Trial Outcomes & Findings for The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers (NCT NCT02761733)

Last Updated: 2017-04-26

Results Overview

The physical health subscale (PCS-12; Physical Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess physical aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The aggregate PCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, \& Keller, 1995). PCS scores in the present study ranged from 13.2 to 65.6, with higher values indicating better physical health.

Recruitment status

COMPLETED

Study phase

Target enrollment

240 participants

Primary outcome timeframe

Change in scores on the SF-12 from Baseline to 24 month follow-up

Results posted on

2017-04-26

Participant Flow

The research team distributed recruitment letters (in English and Chinese) via mail and in person in all four research sites. With assistance from case managers, research assistants introduced themselves to patients and invited participation. Recruitment occurred from October 2013 to June 2014.

Enrollment was not directly related to the assignment of intervention, which was randomized at the site level. The screening predetermined criteria (exclusion of cognitive impairment). The number of individuals found eligible to participate was 266, and the research team subsequently randomly selected 240 participants.

Participant milestones

Participant milestones
Measure	Intervention Site - Urban Setting The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Overall Study STARTED	60	60	60	60
Overall Study 9/30/2014	53	56	48	55
Overall Study 3/31/2015	48	47	43	50
Overall Study 9/30/2015	40	44	33	50
Overall Study COMPLETED	30	39	33	45
Overall Study NOT COMPLETED	30	21	27	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Site - Urban Setting The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Overall Study Death	3	5	1	1
Overall Study Lost to Follow-up	6	7	0	3
Overall Study Physician Decision	4	0	0	0
Overall Study Withdrawal by Subject	2	0	0	0
Overall Study Discharged from Study Site	10	9	25	11
Overall Study Cognitive Impairment	5	0	1	0

Baseline Characteristics

Two clients at the rural control site did not report demographic data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Site - Urban Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 Participants Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 Participants Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)	Total n=240 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	0 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	0 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	0 Participants n=58 Participants • Two clients at the rural control site did not report demographic data.	0 Participants n=238 Participants • Two clients at the rural control site did not report demographic data.
Age, Categorical Between 18 and 65 years	13 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	19 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	54 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	50 Participants n=58 Participants • Two clients at the rural control site did not report demographic data.	136 Participants n=238 Participants • Two clients at the rural control site did not report demographic data.
Age, Categorical >=65 years	47 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	41 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	6 Participants n=60 Participants • Two clients at the rural control site did not report demographic data.	8 Participants n=58 Participants • Two clients at the rural control site did not report demographic data.	102 Participants n=238 Participants • Two clients at the rural control site did not report demographic data.
Sex/Gender, Customized Female	34 Participants n=60 Participants	30 Participants n=60 Participants	28 Participants n=60 Participants	35 Participants n=60 Participants	127 Participants n=240 Participants
Sex/Gender, Customized Male	26 Participants n=60 Participants	29 Participants n=60 Participants	32 Participants n=60 Participants	25 Participants n=60 Participants	112 Participants n=240 Participants
Sex/Gender, Customized Other	0 Participants n=60 Participants	1 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	1 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · White, not Hispanic	30 Participants n=60 Participants	38 Participants n=60 Participants	25 Participants n=60 Participants	37 Participants n=60 Participants	130 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black, not Hispanic	6 Participants n=60 Participants	10 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	16 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	5 Participants n=60 Participants	4 Participants n=60 Participants	32 Participants n=60 Participants	20 Participants n=60 Participants	61 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian or Pacific Islander	16 Participants n=60 Participants	5 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	21 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaskan Native	0 Participants n=60 Participants	1 Participants n=60 Participants	1 Participants n=60 Participants	0 Participants n=60 Participants	2 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · Mixed	0 Participants n=60 Participants	1 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	1 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	3 Participants n=60 Participants	1 Participants n=60 Participants	1 Participants n=60 Participants	0 Participants n=60 Participants	5 Participants n=240 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown	0 Participants n=60 Participants	0 Participants n=60 Participants	1 Participants n=60 Participants	3 Participants n=60 Participants	4 Participants n=240 Participants
Region of Enrollment United States	60 Participants n=60 Participants	60 Participants n=60 Participants	60 Participants n=60 Participants	60 Participants n=60 Participants	240 Participants n=240 Participants

PRIMARY outcome

Timeframe: Change in scores on the SF-12 from Baseline to 24 month follow-up

Population: Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.

Outcome measures

Outcome measures
Measure	Intervention Site - Urban Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 Participants Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 Participants Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale Baseline	38.167 units on a scale Standard Deviation 11.067	38.601 units on a scale Standard Deviation 10.595	37.187 units on a scale Standard Deviation 12.585	37.108 units on a scale Standard Deviation 10.148
Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale 24 Month Follow-up	34.386 units on a scale Standard Deviation 8.801	35.884 units on a scale Standard Deviation 12.343	36.354 units on a scale Standard Deviation 9.734	37.163 units on a scale Standard Deviation 12.555

PRIMARY outcome

Timeframe: Change in scores on the SF-12 from Baseline to 24 month follow-up Description: The Health Survey Short Form-12 (SF-12) includes 12 items that assess for physical and mental aspects of health and well-being.

The mental health subscale (MCS-12; Mental Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess mental aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The physical health subscale of the SF-12 was utilized as a key client functioning outcome in the current study. The aggregate MCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, \& Keller, 1995). MCS scores in the present study ranged from 9.6 to 72.0, with higher values indicating better physical health.

Outcome measures

Outcome measures
Measure	Intervention Site - Urban Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 Participants Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 Participants Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Short Form Health Survey-12 (SF-12) Mental Symptoms Baseline	43.828 units on a scale Standard Deviation 14.150	38.647 units on a scale Standard Deviation 13.623	34.153 units on a scale Standard Deviation 12.288	39.970 units on a scale Standard Deviation 13.033
Short Form Health Survey-12 (SF-12) Mental Symptoms 24 Month Follow-up	39.931 units on a scale Standard Deviation 12.795	39.570 units on a scale Standard Deviation 13.714	35.850 units on a scale Standard Deviation 11.915	37.768 units on a scale Standard Deviation 11.092

PRIMARY outcome

Timeframe: Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up

The Outcome Rating Scale (ORS) was utilized as a repeated measure of general therapy outcomes and quality of life changes during the course of therapy. The Outcome Rating Scale includes a visual analog scale (a horizontal line on which the participants marks how well they are doing within the last week from low to high) that records four questions about general well-being, personal well-being, close relationships, and work/school/friend relationships. Physical marks for each of four domains on the visual analog scale are measured by research team members with a ruler and converted to a score from 1 to 100. The four items are then averaged for an overall therapy outcome score. The total averaged ORS score ranges from 1 to 100, with higher scores indicating a better outcome. Analyses will examine treatment progress via change in ORS scores from pre- to post-intervention.

Outcome measures

Outcome measures
Measure	Intervention Site - Urban Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 Participants Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 Participants Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Outcome Rating Scale (ORS) Baseline	58.085 units on a scale Standard Deviation 24.192	49.003 units on a scale Standard Deviation 29.995	57.522 units on a scale Standard Deviation 23.978	59.583 units on a scale Standard Deviation 24.171
Outcome Rating Scale (ORS) 24 Month Follow-up	54.083 units on a scale Standard Deviation 29.634	56.987 units on a scale Standard Deviation 28.737	47.083 units on a scale Standard Deviation 29.460	61.433 units on a scale Standard Deviation 21.688

PRIMARY outcome

Timeframe: Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up

A 6-item modified version of the Shared Decision Making Questionnaire (SDM-Q-9) 46 was utilized to assess client reports about the degree to which their provider involved them in understanding and making a treatment decision. Examples items included "My provider discussed the advantages and disadvantages of options and strategies" or "My provider helped me understand all the information" measured on a 6-point scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, and completely agree). The total average score ranges from 1 to 6 with higher scores indicating a better outcome of greater shared decision making. Analyses will examine change in Shared Decision Making Questionnaire scores from pre- to post-intervention.

Outcome measures

Outcome measures
Measure	Intervention Site - Urban Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 Participants Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 Participants Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Shared Decision Making Questionnaire Baseline	4.698 units on a scale Standard Deviation 1.289	4.005 units on a scale Standard Deviation 1.293	4.995 units on a scale Standard Deviation 0.907	5.220 units on a scale Standard Deviation 0.673
Shared Decision Making Questionnaire 24 Month Follow-up	4.512 units on a scale Standard Deviation 0.872	4.363 units on a scale Standard Deviation 0.999	5.270 units on a scale Standard Deviation 0.827	5.239 units on a scale Standard Deviation 0.665

PRIMARY outcome

Timeframe: Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up

The Working Alliance Inventory measures the perception of therapeutic alliance in a clinical dyad during the process of developing a relationship required for effective psychotherapy. The current study utilized the client version of the Working Alliance Inventory included 7 items measured on a 7-point scale (never, rarely, occasionally, sometimes, often, very often, always). Example items included "I am confident in my provider's ability to help me" and "My provider and I trust one another." The Working Alliance Inventory total average score ranges from 1 to 7, with high scores indicating a more positive outcome. Analyses will examine change in patient-reported Working Alliance Inventory scores from pre- to post-intervention.

Outcome measures

Outcome measures
Measure	Intervention Site - Urban Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 Participants Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 Participants Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Working Alliance Inventory Baseline	5.896 units on a scale Standard Deviation 1.065	5.494 units on a scale Standard Deviation 1.086	6.203 units on a scale Standard Deviation 0.751	6.058 units on a scale Standard Deviation 1.045
Working Alliance Inventory 24 Month Follow-up	5.842 units on a scale Standard Deviation 0.941	5.810 units on a scale Standard Deviation 1.344	5.723 units on a scale Standard Deviation 1.182	5.751 units on a scale Standard Deviation 1.042

PRIMARY outcome

Timeframe: Change in scores on the Communication Satisfaction Questionnaire from Baseline to 24 month follow-up

Communication satisfaction was measured utilizing a modified version of a 19-item measure of communication patterns between physicians and their clients (Campbell et al., 2007). Thirteen items focusing on the client's satisfaction with communication with their provider and their engagement in treatment were measured on a 7-point scale (strongly agree, agree, agree somewhat, undecided, disagree somewhat, disagree, strongly disagree). Example items included "My provider checks to be sure that I understand everything" or "My provider involves me in decisions as much as I want." Total average scores range from 1 to 7 with higher scores indicating better communication satisfaction. Analyses will examine change in Satisfaction Questionnaire scores from pre- to post-intervention.

Outcome measures

Outcome measures
Measure	Intervention Site - Urban Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 Participants Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 Participants The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 Participants Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
Communication Satisfaction Questionnaire Baseline	4.283 units on a scale Standard Deviation 0.530	4.024 units on a scale Standard Deviation 0.706	4.363 units on a scale Standard Deviation 0.564	4.473 units on a scale Standard Deviation 0.578
Communication Satisfaction Questionnaire 24 Month Follow-up	3.947 units on a scale Standard Deviation 0.478	4.093 units on a scale Standard Deviation 0.529	4.135 units on a scale Standard Deviation .769	4.065 units on a scale Standard Deviation .690

Adverse Events

Intervention Site - Urban Setting

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Site - Urban Setting

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Site - Rural Setting

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Site - Rural Setting

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Site - Urban Setting n=60 participants at risk The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)	Control Site - Urban Setting n=60 participants at risk Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)	Intervention Site - Rural Setting n=60 participants at risk The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)	Control Site - Rural Setting n=60 participants at risk Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
General disorders Serious Adverse Event (Death)	5.0% 3/60 • Number of events 3 • Every 6 months up to two years. Every 6 months, up to two years, research data (including information about adverse events) was collected. Serious adverse events (including death) were reported to the IRB.	8.3% 5/60 • Number of events 5 • Every 6 months up to two years. Every 6 months, up to two years, research data (including information about adverse events) was collected. Serious adverse events (including death) were reported to the IRB.	1.7% 1/60 • Number of events 1 • Every 6 months up to two years. Every 6 months, up to two years, research data (including information about adverse events) was collected. Serious adverse events (including death) were reported to the IRB.	1.7% 1/60 • Number of events 1 • Every 6 months up to two years. Every 6 months, up to two years, research data (including information about adverse events) was collected. Serious adverse events (including death) were reported to the IRB.

Other adverse events

Adverse event data not reported

Additional Information

Joyce Chu (Principal Investigator)

Felton Institute & Palo Alto University

Phone: 650-814-8376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place