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1.  Improving Urban African Americans’ Blood Pressure Control through Multi-level Interventions in the Achieving Blood Pressure Control Together (ACT) Study: A Randomized Clinical Trial 
Contemporary clinical trials  2014;38(2):370-382.
Background
Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients’ management of a variety of chronic illnesses. However, studies of multilevel interventions designed specifically to improve urban African American patients’ blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking.
Methods/Design
We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients’ improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients’ blood pressure control at 12 months.
Discussion
Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients’ hypertension control.
doi:10.1016/j.cct.2014.06.009
PMCID: PMC4169070  PMID: 24956323
hypertension; self-management; community health worker
2.  Effectiveness of Educational and Social Worker Interventions to Activate Patients’ Discussion and Pursuit of Preemptive Living Donor Kidney Transplantation: A Randomized Controlled Trial 
Background
Many patients with chronic kidney disease (CKD) have difficulties becoming actively engaged in the pursuit of pre-emptive living donor kidney transplantation.
Study Design
The Talking About Live Kidney Donation (TALK) study was a randomized controlled trial of the effectiveness of educational and social worker interventions designed to encourage early discussions and active pursuit of pre-emptive LKT among patients with progressive CKD.
Setting & Participants
We recruited participants with progressive CKD from academically affiliated nephrology practices in Baltimore, Maryland.
Intervention
Participants randomly received 1) “Usual Care” (routine care with their nephrologists), 2) “TALK Education” intervention (video and booklet), or the 3) “TALK Social Worker” intervention (video and booklet plus patient and family social worker visits).
Outcomes
We followed participants for 6 months to assess their self-reported achievement of behaviors reflecting their discussions about LKT and/or pursuit of LKT (discussions with family; discussions with physicians; initiating recipient evaluation; completing recipient evaluation; identifying a potential living donor).
Measurements
We assessed outcomes via questionnaire at 1, 3, and 6-month follow up.
Results
Participants receiving Usual Care with their nephrologists (n=44), TALK Education (n=43), and the TALK Social Worker (n=43) were similar at baseline. TALK Study interventions improved participants’ LKT discussion and pursuit behaviors, with the Social Worker leading to greater patient activation (participants’ predicted probability (95% confidence interval) of achieving LKT discussions, evaluations, or donor identification over 6 months in Usual Care, TALK Education, and TALK Social Worker groups: 30% (20%–46%), 42% (33% –54%), and 58% (41% –83%), respectively (p=0.03).
Limitations
Our population was well educated and mostly insured, potentially limiting generalizability of our findings.
Conclusions
TALK interventions improved discussion and active pursuit of LKT among patients with progressive CKD and may improve their utilization of pre-emptive LKT.
doi:10.1053/j.ajkd.2012.08.039
PMCID: PMC3710736  PMID: 23089512
3.  Feasibility and Acceptability of the TALK Social Worker Intervention to Improve Live Kidney Transplantation 
Health and Social Work  2012;37(4):234-249.
Live kidney transplantation (LKT) is underused by patients with end-stage renal disease. Easily implementable and effective interventions to improve patients' early consideration of LKT are needed. The Talking About Live Kidney Donation (TALK) social worker intervention (SWI) improved consideration and pursuit of LKT among patients with progressive chronic kidney disease in a recent randomized controlled trial: Patients and their families were invited to meet twice with a social worker to discuss their self-identified barriers to seeking LKT and to identify solutions to barriers. The authors audio recorded and transcribed all social worker visits to assess implementation of the TALK SWI and its acceptability to patients and families. The study social worker adhered to the TALK SWI protocol more than 90 percent of the time. Patients and families discussed medical (for example, long-term risks of transplant), psychological (for example, patients' denial of the severity of their disease), and economic (for example, impact of donation on family finances) concerns regarding LKT. Most patients and families felt that the intervention was helpful. Consistently high adherence to the TALK SWI protocol and acceptability of the intervention among patients and families suggest that the TALK SWI can be feasibly implemented in clinical practice.
doi:10.1093/hsw/hls034
PMCID: PMC3954101  PMID: 23301437
clinical interventions; clinical social work; health disparities; transplants
4.  Selecting renal replacement therapies: what do African American and non-African American patients and their families think others should know? A mixed methods study 
BMC Nephrology  2013;14:9.
Background
Little is known regarding the types of information African American and non-African American patients with chronic kidney disease (CKD) and their families need to inform renal replacement therapy (RRT) decisions.
Methods
In 20 structured group interviews, we elicited views of African American and non-African American patients with CKD and their families about factors that should be addressed in educational materials informing patients’ RRT selection decisions. We asked participants to select factors from a list and obtained their open-ended feedback.
Results
Ten groups of patients (5 African American, 5 non-African American; total 68 individuals) and ten groups of family members (5 African American, 5 non-African American; total 62 individuals) participated. Patients and families had a range (none to extensive) of experiences with various RRTs. Patients identified morbidity or mortality, autonomy, treatment delivery, and symptoms as important factors to address. Family members identified similar factors but also cited the effects of RRT decisions on patients’ psychological well-being and finances. Views of African American and non-African American participants were largely similar.
Conclusions
Educational resources addressing the influence of RRT selection on patients’ morbidity and mortality, autonomy, treatment delivery, and symptoms could help patients and their families select RRT options closely aligned with their values. Including information about the influence of RRT selection on patients’ personal relationships and finances could enhance resources’ cultural relevance for African Americans.
doi:10.1186/1471-2369-14-9
PMCID: PMC3565884  PMID: 23317336
Decision-making; Renal replacement therapy; Family members; African American
5.  Development of a decision aid to inform patients’ and families’ renal replacement therapy selection decisions 
Background
Few educational resources have been developed to inform patients’ renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients’ treatment and support patients’ decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function.
Methods
We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in “stages.” For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families.
Results
The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals’ testimonials regarding various considerations that might influence patients’ and families’ treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably.
Conclusions
This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.
doi:10.1186/1472-6947-12-140
PMCID: PMC3560257  PMID: 23198793
Kidney disease; Decision aid; Literacy; Numeracy; Cognitive function
6.  The providing resources to enhance African American patients’ readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial 
BMC Nephrology  2012;13:135.
Background
Living related kidney transplantation (LRT) is underutilized, particularly among African Americans. The effectiveness of informational and financial interventions to enhance informed decision-making among African Americans with end stage renal disease (ESRD) and improve rates of LRT is unknown.
Methods/design
We report the protocol of the Providing Resources to Enhance African American Patients’ Readiness to Make Decisions about Kidney Disease (PREPARED) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test the effectiveness of informational (focused on shared decision-making) and financial interventions to overcome barriers to pursuit of LRT among African American patients and their families. Study Phase I involved the evidence-based development of informational materials as well as a financial intervention to enhance African American patients’ and families’ proficiency in shared decision-making regarding LRT. In Study Phase 2, we are currently conducting a randomized controlled trial in which patients with new-onset ESRD receive 1) usual dialysis care by their nephrologists, 2) the informational intervention (educational video and handbook), or 3) the informational intervention in addition to the option of participating in a live kidney donor financial assistance program. The primary outcome of the randomized controlled trial will include patients’ self-reported rates of consideration of LRT (including family discussions of LRT, patient-physician discussions of LRT, and identification of a LRT donor).
Discussion
Results from the PREPARED study will provide needed evidence on ways to enhance the decision to pursue LRT among African American patients with ESRD.
Trial registration
ClinicalTrials.gov NCT01439516
doi:10.1186/1471-2369-13-135
PMCID: PMC3489555  PMID: 23057616
Shared decision-making; Live kidney transplantation; Live kidney donation; Chronic kidney disease; End stage renal disease
7.  Protocol of a Randomized Controlled Trial of Culturally Sensitive Interventions to Improve African Americans' and Non-African Americans' Early, Shared, and Informed Consideration of Live Kidney Transplantation: The talking about Live Kidney Donation (TALK) study 
BMC Nephrology  2011;12:34.
Background
Live kidney transplantation (LKT) is underutilized, particularly among ethnic/racial minorities. The effectiveness of culturally sensitive educational and behavioral interventions to encourage patients' early, shared (with family and health care providers) and informed consideration of LKT and ameliorate disparities in consideration of LKT is unknown.
Methods/Design
We report the protocol of the Talking About Live Kidney Donation (TALK) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test culturally sensitive interventions to improve patients' shared and informed consideration of LKT. Study Phase 1 involved the evidence-based development of culturally sensitive written and audiovisual educational materials as well as a social worker intervention to encourage patients' engagement in shared and informed consideration of LKT. In Study Phase 2, we are currently conducting a randomized controlled trial in which participants with progressing chronic kidney disease receive: 1) usual care by their nephrologists, 2) usual care plus the educational materials, or 3) usual care plus the educational materials and the social worker intervention. The primary outcome of the randomized controlled trial will include patients' self-reported rates of consideration of LKT (including family discussions of LKT, patient-physician discussions of LKT, and identification of an LKT donor). We will also assess differences in rates of consideration of LKT among African Americans and non-African Americans.
Discussion
The TALK Study rigorously developed and is currently testing the effectiveness of culturally sensitive interventions to improve patients' and families' consideration of LKT. Results from TALK will provide needed evidence on ways to enhance consideration of this optimal treatment for patients with end stage renal disease.
Trial Registration
ClinicalTrials.gov number, NCT00932334
doi:10.1186/1471-2369-12-34
PMCID: PMC3150247  PMID: 21736762

Results 1-7 (7)