The PACE/PACENET Behavioral Health Laboratory Project

NCT02440594 | Completed Results

• 1 other identifier: 807774
• Study Type: interventional
• Target: 2,432
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current project is to conduct a program evaluation that examines the impact of the The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program - a telephone-based clinical service designed to help identify and manage behavioral health issues among enrollees in the Commonwealth of Pennsylvania Department of Aging's Pharmaceutical Assistance Contract for the Elderly and the PACE Needs Enhancement Tier Program (PACE/PACENET) - on enrollee outcomes and to evaluate the feasibility and impact of an enhancement to the current clinical program.

Conditions

Depression

Keywords

Primary Care; Depression; Elderly

Outcome Measures

Primary Outcomes (2)

• Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score

  A measure of overall mental health functioning as measured by the Medical Outcomes Survey Short Form (SF12) MCS subscale. Possible range = 0-100; higher scores mean better overall health functioning.

  Baseline and 3 and 6 month follow-up

• Zarit Burden Interview (ZBI)

  Brief, 4-item version of the Zarit Burden Interview; Possible range = 0-16; higher scores denote greater perceived caregiving burden. This measure was only collected of caregivers who participated in SUSTAIN program services.

  Baseline and 3 and 6 month follow-up

Secondary Outcomes (3)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline and 3 and 6 month follow-up

• Generalized Anxiety Disorder - 7 (GAD-7)

  Baseline and 3 and 6 month follow-up

• Number of Participants With Moderately Severe to Severe Depression (Per Patient Health Questionnaire-9 (PHQ-9))

  Baseline and 3 and 6 month follow-up

Study Arms (8)

Enhanced Care High-Symptom AD/AX

EXPERIMENTAL

Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.

Behavioral: Enhanced BHL Program Services

Standard Care High-Symptom AD/AX

ACTIVE COMPARATOR

Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.

Behavioral: Standard BHL Program Services

Enhanced Monitoring Low-Symptom AD/AX/AP

EXPERIMENTAL

Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.

Behavioral: Enhanced BHL Program Services

Standard Monitoring Low-Symptom AD/AX/AP

ACTIVE COMPARATOR

Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.

Behavioral: Standard BHL Program Services

Enhanced Care High-Symptom AP

EXPERIMENTAL

Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.

Behavioral: Enhanced BHL Program Services

Standard Care High-Symptom AP

ACTIVE COMPARATOR

Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.

Behavioral: Standard BHL Program Services

Caregiver TEP Intervention

EXPERIMENTAL

Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.

Behavioral: Enhanced BHL Program Services

Caregiver Control

ACTIVE COMPARATOR

Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services

Behavioral: Standard BHL Program Services

Interventions

Enhanced BHL Program Services BEHAVIORAL

Patients or their caregivers will work with a BHP to provided additional support and education beyond the services received in the Standard BHL Program.

Caregiver TEP Intervention; Enhanced Care High-Symptom AD/AX; Enhanced Care High-Symptom AP; Enhanced Monitoring Low-Symptom AD/AX/AP

Standard BHL Program Services BEHAVIORAL

Patients or their caregivers receive a baseline clinical assessment as well as monitoring of symptoms and referral to community resources.

Caregiver Control; Standard Care High-Symptom AD/AX; Standard Care High-Symptom AP; Standard Monitoring Low-Symptom AD/AX/AP

Eligibility Criteria

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

You may qualify if:

• Enrollment in the current PACE/PACENET BHL Clinical Program. Though not part of the research program, the current program targets older, community-dwelling adults (i.e., 65 years and older) enrolled in the PACE/PACENET programs, who have filled at least one new prescription for an antidepressant, antipsychotic, and/or anxiolytic medication. The BHL program does require the basic ability to communicate by telephone; either the enrollee or an identified caregiver must meet this criterion for participation in the BHL Clinical Program.

You may not qualify if:

• having severe cognitive impairment (BOMC score 14 or greater) in the absence of a caregiver, and/or
• endorsement of psychosis or mania during the initial clinical interview, and/or
• a PHQ score of 25 or greater, and/or
• positive drug abuse screen, and/or
• alcohol dependence.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Magellan Health Services: collaborator

Study Sites (1)

Department of Psychiatry (Addictions/Geriatric), University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• Oslin DW, Ross J, Sayers S, Murphy J, Kane V, Katz IR. Screening, assessment, and management of depression in VA primary care clinics. The Behavioral Health Laboratory. J Gen Intern Med. 2006 Jan;21(1):46-50. doi: 10.1111/j.1525-1497.2005.0267.x.

  PMID: 16423122 BACKGROUND

• Maust DT, Mavandadi S, Eakin A, Streim JE, Difillipo S, Snedden T, Oslin DW. Telephone-based behavioral health assessment for older adults starting a new psychiatric medication. Am J Geriatr Psychiatry. 2011 Oct;19(10):851-8. doi: 10.1097/JGP.0b013e318202c1dc.

  PMID: 21946801 BACKGROUND

• Maust DT, Mavandadi S, Benson A, Streim JE, Difilippo S, Snedden T, Weber AL, Oslin DW. Telephone-based care management for older adults initiated on psychotropic medication. Int J Geriatr Psychiatry. 2013 Apr;28(4):410-6. doi: 10.1002/gps.3839. Epub 2012 Jun 7.

  PMID: 22678956 RESULT

• Maust DT, Chen SH, Benson A, Mavandadi S, Streim JE, DiFilippo S, Snedden TM, Oslin DW. Older adults recently started on psychotropic medication: where are the symptoms? Int J Geriatr Psychiatry. 2015 Jun;30(6):580-6. doi: 10.1002/gps.4187. Epub 2014 Aug 12.

  PMID: 25116369 RESULT

• Mavandadi S, Benson A, DiFilippo S, Streim JE, Oslin D. A Telephone-Based Program to Provide Symptom Monitoring Alone vs Symptom Monitoring Plus Care Management for Late-Life Depression and Anxiety: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1211-8. doi: 10.1001/jamapsychiatry.2015.2157.

  PMID: 26558530 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Shahrzad Mavandadi
• Organization: University of Pennsylvania

shahrzad.mavandadi@va.gov

215-823-5211

Study Officials

• David W Oslin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Department of Psychiatry, Perelman School of Medicine

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: August 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 7, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-09

Locations

US (1)