implementation, and maintenance (RE-AIM framework) of the LOCATE model of care. …”
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Heart failure with reduced ejection fraction polypill implementation strategy in Sri Lanka: design and protocol of a pilot type I hybrid randomised clinical trial by Anushka Patel, Anthony Rodgers, Dorairaj Prabhakaran, Anubha Agarwal, Mark D Huffman, Abdul Salam, Rupasvi Dhurjati, Asita de Silva, Charles W Goss, Mansi Agarwal, Saumiyah Ajanthan, Anuradha Dahanayaka, Chanaka Fernando, Gamini Galappatthy, Adam Hively, Pathiyil B Jayagopal, Padinhare P Mohanan, Mohamed Rahuman, Karl Roberts, Hyndavi Salwa

“…The findings of this pilot trial will inform the design and implementation of a future large-scale type I hybrid trial to assess the efficacy and safety of an HFrEF polypill in improving clinical outcomes.Trial registration numbers Sri Lanka Clinical Trials Registry (SLCTR/2024/003); ClinicalTrials Registry (NCT06831864).…”
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Intervention for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders: Protocol for a Randomized Controlled Hybrid Effectiveness-Implement... by Kathryn Bruzios, Paige M Shaffer, Daniel M Blonigen, Michael A Cucciare, Michael Andre, Thomas Byrne, Jennifer Smith, David Smelson

“…The quantitative and qualitative components of this project are intended to work synergistically to reinforce knowledge of MISSION-CJ’s effectiveness, implementation, and scalability. ConclusionsIf effective, the implementation of MISSION-CJ alongside the MH RRTPs may be advantageous to address risk factors related to recidivism. …”
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Implementation of an electronic medication management support system in hospitalised polypharmacy patients: study protocol of a stepped-wedge cluster-randomised controlled trial (T... by Peter Ihle, Katrin Christiane Reber, Juliane Köberlein-Neu, Ingo Meyer, Matthias Schilling, Daniel Grandt, Till Beckmann, Lara Düvel, Sara Söling, Simone Grandt, Wolfgang Greiner, Sarah Meyer, David Lampe, Adriana Poppe, Raphaele Bartels, Christoph Klaas, Adda Dumröse, Susanne Dolfen, Nathalie Sinnen, Carolin Polte, Olga Resch, Nicole Faulenbach, Hannah Britz, Beate Halex, Sofie May, Christof Shelian

“…Results will be disseminated through workshops, peer-reviewed publications and local and international conferences.Trial registration number DRKS00025485.…”
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Multicomponent intervention for controlling hypertension in the adult rural population of Pakistan: a protocol for a hybrid type III implementation-effectiveness cluster randomised... by Catherine Hewitt, Aziz Sheikh, Simon Walker, Sajid Soofi, Kamran Siddiqi, Zulfiqar Ahmed Bhutta, Zainab Samad, Aysha Almas, Saima Afaq, Hajra Khwaja, Shiraz Hashmi, Imran Naeem, Salim S Virani, Saira Bukhari, Sawera Hanif

“…Using Expert Recommendations for Implementing Change and the modified Delphi technique, a set of implementation strategies addressing barriers will be identified. …”
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Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial by Rachel Beth Rosansky Chalmer, Emmeline Ayers, Erica F Weiss, Nicole R Fowler, Andrew Telzak, Diana Summanwar, Jessica Zwerling, Cuiling Wang, Huiping Xu, Richard J Holden, Kevin Fiori, Dustin D French, Celeste Nsubayi, Asif Ansari, Paul Dexter, Anna Higbie, Pratibha Yadav, James M Walker, Harrshavasan Congivaram, Dristi Adhikari, Mairim Melecio-Vazquez, Malaz Boustani, Joe Verghese

“…We will analyze the 5-Cog’s implementation process, context, and outcomes through the Consolidated Framework for Implementation Research using a mixed methods design (surveys and interviews). …”
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Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised tr... by Shelby D Reed, Adam P Goode, Rowena J Dolor, Barcey T Levy, Stacie A Salsbury, Christine Goertz, Hrishikesh Chakraborty, Samuel Broderick, Kelley Ryan, Sharon Settles, Shoshana Hort, Elizabeth A Chrischilles, Stacie Kasper, James E Stahl, Chandra Almond, Zacariah Shannon, Debra Harris, Jeanette Daly, Patricia Winokur, Jon D Lurie

“…Study data will be made available on completion, in compliance with National Institutes of Health data sharing policies.Trial registration number NCT05626049.…”
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Implementation and evaluation of a navigation program for people with cancer in old age and their family caregivers: study protocol for the EU NAVIGATE International Pragmatic Rand... by Tinne Smets, Lara Pivodic, Rose Miranda, Fien Van Campe, Chelsea Vinckier, Barbara Pesut, Wendy Duggleby, Andrew N. Davies, Amanda Lavan, Peter May, Barbara Gomes, Maja Furlan de Brito, Vitor Rodrigues, Katarzyna Szczerbińska, Violetta Kijowska, Ilona Barańska, Stefanie De Buyser, Davide Ferraris, Sara Alfieri, Bianca Scacciati, Helena Du Cheyne, Kenneth Chambaere, Joni Gilissen, Annicka G.M. van der Plas, Roeline H. Pasman, Bregje D. Onwuteaka-Philipsen, on behalf of EU NAVIGATE, Lieve Van den Block

“…While promising for older people with cancer, these programs are scarce in Europe, and research on their effectiveness and implementation is limited. We describe the protocol of the EU NAVIGATE randomized controlled trial, aimed to evaluate (1) effectiveness and cost-effectiveness of NavCare-EU, an intervention that aims to support older people with cancer throughout their illness trajectory, spanning the continuum of supportive, palliative, and end-of-life care, and (2) the intervention’s implementation processes and feasibility of its integration into different health care systems in Europe, contextual barriers and facilitators for effective and sustainable implementation, and mechanisms involved in reaching the outcomes. …”
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Readiness for scale up following effectiveness-implementation trial: results of scalability assessment of the Community Partnership Program for diabetes self-management for older a... by Melissa Northwood, Tracey Chambers, Kathryn Fisher, Rebecca Ganann, Maureen Markle-Reid, Marie-Lee Yous, Ron Beleno, Gary Gaudet, Andrea Gruneir, Helen Leung, Craig Lindsay, Kasia Luebke, Gail Macartney, Ethel Macatangay, Janet MacIntyre, Carolyn MacPhail, William Montelpare, Allan Morrison, Lisa Shaffer, Martha St. Pierre, Frank Tang, Catharine Whiteside

“…Registration date: September 10, 2018.…”
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Evaluation of the implementation and the associated operating costs of a medicine regulatory harmonisation model in Africa: the case of ZaZiBoNa, a SADC work-sharing initiative by S. Dube-Mwedzi, F. Suleman

“…This study evaluated ZaZiBoNa from project implementation and cost perspectives, at the 5-year mark, to establish a business case for further investment.Methods A quantitative and desk review were undertaken. …”
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Evaluation of content validity and feasibility of the World Falls Guidelines’ three key questions to identify falls among older adult users of home care services in Norway by Rune Solli, Linda Aimée Hartford Kvæl, Nina Rydland Olsen, Therese Brovold

“…Trial registration Open Science Framework Identifier https://doi.org/10.17605/OSF.IO/2JFHV . …”
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Te Ara Waiora-Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a non-inferiority trial. by Melanie Gibson-Helm, Tania Slater, Evelyn J MacDonald, Kendall Stevenson, Anna Adcock, Stacie Geller, Varsha Parag, Charles Lambert, Matthew Bennett, Merilyn Hibma, Peter Sykes, Marion Saville, David Hawkes, Jo-Ann Stanton, Mary-Ann Clueard, Grahame Jelley, Bev Lawton

“…Currently, we do not know the best model for implementing an equitable HPV self-testing screening programme.…”
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What types of dissemination of information occurred between researchers, providers and clinical staff while implementing an asthma shared decision-making intervention: a directed c... by Thomas Ludden, Lindsay Shade, Madelyn Welch, Jacqueline Halladay, Katrina E Donahue, Tamera Coyne-Beasley, Paul Bray, Hazel Tapp

“…These exploratory dissemination of information results provide additional mechanisms for evaluating implementation science.Trial registration number NCT02047929; Post-results…”
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The impact of implementing a nursing care program based on Johnson’s model on the behavioral systems of patients undergoing coronary artery bypass graft: a Randomized clinical tria... by Sakineh Rostami, Shahram Molavynejad, Nasrin Elahi, Elham Maraghi

“…This study aimed to determine the effect of implementing a nursing care program based on Johnson’s model on the behavioral systems of patients undergoing CABG in Ahvaz teaching hospitals in 2022. …”
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Implementation of the Symptom Navi © Programme for cancer patients in the Swiss outpatient setting: a study protocol for a cluster randomised pilot study (Symptom Navi© Pilot Study... by Marika Bana, Karin Ribi, Susanne Kropf-Staub, Sabin Zürcher-Florin, Ernst Näf, Tanja Manser, Lukas Bütikofer, Solange Peters, Manuela Eicher

“…It consists of written patient information (Symptom Navi© Flyers (SN©Flyers)), semistructured consultations and a training manual for nurses.Methods and analysis This pilot study will evaluate the implementation of the SN©P based on the Reach Effectiveness—Adoption Implementation Maintenance framework at Swiss outpatient cancer centres. …”
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Evaluation of a Global Initiative for Asthma Education and Implementation Program to Improve Asthma Care Quality (CARE4ALL): Protocol for a Multicenter, Single-Arm Study by Kewu Huang, Wenjun Wang, Ying Wang, Yanming Li, Xiaokai Feng, Huahao Shen, Chen Wang

“…During this study, GINA implementation performance will be continuously monitored to inform necessary adjustments at the hospital level. …”
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Impact of an adapted diabetes prevention program in a spanish primary care setting: protocol for a type II hybrid effectiveness-implementation cluster-randomized trial (ALADIM) by Miquel Bennasar-Veny, Manuela Abbate, Miquel Colom-Rosselló, Laura Capitán-Moyano, Ivonne C. Hernández-Bermúdez, Ignacio Ricci-Cabello, Aina M. Yañez, Maria E. Fernandez, the ALADIM investigators

“…The primary effectiveness outcome is weight, the co-primary implementation outcome is implementation fidelity. We will also assess the effect of DPP implementation on overall prediabetes management within the PCCs (spillover) by measuring the percentage of people with prediabetes receiving lifestyle advice. …”
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Evaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options... by Allan Musinguzi, Joan R Kasidi, Jillian L Kadota, Fred Welishe, Anne Nakitende, Lydia Akello, Jane Nakimuli, Lynn T Kunihira, Bishop Opira, Yeonsoo Baik, Devika Patel, Amanda Sammann, Christopher A Berger, Hélène E Aschmann, Payam Nahid, Robert Belknap, Moses R Kamya, Margaret A Handley, Patrick P J Phillips, Noah Kiwanuka, Achilles Katamba, David W Dowdy, Adithya Cattamanchi, Fred C Semitala, Anne R Katahoire

“…Refresher training and collaboration among HCPs enabled implementation whereas limited diagnostic facilities for adverse events at the clinic hindered implementation. …”
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