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Formative Evaluation in Implementation Research: Guideline Development

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00683540
First received: May 20, 2008
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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 noteswhich 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.


Condition
Chronic Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Formative Evaluation in Implementation Research: Guideline Development

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Investigators attitudes toward formative evaluation [ Time Frame: Current ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
VA HSR&D and QUERI investigators

Detailed Description:

Objectives: 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 noteswhich 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. The specific aims for this proposal include the following: Specific Aim 1: Conduct a systematic review of VA funded implementation projects to classify the specific types of FE procedures employed. Specific Aim 2: Conduct in-depth telephone interviews with investigators of VA-funded implementation projects to establish which FE methods were used and which were considered most/least successful.

Specific Aim 3: Using the national experts gathered together under the umbrella of the Center for Health Equity Research and Promotions (CHERP) Implementation Research Collaborative, develop a set of guidelines outlining best FE practices in VA implementation research. Relevance to the VA, Anticipated Results, and Future Directions: This Short Term Project is designed to provide rapid results for developing the best approach toward the use of FE in VA implementation science. As such this proposal is responsive to the VA Health Services Research & Development (HSR&D) priority topics for both implementation and management and research methodology. The systematic review, the qualitative report, and the FE guidelines that will emerge from the project will have wide-spread applications within the VA implementation community, thereby supporting the HSR&D research mission. The study will also serve as needed pilot data for a future Merit Review award application designed to provide the theoretical and practical approaches toward FE use within the VA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

VA health services investigators

Criteria

Inclusion Criteria:

  • VA health services investigators

Exclusion Criteria:

  • N/A
  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: NCT00683540

Locations
United States, Pennsylvania
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
Investigators
Principal Investigator: Susan L. Zickmund, PhD Center for Health Equity Research and Promotion
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00683540     History of Changes
Other Study ID Numbers: SHP 08-156, SHP 08-156
Study First Received: May 20, 2008
Last Updated: August 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
implementation
evaluation
research methodology
intervention

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014