DepressionSUSTAINIVNCT02463266
Evaluation of the PACE/PACENET BHL Clinical Program
An observational study of Depression and Anxiety, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Anxiety, Pain, Chronic
- What is being tested?
- SUSTAIN Monitoring and Care Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: PACE/PACENET beneficiaries who are participating in the PACE/PACENET SUSTAIN Clinical Program.
Who may be able to join
- Aged 65 and older, males and females.
- Participating in the SUSTAIN Clinical Program
- 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.
Who cannot join
- Not meeting the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Psychiatry (Center for Psychotherapy Research), University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mary Beth Gibbons, PhD, (215)662-3488, gibbonsm@pennmedicine.upenn.edu
David W Oslin, MD
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Depression, Anxiety, Pain, Chronic
- Being tested
- SUSTAIN Monitoring and Care Management
- Keywords
- Primary Care, Elderly, Depression
- Medical subject headings
- Depression, Anxiety Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUSTAIN Monitoring and Care ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SUSTAIN Monitoring and Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans Rand - 12 Item Health Survey (VR-12)
A measure of physical and mental health functioning
Measured: 6 months
Secondary outcomes (2)
Patient Health Questionnaire - 9 item Scale (PHQ-9)
A measure of depression severity
Measured: 6 months
Generalized Anxiety Disorder - 7 item Scale (GAD-7)
A measure of anxiety severity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Magellan Health Services
- Responsible party
- Principal investigator, Mary Beth Gibbons, Ph.D., University of Pennsylvania
- Investigators
- Mary Beth Gibbons, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463266
- Sponsor's protocol ID
- 819712
- Acronym
- SUSTAINIV
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2015
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25116369Maust 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.
PubMed 22678956Oslin 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.
PubMed 16423122Maust 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.
PubMed 21946801Mavandadi 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.
PubMed 26558530Gerlach 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.
PubMed 28967325Gerlach 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.
PubMed 30208384
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PACE/PACENET BHL Clinical Program
- ClinicalTrials.gov ID
- NCT02463266
- Acronym / sponsor ID
- SUSTAINIV / 819712
- Conditions
- Depression, Anxiety, Pain, Chronic
- Keywords
- Primary Care, Elderly, Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Magellan Health Services
- Study start
- Mar 2014
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUSTAIN Monitoring and Care Management | – | Behavioral: SUSTAIN Monitoring and Care ManagementSUSTAIN program participants who complete an initial clinical assessment and, if indicated, agree to follow-up services including Monitoring and/or Care Management. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- PACE/PACENET beneficiaries who are participating in the PACE/PACENET SUSTAIN Clinical Program.
Key inclusion criteria (3 listed)
- Aged 65 and older, males and females.
- Participating in the SUSTAIN Clinical Program
- 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.
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria listed above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUSTAIN Monitoring and Care ManagementProgram 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. | Behavioural | SUSTAIN Monitoring and Care Management |
Primary outcome
Veterans Rand - 12 Item Health Survey (VR-12)
Time frame: 6 months
A measure of physical and mental health functioning
2 secondary outcomes
Patient Health Questionnaire - 9 item Scale (PHQ-9)
Time frame: 6 months
Generalized Anxiety Disorder - 7 item Scale (GAD-7)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 25116369Maust 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.
- Background: PubMed 22678956Maust 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.
- Background: PubMed 16423122Oslin 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.
- Background: PubMed 21946801Maust 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.
- Background: PubMed 26558530Mavandadi 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.
- Background: PubMed 28967325Gerlach 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.
- Background: PubMed 30208384Gerlach 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Beth Gibbons, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Beth Gibbons, PhD ((215)662-3488, gibbonsm@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veterans Rand - 12 Item Health Survey (VR-12) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463266, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.