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

NCT01505660 | Unknown DMC

• 4 other identifiers: 41128-KR01MH084759U01AR057954ADH HIV001
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

Adherence; Depression; Care management; Stepped care; HIV; Patient reported outcomes; Antiretroviral medication adherence

Outcome Measures

Primary Outcomes (1)

• Self-reported adherence

  up to 1 year after enrollment

Secondary Outcomes (5)

• HIV-1 RNA level

  up to 1 year after enrollment

• Self-reported substance use

  Up to 1 year after enrollment

• Health related quality of life

  Up to 1 year after enrollment

• Physical activity levels

  up to 1 year after enrollment

• Self-reported depression

  Up to 1 year

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Care management

EXPERIMENTAL

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

Interventions

Care management BEHAVIORAL

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.

Care management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected individuals
• English speaking
• 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

You may not qualify if:

• Do not speak English
• Not receiving antiretroviral medications

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98125, United States

Location

Related Publications (1)

• Crane HM, Fredericksen RJ, Church A, Harrington A, Ciechanowski P, Magnani J, Nasby K, Brown T, Dhanireddy S, Harrington RD, Lober WB, Simoni J, Safren SA, Edwards TC, Patrick DL, Saag MS, Crane PK, Kitahata MM. 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: Rationale and Design. JMIR Res Protoc. 2016 Oct 5;5(4):e156. doi: 10.2196/resprot.5492.

  PMID: 27707688 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)