Autism Spectrum DisorderNCT01579669
Partnering With Autistic Adults to Improve Healthcare
A study testing Use of toolkit in people with Autism Spectrum Disorder, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this proposal is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Use of toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Aug 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical diagnosis of autism spectrum disorder (including autistic disorder, Asperger's disorder, Childhood Disintegrative Disorder, and pervasive developmental disorder NOS)
- Understands written or spoken English or has a support person available who understands written or spoken English
- Has a primary care provider
Who cannot join
- Is not a resident of the United States
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Partnering With Autistic Adults to Develop Tools to Improve Primary Healthcare
The goal of this proposal is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs).
Read the detailed description
The goal of this study is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs). One tool will allow autistic adults and/or their supporters to provide individualized information to PCPs about how being on the spectrum affects their healthcare and possible strategies to facilitate quality care. Another tool will capitalize on the power of patient narrative to educate PCPs about autism. These tools and other resources will be housed on an interactive website for autistic adults, supporters, and PCPs. The research team will evaluate the feasibility and acceptability of using the new web-based patient-centered care tools with autistic adults and their primary care providers. This study will provide data for a future trial testing the effectiveness of these tools in improving the health of autistic adults by increasing patient-centered care and patient activation.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Use of toolkit
- Keywords
- Autism Spectrum Disorder, Primary Care Services, Patient-Provider Communication, Adults
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of toolkitBehavioural
Patient participants will be given access to the toolkit and will create a customized report for their provider. Team will send report to providers and ask them to schedule appointment with patient to discuss.
| Study group | Role | What they receive |
|---|---|---|
| Use of Toolkit | Experimental | All participants will have access to the toolkit Receives: Behavioral: Use of toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.
Measured: 1 month after use of toolkit
Secondary outcomes (5)
Provider Satisfaction
Providers participated in a brief survey to assess satisfaction with the toolkit. Items addressed overall satisfaction and if they would or would not use the tools with other patients.
Measured: 1-2 months after patient uses toolkit
Patient Use of Toolkit Components
We collected data on whether or not participants completed the Autism Healthcare Accommodations Tool (AHAT) survey and whether or not they allowed the research team to send a copy of the report to their primary care provider.
Measured: 1 month after use of toolkit
Change in Patient Satisfaction With Healthcare
Patients completed an 8-item instrument assessing satisfaction with their primary healthcare experiences. The scale was previously adapted from the 2007 Health Information National Trends Survey (HINTS). In the pre-intervention survey autistic participants were asked to think about their last visit with their primary care provider. We did not assess patient-provider communication for those who were participating via a proxy as we did not feel that a proxy could adequately rate how satisfied the patient was with communication. Only autistic participants who said they had seen their PCP since using the healthcare toolkit were re-asked these items in the post-intervention survey. Responses used a 5-point Likert scale with anchors of "1 - Strongly Disagree" to "5 - Strongly Agree". We analyzed items by summing the responses into a composite score (range 8-40; higher scores indicate higher satisfaction). Cronbach's alpha = 0.92.
Measured: before and 1 month after use of toolkit
Change in Patient's Perceived Barriers to Healthcare
Autistic participants were presented with a list of 16 barriers to healthcare and asked which ones keep them from obtaining good care. We compared the total number of barriers endorsed by participants in the pre- and post-intervention surveys. The proxy version of the survey included a few modified items to differentiate between barriers faced by the autistic individuals and those faced by the supporter. Due to differences in the wording, we could not combine results from those who participated directly with those who participated by proxy. Only data from autistic adults who participated directly is shown.
Measured: Before and 1 month after use of toolkit
Change in Patient Healthcare Self-Efficacy
Autistic participants completed a 21-item healthcare self-efficacy scale before and 1 month after use of the toolkit. The scale was created de novo for this study, based on our prior qualitative work. Items addressed aspects related to healthcare navigation (e.g. "How confident are you that you can make an appointment with your healthcare provider when needed?"), successful interactions with providers, (e.g. "How confident are you that you can describe your symptoms or healthcare concerns to your provider?"), and self-management (e.g. "How confident are you that you can take medications the way you are supposed to take them?"). Response options used a 4-point Likert scale with anchors of "0 - Not at all confident" to "3 - Totally confident". We scored self-efficacy by adding responses from the 21 items, resulting in a possible range of 0 to 63, with higher scores corresponding to higher self-efficacy. Cronbach's alpha was 0.92.
Measured: Before and 1 month after use of toolkit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Syracuse University, Indiana University, Autistic Self Advocacy Network, Portland State University
- Responsible party
- Principal investigator, Christina M. Nicolaidis, Oregon Health and Science University
- Investigators
- Christina Nicolaidis, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579669
- Sponsor's protocol ID
- R34MH092503
- Other IDs
- R34MH092503
- Status last verified
- Oct 2015
- First submitted
- 13 Apr 2012
- Last updated
- 7 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nicolaidis C, Raymaker D, McDonald K, Kapp S, Weiner M, Ashkenazy E, Gerrity M, Kripke C, Platt L, Baggs A. The Development and Evaluation of an Online Healthcare Toolkit for Autistic Adults and their Primary Care Providers. J Gen Intern Med. 2016 Oct;31(10):1180-9. doi: 10.1007/s11606-016-3763-6. Epub 2016 Jun 6.
PubMed 27271730
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering With Autistic Adults to Develop Tools to Improve Primary Healthcare
- ClinicalTrials.gov ID
- NCT01579669
- Acronym / sponsor ID
- R34MH092503
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Primary Care Services, Patient-Provider Communication, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Syracuse University, Indiana University, Autistic Self Advocacy Network, Portland State University
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Posted 7 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this proposal is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs).
Detailed description
The goal of this study is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs). One tool will allow autistic adults and/or their supporters to provide individualized information to PCPs about how being on the spectrum affects their healthcare and possible strategies to facilitate quality care. Another tool will capitalize on the power of patient narrative to educate PCPs about autism. These tools and other resources will be housed on an interactive website for autistic adults, supporters, and PCPs. The research team will evaluate the feasibility and acceptability of using the new web-based patient-centered care tools with autistic adults and their primary care providers. This study will provide data for a future trial testing the effectiveness of these tools in improving the health of autistic adults by increasing patient-centered care and patient activation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Toolkit | Experimental | Behavioral: Use of toolkitAll participants will have access to the toolkit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical diagnosis of autism spectrum disorder (including autistic disorder, Asperger's disorder, Childhood Disintegrative Disorder, and pervasive developmental disorder NOS)
- Understands written or spoken English or has a support person available who understands written or spoken English
- Has a primary care provider
Key exclusion criteria (1 listed)
- Is not a resident of the United States
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 |
|---|---|---|
| Use of toolkitPatient participants will be given access to the toolkit and will create a customized report for their provider. Team will send report to providers and ask them to schedule appointment with patient to discuss. | Behavioural | Use of Toolkit |
Primary outcome
Patient Satisfaction
Time frame: 1 month after use of toolkit
Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.
5 secondary outcomes
Provider Satisfaction
Time frame: 1-2 months after patient uses toolkit
Patient Use of Toolkit Components
Time frame: 1 month after use of toolkit
Change in Patient Satisfaction With Healthcare
Time frame: before and 1 month after use of toolkit
Change in Patient's Perceived Barriers to Healthcare
Time frame: Before and 1 month after use of toolkit
Change in Patient Healthcare Self-Efficacy
Time frame: Before and 1 month after use of toolkit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27271730Nicolaidis C, Raymaker D, McDonald K, Kapp S, Weiner M, Ashkenazy E, Gerrity M, Kripke C, Platt L, Baggs A. The Development and Evaluation of an Online Healthcare Toolkit for Autistic Adults and their Primary Care Providers. J Gen Intern Med. 2016 Oct;31(10):1180-9. doi: 10.1007/s11606-016-3763-6. Epub 2016 Jun 6.
- AASPIRE toolkit study informationLink provided by the sponsor.
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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.
Christina Nicolaidis, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of toolkit in people with Autism Spectrum Disorder, run by Oregon Health and Science University at 1 site in United States.
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 3 inclusion and 1 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 7 Dec 2015). 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?
Patient Satisfaction (time frame: 1 month after use of toolkit). 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 NCT01579669, which also lists 1 linked publication.
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 7 Dec 2015.