Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Washington.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Heidi Crane, University of Washington
ClinicalTrials.gov Identifier:
NCT01505660
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012

January 4, 2012
January 5, 2012
January 2012
June 2013   (final data collection date for primary outcome measure)
Self-reported adherence [ Time Frame: up to 1 year after enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01505660 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
HIV
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.
  • 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.
    Intervention: Behavioral: Care management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
270
January 2014
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected individuals
  • English speaking
  • 18 years of age or older
  • Access to either a home phone or cell phone at enrollment
  • In care at least 6 months.
  • Self-reported inadequate adherence based on routine clinic assessment

Exclusion Criteria:

  • Do not speak English
  • Not receiving antiretroviral medications
Both
18 Years and older
No
Contact: Heidi M Crane, MD, MPH 206-744-6649 hcrane@uw.edu
Contact: Rob Fredericksen, PhD rfrederi@uw.edu
United States
 
NCT01505660
41128-K, R01MH084759, U01AR057954, ADH HIV001
Yes
Heidi Crane, University of Washington
University of Washington
  • National Institutes of Health (NIH)
  • National Institute of Mental Health (NIMH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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
University of Washington
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP