Improving Transitional Care Experiences in Mental Health

• ClinicalTrials.gov Identifier: NCT02213198
• Recruitment Status: Completed
• First Posted: August 11, 2014
• Results First Posted: March 15, 2017
• Last Update Posted: February 21, 2019
• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Standard Treatment Versus Engagement Focused Treatment	Behavioral: Engagement focused care; Behavioral: Standard Care	Not Applicable

Detailed Description:

Aim 1: To compare EFC to SC with respect to linkage to TCC services. Hypothesis A: Patients referred to EFC will exhibit a significantly greater rate of attendance at their TCC intake appointment than SC patients.

Aim 2: To compare EFC to SC with respect to patient participation in outpatient treatment.

Hypothesis B: Patients referred to EFC will report significantly greater shared decision-making in their TCC prescriber appointments than SC patients.

Hypothesis C: Patients referred to EFC will exhibit significantly greater attendance at post-intake scheduled TCC appointments than SC patients.

Hypothesis D: Patients referred to EFC will exhibit a significantly greater rate of attendance at initial post-TCC scheduled mental health appointments than SC patients.

Aim 3: To compare Engagement-focused Care (EFC) to Standard Care (SC) with respect to patients' long term quality of life.

Hypothesis E: Patients who receive EFC will exhibit significantly greater quality of life than SC patients six months after TCC termination.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 465 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Improving Transitional Care Experiences in Mental Health
• Study Start Date: August 2014
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Engagement Focused Care; 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; 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.
Active Comparator: Standard Care; 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; 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

Outcome Measures

Primary Outcome Measures :

1. Subjective Quality of Life [ Time Frame: baseline, 3 months and 6 months ]
   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
2. Engagement in Treatment [ Time Frame: 6 months ]
   Whether patient kept appointment post TCC

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable to complete assessments

Contacts and Locations

Locations

United States, Texas

UTHSCSA

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Dawn I Velligan, PhD; University of Texas

More Information

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02213198
• Other Study ID Numbers: IH-1304-6506
• First Posted: August 11, 2014
• Results First Posted: March 15, 2017
• Last Update Posted: February 21, 2019
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Deidentified data provided by PI as requested velligand@uthscsa.edu

Keywords provided by The University of Texas Health Science Center at San Antonio:

Serious mental illness transitions shared decision making