NCT00683540

Brief Summary

The Veterans Administration (VA) has embraced the use of implementation research as a critical way to improve care by facilitating the adoption of proven medical practices. Yet implementation science still remains rudimentary. Challenges exist in judging the success of an implementation project. Rather than relying solely on hard outcomes, an investigator must also assess how effectively an intervention is put into place at a site. This assessment comes via a formative evaluation (FE) plan. The FE plan can contain such diverse data elements as the number of fliers distributed about the intervention, how often an intervention advocate speaks to participants, the content derived from team meeting notes, and themes extracted from focus groups. The diversity of such data elements can appear foreign to investigators trained in traditional health services research. The FE plan can also lead to confusion about what to measure, when, and how to integrate the various measures into a unified whole. Complicating matters is the fact that FE is often qualitative--such as interviews, focus groups, and meeting notes which can make data difficult for investigators to interpret. Thus, there is a pressing need to provide clarity on how FE is to be used in implementation studies. This Short Term Project proposal offers a three-part approach toward specifying the best FE practices: first, a systematic review of the literature; second, qualitative interviews with VA implementation investigators; and third, a panel discussion of national experts, funded through a VA Implementation Collaborative Award. The panel discussion will outline FE guidelines based on the researchers expertise, the systematic review, and the qualitative interviews.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

January 23, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2009

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2009

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

May 20, 2008

Last Update Submit

June 2, 2017

Conditions

Keywords

implementationevaluationresearch methodologyintervention

Outcome Measures

Primary Outcomes (1)

  • Investigators attitudes toward formative evaluation

    Current

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

VA health services investigators

You may qualify if:

  • VA health services investigators

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan L. Zickmund, PhD

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 23, 2008

Study Start

January 23, 2009

Primary Completion

March 30, 2009

Study Completion

March 31, 2009

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations