Clinical trial NCT02440594: The PACE/PACENET Behavioral Health Laboratory Project
Official title: The PACE/PACENET Behavioral Health Laboratory Project: Evaluation of a Clinical Management Program Among Older Adults Newly Prescribed Medication for Behavioral Health Issues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Primary Care
Depression
Elderly
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Magellan Health Services
First posted: 2015-05-12
Enrollment: 2432
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

1. 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.
2. 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:

1. 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.
2. 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. 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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. To be eligible for the Enhanced BHL Program, the only inclusion criterion is to have participated in an initial telephone assessment as part of the current PACE/PACENET BHL Clinical Program.
2. Similarly, to be eligible for the BHL Program Evaluations (i.e., BHL Clinical Data Evaluation, 3/6 Month Outcome Evaluation), the inclusion criterion is to have participated in an initial telephone assessment as part of the current PACE/PACENET BHL Clinical Program.
3. 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.

Exclusion Criteria:

Exclusion criteria for participation in the Enhanced BHL Program and the 3/6 Month Outcome Evaluation are:

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

Enrollees endorsing any of above mentioned exclusions will be offered assistance with referral to community specialty-care resources as part of the PACE/PACENET BHL Clinical Program.

Exclusion criteria for caregiver participation in the TEP component of Enhanced Care is lack of report of cognitive impairment when only the Caregiver interview was completed.

Primary outcomes:
measure: Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score
timeFrame: Baseline and 3 and 6 month follow-up
measure: Zarit Burden Interview (ZBI)
timeFrame: Baseline and 3 and 6 month follow-up
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 3 and 6 month follow-up
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Baseline and 3 and 6 month follow-up
measure: Number of Participants With Moderately Severe to Severe Depression (Per Patient Health Questionnaire-9 (PHQ-9))
timeFrame: Baseline and 3 and 6 month follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Department of Psychiatry (Addictions/Geriatric), University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David W Oslin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.