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Improving Transitional Care Experiences in Mental Health

Improving Transitional Care Experiences in Mental Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02213198
Enrollment
465
Registered
2014-08-11
Start date
2014-08-31
Completion date
2016-07-31
Last updated
2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Standard Treatment Versus Engagement Focused Treatment

Keywords

Serious mental illness transitions shared decision making

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.

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.

Interventions

BEHAVIORALEngagement 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.

BEHAVIORALStandard 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

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective Quality of Lifebaseline, 3 months and 6 monthsThe 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
Engagement in Treatment6 monthsWhether patient kept appointment post TCC

Countries

United States

Participant flow

Participants by arm

ArmCount
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 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.
219
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. 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
107
Total326

Withdrawals & dropouts

PeriodReasonFG000FG001
Baselineincarcerated,violent01
BaselineLost to Follow-up4021
BaselineNo show for intake79
Baselinetransferred out of clinic79
BaselineWithdrawal by Subject3411
Follow up 1 3 Mos Post BL End of TCC txDeath10
Follow up 1 3 Mos Post BL End of TCC txLost to Follow-up6825
Follow up 1 3 Mos Post BL End of TCC txrehab/incarceration/violence32
Follow up 1 3 Mos Post BL End of TCC txunable to contact at 3 but got 6 post DC1710
Follow up 1 3 Mos Post BL End of TCC txWithdrawal by Subject44
Follow up 2 6 Months Post TCC TreatmentLost to Follow-up237

Baseline characteristics

CharacteristicStandard CareEngagement Focused CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
107 Participants219 Participants326 Participants
Age, Continuous39.9 years
STANDARD_DEVIATION 13.1
37.1 years
STANDARD_DEVIATION 11.4
38 years
STANDARD_DEVIATION 11.9
Region of Enrollment
United States
107 participants219 participants326 participants
Sex: Female, Male
Female
56 Participants123 Participants179 Participants
Sex: Female, Male
Male
51 Participants96 Participants147 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 3060 / 159
serious
Total, serious adverse events
0 / 3060 / 159

Outcome results

Primary

Engagement in Treatment

Whether patient kept appointment post TCC

Time frame: 6 months

Population: All patients for whom survey (call data) were available post TCC discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Engagement Focused CareEngagement in Treatment78 Participants
Standard CareEngagement in Treatment40 Participants
Primary

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

Population: All patients with baseline and at least one follow up on QOL

ArmMeasureGroupValue (MEAN)Dispersion
Engagement Focused CareSubjective Quality of LifeBaseline3.9 units on a scaleStandard Deviation 1.1
Engagement Focused CareSubjective Quality of LifeTCC Discharge at 3 months4.3 units on a scaleStandard Deviation 1.1
Engagement Focused CareSubjective Quality of LifeFollow up 6 mos post TCC4.5 units on a scaleStandard Deviation 1.1
Standard CareSubjective Quality of LifeBaseline3.8 units on a scaleStandard Deviation 1.1
Standard CareSubjective Quality of LifeTCC Discharge at 3 months4.0 units on a scaleStandard Deviation 1
Standard CareSubjective Quality of LifeFollow up 6 mos post TCC4.2 units on a scaleStandard Deviation 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026