Trial Outcomes & Findings for Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients (NCT NCT02504502)
NCT ID: NCT02504502
Last Updated: 2018-02-12
Results Overview
3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
3 months after receipt of enhanced report
Results posted on
2018-02-12
Participant Flow
Subjects participating in the whole genome sequencing study for undiagnosed developmental delay at Geisinger Health System were invited to participate.
parents were randomized together (e.g. parents were both randomized to the same arm). parents were grouped by genomic sequencing finding (causal variant found vs. non-causal variant found) prior to randomization to ensure equal number of causal variants and non-causal variants in each arm.
Participant milestones
| Measure |
Routine Care With Delayed Access to Report
Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
|
Routine Clinical Care Plus Enhanced Genomic Report
Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
|
|---|---|---|
|
Routine Care vs. Enhanced Report
STARTED
|
24
|
28
|
|
Routine Care vs. Enhanced Report
COMPLETED
|
20
|
21
|
|
Routine Care vs. Enhanced Report
NOT COMPLETED
|
4
|
7
|
|
Crossover to Enhanced Report
STARTED
|
20
|
0
|
|
Crossover to Enhanced Report
COMPLETED
|
15
|
0
|
|
Crossover to Enhanced Report
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Routine Care With Delayed Access to Report
Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
|
Routine Clinical Care Plus Enhanced Genomic Report
Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
|
|---|---|---|
|
Routine Care vs. Enhanced Report
Lost to Follow-up
|
4
|
7
|
|
Crossover to Enhanced Report
Lost to Follow-up
|
5
|
0
|
Baseline Characteristics
Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients
Baseline characteristics by cohort
| Measure |
Control With Delayed Access
n=24 Participants
Those resulting in variants of significance will receive routine clinical care and receive the enhanced genomic report after returning 3 month survey.
Routine Clinical Care: Participants will receive routine clinical care. After returning the 3 month survey the participants will also receive the enhanced genomic report.
|
Enhanced Genomic Report
n=28 Participants
Those resulting in variants of significance will received routine clinical care and access to the enhanced genomic lab report.
Enhanced Genomic Report: Routine clinical care vs. enhanced genomic report
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Child's WGS Result
Causal Variant Result
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Child's WGS Result
Non-Causal Variant Result
|
20 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Education
Some high school (9-12)
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Education
High school graduate or GED
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Education
Post high school training other than college
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Education
Some college
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Education
Bachelor's degree or equivalent
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Education
Master's degree
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Education
Doctor or other professional degree
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Income
Less than $15,000
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Income
$15,000 to $29,999
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Income
$30,000 to $44,999
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Income
$45,000 to $59,999
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Income
$60,000 to $89,999
|
4 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Income
$90,000 to $149,999
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Income
$150,000 to $199,999
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Income
$200,000 or above
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Income
Missing
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Health Literacy
Never
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Health Literacy
Occasionally
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Health Literacy
Sometimes
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Health Literacy
Often
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Health Literacy
Always
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Health Literacy
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Numeracy
Very Easy
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Numeracy
Easy
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Numeracy
Hard
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Numeracy
Very Hard
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Numeracy
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Access to Child's Record
None
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Access to Child's Record
1-2 times
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Access to Child's Record
3-5 times
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Access to Child's Record
6-9 times
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Access to Child's Record
10 or more times
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Access to Child's Record
Missing
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months after receipt of enhanced reportPopulation: parents who opened the enhanced report per electronic confirmation. For Clinical care then enhanced report N=4 CV; 2NCV - these 2 NCV parents did not answer the survey questions about the report ("missing"). For routine care with enhanced report first N=9 NCV.
3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.
Outcome measures
| Measure |
Routine Clinical Care First, Then Enhanced Report
n=6 Participants
Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
|
Routine Clinical Care Plus Enhanced Genomic Report
n=9 Participants
Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
|
|---|---|---|
|
Satisfaction With Genomic Test Report
Detailed Explanation · Not Helpful
|
0 Participants
|
2 Participants
|
|
Satisfaction With Genomic Test Report
Summary · Not Helpful
|
0 Participants
|
2 Participants
|
|
Satisfaction With Genomic Test Report
Summary · A little bit helpfu
|
1 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Summary · Somewhat helpful
|
1 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Summary · Quite a bit helpful
|
2 Participants
|
3 Participants
|
|
Satisfaction With Genomic Test Report
Summary · Very helpful
|
0 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Summary · Missing
|
2 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Detailed Explanation · A little bit helpfu
|
1 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Detailed Explanation · Somewhat helpful
|
1 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Detailed Explanation · Quite a bit helpful
|
2 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Detailed Explanation · Very helpful
|
0 Participants
|
3 Participants
|
|
Satisfaction With Genomic Test Report
Detailed Explanation · Missing
|
2 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Care Instructions · Not Helpful
|
0 Participants
|
4 Participants
|
|
Satisfaction With Genomic Test Report
Care Instructions · A little bit helpfu
|
2 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Care Instructions · Somewhat helpful
|
1 Participants
|
2 Participants
|
|
Satisfaction With Genomic Test Report
Care Instructions · Quite a bit helpful
|
1 Participants
|
0 Participants
|
|
Satisfaction With Genomic Test Report
Care Instructions · Very helpful
|
0 Participants
|
1 Participants
|
|
Satisfaction With Genomic Test Report
Care Instructions · Missing
|
2 Participants
|
1 Participants
|
Adverse Events
Routine Clinical Care First, Then Enhanced Report
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Clinical Care Plus Enhanced Genomic Report
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place