Trial Outcomes & Findings for A Comparative Effectiveness Trial of Optimal Patient-Centered Care (NCT NCT02274688)
NCT ID: NCT02274688
Last Updated: 2017-11-21
Results Overview
The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
171 participants
Primary outcome timeframe
The investigators assessed at baseline, 1-, 3-, and 6-month.
Results posted on
2017-11-21
Participant Flow
Participant milestones
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
|
Overall Study
COMPLETED
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparative Effectiveness Trial of Optimal Patient-Centered Care
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 16 • n=93 Participants
|
41.2 years
STANDARD_DEVIATION 16.1 • n=4 Participants
|
42.4 years
STANDARD_DEVIATION 16.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
156 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=93 Participants
|
85 participants
n=4 Participants
|
171 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
Baseline
|
80 Participants
|
83 Participants
|
|
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
1-month
|
55 Participants
|
59 Participants
|
|
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
3-month
|
45 Participants
|
48 Participants
|
|
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
6-month
|
42 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
Baseline
|
42.9 units on a scale
Standard Deviation 11.2
|
42.5 units on a scale
Standard Deviation 11.3
|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
1-month
|
41.7 units on a scale
Standard Deviation 14.3
|
43.7 units on a scale
Standard Deviation 14.9
|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
3-month
|
40.7 units on a scale
Standard Deviation 14.7
|
38.7 units on a scale
Standard Deviation 13.7
|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
6-month
|
39.3 units on a scale
Standard Deviation 14.7
|
38.6 units on a scale
Standard Deviation 16.0
|
PRIMARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
6-month
|
10.7 units on a scale
Standard Deviation 6.4
|
9.3 units on a scale
Standard Deviation 6.8
|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
Baseline
|
14.8 units on a scale
Standard Deviation 4.2
|
14.3 units on a scale
Standard Deviation 4.5
|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
1-month
|
12.1 units on a scale
Standard Deviation 6.2
|
13.2 units on a scale
Standard Deviation 6.5
|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
3-month
|
11.7 units on a scale
Standard Deviation 7.2
|
10.8 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Alcohol Use Problems
Baseline
|
3.7 units on a scale
Standard Deviation 3.2
|
3.4 units on a scale
Standard Deviation 3.2
|
|
Alcohol Use Problems
1-month
|
1.1 units on a scale
Standard Deviation 2.6
|
0.5 units on a scale
Standard Deviation 1.6
|
|
Alcohol Use Problems
3-month
|
1.7 units on a scale
Standard Deviation 2.8
|
1.1 units on a scale
Standard Deviation 1.9
|
|
Alcohol Use Problems
6-month
|
2.3 units on a scale
Standard Deviation 2.9
|
1.6 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. No other subscales will be used.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Functional Status
3-month
|
39.3 units on a scale
Standard Deviation 9.9
|
39.8 units on a scale
Standard Deviation 8.0
|
|
Functional Status
Baseline
|
48.4 units on a scale
Standard Deviation 9.1
|
48.5 units on a scale
Standard Deviation 9.2
|
|
Functional Status
1-month
|
38.3 units on a scale
Standard Deviation 10.4
|
37.1 units on a scale
Standard Deviation 10.9
|
|
Functional Status
6-month
|
39.9 units on a scale
Standard Deviation 9.9
|
42.3 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of \> 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Number of Participants With Suicidal Ideation
Baseline
|
19 Participants
|
22 Participants
|
|
Number of Participants With Suicidal Ideation
1-month
|
13 Participants
|
18 Participants
|
|
Number of Participants With Suicidal Ideation
3-month
|
21 Participants
|
14 Participants
|
|
Number of Participants With Suicidal Ideation
6-month
|
16 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigation used a single yes/no item to assess whether the patient was carrying a weapon.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Number of Patients Carrying a Weapon
Baseline
|
7 Participants
|
12 Participants
|
|
Number of Patients Carrying a Weapon
1-month
|
4 Participants
|
3 Participants
|
|
Number of Patients Carrying a Weapon
3-month
|
7 Participants
|
5 Participants
|
|
Number of Patients Carrying a Weapon
6-month
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: The investigators assessed emergency department service use over the course of the study.The investigators used population level data on emergency department health service use for the intent-to-treat sample
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Number of Participants With One or More Emergency Department Visits Over Time
3-6 month
|
26 Participants
|
14 Participants
|
|
Number of Participants With One or More Emergency Department Visits Over Time
6-9 month
|
27 Participants
|
18 Participants
|
|
Number of Participants With One or More Emergency Department Visits Over Time
Baseline
|
41 Participants
|
44 Participants
|
|
Number of Participants With One or More Emergency Department Visits Over Time
9-12 month
|
26 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used.
Outcome measures
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 Participants
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 Participants
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Drug Use Problems
Baseline
|
2.0 units on a scale
Standard Deviation 1.9
|
2.2 units on a scale
Standard Deviation 2.0
|
|
Drug Use Problems
1-month
|
1.4 units on a scale
Standard Deviation 1.2
|
1.3 units on a scale
Standard Deviation 1.2
|
|
Drug Use Problems
3-month
|
1.4 units on a scale
Standard Deviation 1.4
|
1.3 units on a scale
Standard Deviation 1.1
|
|
Drug Use Problems
6-month
|
1.3 units on a scale
Standard Deviation 1.0
|
1.5 units on a scale
Standard Deviation 1.4
|
Adverse Events
Enhanced Usual Care - Nurse Notification of Patient Concerns
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Patient-centered Care Transition
Serious events: 2 serious events
Other events: 39 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 participants at risk
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 participants at risk
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
1.2%
1/86 • Number of events 1 • 1 year, 6 months
Serious adverse event = Any documented suicide attempt Adverse event = Any PHQ-9, item 9, score \>0
|
2.4%
2/85 • Number of events 2 • 1 year, 6 months
Serious adverse event = Any documented suicide attempt Adverse event = Any PHQ-9, item 9, score \>0
|
Other adverse events
| Measure |
Enhanced Usual Care - Nurse Notification of Patient Concerns
n=86 participants at risk
Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed.
|
Patient-centered Care Transition
n=85 participants at risk
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
|
|---|---|---|
|
Psychiatric disorders
PHQ-9 Score of >0
|
45.3%
39/86 • 1 year, 6 months
Serious adverse event = Any documented suicide attempt Adverse event = Any PHQ-9, item 9, score \>0
|
45.9%
39/85 • 1 year, 6 months
Serious adverse event = Any documented suicide attempt Adverse event = Any PHQ-9, item 9, score \>0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place