Applying Community Engagement Principles to Research Design and

Implementation Epi 248

Margaret Handley, PhD MPHKevin Grumbach, MD

January 21, 2010

Learning Objectives

I. Become familiar with how adding qualitative methods may inform/enhance your research partnerships and outcomes

II. Understand how CE-strategies can improve research relevance and validity related to:

i. study SETTING, SAMPLING, and RECRUITMENT ii. study DESIGN

iii. INSTRUMENT development iv. INTERVENTION design

III. Identify CE design tools/techniques relevant to your research areas

I. Qualitative Methods Relevant to CE

“If the only tool researchers have is a hammer, they tend to see every problem as a nail. An appreciation of both quantitative and qualitative approaches can enhance a researcher’s ability to answer complex questions in a manner which is efficient, internally valid, and generalizable”

- Stange and Zyzanski, 1989

MIXED METHODS –

Integrating quantitative and qualitative elements

(in-depth interviews, focus groups, key informant, participant observation)

Integration into single study or for different phases of work in a research area

Requires strategic relationship between data sources so that they can be combined for:

sequencing of methods, priority of methods, and timing of the data integration

Mixed Methods - Goals

1. Understand key themes to inform research Q, data collection, and intervention design

e.g. Somali refugee project, lead outbreak investigation, guideline dev. for provider-interpreter trust

2. Understand the intervention better

e.g. adopters/non-adopters of intervention via in-depth interviews, focus groups re intervention barriers, uptake adherence, participant observation for shifts in practice

Creswall, et al 2004; Johnson et al, 2009

Mixed Methods

Relevance to CE?

Focuses on establishing dialogue with community that is essential to supporting doing the right work

How can it improve research quality?

Expanding the gaze –contextual interpretive relevance

Partnerships may improve trust and thereby, participation, quality of information, and reach

Moves research forward - simultaneously gathering information to improve tools and their acceptance

Qualitative Research Sampling/Recruitment

1. Sampling approach comes from goals

Is the purpose of the qualitative work to achieve:

Maximum diversity on unstudied topic? Engagement with key sub-groups? Partnership via stakeholder participation?

2. Sampling and recruitment are linked to CE

Key informants can shape the sample with you:

e.g. ‘Snowball’ w/ key informants > >contacts

e.g. ‘Purposeful’ w/ groups you want to work with for either diversity or representativeness

RESEARCH APPROACH- Researchers and communities ….

Methods and Examples

1. Determine SETTING, SAMPLING, RECRUITMENT

- RE-AIM framework

- IDEALL Project for diabetes

2. Determine DESIGN - Quasi-experimental and

observational designs-Fluoride varnish intervention

- Lead outbreak investigation3. Develop INSTRUMENTS and INTERVENTIONS - CBPR

-Colorado Community Cancer Screening Program

4. IMPLEMENT INSTRUMENTS and INTERVENTIONS emphasis on overcoming concerns of community partners

- CBPR-Somali refugee project

II. CE Research Methods for Partnered Approach

Setting, Sampling and RE-AIM

REAIM

Relevance to CE?

How can it improve research quality?

1. Broadens criteria to design and evaluate interventions:

More external validity measures like reach into vulnerable groups, representativeness, participation in sub-groups, limited exclusions– which are closely linked to CE

2. Incorporating should involve engaging stakeholders too

RE-AIM

R Increase Reach

E Increase Effectiveness

A Increase Adoption

I IncreaseImplementation

M Increase Maintenance

Glasgow, et al. Ann Behav Med 2004;27(1):3-12

RE-AIM Design/Evaluation QsArea Evaluation question to include

Reach

(setting, sample, recruitment)

Efficacy or Effectiveness

Adoption

Implementation

Maintenance

What percent of potentially eligible participants a) were excluded, b) took part and c) how representative? WHO?

What impact on a) all participants; b) on process intermediate, and primary outcomes; and c) on both positive and negative outcomes? WHAT HAPPENED? WHY?

What % overall and within settings (e.g., schools/educators, clinics/clinicians) a) were excluded, b) participated and c) how representative? WHERE THE MOST IMPACT?

Were intervention components delivered as intended?

Long-term effects? who dropped-out? were different intervention components continued? What was modified?

EXAMPLE- Setting, Sampling, Recruitment

Improving Diabetes Efforts Across Language and Literacy

Research dilemma –

Clinic-based or community-based self management support program? Which patients to reach? How to measure reach?

Participatory Approaches: patient focus groups, clinician and clinic management interviews to determine setting

Research Decision: ‘Extra care’ adjunctive model, focused on RE-AIM in safety net, recruitment at point of

entry to care, RCT with two interventions

Impact of Participatory Findings: critical

Schillinger et al, 2008, Handley et al 2006

Design – Quasi-Experimental and Observational Designs

Quasi-Experimental Designs

Stepped Wedge Design

Wait-List Design

Multiple Arms with Treatment Preference Options

Observational Designs

Descriptive cohorts

Case-cluster

Stepped Wedge Design

Relevance to CE? How can it improve research quality?

• RCT design often is not acceptable to community partners and every site gets the intervention with this design

• RCT would not be ethical since the intervention may be clearly established to provide some benefit

• Not disruptive to existing models of care delivery, but enables the upgrade or augmentation to be controlled

• Often best strategy to study an intervention targeting high health disparity situations

Stepped Wedge Design

• Intervention roll-out in two or more stages- often not possible to roll-out intervention all at once anyway

• For cluster-interventions

• Enables all sites to receive intervention - is widely used for evaluating population-based research

• Each of the sites collect data at each roll out stage

• Design provides multiple baseline data with pre-intervention providing control data

Hawkins et al 2007, Mercer et al, 2007; Hussey et al, 2007 Cilberto et al 2005; Patel et al 2005; Brown and Lilford 2006

Stepped Wedge Design

5

4

3

2

11 2 3 4 5 6

Shaded cells represent intervention periodsBlank cells represent control periodsEach cell represents a data collection point

Time periods

Par

ticip

ants

/Clu

ster

s

Stepped Wedge Design

Fig. 1 . Timing of the intervention rollout in a stepped-wedge evaluation of two strategies to enroll HIV-infected women into antiretroviral therapy, Lusaka, Zambia July 2007 to 2008.

Antiretroviral therapy in antenatal care to increase treatment initiation in HIV-infected pregnant women: a stepped-wedge evaluation. Killam, William; Tambatamba, Bushimbwa; Chintu, Namwinga; Rouse, Dwight; Stringer, Elizabeth; Bweupe, Maximillian; Yu, Yong; Stringer, Jeffrey AIDS. 24(1):85-91, January 2, 2010.

Wait List Design/Choice

Relevance to CE? How can it improve research quality?

• RCT design often is not acceptable to community partners

and everyone gets an intervention

• RCT would not be ethical since the intervention may be clearly established to provide some benefit

• Applied to interventions for individuals or clusters

• Not disruptive to existing models of care delivery, but enables the upgrade or augmentation to be controlled

Wait List Design Fluoride Varnish REACH Study24 Primary Care Clinics 24 WIC sites

Randomize site Randomize site

On-site FV + Educ

Referral to DDS+

Educ

On-site FV + Educ

Referral to DDS +

Educ

NIH/NIDCR U54 DE 019285, UCSF CAN DO Center

On-site FV + Educ

On-site FV + Educ

THIS IS WHEN THE SITES THAT WERE ONWAIT LIST, ARE IN THE FV ARM

EXAMPLE - Design

Binational Outbreak Investigation of Lead Poisoning

Research dilemma-

What is the best way to extend the outbreak investigation of lead poisoning to community of origin – a particularly vulnerable pop. in Mexico?

Participatory Approaches: Mixed methods, key informants to determine how to study the problem with a focus on long-term trust and community education outcomes. Community contacts in Ca. and Oaxaca, health officials, anthropologists

Research Decision: Case-cluster investigation with environmental sampling, with extended families of Ca cases

Impact of Participatory Findings: critical

Handley and Grieshop, 2007; Villalobos et at, 2009

EXAMPLE- Intervention Development

Improving Colorectal Cancer Screening Awareness

Research dilemma-

Which forms of communication would reach population, which components to include in outreach?

Participatory Approaches: CAB, pt. focus groups, clinician and clinic management interviews to design instruments

Research Decision: Simple messages with broad forms of communication involving local community stakeholders.

Impact of Participatory Findings: critical

Zittleman et al, 2009

EXAMPLE - Implementation Approach

Culturally-appropriate care for Somali refugee women

Research dilemma –

How can we address the unmet healthcare needs of this population and engage them in trust building to access care? How to build on what we learn to train our healthcare providers?

Participatory Approaches: Community dialogue and social networking, formation of CAB, in-depth IX, focus groups w/ video-elicitation

Research Decision: CBPR with mixed methods>> social networks developed purposeful sampling strategy of neighborhoods for a survey intended to be representative

Impact of Participatory Findings: critical

Johnson et al, 2009; Ellis et al, 2007

III. DISCUSSION GROUPS

Identify CE design tools/techniques relevant to your research areas

Homework Assignment

For your proposed project, describe and explain the rationale for your:

SETTING, SAMPLING, RECRUITMENT DESIGN INSTRUMENTS INTERVENTIONS 

For each the steps above, describe how you can involve your community partners and stakeholders.