Using the Multiphase Optimization Strategy (MOST) framework to test intervention delivery strategies: a study protocol.
Age Factors
Boston
Child
Child Behavior
Child Behavior Disorders
/ diagnosis
Child Health Services
/ organization & administration
Child, Preschool
Continuity of Patient Care
/ organization & administration
Culturally Competent Care
/ organization & administration
Delivery of Health Care, Integrated
/ organization & administration
Female
Health Services Accessibility
/ organization & administration
Healthcare Disparities
Humans
Male
Mental Health Services
/ organization & administration
Patient Navigation
/ organization & administration
Patient Participation
Professional-Family Relations
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome
Child behavioral health services
Family Navigation
Health disparities
Multiphase Optimization Strategy
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
16 Dec 2019
16 Dec 2019
Historique:
received:
17
08
2019
accepted:
25
10
2019
entrez:
18
12
2019
pubmed:
18
12
2019
medline:
1
9
2020
Statut:
epublish
Résumé
Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions-and furthermore understanding the impact of each strategy on effectiveness-has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation. The MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as "at-risk" for behavioral health disorders (n = 304) at a large, urban federally qualified community health center will be referred to a Family Partner-a bicultural, bilingual member of the community with training in behavioral health and systems navigation-who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost. In this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation. ClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions-and furthermore understanding the impact of each strategy on effectiveness-has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation.
METHODS/DESIGN
METHODS
The MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as "at-risk" for behavioral health disorders (n = 304) at a large, urban federally qualified community health center will be referred to a Family Partner-a bicultural, bilingual member of the community with training in behavioral health and systems navigation-who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost.
DISCUSSION
CONCLUSIONS
In this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.
Identifiants
pubmed: 31842963
doi: 10.1186/s13063-019-3853-y
pii: 10.1186/s13063-019-3853-y
pmc: PMC6915979
doi:
Banques de données
ClinicalTrials.gov
['NCT03569449']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
728Subventions
Organisme : NIMH NIH HHS
ID : K23 MH109673
Pays : United States
Organisme : NIMH NIH HHS
ID : R01 MH117123
Pays : United States
Organisme : AHRQ HHS
ID : T32 HS022242
Pays : United States
Organisme : NIMH NIH HHS
ID : R01MH11712302
Pays : United States
Références
Patient Educ Couns. 2017 Mar;100(3):436-448
pubmed: 27771161
Acad Pediatr. 2012 Sep-Oct;12(5):456-67
pubmed: 22921494
J Gen Intern Med. 2011 Feb;26(2):116-22
pubmed: 20607432
JAMA Psychiatry. 2017 Aug 1;74(8):781-789
pubmed: 28614554
Health Policy. 2017 Jul;121(7):755-763
pubmed: 28535996
Psychooncology. 2012 Sep;21(9):986-92
pubmed: 21681995
Soc Work Public Health. 2016 Oct;31(6):504-10
pubmed: 27195704
Am J Psychiatry. 1991 Aug;148(8):1031-6
pubmed: 1853952
Psychiatr Serv. 2009 Jul;60(7):898-907
pubmed: 19564219
Contemp Clin Trials. 2012 Sep;33(5):1094-102
pubmed: 22771577
Health Aff (Millwood). 2008 Mar-Apr;27(2):393-403
pubmed: 18332495
Psychol Addict Behav. 2005 Sep;19(3):303-10
pubmed: 16187810
JAMA. 2003 May 21;289(19):2545-53
pubmed: 12759326
Pediatrics. 2015 Apr;135(4):e858-67
pubmed: 25802346
J Pediatr. 1996 Dec;129(6):864-9
pubmed: 8969728
Am J Obstet Gynecol. 2018 Mar;218(3):280-286
pubmed: 28844825
J Clin Child Adolesc Psychol. 2018;47(sup1):S306-S320
pubmed: 28278600
JAMA Pediatr. 2014 Jan;168(1):16-24
pubmed: 24190691
Clin Pediatr (Phila). 2017 Oct;56(11):1023-1031
pubmed: 28449589
J Eval Clin Pract. 2015 Dec;21(6):1205-11
pubmed: 26200039
Contemp Clin Trials. 2018 Mar;66:1-8
pubmed: 29287665
J Womens Health (Larchmt). 2015 Jan;24(1):30-6
pubmed: 25513858
Annu Rev Psychol. 2007;58:593-614
pubmed: 16968208
J Gen Intern Med. 2016 Jan;31(1):68-76
pubmed: 26259762
Implement Sci. 2009 Aug 07;4:50
pubmed: 19664226
BMC Public Health. 2015 Jul 09;15:627
pubmed: 26155841
BMC Public Health. 2017 May 4;17(1):383
pubmed: 28472928
J Pediatr. 1988 Feb;112(2):201-9
pubmed: 3339501
Psychiatr Serv. 2016 Aug 1;67(8):912-5
pubmed: 27133722
J Public Health Manag Pract. 2014 Jul-Aug;20(4):E15-24
pubmed: 24858322
Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59
pubmed: 20633738
Trials. 2018 Apr 27;19(1):255
pubmed: 29703237
J Health Care Poor Underserved. 2017;28(3):988-1011
pubmed: 28804073
Child Care Health Dev. 1987 Mar-Apr;13(2):111-25
pubmed: 3581439
Milbank Q. 2001;79(4):579-612, iv-v
pubmed: 11789118
Adm Policy Ment Health. 2006 Mar;33(2):182-97
pubmed: 16489482
Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31
pubmed: 27371105
Am J Manag Care. 2017 Jul;23(7):429-434
pubmed: 28817782
BMC Public Health. 2016 Nov 22;16(1):1181
pubmed: 27876027
Autism. 2019 Jul 16;:1362361319864079
pubmed: 31311287
Harv Bus Rev. 2011 Sep;89(9):46-52, 54, 56-61 passim
pubmed: 21939127
Contemp Clin Trials. 2014 Jul;38(2):251-9
pubmed: 24846621
J Am Acad Child Adolesc Psychiatry. 1992 Nov;31(6):1105-11
pubmed: 1429413
Control Clin Trials. 2002 Dec;23(6):662-74
pubmed: 12505244
Drug Alcohol Rev. 2018 Jan;37(1):79-86
pubmed: 28480521
Autism. 2019 Jul;23(5):1288-1299
pubmed: 30404548
Biometrics. 1975 Mar;31(1):103-15
pubmed: 1100130
J Health Care Poor Underserved. 2017;28(1):14-23
pubmed: 28238982
Eval Program Plann. 1979;2(3):197-207
pubmed: 10245370
Psychol Methods. 2002 Dec;7(4):422-45
pubmed: 12530702
Fam Syst Health. 2016 Sep;34(3):281-6
pubmed: 27505070
Ann Behav Med. 2005 Aug;30(1):65-73
pubmed: 16097907
Front Oncol. 2016 Jan 28;6:2
pubmed: 26858934
Community Ment Health J. 2012 Aug;48(4):436-49
pubmed: 21691821
Med Care. 2003 Nov;41(11):1284-92
pubmed: 14583691
Clin Pharmacol Ther. 1974 May;15(5):443-53
pubmed: 4597226
Am J Public Health. 2019 Feb;109(S2):S128-S129
pubmed: 30785800
Transl Behav Med. 2014 Sep;4(3):252-9
pubmed: 25264465
J Subst Abuse Treat. 2006 Jul;31(1):67-73
pubmed: 16814012