TY - JOUR
T1 - A randomized controlled trial protocol to evaluate the effectiveness of an integrated care management approach to improve adherence among HIV-infected patients in routine clinical care
T2 - Rationale and design
AU - Crane, Heidi M.
AU - Fredericksen, Rob J.
AU - Church, Anna
AU - Harrington, Anna
AU - Ciechanowski, Paul
AU - Magnani, Jennifer
AU - Nasby, Kari
AU - Brown, Tyler
AU - Dhanireddy, Shireesha
AU - Harrington, Robert D.
AU - Lober, William B.
AU - Simoni, Jane
AU - Safren, Stevan A.
AU - Edwards, Todd C.
AU - Patrick, Donald L.
AU - Saag, Michael S.
AU - Crane, Paul K.
AU - Kitahata, Mari M.
N1 - Publisher Copyright:
© Heidi M Crane, Rob J Fredericksen, Anna Church, Anna Harrington, Paul Ciechanowski, Jennifer Magnani, Kari Nasby, Tyler Brown, Shireesha Dhanireddy, Robert D Harrington, William B Lober, Jane Simoni, Stevan A Safren, Todd C Edwards, Donald L Patrick, Michael S Saag, Paul K Crane, Mari M Kitahata. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.10.2016. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
PY - 2016/10
Y1 - 2016/10
N2 - Background: Adherence to antiretroviral medications is a key determinant of clinical outcomes. Many adherence intervention trials investigated the effects of time-intensive or costly interventions that are not feasible in most clinical care settings. Objective: We set out to evaluate a collaborative care approach as a feasible intervention applicable to patients in clinical care including those with mental illness and/or substance use issues. Methods: We developed a randomized controlled trial (RCT) investigating an integrated, clinic-based care management approach to improve clinical outcomes that could be integrated into the clinical care setting. This is based on the routine integration and systematic follow-up of a clinical assessment of patient-reported outcomes targeting adherence, depression, and substance use, and adapts previously developed and tested care management approaches. The primary health coach or care management role is provided by clinic case managers allowing the intervention to be generalized to other human immunodeficiency virus (HIV) clinics that have case managers. We used a stepped-care approach to target interventions to those at greatest need who are most likely to benefit rather than to everyone to maintain feasibility in a busy clinical care setting. Results: The National Institutes of Health funded this study and had no role in study design, data collection, or decisions regarding whether or not to submit manuscripts for publication. This trial is currently underway, enrollment was completed in 2015, and follow-up time still accruing. First results are expected to be ready for publication in early 2017. Discussion: This paper describes the protocol for an ongoing clinical trial including the design and the rationale for key methodological decisions. There is a need to identify best practices for implementing evidence-based collaborative care models that are effective and feasible in clinical care. Adherence efficacy trials have not led to sufficient improvements, and there remains little guidance regarding how adherence interventions should be implemented into clinical care. By focusing on improving adherence within care settings using existing staff, routine assessment of key domains, such as depression, adherence, and substance use, and feasible interventions, we propose to evaluate this innovative way to improve clinical outcomes.
AB - Background: Adherence to antiretroviral medications is a key determinant of clinical outcomes. Many adherence intervention trials investigated the effects of time-intensive or costly interventions that are not feasible in most clinical care settings. Objective: We set out to evaluate a collaborative care approach as a feasible intervention applicable to patients in clinical care including those with mental illness and/or substance use issues. Methods: We developed a randomized controlled trial (RCT) investigating an integrated, clinic-based care management approach to improve clinical outcomes that could be integrated into the clinical care setting. This is based on the routine integration and systematic follow-up of a clinical assessment of patient-reported outcomes targeting adherence, depression, and substance use, and adapts previously developed and tested care management approaches. The primary health coach or care management role is provided by clinic case managers allowing the intervention to be generalized to other human immunodeficiency virus (HIV) clinics that have case managers. We used a stepped-care approach to target interventions to those at greatest need who are most likely to benefit rather than to everyone to maintain feasibility in a busy clinical care setting. Results: The National Institutes of Health funded this study and had no role in study design, data collection, or decisions regarding whether or not to submit manuscripts for publication. This trial is currently underway, enrollment was completed in 2015, and follow-up time still accruing. First results are expected to be ready for publication in early 2017. Discussion: This paper describes the protocol for an ongoing clinical trial including the design and the rationale for key methodological decisions. There is a need to identify best practices for implementing evidence-based collaborative care models that are effective and feasible in clinical care. Adherence efficacy trials have not led to sufficient improvements, and there remains little guidance regarding how adherence interventions should be implemented into clinical care. By focusing on improving adherence within care settings using existing staff, routine assessment of key domains, such as depression, adherence, and substance use, and feasible interventions, we propose to evaluate this innovative way to improve clinical outcomes.
KW - Adherence
KW - Alcohol use
KW - Care management
KW - Depression
KW - HIV
KW - Intervention
KW - Randomized controlled trial
KW - Substance use
UR - http://www.scopus.com/inward/record.url?scp=85078867571&partnerID=8YFLogxK
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U2 - 10.2196/resprot.5492
DO - 10.2196/resprot.5492
M3 - Article
AN - SCOPUS:85078867571
VL - 5
JO - JMIR Research Protocols
JF - JMIR Research Protocols
SN - 1929-0748
IS - 4
M1 - e156
ER -