Standard Treatment Versus Engagement Focused Treatment
Conditions
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
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Subjective Quality of Life | 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 |
| Engagement in Treatment | 6 months | Whether patient kept appointment post TCC |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline | incarcerated,violent | 0 | 1 |
| Baseline | Lost to Follow-up | 40 | 21 |
| Baseline | No show for intake | 7 | 9 |
| Baseline | transferred out of clinic | 7 | 9 |
| Baseline | Withdrawal by Subject | 34 | 11 |
| 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 | rehab/incarceration/violence | 3 | 2 |
| 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 1 3 Mos Post BL End of TCC tx | Withdrawal by Subject | 4 | 4 |
| Follow up 2 6 Months Post TCC Treatment | Lost to Follow-up | 23 | 7 |
Baseline characteristics
| Characteristic | Standard Care | Engagement Focused Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 219 Participants | 326 Participants |
| Age, Continuous | 39.9 years STANDARD_DEVIATION 13.1 | 37.1 years STANDARD_DEVIATION 11.4 | 38 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 107 participants | 219 participants | 326 participants |
| Sex: Female, Male Female | 56 Participants | 123 Participants | 179 Participants |
| Sex: Female, Male Male | 51 Participants | 96 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 306 | 0 / 159 |
| serious Total, serious adverse events | 0 / 306 | 0 / 159 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engagement Focused Care | Engagement in Treatment | 78 Participants |
| Standard Care | Engagement in Treatment | 40 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engagement Focused Care | Subjective Quality of Life | Baseline | 3.9 units on a scale | Standard Deviation 1.1 |
| Engagement Focused Care | Subjective Quality of Life | TCC Discharge at 3 months | 4.3 units on a scale | Standard Deviation 1.1 |
| Engagement Focused Care | Subjective Quality of Life | Follow up 6 mos post TCC | 4.5 units on a scale | Standard Deviation 1.1 |
| Standard Care | Subjective Quality of Life | Baseline | 3.8 units on a scale | Standard Deviation 1.1 |
| Standard Care | Subjective Quality of Life | TCC Discharge at 3 months | 4.0 units on a scale | Standard Deviation 1 |
| Standard Care | Subjective Quality of Life | Follow up 6 mos post TCC | 4.2 units on a scale | Standard Deviation 1 |