PregnancyIDEASNCT01784575
Increasing Use of Publicly Reported Pediatric Quality Data
A study testing Patient Navigator Intervention in people with Pregnancy, run by Baystate Medical Center at 1 site in United States.
Trial summary
Numerous factors prevent consumers from making effective use of publicly reported information about the quality of health care, including limited recognition that quality of care varies between physicians, lack of awareness of the existing quality websites, limited internet access, and low health literacy and… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Patient Navigator Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 20-34 weeks of pregnancy
- comfortable speaking English
- ages 16-50
Who cannot join
- age 15 or younger
- age 51 or greater
- not comfortable speaking or understanding English
- less than 20 or greater than 34 weeks of pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: IDEAS for a Healthy Baby: Reducing Disparities in Consumer Use of Publicly Reported Quality Data
Numerous factors prevent consumers from making effective use of publicly reported information about the quality of health care, including limited recognition that quality of care varies between physicians, lack of awareness of the existing quality websites, limited internet access, and low health literacy and numeracy. In the proposed randomized controlled trial we will evaluate the impact of providing assistance for using and interpreting information about the quality of pediatric care on the Massachusetts Health Quality Partners Quality Insights website among a population of low income pregnant women. Results of the study will advance our understanding of effective strategies for overcoming barriers to using publicly reported information among vulnerable populations.
Read the detailed description
Efforts to increase transparency regarding health care quality and safety are partially guided by the belief that making performance information publicly available will enable patients to make more informed choices. Although the amount of information reported on websites and through other channels has increased dramatically, use by consumers remains limited and largely restricted to white, college educated and middle aged consumers. There are many barriers that prevent patients from making effective use of current public reporting websites, including failure to recognize that quality may vary between providers, lack of awareness of publicly reported data, limited internet access, and low health literacy and numeracy. Innovative approaches are therefore needed to overcome barriers to using these data, particularly in vulnerable populations, to ensure a health care system in which every consumer can benefit from public reporting. Patient navigators have helped patients take greater advantage of the complex health care delivery environment, and use of patient navigators may be an effective approach to engage consumers and to help them to interpret the information presented in public reports.
The scientific aims of the study are: 1) to test the efficacy of an office-based patient navigator to assist low income pregnant women in using publicly reported data to select a pediatric care provider; 2) to assess the efficacy of the intervention in subgroups defined by parity, race/ethnicity, and health literacy; 3) to evaluate the importance of publicly reported information about quality compared to other factors when selecting a pediatric provider; and 4) to assess the intervention's impact on self-management of health care. English speaking women ages 16-45 attending the prenatal clinic at a large urban medical center will be recruited, enrolled, consented and randomized to the navigator intervention or an informational pamphlet control between 24-34 weeks of gestation. Women randomized to the intervention arm will receive two 20 minute sessions with a trained patient navigator who will guide women in navigating and interpreting information about the quality of care provided at local pediatric practices on the Massachusetts Health Quality Partners web site. A survey designed for the purpose of this study will be administered at baseline and post-intervention. Health literacy, numeracy and level of activation for self-management of health care will also be assessed as potential mediators of intervention effectiveness. The primary study outcome will be the average performance on quality measures for the practices selected in the intervention and control groups. Secondary outcomes will include analyses of efficacy among groups of women defined by parity and an assessment of the relative importance of factors considered when choosing a pediatric care provider. Successful completion of the study aims will yield important new knowledge about the value of guided web-site navigation as a strategy to reduce disparities in the use of publicly reported information.
- Conditions
- Pregnancy
- Being tested
- Patient Navigator Intervention
- Keywords
- Quality of care, Pediatric, Pregnancy, Low-income, Low literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigator InterventionOther
The Patient Navigator Intervention will include 2 - 20 minute sessions with a patient navigator in which women are shown publicly available health care quality data about local pediatric practices on a non-profit quality collaborative's web site.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigator Intervention | Experimental | The Patient Navigator Intervention arm will have two 20 minute interactive sessions with a patient navigator in which they will learn about quality measures and view scores on the Massachusetts Health Quality Partner's website. Receives: Other: Patient Navigator Intervention |
| Control | Active comparator | The control arm will receive an information pamphlet about health care quality. Receives: Other: Patient Navigator Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality score of pediatric practices chosen by participants
Each pediatric practice will be given a composite clinical quality and patient experience score based upon scores reported on the Massachusetts Health Quality Partners "Quality Insights" reports. The mean scores of practices chosen by women in the intervention compared to the control arm will assessed.
Measured: 6-20 weeks
Secondary outcomes (1)
Factors important to pregnant women when choosing a pediatric practice
The study survey will assess relative importance of a range of factors that might be important to women when selecting a pediatric practice.
Measured: 6-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah L Goff, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784575
- Sponsor's protocol ID
- 1R21HS021864-01
- Other IDs
- R21HS021864-01
- Acronym
- IDEAS
- Status last verified
- Jan 2015
- First submitted
- 4 Feb 2013
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Goff SL, Mazor KM, Guhn-Knight H, Budway YY, Murphy L, White KO, Lagu T, Pekow PS, Priya A, Lindenauer PK. Factors That Matter to Low-Income and Racial/Ethnic Minority Mothers When Choosing a Pediatric Practice: a Mixed Methods Analysis. J Racial Ethn Health Disparities. 2017 Dec;4(6):1051-1060. doi: 10.1007/s40615-016-0309-x. Epub 2017 Mar 8.
PubMed 28275998Goff SL, Mazor KM, Pekow PS, White KO, Priya A, Lagu T, Guhn-Knight H, Murphy L, Youssef Budway Y, Lindenauer PK. Patient Navigators and Parent Use of Quality Data: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20161140. doi: 10.1542/peds.2016-1140. Epub 2016 Sep 6.
PubMed 27600316Goff SL, Youssef Y, Pekow PS, White KO, Guhn-Knight H, Lagu T, Mazor KM, Lindenauer PK. Successful Strategies for Practice-Based Recruitment of Racial and Ethnic Minority Pregnant Women in a Randomized Controlled Trial: the IDEAS for a Healthy Baby Study. J Racial Ethn Health Disparities. 2016 Dec;3(4):731-737. doi: 10.1007/s40615-015-0192-x. Epub 2016 Apr 11.
PubMed 27068662Goff SL, Pekow PS, White KO, Lagu T, Mazor KM, Lindenauer PK. IDEAS for a healthy baby--reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial. Trials. 2013 Aug 7;14:244. doi: 10.1186/1745-6215-14-244.
PubMed 23919671
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDEAS for a Healthy Baby: Reducing Disparities in Consumer Use of Publicly Reported Quality Data
- ClinicalTrials.gov ID
- NCT01784575
- Acronym / sponsor ID
- IDEAS / 1R21HS021864-01
- Conditions
- Pregnancy
- Keywords
- Quality of care, Pediatric, Pregnancy, Low-income, Low literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous factors prevent consumers from making effective use of publicly reported information about the quality of health care, including limited recognition that quality of care varies between physicians, lack of awareness of the existing quality websites, limited internet access, and low health literacy and numeracy. In the proposed randomized controlled trial we will evaluate the impact of providing assistance for using and interpreting information about the quality of pediatric care on the Massachusetts Health Quality Partners Quality Insights website among a population of low income pregnant women. Results of the study will advance our understanding of effective strategies for overcoming barriers to using publicly reported information among vulnerable populations.
Detailed description
Efforts to increase transparency regarding health care quality and safety are partially guided by the belief that making performance information publicly available will enable patients to make more informed choices. Although the amount of information reported on websites and through other channels has increased dramatically, use by consumers remains limited and largely restricted to white, college educated and middle aged consumers. There are many barriers that prevent patients from making effective use of current public reporting websites, including failure to recognize that quality may vary between providers, lack of awareness of publicly reported data, limited internet access, and low health literacy and numeracy. Innovative approaches are therefore needed to overcome barriers to using these data, particularly in vulnerable populations, to ensure a health care system in which every consumer can benefit from public reporting. Patient navigators have helped patients take greater advantage of the complex health care delivery environment, and use of patient navigators may be an effective approach to engage consumers and to help them to interpret the information presented in public reports.
The scientific aims of the study are: 1) to test the efficacy of an office-based patient navigator to assist low income pregnant women in using publicly reported data to select a pediatric care provider; 2) to assess the efficacy of the intervention in subgroups defined by parity, race/ethnicity, and health literacy; 3) to evaluate the importance of publicly reported information about quality compared to other factors when selecting a pediatric provider; and 4) to assess the intervention's impact on self-management of health care. English speaking women ages 16-45 attending the prenatal clinic at a large urban medical center will be recruited, enrolled, consented and randomized to the navigator intervention or an informational pamphlet control between 24-34 weeks of gestation. Women randomized to the intervention arm will receive two 20 minute sessions with a trained patient navigator who will guide women in navigating and interpreting information about the quality of care provided at local pediatric practices on the Massachusetts Health Quality Partners web site. A survey designed for the purpose of this study will be administered at baseline and post-intervention. Health literacy, numeracy and level of activation for self-management of health care will also be assessed as potential mediators of intervention effectiveness. The primary study outcome will be the average performance on quality measures for the practices selected in the intervention and control groups. Secondary outcomes will include analyses of efficacy among groups of women defined by parity and an assessment of the relative importance of factors considered when choosing a pediatric care provider. Successful completion of the study aims will yield important new knowledge about the value of guided web-site navigation as a strategy to reduce disparities in the use of publicly reported information.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigator Intervention | Experimental | Other: Patient Navigator InterventionThe Patient Navigator Intervention arm will have two 20 minute interactive sessions with a patient navigator in which they will learn about quality measures and view scores on the Massachusetts Health Quality Partner's website. |
| Control | Active comparator | Other: Patient Navigator InterventionThe control arm will receive an information pamphlet about health care quality. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 20-34 weeks of pregnancy
- comfortable speaking English
- ages 16-50
Key exclusion criteria (4 listed)
- age 15 or younger
- age 51 or greater
- not comfortable speaking or understanding English
- less than 20 or greater than 34 weeks of pregnancy
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 |
|---|---|---|
| Patient Navigator InterventionThe Patient Navigator Intervention will include 2 - 20 minute sessions with a patient navigator in which women are shown publicly available health care quality data about local pediatric practices on a non-profit quality collaborative's web site. | Other | Control, Patient Navigator Intervention |
Primary outcome
Quality score of pediatric practices chosen by participants
Time frame: 6-20 weeks
Each pediatric practice will be given a composite clinical quality and patient experience score based upon scores reported on the Massachusetts Health Quality Partners "Quality Insights" reports. The mean scores of practices chosen by women in the intervention compared to the control arm will assessed.
1 secondary outcome
Factors important to pregnant women when choosing a pediatric practice
Time frame: 6-20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Derived from this study: PubMed 28275998Goff SL, Mazor KM, Guhn-Knight H, Budway YY, Murphy L, White KO, Lagu T, Pekow PS, Priya A, Lindenauer PK. Factors That Matter to Low-Income and Racial/Ethnic Minority Mothers When Choosing a Pediatric Practice: a Mixed Methods Analysis. J Racial Ethn Health Disparities. 2017 Dec;4(6):1051-1060. doi: 10.1007/s40615-016-0309-x. Epub 2017 Mar 8.
- Derived from this study: PubMed 27600316Goff SL, Mazor KM, Pekow PS, White KO, Priya A, Lagu T, Guhn-Knight H, Murphy L, Youssef Budway Y, Lindenauer PK. Patient Navigators and Parent Use of Quality Data: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20161140. doi: 10.1542/peds.2016-1140. Epub 2016 Sep 6.
- Derived from this study: PubMed 27068662Goff SL, Youssef Y, Pekow PS, White KO, Guhn-Knight H, Lagu T, Mazor KM, Lindenauer PK. Successful Strategies for Practice-Based Recruitment of Racial and Ethnic Minority Pregnant Women in a Randomized Controlled Trial: the IDEAS for a Healthy Baby Study. J Racial Ethn Health Disparities. 2016 Dec;3(4):731-737. doi: 10.1007/s40615-015-0192-x. Epub 2016 Apr 11.
- Derived from this study: PubMed 23919671Goff SL, Pekow PS, White KO, Lagu T, Mazor KM, Lindenauer PK. IDEAS for a healthy baby--reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial. Trials. 2013 Aug 7;14:244. doi: 10.1186/1745-6215-14-244.
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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.
Sarah L Goff, MD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator Intervention in people with Pregnancy, run by Baystate Medical Center 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 4 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 28 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality score of pediatric practices chosen by participants (time frame: 6-20 weeks). 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 NCT01784575, which also lists 4 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 28 Jan 2015.