Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
Among HIV-infected patients, adherence to antiretroviral medications is one of the most important determinants of clinical outcomes including viral suppression, viral resistance, disease progression, and death. Unfortunately poor adherence among patients with HIV is very common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse, and mental illness particularly depression symptoms are key predictors of poor adherence, common among HIV-infected individuals, and important to identify and treat among nonadherent patients. This study will examine the ability of patient reported outcomes (PROs) and a targeted care management approach to improve clinical outcomes with a randomized controlled trial (RCT) in routine clinical care of patients with HIV. The investigators will determine whether healthcare delivery team notification of PROs including antiretroviral medication adherence and barriers of adherence such as depression and substance abuse along with tailored intervention recommendations and targeted care management leads to improvement in both process and clinical outcomes including patient-reported outcomes. The investigators will examine process outcomes such as use of clinic support services, and patient outcomes such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
- Self-reported adherence [ Time Frame: up to 1 year after enrollment ] [ Designated as safety issue: No ]
- HIV-1 RNA level [ Time Frame: up to 1 year after enrollment ] [ Designated as safety issue: No ]
- Self-reported substance use [ Time Frame: Up to 1 year after enrollment ] [ Designated as safety issue: No ]
- Health related quality of life [ Time Frame: Up to 1 year after enrollment ] [ Designated as safety issue: No ]
- Physical activity levels [ Time Frame: up to 1 year after enrollment ] [ Designated as safety issue: No ]
- Self-reported depression [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care
Patients not randomized to the intervention will receive usual care which includes a patient reported outcomes assessment every 6 months as part of routine clinical procedures and patient-initiated interactions with case managers.
Experimental: Care management
The intervention will include frequent healthcare delivery team notification of PROs including medication adherence and adherence barriers such as depression symptoms along with tailored intervention recommendations and targeted care management using a stepped care approach.
Behavioral: Care management
The intervention will include healthcare delivery team notification of patient reported outcomes (PROs) including medication adherence and adherence barriers such as depression symptoms along with intervention recommendations and targeted care management using a stepped care approach. Patients will receive structured calls from their care manager 2 and 6 weeks after enrollment. An assessment including depression, adherence, and substance use will be completed at the beginning of each call. After the 2nd call, a stepped care approach will be used where patients with a greater need based on adherence and depression will receive more intensive interventions based on the PEARL intervention. The components include: a) problem solving treatment, b) social and physical activation, c) pleasant events scheduling, d) patient support and education regarding medication use, and e) medical and psychiatric consultation. Patients will also receive follow-up calls at ~9 and 12 months after enrollment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505660
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98125|
|Principal Investigator:||Heidi M Crane, MD, MPH||University of Washington|
|Principal Investigator:||Paul K Crane, MD MPH||University of Washington|
|Principal Investigator:||Donald Patrick, PhD||University of Washington|