Evaluation of the PACE/PACENET BHL Clinical Program (SUSTAINIV)

The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is a telephone-based clinical service designed to help identify and manage behavioral health issues among PACE/PACENET enrollees. The purpose of the current project is to a) explore moderators of treatment response among beneficiaries in the SUSTAIN Clinical Program and b) to evaluate the sustained clinical effects of the program.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety; Pain, Chronic
• Intervention / Treatment: Behavioral: SUSTAIN Monitoring and Care Management

Detailed Description

The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is an evidence-based clinical service administered via telephone and designed to help identify and manage behavioral health issues among enrollees of the Commonwealth of Pennsylvania Department of Aging's Pharmaceutical Assistance Contract for the Elderly (PACE) and the PACE Needs Enhancement Tier (PACENET) Program who have been newly prescribed psychotropic medications. The SUSTAIN program has adapted the existing software and staffing model from Penn's Behavioral Health Laboratory (BHL), which has been used to integrate Mental Health (MH) care within primary care in other health systems, including the VA where it was originally developed. The SUSTAIN program is a novel and flexible clinical service that addresses some of the barriers that hinder treatment outcomes for MH problems. Given the fact that the SUSTAIN program provides assessment, monitoring, early intervention, disease management, and referral management over the telephone, the program can be tailored to each individual's specific needs. The SUSTAIN program also overcomes logistical barriers such as the necessity of frequent face-to-face contact in specialty programs, and thus can enhance existing specialty care programs by reducing wait times and "no-show" rates. As a result, the SUSTAIN program has the potential to result in higher patient satisfaction, improved health, and, accordingly, greater independent functioning.

The SUSTAIN program assesses individuals with behavioral health issues and offers a subset of these individuals ongoing follow-up services based on clinical need and symptom severity. Follow-up service options include Monitoring and Care Management. Monitoring consists of up to 4 brief (5-10 minutes), structured assessments following the baseline assessment. These follow-up contacts are conducted over the telephone by the Heath Technician (HT) or Behavioral Health Provider (BHP) and take place during the initial 12 weeks of pharmaceutical treatment. These brief interviews monitor symptoms, adherence, side effects, and response to treatment. Care Management is algorithm-driven care for conditions such as depression, panic disorder, generalized anxiety disorder, and chronic pain, and is delivered by a BHP as an adjunct to primary care. The BHP monitors and encourages patient acceptance and adherence to treatment recommendations through support, education, and motivational engagement.

The investigators will evaluate the extent to which SUSTAIN is related to program participants' outcomes. The evaluation of the program relies on 2 sources of data: 1) a retrospective chart review of data collected as part of the clinical program, which includes data from the baseline and follow-up clinical interviews, and 2) data collected during a one-time 6 Month Outcome Research Evaluation interview completed with SUSTAIN program participants who provide verbal consent. The retrospective chart review will evaluate the clinical data from 5500 PACE/PACENET enrollees who participate in the PACE/PACENET SUSTAIN Clinical Program (which includes both Monitoring and Care Management). The 6 Month Outcome Research Evaluation will evaluate long term outcomes among a subset of participants.

Clinical Program Procedures:

Referred PACE/PACENET enrollees are contacted to complete an initial baseline clinical interview. Following the baseline interview, enrollees are offered several different services, depending on clinical need: Referral Management, Care Management, or Monitoring. Enrollee participation in the program occurs over the span of up to six months, with the number of calls based upon the follow-up service.

Study Procedures:

A. Retrospective Chart Review Procedures:

The retrospective chart review of the clinical data (i.e., data collected at baseline and during Monitoring and Care Management visits) will be conducted and saved as a separate research database. The research database will be de-identified (but include coded data) and kept in a separate password protected file.

B. 6 Month Outcome Research Evaluation Procedures:

PACE/PACENET enrollees who participate in the SUSTAIN Clinical Program will be asked to provide verbal HIPAA authorization and consent for participation in the 6 Month Outcome Research Evaluation at the end of the acute phase of clinical care, usually at three months. Enrollees providing verbal consent to participate in the 6 Month Outcome Research Evaluations will be called again at 6 months following the date of the initial clinical interview. At the 6 Month Outcome Research call, assessments will be conducted that mirror the SUSTAIN Clinical Program baseline assessment.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Mary Beth Gibbons, PhD; Phone Number: (215)662-3488; Email: gibbonsm@pennmedicine.upenn.edu
• Study Contact Backup: Name: Elizabeth Grecco, MSS, LCSW; Phone Number: (215) 746-2980; Email: egrecco@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Department of Psychiatry (Center for Psychotherapy Research), University of Pennsylvania
      • Contact: Mary Beth Gibbons, PhD; Phone Number: (215)662-3488; Email: gibbonsm@pennmedicine.upenn.edu
      • Sub-Investigator: David W Oslin, MD
      • Principal Investigator: Mary Beth Gibbons, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

PACE/PACENET beneficiaries who are participating in the PACE/PACENET SUSTAIN Clinical Program.

Description

Inclusion Criteria:

1. Aged 65 and older, males and females.
2. Participating in the SUSTAIN Clinical Program
3. For the 6 Month Outcome Research Evaluation, in addition to meeting criteria 1 and 2, willing to provide verbal informed consent to participate in the 6 Month Outcome Research Evaluation at the end of the acute phase of clinical care, usually at three months.

Exclusion Criteria:

• Not meeting the inclusion criteria listed above.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SUSTAIN Monitoring and Care Management; SUSTAIN program participants who complete an initial clinical assessment and, if indicated, agree to follow-up services including Monitoring and/or Care Management.

Behavioral: SUSTAIN Monitoring and Care Management; Program participants are offered clinical services based on symptom severity and clinical need. Follow-up Monitoring consists of up to 4 brief, structured assessments following the baseline clinical assessment. These follow-up contacts are conducted over the telephone by the HT/BHP and take place during the initial 12 weeks of pharmaceutical treatment. These brief interviews monitor symptoms, adherence, side effects, and response to treatment. Care Management 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. The BHP monitors and encourages patient acceptance and adherence to treatment recommendations through support, education, and motivational engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Veterans Rand - 12 Item Health Survey (VR-12)	A measure of physical and mental health functioning	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 9 item Scale (PHQ-9)	A measure of depression severity	6 months
Generalized Anxiety Disorder - 7 item Scale (GAD-7)	A measure of anxiety severity	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Magellan Health Services
• Investigators: Principal Investigator: Mary Beth Gibbons, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Gerlach LB, Mavandadi S, Maust DT, Streim JE, Oslin DW. Improving Access to Collaborative Behavioral Health Care for Rural-Dwelling Older Adults. Psychiatr Serv. 2018 Jan 1;69(1):117-120. doi: 10.1176/appi.ps.201700026. Epub 2017 Oct 2.
• Gerlach LB, Maust DT, Leong SH, Mavandadi S, Oslin DW. Factors Associated With Long-term Benzodiazepine Use Among Older Adults. JAMA Intern Med. 2018 Nov 1;178(11):1560-1562. doi: 10.1001/jamainternmed.2018.2413.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimated): June 4, 2015

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Elderly; Primary Care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Anxiety Disorders; Chronic Pain; Depression; Anti-Infective Agents; Sulfamethazine
• Other Study ID Numbers: 819712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No