Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial).
Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial).
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一项因子随机对照试验的研究方案，评估初级保健中药物使用障碍的数字疗法的实施、成本、有效性和维持性(数字试验)。
DOI：
10.1186/s13012-022-01258-9
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发表时间：
2023-02-01
影响因子：
7.2
通讯作者：
Bradley, Katharine A.
中科院分区：
文献类型：
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作者：
Glass, Joseph E.;Dorsey, Caitlin N.;Beatty, Tara;Bobb, Jennifer F.;Wong, Edwin S.;Palazzo, Lorella;King, Deborah;Mogk, Jessica;Stefanik-Guizlo, Kelsey;Idu, Abisola;Key, Dustin;Fortney, John C.;Thomas, Rosemarie;McWethy, Angela Garza;Caldeiro, Ryan M.;Bradley, Katharine A.
关键词：
Experts recommend that treatment for substance use disorder (SUD) be integrated into primary care. The Digital Therapeutics for Opioids and Other SUD (DIGITS) Trial tests strategies for implementing reSET® and reSET-O®, which are prescription digital therapeutics for SUD and opioid use disorder, respectively, that include the community reinforcement approach, contingency management, and fluency training to reinforce concept mastery. This purpose of this trial is to test whether two implementation strategies improve implementation success (Aim 1) and achieve better population-level cost effectiveness (Aim 2) over a standard implementation approach. The DIGITS Trial is a hybrid type III cluster-randomized trial. It examines outcomes of implementation strategies, rather than studying clinical outcomes of a digital therapeutic. It includes 22 primary care clinics from a healthcare system in Washington State and patients with unhealthy substance use who visit clinics during an active implementation period (up to one year). Primary care clinics implemented reSET and reSET-O using a multifaceted implementation strategy previously used by clinical leaders to roll-out smartphone apps (“standard implementation” including discrete strategies such as clinician training, electronic health record tools). Clinics were randomized as 21 sites in a 2x2 factorial design to receive up to two added implementation strategies: (1) practice facilitation, and/or (2) health coaching. Outcome data are derived from electronic health records and logs of digital therapeutic usage. Aim 1’s primary outcomes include reach of the digital therapeutics to patients and fidelity of patients’ use of the digital therapeutics to clinical recommendations. Substance use and engagement in SUD care are additional outcomes. In Aim 2, population-level cost effectiveness analysis will inform the economic benefit of the implementation strategies compared to standard implementation. Implementation is monitored using formative evaluation, and sustainment will be studied for up to one year using qualitative and quantitative research methods. The DIGITS Trial uses an experimental design to test whether implementation strategies increase and improve the delivery of digital therapeutics for SUDs when embedded in a large healthcare system. It will provide data on the potential benefits and cost-effectiveness of alternative implementation strategies. ClinicalTrials.gov Identifier: NCT05160233 (Submitted 12/3/2021). https://clinicaltrials.gov/ct2/show/NCT05160233 The online version contains supplementary material available at 10.1186/s13012-022-01258-9.
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影响因子：
2.7
作者：
Campbell, Aimee N. C.;Turrigiano, Eva;Nunes, Edward V.
通讯作者：
Nunes, Edward V.
影响因子：
5.5
作者：
Collins, Linda M.;Dziak, John J.;Kugler, Kari C.;Trail, Jessica B.
通讯作者：
Trail, Jessica B.
影响因子：
1.3
作者：
Campbell ANC;Montgomery L;Sanchez K;Pavlicova M;Hu M;Newville H;Weaver L;Nunes EV
通讯作者：
Nunes EV
影响因子：
3.7
作者：
Campbell CI;Saxon AJ;Boudreau DM;Wartko PD;Bobb JF;Lee AK;Matthews AG;McCormack J;Liu DS;Addis M;Altschuler A;Samet JH;LaBelle CT;Arnsten J;Caldeiro RM;Borst DT;Stotts AL;Braciszewski JM;Szapocznik J;Bart G;Schwartz RP;McNeely J;Liebschutz JM;Tsui JI;Merrill JO;Glass JE;Lapham GT;Murphy SM;Weinstein ZM;Yarborough BJH;Bradley KA
通讯作者：
Bradley KA
DOI：
10.1186/1748-5908-8-117
发表时间：
2013-10-02
期刊：
Implementation science : IS
影响因子：
--
作者：
Chambers DA;Glasgow RE;Stange KC
通讯作者：
Stange KC