HIV Translating Initiatives for Depression Into Effective Solutions

NCT ID: NCT00304915

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2016-11-30

Brief Summary

This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.

Detailed Description

Background: Depression is the most common mental disorder in HIV infected patients. Despite the availability of efficacious treatments for depression, evidence suggests that it is under-diagnosed and under-treated in routine HIV care. To address this problem, the investigators will adapt and implement a collaborative stepped-care model for depression treatment in HIV clinics. This proposal builds on past success of the TIDES/WAVES programs used in VA primary care. The project (HI-TIDES or HIV Translating Initiatives for Depression into Effective Solutions) will implement the primary care collaborative care model for depression treatment in HIV clinics using evidence-based implementation strategies. Objectives: The objectives of this proposal are to: 1) Develop and evaluate the process of adapting, implementing, and sustaining collaborative care for depression in VA HIV clinics, 2) Compare the quality of depression care and the clinical effectiveness of HI-TIDES to usual care in the HIV clinics, and 3) Evaluate the cost-effectiveness of patients assigned to HI-TIDES relative to patients assigned to usual care in HIV clinics. Methods: The implementation framework for this proposal is primarily informed by the Rogers diffusion of innovation model, Simpson Transfer Model, and the PRECEDE model. The VA and American Psychiatric Association Practice Guidelines inform the stepped care collaborative model intervention as source documents for summarizing the evidence for depression treatment for the general population. An expert panel will be convened to rate the quality of available evidence for depression treatment in the context of HIV. Patients will be recruited from VA HIV clinics: Little Rock, Atlanta, and Houston. The intervention will be randomized at the level of the patient. The investigators expect to recruit a total of 140 intervention and 140 usual care patients. Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in the VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager. A formative evaluation will occur during start-up and throughout the implementation of the intervention. A summative evaluation will document the effectiveness and cost-effectiveness of the intervention using an intent to treat analysis plan. Findings: No results at this time. Status: Start-up activities. Impact: The proposed study is highly relevant to the VA and the Veterans it serves for many reasons. First, the majority of VA patients with HIV are not seen in the primary care clinics and therefore will not benefit from VA's efforts in primary care settings to improve depression identification and treatment. Second, in addition to the negative outcomes of depression generally, depression in HIV patients is associated with additional negative outcomes including accelerated HIV disease progression, decreased immune system functioning, and premature death. Third, directly moving collaborative depression care from primary care clinics to HIV clinics is likely to fail for several reasons including the comorbidities associated with depressed HIV patient and the potential for drug-drug interactions. The proposed project will address these gaps and provide effectiveness and cost-effectiveness analyses to inform decisions about larger scale implementation of the HI-TIDES intervention.

Conditions

HIV, Depression

Keywords

HIV, depression; patient care management; patient care team

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Collaborative Care Intervention

HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received collaborative care intervention.

Group Type: EXPERIMENTAL

Collaborative Care Interventions

Intervention Type: BEHAVIORAL

Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.

Arm 2: Usual Care

HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Collaborative Care Interventions

Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and

2. current treatment in the HIV clinic.

Exclusion Criteria

1. patients who do not have access to a telephone,

2. patients with current suicidal ideation,

3. patients with significant cognitive impairment as indicated by a score < 10 on the HIV Dementia Scale, and

4. patients with a chart diagnosis of schizophrenia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey M Pyne, MD

Role: PRINCIPAL_INVESTIGATOR

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Locations

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Countries

United States

References

Pyne JM, Asch SM, Lincourt K, Kilbourne AM, Bowman C, Atkinson H, Gifford A. Quality indicators for depression care in HIV patients. AIDS Care. 2008 Oct;20(9):1075-83. doi: 10.1080/09540120701796884.

Reference Type: RESULT

PMID: 18825515 (View on PubMed)

Fortney JC, Pyne JM, Smith JL, Curran GM, Otero JM, Enderle MA, McDougall S. Steps for implementing collaborative care programs for depression. Popul Health Manag. 2009 Apr;12(2):69-79. doi: 10.1089/pop.2008.0023.

Reference Type: RESULT

PMID: 19320606 (View on PubMed)

Ackerman B, Pyne JM, Fortney JC. Challenges associated with being an off-site depression care manager. J Psychosoc Nurs Ment Health Serv. 2009 Apr;47(4):43-9. doi: 10.3928/02793695-20090401-01.

Reference Type: RESULT

PMID: 19437931 (View on PubMed)

Pyne JM, Fortney JC, Curran GM, Tripathi S, Atkinson JH, Kilbourne AM, Hagedorn HJ, Rimland D, Rodriguez-Barradas MC, Monson T, Bottonari KA, Asch SM, Gifford AL. Effectiveness of collaborative care for depression in human immunodeficiency virus clinics. Arch Intern Med. 2011 Jan 10;171(1):23-31. doi: 10.1001/archinternmed.2010.395.

Reference Type: RESULT

PMID: 21220657 (View on PubMed)

Curran GM, Pyne J, Fortney JC, Gifford A, Asch SM, Rimland D, Rodriguez-Barradas M, Monson TP, Kilbourne AM, Hagedorn H, Atkinson JH. Development and implementation of collaborative care for depression in HIV clinics. AIDS Care. 2011 Dec;23(12):1626-36. doi: 10.1080/09540121.2011.579943. Epub 2011 Jun 30.

Reference Type: RESULT

PMID: 21714689 (View on PubMed)

Fortney JC, Pyne JM, Steven CA, Williams JS, Hedrick RG, Lunsford AK, Raney WN, Ackerman BA, Ducker LO, Bonner LM, Smith JL. A Web-based clinical decision support system for depression care management. Am J Manag Care. 2010 Nov;16(11):849-54.

Reference Type: RESULT

PMID: 21348556 (View on PubMed)

Chapman J, Oser M, Hockemeyer J, Weitlauf J, Jones S, Cheung R. Changes in depressive symptoms and impact on treatment course among hepatitis C patients undergoing interferon-alpha and ribavirin therapy: a prospective evaluation. Am J Gastroenterol. 2011 Dec;106(12):2123-32. doi: 10.1038/ajg.2011.252. Epub 2011 Aug 9.

Reference Type: RESULT

PMID: 21826113 (View on PubMed)

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

Reference Type: RESULT

PMID: 22310560 (View on PubMed)

Bottonari KA, Tripathi SP, Fortney JC, Curran G, Rimland D, Rodriguez-Barradas M, Gifford AL, Pyne JM. Correlates of antiretroviral and antidepressant adherence among depressed HIV-infected patients. AIDS Patient Care STDS. 2012 May;26(5):265-73. doi: 10.1089/apc.2011.0218. Epub 2012 Mar 21.

Reference Type: RESULT

PMID: 22536930 (View on PubMed)

Painter JT, Fortney JC, Gifford AL, Rimland D, Monson T, Rodriguez-Barradas MC, Pyne JM. Cost-Effectiveness of Collaborative Care for Depression in HIV Clinics. J Acquir Immune Defic Syndr. 2015 Dec 1;70(4):377-85. doi: 10.1097/QAI.0000000000000732.

Reference Type: RESULT

PMID: 26102447 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/26126749

PubMed

Other Identifiers

MNT 05-152

Identifier Type: -

Identifier Source: org_study_id