Chronic DiseaseNCT00683540
Formative Evaluation in Implementation Research: Guideline Development
An observational study of Chronic Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2009to 31 Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VA health services investigators
Who may be able to join
- VA health services investigators
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
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.
Read the 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 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. 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.
- Conditions
- Chronic Disease
- Keywords
- implementation, evaluation, research methodology, intervention
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators attitudes toward formative evaluation
Measured: Current
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study start23 Jan 2009
- Primary completion30 Mar 2009
- Study completion31 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan L. Zickmund, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683540
- Sponsor's protocol ID
- SHP 08-156
- Status last verified
- Jun 2017
- First submitted
- 20 May 2008
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Evaluation in Implementation Research: Guideline Development
- ClinicalTrials.gov ID
- NCT00683540
- Acronym / sponsor ID
- SHP 08-156
- Conditions
- Chronic Disease
- Keywords
- implementation, evaluation, research methodology, intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Jan 2009 (actual)
- Primary completion
- 30 Mar 2009 (actual)
- Study completion
- 31 Mar 2009 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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. 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VA health services investigators
Key inclusion criteria (1 listed)
- VA health services investigators
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigators attitudes toward formative evaluation
Time frame: Current
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L. Zickmund, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigators attitudes toward formative evaluation (time frame: Current). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.