Preventive ServicesNCT00115557
Delivery of Preventive Services in Primary Care
A study testing Practice intervention and Practice intervention 2 in people with Preventive Services and Immunizations, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
The major goal of this project is to determine the effectiveness of a multi-component intervention designed to help primary care practices implement three office system strategies known to increase delivery of immunizations and other preventive services. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Preventive Services, Immunizations, Screening
- What is being tested?
- Practice intervention and Practice intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jul 2006
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care physician
- Member of the Oklahoma Physicians Resource/Research Network
- Computer with internet connection
- More than 30 patients seen per week
- Provides care to 2-3 year-olds and/or 50-75 year olds
Who cannot join
- Does not provide preventive services
- Inclusion of more than two of the preventive service delivery strategies at baseline
- Involved in another network project
- Unwilling to work with an external practice facilitator
- IRB used by the practice will not allow records audits without individual patient consent
Trial locations and contacts
1 site in 1 country.
About this study
The major goal of this project is to determine the effectiveness of a multi-component intervention designed to help primary care practices implement three office system strategies known to increase delivery of immunizations and other preventive services. This two-year study will contribute to our understanding of multi-component translational interventions in primary care, and particularly within practice-based research networks.
Read the detailed description
The multi-component translational intervention that we plan to test includes medical record audits with feedback and benchmarking, academic detailing by an opinion leader including information from literature review plus the advice of local exemplars, a practice facilitator, who will work with the practices over a six-month period, and an IT application that provides decision-support, prompts, and reminders to office staff and patients.
The proposed project will be a randomized controlled trial of a multi-component strategy designed to facilitate the incorporation into primary care practices of three office management components known to increase preventive service delivery rates: 1) nurse standing orders; 2) special immunization/ preventive services "clinics;" and 3) recall and reminder systems. Twenty-four practices, all members of a primary care practice-based research network, will be enrolled and randomized to receive the complete intervention or performance feedback with benchmarking only. The primary outcomes will be number of management components implemented. Characteristics of clinicians and practices that are associated with greater or lesser success in implementing the three strategies and barriers encountered will also be examined, and we will measure and compare rates of selected immunizations and preventive services delivered.
The specific aims for this project are to:
- Determine the effectiveness of a multi-component translational intervention on adoption of three strategies known to increase delivery of preventive services: nurse standing orders, a reminder/recall system (preferably PSRS), and special immunization and/or preventive services clinics. The intervention will include: a) performance feedback and benchmarking; b) training of clinicians and office staff in principles of effective preventive services (enhanced academic detailing by a physician opinion leader); c) practice enhancement assistants to facilitate office system changes; and d) an IT application that provides prompts and reminders to office staff, clinicians, and patients.
- Document contextual factors and barriers to the adoption of the three strategies and their impact on the intervention.
- Measure the impact of the intervention on rates of delivery of the following preventive services: DtaP#4, MMR#1, and HepB#3 in 2-3 year olds, and pneumococcal immunization, colorectal cancer screening, and mammography in adults 50 - 75 years of age.
- Conditions
- Preventive Services, Immunizations, Screening
- Being tested
- Practice intervention, Practice intervention 2
- Keywords
- translational research, prevention, primary care, practice-based research network
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice interventionOther
Performance feedback, academic detailing, practice facilitation, IT support
Practice intervention 2Other
Performance feedback only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Performance feedback, academic detailing, practice facilitation, IT support Receives: Other: Practice intervention |
| 2 | Active comparator | Performance feedback only Receives: Other: Practice intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of one or more of three evidence-based strategies
Measured: 6 months
Secondary outcomes (1)
Rates of delivery of selected preventive services
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive ServicesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Investigators
- James W Mold, MD, MPH, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115557
- Sponsor's protocol ID
- 1R21HS014850
- Status last verified
- Sep 2007
- First submitted
- 23 Jun 2005
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of Preventive Services in Primary Care
- ClinicalTrials.gov ID
- NCT00115557
- Acronym / sponsor ID
- 1R21HS014850
- Conditions
- Preventive Services, Immunizations, Screening
- Keywords
- translational research, prevention, primary care, practice-based research network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Oct 2004
- Primary completion
- May 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 24 Jun 2005 (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 major goal of this project is to determine the effectiveness of a multi-component intervention designed to help primary care practices implement three office system strategies known to increase delivery of immunizations and other preventive services. This two-year study will contribute to our understanding of multi-component translational interventions in primary care, and particularly within practice-based research networks.
Detailed description
The multi-component translational intervention that we plan to test includes medical record audits with feedback and benchmarking, academic detailing by an opinion leader including information from literature review plus the advice of local exemplars, a practice facilitator, who will work with the practices over a six-month period, and an IT application that provides decision-support, prompts, and reminders to office staff and patients.
The proposed project will be a randomized controlled trial of a multi-component strategy designed to facilitate the incorporation into primary care practices of three office management components known to increase preventive service delivery rates: 1) nurse standing orders; 2) special immunization/ preventive services "clinics;" and 3) recall and reminder systems. Twenty-four practices, all members of a primary care practice-based research network, will be enrolled and randomized to receive the complete intervention or performance feedback with benchmarking only. The primary outcomes will be number of management components implemented. Characteristics of clinicians and practices that are associated with greater or lesser success in implementing the three strategies and barriers encountered will also be examined, and we will measure and compare rates of selected immunizations and preventive services delivered.
The specific aims for this project are to:
- Determine the effectiveness of a multi-component translational intervention on adoption of three strategies known to increase delivery of preventive services: nurse standing orders, a reminder/recall system (preferably PSRS), and special immunization and/or preventive services clinics. The intervention will include: a) performance feedback and benchmarking; b) training of clinicians and office staff in principles of effective preventive services (enhanced academic detailing by a physician opinion leader); c) practice enhancement assistants to facilitate office system changes; and d) an IT application that provides prompts and reminders to office staff, clinicians, and patients.
- Document contextual factors and barriers to the adoption of the three strategies and their impact on the intervention.
- Measure the impact of the intervention on rates of delivery of the following preventive services: DtaP#4, MMR#1, and HepB#3 in 2-3 year olds, and pneumococcal immunization, colorectal cancer screening, and mammography in adults 50 - 75 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Practice interventionPerformance feedback, academic detailing, practice facilitation, IT support |
| 2 | Active comparator | Other: Practice intervention 2Performance feedback only |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary care physician
- Member of the Oklahoma Physicians Resource/Research Network
- Computer with internet connection
- More than 30 patients seen per week
- Provides care to 2-3 year-olds and/or 50-75 year olds
Key exclusion criteria (5 listed)
- Does not provide preventive services
- Inclusion of more than two of the preventive service delivery strategies at baseline
- Involved in another network project
- Unwilling to work with an external practice facilitator
- IRB used by the practice will not allow records audits without individual patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice interventionPerformance feedback, academic detailing, practice facilitation, IT support | Other | 1 |
| Practice intervention 2Performance feedback only. | Other | 2 |
Primary outcome
Implementation of one or more of three evidence-based strategies
Time frame: 6 months
1 secondary outcome
Rates of delivery of selected preventive services
Time frame: 6 months
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 12 Aug 2010.
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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.
James W Mold, MD, MPH principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice intervention and Practice intervention 2 in people with Preventive Services and Immunizations, run by Agency for Healthcare Research and Quality (AHRQ) 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 5 inclusion and 5 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 12 Aug 2010. 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?
Implementation of one or more of three evidence-based strategies (time frame: 6 months). 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 12 Aug 2010.