An interventional study of Engagement focused care and Standard Care in Standard Treatment Versus Engagement Focused Treatment, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Other
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.
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.
The University of Texas Health Science Center at San Antonio is the lead sponsor of 443 studies on the registry; 88 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.
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Exclusion Criteria:
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 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
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.
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
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
Time frame: baseline, 3 months and 6 months
Engagement in Treatment
Whether patient kept appointment post TCC
Time frame: 6 months
| Milestone | Engagement Focused Care | Standard Care |
|---|---|---|
| Started | 306 | 159 |
| Completed | 218 | 108 |
| Not completed | 88 | 51 |
| Withdrew: No show for intake | 7 | 9 |
| Withdrew: Withdrawal by subject | 34 | 11 |
| Withdrew: Transferred out of clinic | 7 | 9 |
| Withdrew: Lost to follow-up | 40 | 21 |
| Withdrew: Incarcerated,violent | 0 | 1 |
| Milestone | Engagement Focused Care | Standard Care |
|---|---|---|
| Started | 218 | 108 |
| Completed | 125 | 67 |
| Not completed | 93 | 41 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Rehab/incarceration/violence | 3 | 2 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 68 | 25 |
| Withdrew: Unable to contact at 3 but got 6 post dc | 17 | 10 |
| Milestone | Engagement Focused Care | Standard Care |
|---|---|---|
| Started | 125 | 67 |
| Completed | 102 | 60 |
| Not completed | 23 | 7 |
| Withdrew: Lost to follow-up | 23 | 7 |
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
| units on a scale | Engagement Focused Care | Standard Care |
|---|---|---|
| Baseline | 3.9 ± 1.1 | 3.8 ± 1.1 |
| TCC Discharge at 3 months | 4.3 ± 1.1 | 4.0 ± 1.0 |
| Follow up 6 mos post TCC | 4.5 ± 1.1 | 4.2 ± 1.0 |
Whether patient kept appointment post TCC
| Participants | Engagement Focused Care | Standard Care |
|---|---|---|
| Engagement in Treatment | 78 | 40 |
Collected over 9-12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Engagement Focused Care | — | 0/306 (0%) | 0/306 (0%) |
| Standard Care | — | 0/159 (0%) | 0/159 (0%) |
| Age, Categorical(Participants) | Engagement Focused Care | Standard Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 219 | 107 | 326 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Engagement Focused Care | Standard Care | Total |
|---|---|---|---|
| Mean | 37.1 ± 11.4 | 39.9 ± 13.1 | 38 ± 11.9 |
| Sex: Female, Male(Participants) | Engagement Focused Care | Standard Care | Total |
|---|---|---|---|
| Female | 123 | 56 | 179 |
| Male | 96 | 51 | 147 |
| Region of Enrollment(participants) | Engagement Focused Care | Standard Care | Total |
|---|---|---|---|
| United States | 219 | 107 | 326 |
Plan to share: Yes — Deidentified data provided by PI as requested velligand@uthscsa.edu
No publications or documents are linked to this record.
The record gives a start of Aug 2014, a primary completion of Jul 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2017, 8 months after primary completion.
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