Trial Outcomes & Findings for Asthma in Families Facing Out-of-pocket Requirements With Deductibles (NCT NCT03175536)

NCT ID: NCT03175536

Last Updated: 2024-09-03

Results Overview

Adjusted mean change in adherence for inhaled corticosteroid medications as measured by change in percentage of days covered (PDC), relative to change in PDC for controls

• Recruitment status: COMPLETED
• Target enrollment: 12238 participants
• Primary outcome timeframe: baseline year to follow up year
• Results posted on: 2024-09-03

Participant Flow

Note that Aim 1 of the project was a qualitative study with a separate protocol under the larger project approved by the IRB, and recruited entirely separate participants from the other Aims.

Aims 2 was an observational cohort study using pre-existing secondary claims data, not a clinical trial. After the study began, we found that we lacked a large enough sample of enrollees in the existing database who were eligible for the "traditional plan" arm. After approval from the funder, we modified the protocol to include a "HDHP without PDL" arm instead; thus the "traditional plan" group was not considered enrolled and we did not collect outcome data for this group.

Participant milestones

Measure	HDHP With PDL Enrollees switched from a high-deductible health plan (HDHP) without a preventive drug list (PDL) to a HDHP with a PDL HDHP with PDL: Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)	HDHP Without PDL Enrollees stayed in a high-deductible health plan (HDHP) without a preventive drug list (PDL).
Overall Study STARTED	6087	6151
Overall Study COMPLETED	6087	6151
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Asthma in Families Facing Out-of-pocket Requirements With Deductibles

Baseline characteristics by cohort

Measure	HDHP With PDL n=6087 Participants Enrollees switched from a high-deductible health plan (HDHP) to a HDHP with a preventive drug list (PDL) HDHP with PDL: Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)	HDHP Without PDL n=6151 Participants Enrollees who stayed in a HDHP without a PDL.	Total n=12238 Participants Total of all reporting groups
Age, Customized Age (years) · 4-17	987 Participants n=5 Participants	976 Participants n=7 Participants	1963 Participants n=5 Participants
Age, Customized Age (years) · 18-29	1289 Participants n=5 Participants	1313 Participants n=7 Participants	2602 Participants n=5 Participants
Age, Customized Age (years) · 30-39	729 Participants n=5 Participants	952 Participants n=7 Participants	1681 Participants n=5 Participants
Age, Customized Age (years) · 40-49	1174 Participants n=5 Participants	1231 Participants n=7 Participants	2405 Participants n=5 Participants
Age, Customized Age (years) · 50-64	1908 Participants n=5 Participants	1679 Participants n=7 Participants	3587 Participants n=5 Participants
Sex: Female, Male Female	3377 Participants n=5 Participants	3447 Participants n=7 Participants	6824 Participants n=5 Participants
Sex: Female, Male Male	2710 Participants n=5 Participants	2704 Participants n=7 Participants	5414 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Asian, Non-Hispanic	137 Participants n=5 Participants	157 Participants n=7 Participants	294 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Black, Non-Hispanic	365 Participants n=5 Participants	361 Participants n=7 Participants	726 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic	422 Participants n=5 Participants	343 Participants n=7 Participants	765 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Other/unknown	290 Participants n=5 Participants	255 Participants n=7 Participants	545 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Non-Hispanic White	4873 Participants n=5 Participants	5035 Participants n=7 Participants	9908 Participants n=5 Participants
Any controller medication fill during baseline Any controller fill	1098 Participants n=5 Participants	1146 Participants n=7 Participants	2244 Participants n=5 Participants
Any controller medication fill during baseline No controller fill	4989 Participants n=5 Participants	5005 Participants n=7 Participants	9994 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline year to follow up year

Population: Participants with any fill in the baseline period. In this difference-in-differences study design, the outcome was the difference between arms in the difference in mean PDC from baseline to follow up. Note: after the study began, we found inadequate sample size for the "traditional plan" arm. After approval from the funder, we changed to using a differently defined study arm with a larger sample size (the "HDHP without PDL" arm) and did not collect outcome data for the "traditional plan" group.

Adjusted mean change in adherence for inhaled corticosteroid medications as measured by change in percentage of days covered (PDC), relative to change in PDC for controls

Outcome measures

Measure	HDHP With PDL n=135 Participants Enrollees switched from a high-deductible health plan (HDHP) to a HDHP with a preventive drug list (PDL) HDHP with PDL: Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)	HDHP Without PDL n=140 Participants Enrollees who stayed in a HDHP without a PDL.
Change in Percentage of Days Covered for Inhaled Corticosteroids baseline period	51.5 percentage of days Interval 47.0 to 56.1	44.7 percentage of days Interval 36.4 to 52.9
Change in Percentage of Days Covered for Inhaled Corticosteroids follow up period	37.0 percentage of days Interval 31.6 to 42.5	29.1 percentage of days Interval 21.3 to 36.9

PRIMARY outcome

Timeframe: baseline year to follow up year

Population: Participants with any fill in the baseline period. In this difference-in-differences study design, the outcome was the difference between arms in the difference in mean PDC from baseline to follow up. Note: after the study began, we found inadequate sample size for the "traditional plan" arm. After approval from the funder, we changed to using a differently defined study arm with a larger sample size (the "HDHP without PDL" arm) and did not collect outcome data for the "traditional plan" group.

Adjusted mean change in adherence for leukotriene inhibitor medications as measured by change in percentage of days covered (PDC), relative to change in PDC for controls

Outcome measures

Measure	HDHP With PDL n=389 Participants Enrollees switched from a high-deductible health plan (HDHP) to a HDHP with a preventive drug list (PDL) HDHP with PDL: Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)	HDHP Without PDL n=392 Participants Enrollees who stayed in a HDHP without a PDL.
Change in Percentage of Days Covered for Leukotriene Inhibitors baseline period	70.3 percentage of days Interval 67.8 to 72.8	72.7 percentage of days Interval 68.0 to 77.4
Change in Percentage of Days Covered for Leukotriene Inhibitors follow up period	58.4 percentage of days Interval 54.9 to 62.0	59.1 percentage of days Interval 52.6 to 65.6

PRIMARY outcome

Timeframe: baseline year to follow up year

Population: Participants with any fill in the baseline period. In this difference-in-differences study design, the outcome was the difference between arms in the difference in mean PDC from baseline to follow up. Note: after the study began, we found inadequate sample size for the "traditional plan" arm. After approval from the funder, we changed to using a differently defined study arm with a larger sample size (the "HDHP without PDL" arm) and did not collect outcome data for the "traditional plan" group.

Adjusted mean change in adherence for Inhaled Corticosteroid-Long-Acting Beta Agonist medications as measured by change in percentage of days covered (PDC), relative to change in PDC for controls

Outcome measures

Measure	HDHP With PDL n=234 Participants Enrollees switched from a high-deductible health plan (HDHP) to a HDHP with a preventive drug list (PDL) HDHP with PDL: Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)	HDHP Without PDL n=237 Participants Enrollees who stayed in a HDHP without a PDL.
Change From Baseline in Percentage of Days Covered for Inhaled Corticosteroid-long-acting Beta Agonist Medications baseline period	55.9 percentage of days Interval 52.8 to 59.0	58.6 percentage of days Interval 54.3 to 62.8
Change From Baseline in Percentage of Days Covered for Inhaled Corticosteroid-long-acting Beta Agonist Medications follow up period	44.3 percentage of days Interval 40.3 to 48.2	40.1 percentage of days Interval 33.8 to 46.4

PRIMARY outcome

Timeframe: baseline year to follow up year

Population: Participants with persistent asthma in the baseline period. In this difference-in-differences design, the outcome was the difference between arms in the difference in mean rates of ED visits from baseline to follow up. Note: after the study began, we found inadequate sample size for the "traditional plan" arm. After approval from the funder, we changed to using a study arm with a larger sample size (the "HDHP without PDL" arm) and did not collect outcome data for the "traditional plan" group.

Absolute change in asthma-related ED visits per 100 patients relative to controls

Outcome measures

Measure	HDHP With PDL n=6087 Participants Enrollees switched from a high-deductible health plan (HDHP) to a HDHP with a preventive drug list (PDL) HDHP with PDL: Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)	HDHP Without PDL n=6087 Participants Enrollees who stayed in a HDHP without a PDL.
Asthma-related Emergency Department (ED) Visits baseline period	2.29 ED visits per 100 patients Interval 1.9 to 2.68	2.48 ED visits per 100 patients Interval 1.72 to 3.25
Asthma-related Emergency Department (ED) Visits follow up period	2.10 ED visits per 100 patients Interval 1.72 to 2.47	2.10 ED visits per 100 patients Interval 1.56 to 2.65

PRIMARY outcome

Timeframe: baseline year to follow up year

Population: Patients with persistent asthma in the baseline period. In this difference-in-differences study design, the outcome was the difference between arms in the difference in mean OOP costs from baseline to follow up. Note: after the study began, we found inadequate sample size for the "traditional plan" arm. After approval from the funder, we changed to using a study arm with a larger sample size (the "HDHP without PDL" arm) and did not collect outcome data for the "traditional plan" group.

change in out-of-pocket (OOP) costs for asthma medications and other health services

Outcome measures

Measure	HDHP With PDL n=6087 Participants Enrollees switched from a high-deductible health plan (HDHP) to a HDHP with a preventive drug list (PDL) HDHP with PDL: Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)	HDHP Without PDL n=6087 Participants Enrollees who stayed in a HDHP without a PDL.
Out-of-pocket Costs follow up period	85 dollars Interval 79.0 to 92.0	112 dollars Interval 100.0 to 124.0
Out-of-pocket Costs baseline period	130 dollars Interval 121.0 to 138.0	122 dollars Interval 110.0 to 133.0

Adverse Events

HDHP With PDL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HDHP Without PDL

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. Alison Galbraith

Harvard Medical School and Harvard Pilgrim Health Care Institute

Phone: 6178674893

Email: alison_galbraith@harvardpilgrim.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place