Intellectual DisabilityNCT02504502
Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients
A study testing enhanced genomic report in people with Intellectual Disability and Autism, run by Geisinger Clinic.
Trial summary
Current lab reports are designed to communicate results from the laboratory to the provider; they are not designed to be accessible to patients. The investigators believe that a new type of genomic test report, tailored for patient- as well as provider-use, will enable patients to have access to information they can… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Intellectual Disability, Autism, Multiple Congenital Anomalies
- What is being tested?
- enhanced genomic report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Research participants who are consented to participate in the WGS Study (#2012-0187).
- Providers who have referred participants to the WGS Study (#2012-0187) and who have participated in the WGS genomic medicine workgroup or who have participated in the WGS Program Oversight Committee.
Who cannot join
- Participants who are not consented to participate in the WGS Study (#2012-0187)
- Providers who have not referred patients to the WGS Study (#2012-0187).
- Providers who have not had a relationship with the oversight of the WGS study (#2012- 0187).
About this study
Current lab reports are designed to communicate results from the laboratory to the provider; they are not designed to be accessible to patients. The investigators believe that a new type of genomic test report, tailored for patient- as well as provider-use, will enable patients to have access to information they can understand allowing them to be more involved in the management of their disorders, better navigate the health care system, and make more informed decisions about their health and health care in conjunction with their providers. This approach has the potential to improve outcomes from both the patient and provider perspectives.
The investigators propose to study the research question, "Can a genomic laboratory report tailored for both providers and families of patients improve interpretation of complex results and facilitate recommended care by enhancing communication and shared decision making?"
Read the detailed description
This is a mixed-methods will be conducted in multiple phases:
Phase 1: development of an enhanced genomic test result report through in-depth interviews with parents and providers
Phase 2: refine the report through parental focus groups and provider interviews and create the final report and delivery method.
Phase 3: implement the enhanced test report and evaluate the impact on patient and providers
Subjects for the study are parents of affected children enrolled in the Whole Genome Sequencing (WGS) Clinical Research Pilot Study (study within a study). All parents receive routine clinical care for WGS and clinical return of results per protocol of the WGS study.
Parents from the WGS study were invited to participate in phases 1 and 2 of this study to help design and test an enhanced genomic test report that would meet their needs for information about their child's condition and communication with providers, caregivers, teachers, and family.
This report in clinicaltrials.gov reports on phase 3 data only. The experimental design to be used for phase 3 of the project is a randomized, single-blinded pre- post-intervention trial with crossover.
According to the WGS study protocol all results of the WGS testing will be provided by a geneticist and genetic counselor at an informing session. At this session, results will be returned and explained, recommendations provided and questions answered (routine clinical care). Following this session, parents will be randomized as couples based on whether their child received a result of a causal variant or non-causal variant to receive either routine clinical care with an enhanced report (intervention arm) or routine clinical care first followed by enhanced report (control with crossover). Randomizing parents as couples is necessary as randomization at the individual level would lead to contamination and spillover if one member of the couple were in the usual care arm and the other in the intervention arm.
After routine clinical care to deliver the WGS test results and randomization, parents will be invited to participate in phase 3 to test the impact of the enhanced report on parental and provider satisfaction, communication, and knowledge. Parents will enter into phase 3 of the study (experimental design) by completing baseline surveys. Upon completion of baseline surveys, parents will be provided the enhanced report (intervention) or another copy of their standard lab report (control with crossover).
All parents will be surveyed at 3 months. Parents in the control with crossover arm will be provided the enhanced report at this time and sent another survey 3 month post enhanced report (6 month post baseline). Standard, validated, survey instruments will be utilized for the baseline and follow-up surveys; therefore, it is possible that important differences between the routine clinical care with crossover and intervention arms could be missed. To insure capture of all important differences and all impact of the enhanced genomic test result report, additional in-depth qualitative interviews will take place after the final survey post enhanced report is administered.
- Being tested
- enhanced genomic report
- Keywords
- Whole Genome Sequencing, Laboratory Report, Patient Centered, Communication of Results, Patient Provider Communication
- Medical subject headings
- Intellectual Disability, Autistic Disorder, Abnormalities, Multiple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced genomic reportOther
a patient-centered version of a genomic results report delivered to patient through the electronic record portal
| Study group | Role | What they receive |
|---|---|---|
| Enhanced genomic report | Experimental | routine clinical care for return of results per whole genome sequencing study with enhanced genetic test results report developed through phase 1 and 2 of this study Receives: Other: enhanced genomic report |
| Control with delayed access | Other | routine clinical care for return of results per whole genome sequencing study and no intervention through three months. This arm will crossover to receipt of enhanced report upon completion of baseline and 3 month post-baseline followup surveys. Participants in this arm will complete a third survey at 3 months post receipt of enhanced report Receives: Other: enhanced genomic report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Genomic Test Report
3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.
Measured: 3 months after receipt of enhanced report
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention = routine clinical care for return of results per whole genome sequencing study with enhanced genetic test results report developed through phase 1 and 2 of this study. Control with delayed intervention = routine clinical care for return of results per whole genome sequencing study with crossover to receipt of enhanced report upon completion of baseline and 3 month post-baseline followup surveys. Participants in this arm will complete a third survey at 3 months post receipt of enhanced report
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Marc S. Williams, Geisinger Clinic
- Investigators
- Marc S Williams, MD, Principal investigator, Geisinger Genomic Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504502
- Sponsor's protocol ID
- 2013-0594
- Status last verified
- Aug 2017
- First submitted
- 7 Jul 2015
- Last updated
- 12 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Scriver CR, Neal JL, Saginur R, Clow A. The frequency of genetic disease and congenital malformation among patients in a pediatric hospital. Can Med Assoc J. 1973 May 5;108(9):1111-5.
PubMed 4704890Wilson J. Acknowledging the expertise of patients and their organisations. BMJ. 1999 Sep 18;319(7212):771-4. doi: 10.1136/bmj.319.7212.771. No abstract available.
PubMed 10488011Levy HP, LoPresti L, Seibert DC. Twenty questions in genetic medicine--an assessment of World Wide Web databases for genetics information at the point of care. Genet Med. 2008 Sep;10(9):659-67. doi: 10.1097/gim.0b013e318180639d.
PubMed 18978677Morgan MA, Driscoll DA, Zinberg S, Schulkin J, Mennuti MT. Impact of self-reported familiarity with guidelines for cystic fibrosis carrier screening. Obstet Gynecol. 2005 Jun;105(6):1355-61. doi: 10.1097/01.AOG.0000163251.54416.a6.
PubMed 15932829Giardiello FM, Brensinger JD, Petersen GM, Luce MC, Hylind LM, Bacon JA, Booker SV, Parker RD, Hamilton SR. The use and interpretation of commercial APC gene testing for familial adenomatous polyposis. N Engl J Med. 1997 Mar 20;336(12):823-7. doi: 10.1056/NEJM199703203361202.
PubMed 9062090Sandhaus LM, Singer ME, Dawson NV, Wiesner GL. Reporting BRCA test results to primary care physicians. Genet Med. 2001 Sep-Oct;3(5):327-34. doi: 10.1097/00125817-200109000-00001.
PubMed 11545685Bloom BS. Effects of continuing medical education on improving physician clinical care and patient health: a review of systematic reviews. Int J Technol Assess Health Care. 2005 Summer;21(3):380-5. doi: 10.1017/s026646230505049x.
PubMed 16110718Hammond EH, Flinner RL. Clinically relevant breast cancer reporting: using process measures to improve anatomic pathology reporting. Arch Pathol Lab Med. 1997 Nov;121(11):1171-5.
PubMed 9372744Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS. Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. Arch Pathol Lab Med. 2004 Dec;128(12):1424-7. doi: 10.5858/2004-128-1424-PSOALM.
PubMed 15578888Lubin IM, McGovern MM, Gibson Z, Gross SJ, Lyon E, Pagon RA, Pratt VM, Rashid J, Shaw C, Stoddard L, Trotter TL, Williams MS, Amos Wilson J, Pass K. Clinician perspectives about molecular genetic testing for heritable conditions and development of a clinician-friendly laboratory report. J Mol Diagn. 2009 Mar;11(2):162-71. doi: 10.2353/jmoldx.2009.080130. Epub 2009 Feb 5.
PubMed 19197001Scheuner MT, Hilborne L, Brown J, Lubin IM; members of the RAND Molecular Genetic Test Report Advisory Board. A report template for molecular genetic tests designed to improve communication between the clinician and laboratory. Genet Test Mol Biomarkers. 2012 Jul;16(7):761-9. doi: 10.1089/gtmb.2011.0328. Epub 2012 Jun 25.
PubMed 22731646Scheuner MT, Edelen MO, Hilborne LH, Lubin IM; RAND Molecular Genetic Test Report Advisory Board. Effective communication of molecular genetic test results to primary care providers. Genet Med. 2013 Jun;15(6):444-9. doi: 10.1038/gim.2012.151. Epub 2012 Dec 6.
PubMed 23222660Lerman CE, Brody DS, Caputo GC, Smith DG, Lazaro CG, Wolfson HG. Patients' Perceived Involvement in Care Scale: relationship to attitudes about illness and medical care. J Gen Intern Med. 1990 Jan-Feb;5(1):29-33. doi: 10.1007/BF02602306.
PubMed 2299426Cella D, Hughes C, Peterman A, Chang CH, Peshkin BN, Schwartz MD, Wenzel L, Lemke A, Marcus AC, Lerman C. A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychol. 2002 Nov;21(6):564-72.
PubMed 12433008Chung WW, Chen CA, Cupples LA, Roberts JS, Hiraki SC, Nair AK, Green RC, Stern RA. A new scale measuring psychologic impact of genetic susceptibility testing for Alzheimer disease. Alzheimer Dis Assoc Disord. 2009 Jan-Mar;23(1):50-6. doi: 10.1097/wad.0b013e318188429e.
PubMed 19266699
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients
- ClinicalTrials.gov ID
- NCT02504502
- Acronym / sponsor ID
- 2013-0594
- Keywords
- Whole Genome Sequencing, Laboratory Report, Patient Centered, Communication of Results, Patient Provider Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Aug 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Posted 15 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current lab reports are designed to communicate results from the laboratory to the provider; they are not designed to be accessible to patients. The investigators believe that a new type of genomic test report, tailored for patient- as well as provider-use, will enable patients to have access to information they can understand allowing them to be more involved in the management of their disorders, better navigate the health care system, and make more informed decisions about their health and health care in conjunction with their providers. This approach has the potential to improve outcomes from both the patient and provider perspectives.
The investigators propose to study the research question, "Can a genomic laboratory report tailored for both providers and families of patients improve interpretation of complex results and facilitate recommended care by enhancing communication and shared decision making?"
Detailed description
This is a mixed-methods will be conducted in multiple phases:
Phase 1: development of an enhanced genomic test result report through in-depth interviews with parents and providers
Phase 2: refine the report through parental focus groups and provider interviews and create the final report and delivery method.
Phase 3: implement the enhanced test report and evaluate the impact on patient and providers
Subjects for the study are parents of affected children enrolled in the Whole Genome Sequencing (WGS) Clinical Research Pilot Study (study within a study). All parents receive routine clinical care for WGS and clinical return of results per protocol of the WGS study.
Parents from the WGS study were invited to participate in phases 1 and 2 of this study to help design and test an enhanced genomic test report that would meet their needs for information about their child's condition and communication with providers, caregivers, teachers, and family.
This report in clinicaltrials.gov reports on phase 3 data only. The experimental design to be used for phase 3 of the project is a randomized, single-blinded pre- post-intervention trial with crossover.
According to the WGS study protocol all results of the WGS testing will be provided by a geneticist and genetic counselor at an informing session. At this session, results will be returned and explained, recommendations provided and questions answered (routine clinical care). Following this session, parents will be randomized as couples based on whether their child received a result of a causal variant or non-causal variant to receive either routine clinical care with an enhanced report (intervention arm) or routine clinical care first followed by enhanced report (control with crossover). Randomizing parents as couples is necessary as randomization at the individual level would lead to contamination and spillover if one member of the couple were in the usual care arm and the other in the intervention arm.
After routine clinical care to deliver the WGS test results and randomization, parents will be invited to participate in phase 3 to test the impact of the enhanced report on parental and provider satisfaction, communication, and knowledge. Parents will enter into phase 3 of the study (experimental design) by completing baseline surveys. Upon completion of baseline surveys, parents will be provided the enhanced report (intervention) or another copy of their standard lab report (control with crossover).
All parents will be surveyed at 3 months. Parents in the control with crossover arm will be provided the enhanced report at this time and sent another survey 3 month post enhanced report (6 month post baseline). Standard, validated, survey instruments will be utilized for the baseline and follow-up surveys; therefore, it is possible that important differences between the routine clinical care with crossover and intervention arms could be missed. To insure capture of all important differences and all impact of the enhanced genomic test result report, additional in-depth qualitative interviews will take place after the final survey post enhanced report is administered.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- intervention = routine clinical care for return of results per whole genome sequencing study with enhanced genetic test results report developed through phase 1 and 2 of this study. Control with delayed intervention = routine clinical care for return of results per whole genome sequencing study with crossover to receipt of enhanced report upon completion of baseline and 3 month post-baseline followup surveys. Participants in this arm will complete a third survey at 3 months post receipt of enhanced report
| Arm | Type | Receives |
|---|---|---|
| Enhanced genomic report | Experimental | Other: enhanced genomic reportroutine clinical care for return of results per whole genome sequencing study with enhanced genetic test results report developed through phase 1 and 2 of this study |
| Control with delayed access | Other | Other: enhanced genomic reportroutine clinical care for return of results per whole genome sequencing study and no intervention through three months. This arm will crossover to receipt of enhanced report upon completion of baseline and 3 month post-baseline followup surveys. Participants in this arm will complete a third survey at 3 months post receipt of enhanced report |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Research participants who are consented to participate in the WGS Study (#2012-0187).
- Providers who have referred participants to the WGS Study (#2012-0187) and who have participated in the WGS genomic medicine workgroup or who have participated in the WGS Program Oversight Committee.
Key exclusion criteria (3 listed)
- Participants who are not consented to participate in the WGS Study (#2012-0187)
- Providers who have not referred patients to the WGS Study (#2012-0187).
- Providers who have not had a relationship with the oversight of the WGS study (#2012- 0187).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced genomic reporta patient-centered version of a genomic results report delivered to patient through the electronic record portal | Other | Control with delayed access, Enhanced genomic report |
Primary outcome
Satisfaction With Genomic Test Report
Time frame: 3 months after receipt of enhanced report
3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4704890Scriver CR, Neal JL, Saginur R, Clow A. The frequency of genetic disease and congenital malformation among patients in a pediatric hospital. Can Med Assoc J. 1973 May 5;108(9):1111-5.
- Background: PubMed 10488011Wilson J. Acknowledging the expertise of patients and their organisations. BMJ. 1999 Sep 18;319(7212):771-4. doi: 10.1136/bmj.319.7212.771. No abstract available.
- Background: PubMed 18978677Levy HP, LoPresti L, Seibert DC. Twenty questions in genetic medicine--an assessment of World Wide Web databases for genetics information at the point of care. Genet Med. 2008 Sep;10(9):659-67. doi: 10.1097/gim.0b013e318180639d.
- Background: PubMed 15932829Morgan MA, Driscoll DA, Zinberg S, Schulkin J, Mennuti MT. Impact of self-reported familiarity with guidelines for cystic fibrosis carrier screening. Obstet Gynecol. 2005 Jun;105(6):1355-61. doi: 10.1097/01.AOG.0000163251.54416.a6.
- Background: PubMed 9062090Giardiello FM, Brensinger JD, Petersen GM, Luce MC, Hylind LM, Bacon JA, Booker SV, Parker RD, Hamilton SR. The use and interpretation of commercial APC gene testing for familial adenomatous polyposis. N Engl J Med. 1997 Mar 20;336(12):823-7. doi: 10.1056/NEJM199703203361202.
- Background: PubMed 11545685Sandhaus LM, Singer ME, Dawson NV, Wiesner GL. Reporting BRCA test results to primary care physicians. Genet Med. 2001 Sep-Oct;3(5):327-34. doi: 10.1097/00125817-200109000-00001.
- Background: PubMed 16110718Bloom BS. Effects of continuing medical education on improving physician clinical care and patient health: a review of systematic reviews. Int J Technol Assess Health Care. 2005 Summer;21(3):380-5. doi: 10.1017/s026646230505049x.
- Background: PubMed 9372744Hammond EH, Flinner RL. Clinically relevant breast cancer reporting: using process measures to improve anatomic pathology reporting. Arch Pathol Lab Med. 1997 Nov;121(11):1171-5.
- Background: PubMed 15578888Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS. Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. Arch Pathol Lab Med. 2004 Dec;128(12):1424-7. doi: 10.5858/2004-128-1424-PSOALM.
- Background: PubMed 19197001Lubin IM, McGovern MM, Gibson Z, Gross SJ, Lyon E, Pagon RA, Pratt VM, Rashid J, Shaw C, Stoddard L, Trotter TL, Williams MS, Amos Wilson J, Pass K. Clinician perspectives about molecular genetic testing for heritable conditions and development of a clinician-friendly laboratory report. J Mol Diagn. 2009 Mar;11(2):162-71. doi: 10.2353/jmoldx.2009.080130. Epub 2009 Feb 5.
- Background: PubMed 22731646Scheuner MT, Hilborne L, Brown J, Lubin IM; members of the RAND Molecular Genetic Test Report Advisory Board. A report template for molecular genetic tests designed to improve communication between the clinician and laboratory. Genet Test Mol Biomarkers. 2012 Jul;16(7):761-9. doi: 10.1089/gtmb.2011.0328. Epub 2012 Jun 25.
- Background: PubMed 23222660Scheuner MT, Edelen MO, Hilborne LH, Lubin IM; RAND Molecular Genetic Test Report Advisory Board. Effective communication of molecular genetic test results to primary care providers. Genet Med. 2013 Jun;15(6):444-9. doi: 10.1038/gim.2012.151. Epub 2012 Dec 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc S Williams, MD principal investigator
Geisinger Genomic Medicine Institute
Questions about this trial
What is this clinical trial studying?
A study testing enhanced genomic report in people with Intellectual Disability and Autism, run by Geisinger Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction With Genomic Test Report (time frame: 3 months after receipt of enhanced report). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02504502, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.