NCT01784575

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
746

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

February 4, 2013

Last Update Submit

January 27, 2015

Conditions

Pregnancy

Keywords

Quality of carePediatricPregnancyLow-incomeLow literacy

Outcome Measures

Primary Outcomes (1)

  • 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.

    6-20 weeks

Secondary Outcomes (1)

  • Factors important to pregnant women when choosing a pediatric practice

    6-20 weeks

Other Outcomes (1)

  • Patient activation

    6-20 weeks

Study Arms (2)

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.

Other: Patient Navigator Intervention

Control

ACTIVE COMPARATOR

The control arm will receive an information pamphlet about health care quality.

Other: Patient Navigator Intervention

Interventions

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.

ControlPatient Navigator Intervention

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • age 15 or younger
  • age 51 or greater
  • not comfortable speaking or understanding English
  • less than 20 or greater than 34 weeks of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (4)

  • 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.

    PMID: 28275998DERIVED

  • Goff 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.

    PMID: 27600316DERIVED

  • Goff 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.

    PMID: 27068662DERIVED

  • Goff 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.

    PMID: 23919671DERIVED

Study Officials

  • Sarah L Goff, MD

    Baystate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 6, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

US(1)