The PACE/PACENET Behavioral Health Laboratory Project | NCT02440594

NCT02440594

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Magellan Health Services	OTHER

Description Module

Detailed Description

Despite advances in the assessment and treatment of behavioral health disorders among older adults, such disorders remain inadequately diagnosed and managed in later life. This is troubling in light of the fact that behavioral health issues often serve as the catalyst for a variety of negative psychosocial and physical health outcomes in later life, including changes in social network functioning, physical disability and morbidity, loss of independence, and institutionalization. Factors such as limited provider resources for conducting frequent monitoring, variability in patient preferences and symptom severity, patients' lack of treatment acceptance and engagement, low medication adherence, formal and informal social support and aid, and logistic issues (e.g., transportation, finances, etc.) all work in concert to influence patient identification and disease management. Yet, these factors are difficult to address when managing conditions using traditional mental health (MH) care delivery models that rely primarily on referrals to specialty care and/or face-to-face contact.

Recognizing that traditional MH care delivery models and treatment strategies do not address both practice- and patient-level logistical issues that are particularly relevant in behavioral health care, where frequent clinical visits for monitoring and therapeutic contact are key components in the successful treatment of patients, the investigators have adopted a strategy of delivering disease management by way of telephone assessments. The Behavioral Health Laboratory (BHL) is a flexible and dynamic telephone-based clinical service designed to help identify and manage behavioral health issues. The principles of the program include: MH as a key component to overall physical health; the need to make early MH screening, assessment, and referral to services a part of common practice; the value in utilizing technology in accessing and delivering MH care; and the importance of research- and evidence-based practice.

An untoward outcome of the efforts to improve rates of treatment is the increased and sometimes inappropriate use of psychotropic medication. Among the general population, the use of psychotropic medication and rates of psychotropic polypharmacy continue to rise, with increased use of medication for both anxiety and depression in both primary care and specialty care. The rates of use have raised concerns regarding inappropriate prescribing among the elderly.

Results from the investigators' initial program of care management services for PACE/PACENET cardholders support the above concerns related to psychotropic medication prescription in the elderly and also raise additional questions about off-label or inappropriate prescribing. The program results indicate that the PACE/PACENET population is mostly female with a mean age of 78.1 years (SD 7.0), and an SF-12 Physical Component Score of 41.6. The average Patient Health Questionnaire-9 (PHQ-9) score for those on antidepressants (AD) was 6.1 (5.4), with no statistically significant difference between medication groups (F(2.436)=2.14, p=0.12); just 9 (6.3%) of those receiving anxiolytics (AX) met criteria for an anxiety disorder, which was not significantly different than other medication classes (x2(2)=1.77, p=0.41). Overall, 208 (47.4%) participants in the sample did not meet criteria for any mental health disorder, including 80 (55.9%) of those receiving anxiolytics.

Thus, the purpose of the current project is to evaluate the impact of the PACE/PACENET BHL clinical programs on older Pennsylvanians and to evaluate the feasibility and impact of enhancements to the current clinical program. The clinical contract for services targets PACE/PACENET beneficiaries who have been newly prescribed an antidepressant, antipsychotic (AP), and/or anxiolytic, and, where appropriate, their caregivers. In order to obtain a representative sample of PACE/PACENET enrollees, the PACE/PACENET program uses a stratified sampling method for the identification and referral of eligible beneficiaries to the PACE/PACENET BHL Clinical Program. Stratification is conducted with respect to two variables--county and medication type, with individuals randomly selected from each strata. Current clinical participants are not being sampled or contacted specifically for research purposes. The research portion of this project relates only to the evaluation of those enrolled in the clinical program and to the delivery and evaluation of the enhancements to the current program. Moreover, while the program provides services to a variety of patients with varying types and levels of symptoms, our primary objectives are specific to patients prescribed an antidepressant or anxiolytic who show significant baseline symptomatology. Nonetheless, we describe all program participants below.

The PACE/PACENET BHL Research Participants:

Enhanced BHL Program Participants:

Upon completion of the initial PACE/PACENET BHL Program interview, the investigators will randomly select a subset of up to 2400 enrollees for the Enhanced BHL Program and invite the enrollees to participate in the Enhanced Program. If the enrollee is not able to complete the full initial BHL interview due to cognitive impairment (either as identified by cognitive screening or caregiver report), the caregiver may be invited to participate in the caregiver component of the Enhanced BHL Program, the Telehealth Education Program (TEP) Module.
BHL Program Evaluations: Participants recruited for the evaluation component of the BHL Programs (Standard and Enhanced) will fall into the following categories:
1. Evaluation of BHL Clinical Data: In order to examine factors such as participant clinical and sociodemographic characteristics, process of care, prescription refills, and use of services, the investigators will ask enrollees for permission to use the clinical data collected during the BHL interviews. To accomplish this component of the evaluation, the investigators will orally consent all individuals who at least begin a Core interview to allow use of the clinical data for research purposes. Participants do not need to consent to use of the clinical data as a prerequisite to participating in the clinical program. The clinical data will include their prescription data supplied by the PACE/PACENET program.
2. 3/6 Month Outcome Evaluation: In order to examine long-term outcomes, participants who complete an initial clinical interview will be offered participation in an outcome evaluation at 3 and 6 months.

Subject Recruitment and Screening:

BHL Clinical Data Evaluation: Following completion of the initial PACE/PACENET BHL clinical assessment (i.e., "Core assessment"), all enrollees will be asked for permission to use the clinical data collected during the BHL interviews.
Enhanced Program Recruitment: Following completion of the initial PACE/PACENET BHL clinical assessment, a subset of enrollees will be asked to participate in the Enhanced BHL Program. Randomization to the Enhanced Program will occur within strata as determined by index medication type and Core interview assessment outcome (i.e., clinically significant depression and/or anxiety symptoms, no clinically significant symptoms, cognitive impairment). After obtaining informed consent, a separate simple randomization protocol will be followed within each substratum of enrollees. For each substratum every other participant will be offered participation in the Enhanced BHL Program.
3/6 Month Outcome Evaluation Recruitment: Following completion of the initial PACE/PACENET clinical assessments and agreement to participation in the Enhanced Program or our Standard Clinical Program, enrollees or the caregivers will be asked to participate in an evaluation of the BHL program at 3 and 6 months from the initial PACE/PACENET BHL clinical interview.

Study Procedures:

The Enhanced BHL Program:

The Enhanced BHL Program: Upon completion of the Core interview, a subset of enrollees will be randomly selected to participate in the Enhanced BHL Program (i.e., Enhanced Monitoring Module or Enhanced Care Management Module). For enrollees who do not report clinically significant mental health symptoms the Enhanced Program consists of the Standard Monitoring Module enhanced with a discussion of continuing versus discontinuing the medication. The Behavioral Health Provider (BHP) will follow-up with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication. For enrollees who report clinically significant depression, anxiety, and/or pain symptoms the Enhanced Program consists of Care Management. The model incorporates the use of a BHP who has expertise in mental health assessment and is well versed in the delivery of algorithm-based management strategies for disorders such as depression and anxiety. The role of the BHP is to facilitate treatment and provide informal psychosocial therapy, using motivational interviewing techniques, in a manner that is consistent with the Agency for Health Care Policy and Research (AHCPR) guidelines. The BHP monitors and encourages patient acceptance and adherence to treatment recommendations through support, education, and motivational engagement. The BHP initiates care management when enrollees are not responding to the initial treatment or as clinically needed based on the initial Core interview and needs assessment. The BHP also uses problem solving therapy to assist patients. In cases where caregivers participate due to the enrollees' cognitive impairment, they will be asked to participate in the Telehealth Education Program (TEP). The TEP is a manual-driven psychosocial support and skills training program for caregivers of individuals with moderate to severe cognitive impairment. The frequency and number of contacts for each individual will vary; individuals typically engage in 1-2 contacts per month for several months. Written updates are provided to the prescribing clinician, as clinically indicated.
3/6 Month Outcome Evaluation: In order to evaluate individual-level outcomes and rates of clinical improvement at 3 and 6 months, the investigators will attempt to collect follow-up data from all enrollees/caregivers who have completed the initial PACE/PACENET BHL Clinical Program assessment. Using data extracted from the enrollee follow-up assessments, the investigators will examine psychological, behavioral, and cognitive symptoms, physical disability, health care utilization, and access to community resources. Using data extracted from caregiver follow-up assessments, the investigators will be able to evaluate care recipients' behavioral, psychological, and cognitive symptoms and level of physical functioning, in addition to caregiver burden and safety concerns.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	A 9-item measure of depressive symptom severity in past 2 weeks. Possible range = 0-27; higher scores indicate higher depressive symptom severity.	Baseline and 3 and 6 month follow-up
Generalized Anxiety Disorder - 7 (GAD-7)

Eligibility Module

Name	Affiliation	Role
David W Oslin, MD	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry (Addictions/Geriatric), University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16423122	Background	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.
21946801	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.

Arm/Group Information

ID	Title	Description
FG000	Enhanced Care High-Symptom AD/AX	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.
FG001	Standard Care High-Symptom AD/AX	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.
FG002	Enhanced Monitoring Low-Symptom AD/AX/AP	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.
FG003	Standard Monitoring Low-Symptom AD/AX/AP	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.
FG004	Enhanced Care High-Symptom AP	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.
FG005	Standard Care High-Symptom AP	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.
FG006	Caregiver TEP Intervention	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.
FG007	Caregiver Control	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Enhanced Care High-Symptom AD/AX	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

SUSTAIN participants who were prescribed an AD or AX (per pharmacy records) and endorsed high baseline MH symptoms during the initial clinical interview. This was not a primary outcome measure for those patients assigned to the other 4 groups; data were extracted from clinical records only for patients assigned to the two designated arms.

Posted

Mean

Standard Deviation

score on a scale

Baseline and 3 and 6 month follow-up

ID	Title	Description
OG000	Enhanced Care High-Symptom AD/AX	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Enhanced Care High-Symptom AD/AX	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior