Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV |
Behavioral: Care management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Supportive Care |
| Official Title: | Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical 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 ]
| Estimated Enrollment: | 270 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Heidi M Crane, MD, MPH | 206-744-6649 | hcrane@uw.edu |
| Contact: Rob Fredericksen, PhD | rfrederi@uw.edu |
| United States, Washington | |
| University of Washington | Not yet recruiting |
| 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 |
More Information
No publications provided
| Responsible Party: | Heidi Crane, Assistant Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01505660 History of Changes |
| Other Study ID Numbers: | 41128-K, R01MH084759, U01AR057954, ADH HIV001 |
| Study First Received: | January 4, 2012 |
| Last Updated: | January 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
Adherence Depression Care management Stepped care |
HIV Patient reported outcomes Antiretroviral medication adherence |
ClinicalTrials.gov processed this record on May 19, 2013