Incorporating theory in grant applications Delphine Tuot, MDCM, MAS Epi 246

1. Incorporating theory in grant applications Delphine Tuot, MDCM, MAS Epi 246

2. Grant sections where you can mention theory • Specific Aims • Significance • Innovation • Approach/Research Strategy • Preliminary studies • Background • Research design/methods

3. My KL2/K-23 grant application Aim 1: To determine the extent to which individual awareness of CKD is associated with health outcomes, in a prospective cohort study. Aim 2: To explore needs, preferences, and barriers for CKD self-management among a group of safety-net patients with CKD in order to inform the content of self-management support programs to slow CKD progression through risk reduction behavior change. Aim 3: To design an automated telephone self-management (ATSM) support program for safety-net patients with CKD and assess its acceptability and feasibility in a pilot study.

4. Grant sections where I mention theory • Specific Aims • Significance • Innovation • Approach/Research Strategy for each Aim • Aim 1 • Aim 2 • Introduction • Expected Outcomes • Aim 3 • Timeline

5. Aim 2: To explore needs, preferences, and barriers for CKD self-management among a group of safety-net patients with CKD in order to inform the content of self-management support programs to slow CKD progression through risk reduction behavior change

6. Introduction Social Cognitive Theory (SCT) describes a dynamic process in which personal factors, environmental factors, and human behavior exert influence on each other and lead to behavior change.45 It also posits individuals who believe they have control over their own behaviors, can change them, even when faced with obstacles.46Pertinent to SCT, studies have demonstrated that patients who suffer from arthritis, diabetes and hypertension experience better outcomes when they are involved with their own illness management.5, 47 It is not clear if this holds true for patients with CKD, given the silent nature of the disease and relative absence of short-term, adverse health outcomes. To accomplish this aim, I will conduct interviews with patients with CKD and analyze the transcripts to identify factors relevant to SCT and emergent themes, using a grounded theory analytical approach. Results will guide the design of sustainable, effective self-management support programs for safety-net patients with CKD.

7. Expected outcomes: In-depth interviews will uncover safety-net patients’ awareness of CKD and their beliefs about kidney disease and risk reduction practices. Consistent with the SCT, we expect to uncover individual-level and community-level challenges to CKD self-management. Also, we expect to identify a need for heightened support for engagement in risk-reduction behaviors as well as preferences for ATSM content. Similar preferences among English-speakers and Spanish-speakers will enable us to adapt educational content that is relevant to both populations in the San Francisco safety-net, but allow us to explore more tailored self-management support messages for the future.

8. In retrospect…. • Wish I had mentioned SCT in the Innovation section, highlighting the lack of existing theory-based interventions in CKD research • Should have included pertinent constructs of SCT in my description of Aim 3 – the actual pilot intervention • Preferably, in a figure

9. Aim 3: To design an automated telephone self-management (ATSM) support program for safety-net patients with CKD and assess its acceptability and feasibility in a pilot study. 2 1 3 5 4

10. R34: NIH-sponsored Clinical Trial Planning Grants • Planning Grants for Translating Chronic Kidney Disease (CKD) Research into Improved Clinical Outcomes • Our study: “Health IT Enhanced for CKD in Safety-Net Primary Care”

11. Aim 1: Develop and implement a registry-based intervention that identifies patients with CKD, notifies providers of their CKD patients, and increases provider and patient awareness/knowledge of CKD through educational materials – Basic CKD Registry Aim 2: Further improve outcomes with an intervention that augments provider CKD management by enhancement of the Basic CKD registry with targeted IT decision support – Enhanced CKD Registry Aim 3: Further improve outcomes by supplementing the enhanced registry with a patient-directed, automated telephone self-management (ATSM) support program – Enhanced CKD Registry Plus Aim 4: Assess the potential for sustainability of interventions examined in Aims 1-3

12. Grant sections where I mention theory • Specific Aims • Significance • Innovation • Research strategy • Preliminary Studies (including multidisciplinary team) • Overall study design (RCT within quasi-experiment) • Study population • Methods for each study aim (Aim 4) • Overall design considerations • Timeline

13. Innovation Section This proposal is innovative in three important ways: • It employs an adapted Social Cognitive Theory,32 which describes a dynamic process of how personal factors, environmental variables, and human behavior reciprocally exert influence on each other and enable behavior change, as outlined in our conceptual model (Figure B.1).

15. Achieving providerbehavioral change, informed by Social Cognitive Theory Interventions (examples) • Registry notification and decision support (behavioral capability, self efficacy) • Dissemination of NKF guidelines • (expectations, self efficacy) • Academic detailing/feedback • (reinforcement)

16. Achieving patientbehavioral change, informed by Social Cognitive Theory Interventions (examples) • NKDEP materials (behavioral capability) • Self-management tools with ATSM (self-efficacy) • Motivational Interviewing • (self-efficacy) • Action Planning (expectations) • Health Coach (reinforcement)

17. Innovation Section (Continued): 3. Its methodologic approach is based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework for enhancing program implementation and evaluation,36 with analysis of the incremental impact and sustainability of each proposed intervention, providing useful results for other healthcare systems considering CKD interventions

18. Aim 4: Assess the potential for sustainability of interventions examined in Aims 1-3 For interventions associated with the best results, we will assess aspects of their (1) reach, (2) effectiveness, (3) adoption, (4) implementation, (5) maintenance, and (6) resources consumed (Table C.4) using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework that encourages focus on external validity elements that improve sustainable adoption and implementation of interventions.36 Providers will be queried regarding their satisfaction with the feedback provided by the registry, by health claims, and/or by health coaches, as applicable. The ease of use, estimated provider burden, and helpfulness of interventions will all be assessed. Patients will also be queried regarding their overall satisfaction with care, comprehension of materials/phone support, and burden of the intervention. The resources associated with starting and maintaining each successful intervention will be assessed, including personnel time, equipment, and IT (Table C.4)

20. NIH Comments….They seem to have appreciated use of theory • … the use of conceptual and implementation models that appear relevant and seem to have been adapted well for this study… • This proposal employs a conceptual model of behavior change and clinical management to prevent the progression of CKD and the development of complication.

21. NIH Comments (strengths) • Evaluation for sustainability is an outcome of the study… • The targeting of structural barriers for providers and patients with interventions using a Social Cognitive Theory approach with both intermediate and longer term outcomes is interesting.