Trial Outcomes & Findings for Improving Transitional Care Experiences in Mental Health (NCT NCT02213198)

Last Updated: 2019-02-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

465 participants

Primary outcome timeframe

baseline, 3 months and 6 months

Results posted on

2019-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Baseline STARTED	306	159
Baseline COMPLETED	218	108
Baseline NOT COMPLETED	88	51
Follow up 1 3 Mos Post BL End of TCC tx STARTED	218	108
Follow up 1 3 Mos Post BL End of TCC tx COMPLETED	125	67
Follow up 1 3 Mos Post BL End of TCC tx NOT COMPLETED	93	41
Follow up 2 6 Months Post TCC Treatment STARTED	125	67
Follow up 2 6 Months Post TCC Treatment COMPLETED	102	60
Follow up 2 6 Months Post TCC Treatment NOT COMPLETED	23	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Baseline No show for intake	7	9
Baseline Withdrawal by Subject	34	11
Baseline transferred out of clinic	7	9
Baseline Lost to Follow-up	40	21
Baseline incarcerated,violent	0	1
Follow up 1 3 Mos Post BL End of TCC tx Withdrawal by Subject	4	4
Follow up 1 3 Mos Post BL End of TCC tx rehab/incarceration/violence	3	2
Follow up 1 3 Mos Post BL End of TCC tx Death	1	0
Follow up 1 3 Mos Post BL End of TCC tx Lost to Follow-up	68	25
Follow up 1 3 Mos Post BL End of TCC tx unable to contact at 3 but got 6 post DC	17	10
Follow up 2 6 Months Post TCC Treatment Lost to Follow-up	23	7

Baseline Characteristics

Improving Transitional Care Experiences in Mental Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Engagement Focused Care n=219 Participants 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.	Standard Care n=107 Participants 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	Total n=326 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	219 Participants n=39 Participants	107 Participants n=41 Participants	326 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	37.1 years STANDARD_DEVIATION 11.4 • n=39 Participants	39.9 years STANDARD_DEVIATION 13.1 • n=41 Participants	38 years STANDARD_DEVIATION 11.9 • n=35 Participants
Sex: Female, Male Female	123 Participants n=39 Participants	56 Participants n=41 Participants	179 Participants n=35 Participants
Sex: Female, Male Male	96 Participants n=39 Participants	51 Participants n=41 Participants	147 Participants n=35 Participants
Region of Enrollment United States	219 participants n=39 Participants	107 participants n=41 Participants	326 participants n=35 Participants

PRIMARY outcome

Timeframe: baseline, 3 months and 6 months

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

Outcome measures

Outcome measures
Measure	Engagement Focused Care n=219 Participants 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.	Standard Care n=107 Participants 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
Subjective Quality of Life Baseline	3.9 units on a scale Standard Deviation 1.1	3.8 units on a scale Standard Deviation 1.1
Subjective Quality of Life TCC Discharge at 3 months	4.3 units on a scale Standard Deviation 1.1	4.0 units on a scale Standard Deviation 1.0
Subjective Quality of Life Follow up 6 mos post TCC	4.5 units on a scale Standard Deviation 1.1	4.2 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: 6 months

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

Whether patient kept appointment post TCC

Outcome measures

Outcome measures
Measure	Engagement Focused Care n=124 Participants 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.	Standard Care n=69 Participants 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
Engagement in Treatment	78 Participants	40 Participants

Adverse Events

Engagement Focused Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dawn Velligan

UTHSCSA

Phone: 210-567-5508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place