Increasing Use of Publicly Reported Pediatric Quality Data (IDEAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Baystate Medical Center
Sponsor:
Information provided by (Responsible Party):
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01784575
First received: February 4, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Pregnancy
Other: Patient Navigator Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: IDEAS for a Healthy Baby: Reducing Disparities in Consumer Use of Publicly Reported Quality Data

Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • Quality score of pediatric practices chosen by participants [ Time Frame: 6-20 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Factors important to pregnant women when choosing a pediatric practice [ Time Frame: 6-20 weeks ] [ Designated as safety issue: No ]
    The study survey will assess relative importance of a range of factors that might be important to women when selecting a pediatric practice.


Other Outcome Measures:
  • Patient activation [ Time Frame: 6-20 weeks ] [ Designated as safety issue: No ]
    We will be assessing changes in patients engagement in self-management of their and their child's health care using Patient Activation Measures.


Estimated Enrollment: 800
Study Start Date: May 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient Navigator Intervention
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.
Other: Patient Navigator Intervention
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.
Active Comparator: Control
The control arm will receive an information pamphlet about health care quality.
Other: Patient Navigator Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20-34 weeks of pregnancy
  • comfortable speaking English
  • ages 16-50

Exclusion Criteria:

  • age 15 or younger
  • age 51 or greater
  • not comfortable speaking or understanding English
  • less than 20 or greater than 34 weeks of pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784575

Contacts
Contact: Jasmin Roberts, MS jasmin.roberts@baystatehealth.org
Contact: Yara Youssef, BA yara.youssef@baystatehealth.org

Locations
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Sub-Investigator: Peter L Lindenauer, MD, MSc         
Sub-Investigator: Katherine O White, MD, MPH         
Sub-Investigator: Penelope S Pekow, PhD         
Sub-Investigator: Kathleen M Mazor, EdD         
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Sarah L Goff, MD Baystate Medical Center
  More Information

No publications provided by Baystate Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01784575     History of Changes
Other Study ID Numbers: 1 R21 HS021864 01, R21 HS021864 01
Study First Received: February 4, 2013
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
Quality of care
Pediatric
Pregnancy
Low-income
Low literacy

ClinicalTrials.gov processed this record on September 22, 2014