Evaluation of the PACE/PACENET BHL Clinical Program

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Not meeting the inclusion criteria listed above.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • SUSTAIN Monitoring and Care Management

    Behavioral

    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.

Treatment groups

4,000 Participants
are divided into 1 treatment group
Group A: SUSTAIN Monitoring and Care Management1 intervention

Trial outcomes

Primary outcomes

1

Veterans Rand - 12 Item Health Survey (VR-12)

A measure of physical and mental health functioning

Time frame
6 months

Secondary outcomes

1

Patient Health Questionnaire - 9 item Scale (PHQ-9)

A measure of depression severity

Time frame
6 months
2

Generalized Anxiety Disorder - 7 item Scale (GAD-7)

A measure of anxiety severity

Time frame
6 months

Other outcomes

Sponsors and contacts

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University of Pennsylvania

Lead sponsor

Magellan Health Services

Collaborator