NCT02653066

Brief Summary

The purpose of this research is to study the utility of using the HealtheRx as a tool to recruit eligible patients into the Pulmonary Research Registry (PRR) (IRB 15543B) at the University of Chicago. HealtheRx is an example of a potential recruitment tool that has high reach in populations typically underrepresented in research studies, uses a high tech infrastructure that allows matching of research opportunities to patient characteristics, but that delivers information in a low-tech, patient-centered mode using the printed HealtheRx prescription.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable asthma

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

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

January 8, 2016

Last Update Submit

April 27, 2020

Conditions

Keywords

recruitment

Outcome Measures

Primary Outcomes (1)

  • Cost per consented subject

    6 months

Secondary Outcomes (1)

  • Mean number of consented subjects per week

    6 months

Other Outcomes (2)

  • Proportion of individuals who consent

    6 months

  • Mean days to consent

    6 months

Study Arms (3)

Control

NO INTERVENTION

Participant is recruited via usual avenues including flyers and physician referral. This includes participants who received a HealtheRx with advertisement for phone survey but did not call in based on advertisement.

Intervention with consent form

EXPERIMENTAL

After completing survey, participant in HealtheRx+ group receives $5 bill with their survey check and blank registry consent form.

Other: HealtheRx+

Intervention with return of consent form

EXPERIMENTAL

After returning signed consent form, participant in HealtheRx++ group is mailed $5 bill.

Other: HealtheRx++

Interventions

Participant receives $5 bill when they returned signed PRR consent form.

Intervention with return of consent form

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of asthma/COPD
  • receipt of HealtheRx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Feldmeth G, Naureckas ET, Solway J, Lindau ST. Embedding research recruitment in a community resource e-prescribing system: lessons from an implementation study on Chicago's South Side. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):840-846. doi: 10.1093/jamia/ocz059.

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stacy Lindau, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

December 1, 2015

Primary Completion

April 25, 2017

Study Completion

December 1, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations