Trial Outcomes & Findings for Shared Decision-Making for Elderly Depressed Primary Care Patients (NCT NCT01031134)
NCT ID: NCT01031134
Last Updated: 2017-06-16
Results Overview
Any mental health service use over 12 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
202 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-06-16
Participant Flow
Participant milestones
| Measure |
Shared Decision Making
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
|
Usual Care
Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
88
|
|
Overall Study
COMPLETED
|
103
|
78
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shared Decision-Making for Elderly Depressed Primary Care Patients
Baseline characteristics by cohort
| Measure |
Shared Decision Making
n=114 Participants
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
|
Usual Care
n=88 Participants
Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
|
Total
n=202 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
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
114 Participants
n=39 Participants
|
88 Participants
n=41 Participants
|
202 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=39 Participants
|
72 Participants
n=41 Participants
|
164 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
101 Participants
n=39 Participants
|
83 Participants
n=41 Participants
|
184 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
111 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
114 Participants
n=39 Participants
|
88 Participants
n=41 Participants
|
202 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 weeksAny mental health service use over 12 weeks.
Outcome measures
| Measure |
Shared Decision Making
n=103 Participants
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
|
Usual Care
n=78 Participants
Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
|
|---|---|---|
|
Number of Participants Who Adhered to Physician Recommended Treatment
|
40 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weekPopulation: fewer number of participants in comparison to primary outcome measure reflect greater numbers of missing observations for the Hamilton outcome
Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.
Outcome measures
| Measure |
Shared Decision Making
n=84 Participants
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
|
Usual Care
n=66 Participants
Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale Scores
|
-6.05 units on a scale
Standard Deviation 7.03
|
-7.35 units on a scale
Standard Deviation 6.97
|
Adverse Events
Shared Decision Making
Serious events: 49 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care
Serious events: 47 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Shared Decision Making
n=114 participants at risk
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
|
Usual Care
n=88 participants at risk
Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
|
|---|---|---|
|
General disorders
ER visit
|
18.4%
21/114 • 24 weeks
|
23.9%
21/88 • 24 weeks
|
|
Surgical and medical procedures
hospitalization
|
0.88%
1/114 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Gastrointestinal disorders
hospitalization
|
0.00%
0/114 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
General disorders
hospitalization
|
0.00%
0/114 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Surgical and medical procedures
ambulatory surgery
|
1.8%
2/114 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
ER visit
|
3.5%
4/114 • 24 weeks
|
10.2%
9/88 • 24 weeks
|
|
Gastrointestinal disorders
ER visit
|
0.88%
1/114 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
ER visit
|
1.8%
2/114 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
ER visit
|
1.8%
2/114 • 24 weeks
|
3.4%
3/88 • 24 weeks
|
|
Psychiatric disorders
ER visit
|
0.88%
1/114 • 24 weeks
|
3.4%
3/88 • 24 weeks
|
|
Renal and urinary disorders
ER visit
|
0.88%
1/114 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ER visit
|
5.3%
6/114 • 24 weeks
|
3.4%
3/88 • 24 weeks
|
|
Surgical and medical procedures
ER visit
|
0.88%
1/114 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Vascular disorders
ER visit
|
6.1%
7/114 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place