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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-BCAssociate ProfessorThe University of North Carolina at Chapel HillSchool of Nursing
Acknowledgments
Barbara Lutz, PhD, RN, APHN-BC Catherine Levonian, PhD, MPH,
BSN Christa Cook, MSN, PhD(c),
APHN-BCToni Watson
Jill Hamilton, PhD, RNDawne RobersonKristen 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
Backgroundo Health disparities researcho 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., 2005.** Viswanathan et al, 2004.
Outcomes with CBPRoAttributed to embedding structural
components of CBPR into intervention and study designso 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*
oMethods 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 Descriptiono RCT n=432 women in WTP w/+CHC (2/07-
4/10)
o PHN health screening, referral, and case management over 9 months, Medicaid training1
o Tailored intervention, questionnaires to needs and preferences of target group2
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; 2Lutz et al., 2009
Methodso 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 totalo Moderators: PI, RA, prior intervention
nurse, doctoral student o Both control and intervention groupo Audio taped, transcribed, field notes,
reflexivity statements
Sample Demographics
o 81% Black, 19% Whiteo 52% Singleo 61% Unemployedo Mean age = 38 yearso 25.8% < HS diploma or GEDo 25.7% w/ HS diploma or GED
Data Analysiso Dimensional analysis (DA) and constant
comparison approach
o Construct explanatory matrix of complex social phenomenono Line-by-line coding to identify salient
dimensionso 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 conceptualizationo 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 therapeutic1
o All relevant for reducing depressive symptoms across intervention and control groups1Banks-Wallace, 1998; Grassley & Nelms, 2009
Comparison with Other Findings
o Instrumentation effects/measurement reactivity1
o Completing psychosocial questionnaire = independent therapeutic effects among women recovering from miscarriage2
o Fibromyalgia sx management RCT = attributed outcomes to interventionist credibility3
o Women with lower socioeconomic status = ‘writing in the margins’ of questionnaires4
1French & Sutton, 2010; Hughes et al., 2005; Rubin et al., 20102 Swanson, 1999 3Beal et al., 2009 4Clayton 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.
