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临床试验/NCT02463266
NCT02463266招募中不适用

Evaluation of the PACE/PACENET BHL Clinical Program

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,000
试验地点
1
主要终点
Veterans Rand - 12 Item Health Survey (VR-12)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Not meeting the inclusion criteria listed above.

结局指标

主要结局

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

时间窗: 6 months

A measure of physical and mental health functioning

次要结局

  • Patient Health Questionnaire - 9 item Scale (PHQ-9)(6 months)
  • Generalized Anxiety Disorder - 7 item Scale (GAD-7)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Beth Gibbons, Ph.D.

Professor of Psychiatry, Director of Center for Psychotherapy Research, Department of Psychiatry University of Pennsylvania

University of Pennsylvania

研究点 (1)

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