Responses to CBPR- and RCT- Specific Study Design Features: Influences on Group Differences in Study Outcomes among Low-Income Women Shawn M. Kneipp, PhD, ANP-BC Associate Professor The University of North Carolina at Chapel Hill School of Nursing

Acknowledgments Barbara Lutz, PhD, RN, APHN-BC Catherine Levonian, PhD, MPH, BSN Christa Cook, MSN, PhD(c), APHN-BC Toni Watson Jill Hamilton, PhD, RN Dawne Roberson Kristen Swanson, PhD, RN, FAAN University of Florida College of Nursing The University of North Carolina at Chapel Hill School of Nursing National Institutes of Health/National Institute of Nursing Research #R01 NR009406

Background o Health disparities research o Shift in target population foci o New intervention (development) approaches need * o Community-based participatory research (CBPR) o Widely applied over past 10 years o Improved study processes, endpoint outcomes when combined with rigorous design ** *Flaskerud & Nyamathi, 2002; Minkler & Wallerstein, 2003; Israel et al., ** Viswanathan et al, 2004.

Outcomes with CBPR o Attributed to embedding structural components of CBPR into intervention and study designs o Equity, community benefit, cultural tailoring o Studies suggest that cultural tailoring enhances personal relevance and the thoughtfulness with which participants view study-related materials. * * Krueter & Wray, 2003; Ochocka et al., 2002; Reeve et al., 2002.

Outcomes with CBPR o Embedded aspects, such as tailoring, could amplify other threats to validity * o Participant experiences of CBPR study features are notably absent o Related issues in the nursing research literature around parsing “active” intervention from interpersonal relationships/interactions ** * French & Sutton, 2010 **Beal et al., 2009; Fogg & Gross, 2000.

CBPR Application o Methodology studies lag behind ~ Except with respect to partnership- building processes, and CBPR partner- IRB interface * o Methods for applying CBPR vary widely, and efficacy / mechanisms of CBPR not well-understood * Mitchell & Baker, 2005; Parker et al., 2003; Pivak & Goelman, 2011; Kobeissi et al., 2011; Brown et al., 2010; Malone et al., 2006.

Through a Sociological Lens... “... the research act inevitably leaves its mark on the object [participant]...” Shalin, 1986, p.22

Study Aims Descriptive, exploratory process evaluation of a recently completed, CBPR-driven RCT 1. Interpretation group differences in health-related outcomes (i.e., depressive symptoms), 2. what aspects of the study were most valuable and/or least desirable, and 3. additional intervention components RCT participants felt they needed

Primary Study Description o RCT n=432 women in WTP w/+CHC (2/07-4/10) o PHN health screening, referral, and case management over 9 months, Medicaid training 1 o Tailored intervention, questionnaires to needs and preferences of target group 2 o Control condition = WTP usual care, w/ offer of attenuated intervention after 9 mo data collection o Hired community research assistants 1 Kneipp et al., 2011; 2 Lutz et al., 2009

Methods o June 2010 – IRB, and contacted participants who completed RCT within past 6 months o Began contacting Monday, full focus group panel by Friday o 5 focus groups, n=31 total o Moderators: PI, RA, prior intervention nurse, doctoral student o Both control and intervention group o Audio taped, transcribed, field notes, reflexivity statements

Sample Demographics o 81% Black, 19% White o 52% Single o 61% Unemployed o Mean age = 38 years o 25.8% < HS diploma or GED o 25.7% w/ HS diploma or GED

Data Analysis o Dimensional analysis (DA) and constant comparison approach o Construct explanatory matrix of complex social phenomenon o Line-by-line coding to identify salient dimensions o Preliminary coding → qualitative data analysis group for peer debriefing and initial categorizing using card sort method o Axial-focused coding to complete conceptual category identification, identify relationships o Dynamic, comprehensive conceptualization o Review & refinement by three consultants

Perspective: Informing RCT Experiences o “It’s like when you first started [the WTP], they [WTP staff] want to take your respect from you.” o “She [the RA] wouldn't never, say, interrupt me or say anything disrespectful or nothing.” o “None of the nurses came off like that. They came off like they really were concerned and they’re very caring. Their voice—I mean the way they talk to you—it’s like ‘I’m here for you regardless of what you’re going through I’m here for you.”

Engagement with Questionnaire o “You had to sure enough dig deep.” o “It made me think... about things that you probably would have pushed aside. It helped me, like, get focused on some things that were important that I was neglecting in my life.” o “[I opened] my feelings up on how I feel and I don't normally do that a whole lot. I put every little problem that I had down. Every little meaning of how I felt.”

Taking Action “[Saying to myself] I’m getting this [the control assignment and the questionnaire], I have to make it ’cause it’s all I got. So, that helped too.”

Taking Action o “It [the health questionnaire] made me go to other people... one of the questions being if you needed a ride or if you needed someone to talk, do you have someone that you could go to?... maybe I should just talk to my aunt... she was like oh, yeah, you can come over and talk to me or oh, yeah, I’ll give you a ride and stuff that I would have never done. It made me, like, step out and do it.”

Consequences: Study Outcomes o Distancing self from ‘welfare recipient’ label with employment o Control group engagement with questionnaire, moved to action for self-help o Engagement with RA, storytelling characteristics as therapeutic 1 o All relevant for reducing depressive symptoms across intervention and control groups 1 Banks-Wallace, 1998; Grassley & Nelms, 2009

Comparison with Other Findings o Instrumentation effects/measurement reactivity 1 o Completing psychosocial questionnaire = independent therapeutic effects among women recovering from miscarriage 2 o Fibromyalgia sx management RCT = attributed outcomes to interventionist credibility 3 o Women with lower socioeconomic status = ‘writing in the margins’ of questionnaires 4 1 French & Sutton, 2010; Hughes et al., 2005; Rubin et al., Swanson, Beal et al., Clayton et al., 1999

Summary o External contextual factors (label) influence study outcomes, experiences o Measurement reactivity, conditional on group assignment o CBPR-precipitated questionnaire tailoring and community RA may have exacerbated this effect o Further research to understand interactions between SES, CBPR features (i.e., tailoring) and engagement, and effects on health-related outcomes.

Questions Kneipp, S. M., Lutz, B. J., Levonian, C., Cook, C., Hamilton, J. B., & Roberson, D. (in press). Women’s experiences in a community-based participatory research randomized controlled trial. Qualitative Health Research.