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Formative Evaluation in Implementation Research: Guideline Development
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, January 2009
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00683540
  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

MedlinePlus related topics: Coping with Chronic Illness
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Formative Evaluation in Implementation Research: Guideline Development

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683540

Contacts
Contact: Susan L Zickmund, PhD (412) 954-5259 susan.zickmund@va.gov
Contact: Mary B Walsh, RN (412) 954-5256 mary.walsh3@va.gov

Locations
United States, Pennsylvania
Center for Health Equity Research and Promotion Recruiting
Pittsburgh, Pennsylvania, United States, 15206
Contact: Mary B Walsh, RN     412-954-5256     mary.walsh3@va.gov    
Contact: Kelly H Burkitt, PhD     (412) 954-5202     kelly.burkitt@va.gov    
Principal Investigator: Susan L. Zickmund, PhD            
Sub-Investigator: Larissa M. Myaskovsky, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Susan L. Zickmund, PhD Center for Health Equity Research and Promotion
  More Information

Responsible Party: Department of Veterans Affairs ( Zickmund, Susan - Principal Investigator )
Study ID Numbers: SHP 08-156
Study First Received: May 20, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00683540  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Chronic Disease

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009