Clinical trial NCT05901272: Implementation of Collaborative Care for Depression in VA HIV Clinics
Official title: Implementation of Collaborative Care for Depression in VA HIV Clinics: Translating Initiatives for Depression Into Effective Solutions (HITIDES)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Depression
Keywords: HIV
Depression
Hybrid type 3 effectiveness-implementation trial
Facilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-06-13
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm randomized controlled trial (RCT) with four VA HIV clinics in each arm. Arm 1 receives a learning collaborative and clinical champions at each site Arm 2 receives these plus external facilitation. Learning collaboratives will be hosted separately for sites in Arm 1 and sites in Arm 2 to avoid contamination. Across all aims, there are research activities proposed to evaluate the quality improvement (referred to as "implementation strategy bundles"). All implementation strategy bundles are supported by educational materials about HITIDES and tools to engage Veterans in implementation activities.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) is a team-based service to manage depression in Veterans Living with HIV (VLWH). This service is more effective for managing depression than the care VLWH usually receive and saves resources. HITIDES is also liked by HIV care providers and VLWH. Despite this, no VA clinics currently offer this service. This study examines two approaches to engage clinics with HITIDES, the resulting effects on VLWH, and the costs of these approaches. The first approach includes recruiting an HIV care provider at the site to help connect with the service and a network of providers to support this person. The second approach uses an additional external expert to facilitate these connections. Understanding how to connect Veterans to the HITIDES service will allow VA to improve depression care for VLWH and save VA resources.

Detailed description: Background: HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) is a collaborative care intervention that adapts the primary care collaborative care model for depression treatment to HIV clinics. In a randomized controlled trial, HITIDES significantly improved depression symptoms for Veterans Living with HIV (VLWH) and delivered cost savings. However, no VHA HIV clinics have implemented HITIDES. The goal of this study is to support broad implementation of the HITIDES intervention by testing two appropriate implementation strategies: a clinical champion from each site who, with the help of a learning collaborative of peers, will work with local clinicians and leadership to implement the HITIDES intervention at their site with and without the assistance of external facilitation from an implementation expert.

Significance/Impact: Preliminary work has been completed to identify implementation strategies acceptable to VLWH and HIV care providers; however, the relative effectiveness and cost of these implementation strategies is unknown. While the HITIDES depression care team (DCT) is housed off-site and can deliver services consistently with high quality and fidelity, the ability of the DCT to interface and engage with HIV care providers at sites is unknown. Additionally, the mediating effect of site-level implementation outcomes such as reach and adoption on effectiveness of the intervention is unknown. Because the DCT can provide services to multiple HIV clinics, a small-scale rollout of the intervention is needed before considering a national roll out.

Innovation: This study employs an innovative hybrid study design to concurrently examine implementation and effectiveness outcomes. The use of implementation success as a mediating factor for intervention effectiveness is also novel. The relative ability of implementation activities to impact care for vulnerable populations is an area of research where little is known. VHA HIV clinics are an ideal test case for examining these questions because VLWH are a group where racial minority, low income, sexual minority Veterans are disproportionately represented.

Specific Aims: 1) Determine, through a cluster-randomized controlled trial among VHA HIV clinics, the effect of adding external facilitation to an implementation strategy consisting of a site-level clinical champion and learning collaborative. 2) Determine the impact of HITIDES on changes in depression and suicidal ideation among HIV-positive Veterans receiving the intervention. 3) Estimate the budget impact of HITIDES implementation strategies by calculating the costs of each strategy.

Methodology: The use of a hybrid type-3 effectiveness-implementation trial to examine the interaction of implementation and intervention effectiveness is an innovative methodology ideal for situations where the lack of robust evidence of effectiveness is coupled with a cost-saving intervention. This hybrid trial will use a cluster randomization of 8 VHA HIV clinics. These clinics will be chosen for balance and diversity of clinic characteristics and randomly assigned to one of the two implementation arms. Evaluation of each aim will use a mix of primary (e.g., QUERI-developed time-tracking tool) and secondary (e.g., clinical data warehouse) data. The investigators expect the clinical champion, learning collaborative, and external facilitation arm to be associated with greater reach and adoption; however, the clinical champion and learning collaborative alone arm is expected to be less costly.

Next steps: The findings from implementation of the HITIDES intervention to 8 VHA HIV clinics will be used to inform selection of implementation strategies for a broad roll out in the future. Findings will be presented in cooperation with the investigators operational partner, VA HIV, Hepatitis C, and Related Condition Program to VACO and VISN leadership.

Eligibility criteria: Inclusion Criteria:

The research team will work with VISN 10 to identify sites that

* have an adequately sized (i.e. greater than 20) population of Veterans Living with HIV,
* have adequate PHQ-2 screen data to assess depression prevalence,
* can identify a clinical champion for implementation activities,
* are willing to participate, and
* allow for diversity and balance of clinic characteristics across arms (e.g. rate of referral to specialty mental health for VLWH and presence of HIV-only specialty clinic versus broad infectious disease clinic).

  * For criterion 5, these factors that are important will be determined with VISN 10 clinical leadership and the research advisory council. Randomization at the VAMC level has limited ability to completely balance observed and unobserved health-system factors. However, efforts to balance key site characteristics are important; therefore, site-level characteristics thought to impact implementation efforts were identified by building consensus among HIV, Hepatitis, and Related Conditions Program (HHRC) leadership and the HIV care and implementation experts on the research team. Data on the following observable site-level characteristics will be collected from these sites during Year 1 of the study: baseline PHQ-2 screen rate, clinic size (unique patients, provider full-time equivalents \[FTE\], change in enrollment over the past 3 years), and current care manager FTE. Based on the five criteria described above and the power calculation below, eight eligible sites will be selected. Sites will be grouped into four couplets based on balance of the identified site-level characteristics.

Exclusion Criteria:

-None.

Primary outcomes:
measure: Reach
timeFrame: 12 months
Secondary outcomes:
measure: Reach
timeFrame: 18 months
measure: Adoption
timeFrame: 12 months
measure: Depression - Patient Health Questionnaire-9
timeFrame: 12 months
measure: Suicidal ideation - Columbia-Suicide Severity Rating Scale
timeFrame: 12 months
measure: Cost - Budget Impact
timeFrame: 12 months
measure: Adoption
timeFrame: 18 months
measure: Depression - Patient Health Questionnaire-9
timeFrame: 18 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System , Little Rock, AR
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System , Little Rock, AR
name: Jacob T Painter, PhD PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Arkansas Veterans Healthcare System , Little Rock, AR
name: Eva N Woodward, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
References: