Background
Specific aims
Specific aim 1
Hypothesis 1.1
Specific aim 2
Hypothesis 2.1
Hypothesis 2.2
Hypothesis 2.3
Specific Aim 3
Hypothesis 3.1
Methods/design
Recruitment and randomization procedures
Inclusion criteria for clusters
Inclusion criteria for patients
Recruitment
Randomization protocol
Power analysis
Intervention design
TRANSLATE elements that will be used in both arms | |
---|---|
T arget: | Common targets will be set for all practices and tracked through the CKD tool. The CDS-only practices will receive a quick reference guide for the treatment of CKD |
R egistry and reminder systems | CINA created a CKD registry and will maintain it throughout the study period. Point-of-care decision support specific to CKD will be provided to practice staff and physicians prior to patient visits. |
A dministrative buy-in | Obtain consent from each practice and all practice sites asked to identify a physician champion and site coordinator to oversee study implementation at their site. |
N etwork Information systems | The information systems (EHRs and CDS) will be used to create system level reports across all practices. |
TRANSLATE element that will be used only in facilitated CDS practices
| |
S ite coordination | A site coordinator at each practice will assemble a quality improvement (QI) team that will meet monthly to review performance data regarding CKD. The site coordinator will also work with the clinicians and practice staff to implement workflow changes such as pre-visit planning, standing orders, and patient education materials to improve efficiency of disease management. In addition, the site coordinator will be in contact with the practice facilitator by videoconference for assistance and advice. |
L ocal physician champion | This person will be the clinician leader and educator for other providers in each practice. Responsibilities will include supporting the site coordinator and the QI team. This physician will be in contact with the academic mentor for the practice regarding clinical questions about CKD and will participate in learning collaboratives with the site coordinator. |
A udit and feedback | Practice, individual provider, and patient-level outcome reports for the intervention practices will be generated through CINA regarding the seven performance measures (BP, HbAIC, LDL, use of ACE/ARB, referral to a nephrologist, smoking cessation and avoidance of NSAID or Cox-2) and will be reviewed by the team. Reports will also be reviewed quarterly with the practice facilitator by videoconference. The videoconference will allow the facilitator to learn what worked in each practice and to share what other practices have implemented successfully. |
T eam approach | A quality improvement (QI) team consisting of the local physician champion, site coordinator and nursing, front office, and administrative staff will meet monthly to review progress of the CKD project. Workflow changes will be recommended and tested. |
E ducation | An educational program using academic detailing and practice facilitation and videoconferencing will be utilized to support the practices’ efforts. All facilitated practices will be assigned an academic practice mentor. This mentor will be available to the office physician champion and practice coordinator to answer any questions and discuss plans. The academic mentor will review the practice’s data and participate in a quarterly videoconference with either the study coordinator or the lead clinician to review progress on the project. |
Facilitation protocol
Data collection
Clinical data
Data element | Measure type |
---|---|
Year of birth | Numerical |
Gender | M/F |
Race/ethnicity | Standard major groups and Other |
Current smoking | Current, never, past |
Height and weight/BMI | Hgt, wgt actual |
Total visits/encounters | Encounter records |
Hemoglobin | Numerical result |
HDL | Numerical result |
LDL-C | Numerical result |
Triglycerides | Numerical result |
Creatinine | Numerical result |
AST | Numerical result |
ALT | Numerical result |
HbA1c | Numerical result |
25 OH Vitamin D | Numerical result |
Electrolytes | Numerical result |
Serum phosphorous | Numerical result |
PTH intact | Numerical result |
All medications | Coded (NDC)/RxNorm |
All diagnosis – active & inactive | ICD-9 |
Blood pressure | Systolic and diastolic |
Estimated GFR | Calculated value |
Urine albumin/creatinine ratio | Calculated value |
Medicare insurance coverage | Flag for medicare insurance |
Nephrologists referrals | Referral records (when available) |
Process evaluation
Process evaluation activities | When collected | Arm(s) |
---|---|---|
• Survey of practices' approaches to chronic care and practice change | Baseline Endpoint | Facilitated-CDS and CDS-only |
• Semi-structured interviews with each Physician/ Clinician Champion. | Baseline Endpoint | Facilitated-CDS and CDS-only |
o Interviews conducted with ALL Facilitated practices | ||
o Interviews conducted with 9 CDS-only practices (4–5 from each round) | ||
• Facilitator activity log on all interactions with the practice including: | Ongoing | Facilitated- CDS |
o Emails | ||
o Phone calls | ||
o Monthly meetings with site coordinator | ||
o QI team meetings | ||
o Webinars/Conference calls | ||
o Collaborative learning | ||
o Interface/Meetings/consultations with the academic mentors | ||
• Academic detailing activity log on interactions with the practice including: | Weekly debrief with | Facilitated- CDS |
o Phone calls with physicians | each academic mentor | |
o Emailsntd | on their contacts with | |
o Webinars/Conference calls | the practices | |
o Collaborative learning | ||
o Interface/Meetings/consultations | ||
• Site visits to 10 interventions and 10 comparator practices to observe workflow. | Final 18 months of | Facilitated-CDS and CDS-only |
o Comparator practices selected at random. | intervention | |
o Intervention practices selected using a dynamic multi-method approach (refer to | ||
o site visit protocol) |