Trial Outcomes & Findings for High Deductible Health Plans and Bipolar Disorder (NCT NCT02560701)
NCT ID: NCT02560701
Last Updated: 2020-08-06
Results Overview
Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients
Recruitment status
COMPLETED
Target enrollment
350823 participants
Primary outcome timeframe
Year 3
Results posted on
2020-08-06
Participant Flow
Participants were identified in claims data. Each was required to have one inpatient episode or two outpatient visits with a corresponding diagnosis of bipolar disorder. Patients with schizophrenia or schizoaffective disorder were excluded.
Study participants without either a) two years of continuous enrollment in a low-deductible health plan OR b) one year of enrollment in a low-deductible plan followed by a continuous year of enrollment in a high-deductible plan were excluded. This brought the sample size from 350,823 to 97,302.
Participant milestones
| Measure |
High-Deductible Health Plan Group
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
|---|---|---|
|
Overall Study
STARTED
|
8060
|
89242
|
|
Overall Study
Carve Out
|
8060
|
88729
|
|
Overall Study
Restrict to Patients Between 12 and 64
|
7598
|
82367
|
|
Overall Study
Bipolar Diagnosis Time Constraints
|
3533
|
39427
|
|
Overall Study
Matched Cohort
|
3517
|
37776
|
|
Overall Study
COMPLETED
|
3517
|
37776
|
|
Overall Study
NOT COMPLETED
|
4543
|
51466
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
10 participants in control group were missing gender information
Baseline characteristics by cohort
| Measure |
High-Deductible Health Plan Group
n=3517 Participants
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
n=37776 Participants
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
Total
n=41293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 13.7 • n=3517 Participants
|
38.3 years
STANDARD_DEVIATION 14.1 • n=37776 Participants
|
38.3 years
STANDARD_DEVIATION 14.1 • n=41293 Participants
|
|
Sex: Female, Male
Female
|
2130 Participants
n=3517 Participants • 10 participants in control group were missing gender information
|
23153 Participants
n=37766 Participants • 10 participants in control group were missing gender information
|
25283 Participants
n=41283 Participants • 10 participants in control group were missing gender information
|
|
Sex: Female, Male
Male
|
1387 Participants
n=3517 Participants • 10 participants in control group were missing gender information
|
14613 Participants
n=37766 Participants • 10 participants in control group were missing gender information
|
16000 Participants
n=41283 Participants • 10 participants in control group were missing gender information
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
126 Participants
n=3517 Participants
|
1458 Participants
n=37776 Participants
|
1584 Participants
n=41293 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3391 Participants
n=3517 Participants
|
36318 Participants
n=37776 Participants
|
39709 Participants
n=41293 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3517 Participants
|
0 Participants
n=37776 Participants
|
0 Participants
n=41293 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3517 Participants
|
0 Participants
n=37776 Participants
|
0 Participants
n=41293 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=3517 Participants
|
519 Participants
n=37776 Participants
|
557 Participants
n=41293 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3517 Participants
|
0 Participants
n=37776 Participants
|
0 Participants
n=41293 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=3517 Participants
|
422 Participants
n=37776 Participants
|
451 Participants
n=41293 Participants
|
|
Race (NIH/OMB)
White
|
2599 Participants
n=3517 Participants
|
25982 Participants
n=37776 Participants
|
28581 Participants
n=41293 Participants
|
|
Race (NIH/OMB)
More than one race
|
685 Participants
n=3517 Participants
|
8701 Participants
n=37776 Participants
|
9386 Participants
n=41293 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
166 Participants
n=3517 Participants
|
2152 Participants
n=37776 Participants
|
2318 Participants
n=41293 Participants
|
|
Region of Enrollment
United States · Midwest
|
1203 Participants
n=3517 Participants
|
11003 Participants
n=37776 Participants
|
12206 Participants
n=41293 Participants
|
|
Region of Enrollment
United States · Northeast
|
253 Participants
n=3517 Participants
|
4720 Participants
n=37776 Participants
|
4973 Participants
n=41293 Participants
|
|
Region of Enrollment
United States · South
|
1616 Participants
n=3517 Participants
|
16283 Participants
n=37776 Participants
|
17899 Participants
n=41293 Participants
|
|
Region of Enrollment
United States · West
|
445 Participants
n=3517 Participants
|
5770 Participants
n=37776 Participants
|
6215 Participants
n=41293 Participants
|
|
Substance Use Disorder Flag
Substance Use Disorder
|
638 Participants
n=3517 Participants
|
6283 Participants
n=37776 Participants
|
6921 Participants
n=41293 Participants
|
|
Substance Use Disorder Flag
No Evidence of Substance Use Disorder
|
2879 Participants
n=3517 Participants
|
31493 Participants
n=37776 Participants
|
34372 Participants
n=41293 Participants
|
|
Rural
Non-Urban
|
258 Participants
n=3517 Participants
|
2492 Participants
n=37776 Participants
|
2750 Participants
n=41293 Participants
|
|
Rural
Urban
|
3259 Participants
n=3517 Participants
|
35284 Participants
n=37776 Participants
|
38543 Participants
n=41293 Participants
|
PRIMARY outcome
Timeframe: Year 3Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients
Outcome measures
| Measure |
High-Deductible Health Plan Group
n=3517 Participants
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
n=37776 Participants
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
|---|---|---|
|
Inpatient Hospitalizations Among Bipolar Patients
|
0.17 hospitalizations per year
Standard Deviation 0.60
|
0.17 hospitalizations per year
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: Year 3Mean number of annual emergency department visits in the follow-up period among bipolar patients
Outcome measures
| Measure |
High-Deductible Health Plan Group
n=3517 Participants
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
n=37776 Participants
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
|---|---|---|
|
Emergency Department Visits Among Patients With Bipolar Disorder
|
0.42 ED visits per year
Standard Deviation 1.26
|
0.38 ED visits per year
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: YEAR 2Mean number of annual bipolar medication fills in the follow-up period among bipolar patients
Outcome measures
| Measure |
High-Deductible Health Plan Group
n=3517 Participants
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
n=37776 Participants
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
|---|---|---|
|
Medication Adherence for Bipolar Disorder
|
0.57 Medication fills per year
Standard Deviation 3.15
|
1.42 Medication fills per year
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: YEAR 2Mean number of annual outpatient mental health visits for bipolar patients, averaged across baseline and follow-up periods
Outcome measures
| Measure |
High-Deductible Health Plan Group
n=3517 Participants
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
n=37776 Participants
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
|---|---|---|
|
Access To Outpatient Services for Bipolar Disorder
|
5.54 visits per year
Standard Deviation 8.48
|
6.15 visits per year
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: YEAR 2Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients
Outcome measures
| Measure |
High-Deductible Health Plan Group
n=3517 Participants
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
n=37776 Participants
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
|---|---|---|
|
Medication Adherence for Bipolar Disorder - Psychotropic Medications
|
0.73 medication fills per year
Standard Deviation 3.73
|
2.57 medication fills per year
Standard Deviation 6.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: YEAR 2, YEAR 3Annual patient out-of-pocket costs (paid deductible, coinsurance, and copayment amounts) for patients with Bipolar Disorder in the baseline period
Outcome measures
| Measure |
High-Deductible Health Plan Group
n=3517 Participants
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
|
Control Group
n=37776 Participants
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
|
|---|---|---|
|
Annual Patient Out-of-pocket Costs for Patients With Bipolar Disorder
|
1674.61 U.S. Dollars per year
Standard Deviation 1576.04
|
1440.45 U.S. Dollars per year
Standard Deviation 1510.86
|
Adverse Events
High-Deductible Health Plan Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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. J. Frank Wharam
Harvard Pilgrim Health Care Institute
Phone: (617) 867-4948
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place