Improving Transitional Care Experiences in Mental Health

NCT02213198 | Completed Results DMC

• 1 other identifier: IH-1304-6506
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

The cost of serious mental illness (SMI) in the U.S. is $317 billion annually. This translates to more than $1000 for every man, women, and child in the U.S. Hospitalization and Emergency Room (ER) visits have the highest costs. Outpatient services are overburdened. There is a push to get people out of hospitals quickly, while they are still quite ill. These factors cause patients to be lost in the transition from inpatient to outpatient care. Many individuals are repeatedly rehospitalized or continue to clog emergency rooms in an attempt to receive care. The importance of transitional care between inpatient/ER facilities and outpatient services to prevent this revolving door phenomenon has been continually stressed. There is little research on the best way to accomplish smooth transition to outpatient care. We developed a 90-day transitional care clinic (TCC) to address this need. We propose a randomized treatment outcome study comparing two transitional service packages within our TCC: a Standard Care package versus an Engagement-Focused package that features a novel intake procedure and a Shared Decision-Making intervention: Access Group is an intake procedure designed to address many of the problems of traditional approaches to post-acute treatment engagement, including failure of patients to reach intake appointments. Shared Decision-Making (SDM) is a structured approach to provider-patient communication that has been shown to increase patient involvement in care and improve outcomes. Despite SMI patients' desire to be more involved in their treatment decisions and promising early evidence of SDM's effectiveness in SMI, SDM has not been systematically evaluated in transitional psychiatric care. In the proposed study, patients referred to TCC will be randomized to either Engagement-focused Care or Standard Care. The relative benefit of these two approaches will be evaluated in 300 individuals who will be randomized to these two treatments in a 2:1 ratio. We hypothesize that attendance at appointments, reported satisfaction, shared decision making and quality of life will be higher for engagement focused care. The new treatment package is designed to get individuals into treatment quickly and to teach them how to be good consumers of mental health treatments going forward.

Conditions

Standard Treatment Versus Engagement Focused Treatment

Keywords

Serious mental illness transitions shared decision making

Outcome Measures

Primary Outcomes (2)

• Subjective Quality of Life

  The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life

  baseline, 3 months and 6 months

• Engagement in Treatment

  Whether patient kept appointment post TCC

  6 months

Study Arms (2)

Engagement Focused Care

EXPERIMENTAL

Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention

Behavioral: Engagement focused care

Standard Care

ACTIVE COMPARATOR

Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.

Behavioral: Standard Care

Interventions

Engagement focused care BEHAVIORAL

Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.

Engagement Focused Care

Standard Care BEHAVIORAL

Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serious mental illness including (schizophrenia, schizoaffective disorder, mood disorders, anxiety disorders), referral from inpatient psychiatric unit or emergency service at the time of discharge to the Transitional Care Clinic, ability to sign informed consent

You may not qualify if:

• Unable to complete assessments

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Dawn Velligan
• Organization: UTHSCSA

velligand@uthscsa.edu

210-567-5508

Study Officials

• Dawn I Velligan, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 21, 2019
• Results First Posted: March 15, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)