Design and Planning of PHCs

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Implementation Research Outcomes

Olakunle Alonge, MD MPH PhD

Learning Objectives

• Describe outcomes that define the effect of implementation • Distinguish implementation outcomes from efficacy, services

and client outcomes • Describe how to measure IR outcomes in order to undertake

implementation research

REVISITING DEFINITIONS

Implementation Research and Practice: Revisiting Definitions

• “Implementation [practice] is the act of carrying an intention into effect, which in health can be policies, programs, or individual practices (collectively called interventions)”

• “Implementation research is the scientific inquiry into questions concerning implementation”

4 Source: Peters, Adam, Alonge, Agyepong and Nhan, BMJ 2013; Gilbert, JRScT 1991

Implementation Research

Translational Research

Implementation Research and Other Common Studies in Public Health

T4 studies

T3 (D&I)

studies

Intervention studies

T2 studies

T1 studies

QI studies

Operation Research

M&E

Research objectives • Intervention efficacy • Intervention effectiveness and • Implementation effectiveness

Purpose of Implementation Research and Practice (IR&P)

• The purpose of IR&P is often to support effective health interventions in producing desired health outcomes

• Why might an effective health intervention not lead to desired health outcomes?

– Failure to adopt or roll out the intervention – Failure to implement the intervention as prescribed – Failure to reach at risk population – Poor penetration of the intervention in the health system – Low coverage of the intervention – Failure to sustain the implementation of the intervention

6 Source: Peters, Adams, Alonge et al 2013

Purpose of Implementation Research and Practice

• In practical terms, implementation research and practice in health focuses on:

– identifying common implementation problems; – understanding the factors that hinder or facilitate access to

health interventions; – developing and testing solutions to tackle implementation

barriers; – determining the best way to introduce potential solutions into a

health system, or – learning how to promote its large scale use and sustainability

7 Source: Peters, Adams, Alonge et al 2013

IMPLEMENTATION OUTCOMES: FRAMEWORK AND DEFINITIONS

Implementation Outcomes

• Implementation outcomes: – Implementation variables that describe effects (results) of a deliberate

and purposive action to implement an intervention – Useful for measuring success or failure of implementation activities – Intermediate outcomes of the effectiveness of an intervention (on

individual/population health outcomes and quality of life) – Underdeveloped constructs; operates across socio-ecological levels

9 Source: Peters, Adams, Alonge et al 2013; Proctol et al. 2011; Fixsen et al. 2005

Implementation Outcomes Feasibility Fidelity

Penetration Acceptability Sustainability

Uptake Costs

*IOM Standards of Care

Conceptual Model for Implementation Research

What?

EBIs ESTs

How?

Implementation Strategies

Implementation Research Methods

Service Outcomes* Efficiency Safety

Effectiveness Equity Patient-

centeredness Timeliness

Health Outcomes

Clinical/health status

Symptoms Function

Satisfaction

Proctor et al 2009 Admin. & Pol. in Mental Health Services

CONTEXT

CO N TE XT

CO N TEXT

The Usual The Core of

Implementation Science

– IRO could also be conceptualized as intermediate outcomes of health outcomes!

Implementation Outcomes - Definitions

Implementation Outcome

Working Definition* Related terms**

Acceptability The perception among stakeholders (e.g. consumers, providers, managers, policy-makers) that an intervention is agreeable

Related factors: (e.g. Comfort, Relative advantage, Credibility)

Adoption The intention, initial decision, or action to try to employ a new intervention

Uptake, Utilization, Intention to try,

Appropriateness The perceived fit or relevance of the intervention in a particular setting or for a particular target audience (e.g. provider or consumer) or issue

Relevance, Perceived fit, Compatibility, Perceived usefulness or suitability

Feasibility The extent to which an intervention can be carried out in a particular setting or organization

Practicality, Actual fit, Utility, Trialability

11 Source: Proctor et al 2011; Peters, Adams, Alonge et al 2013

Implementation Outcomes - Definitions Implementation Outcome

Working Definition* Related terms**

Fidelity The degree to which an intervention was implemented as it was designed in an original protocol, plan, or policy

Adherence, Delivery as intended, Integrity, Quality of delivery, Intensity or dosage of delivery

Implementation cost

The incremental cost of the implementation strategy (i.e. how the services are delivered in a particular setting); including the cost of the intervention itself.

Marginal cost, Total cost***

Penetration/ Coverage

Extent to which a practice or program is integrated within a service settings and system (niche saturation). The degree to which the population that is eligible to benefit from an intervention actually receives it.

Reach, Access, Service Spread or Effective Coverage, Penetration

Sustainability The extent to which an intervention is maintained or institutionalized in a given setting.

Maintenance, Continuation, Routinization, Institutionalization,

12 Source: Proctor et al 2011; Peters, Adams, Alonge et al 2013

IMPLEMENTATION OUTCOMES: MEASUREMENT

Stages of Implementation

• Exploration and Adoption- contemplation & readiness assessment

• Program Installation- Preparation

• Initial Implementation- Piloting and adaptation

• Full Implementation- Program is operating and at least 50% of intended providers are using the program.

• Sustainability- The new program is “business as usual”

(National Implementation Research Network, 2005)

Measuring Implementation Outcomes

15 Source: Proctor et al 2011

Measuring Implementation Outcomes

16 Source: Proctor et al 2011

FIDELITY

Fidelity - Definition

• Degree to which an intervention was implemented as prescribed by the original protocol or program developers

• Adherence to the core program components – Core components: elements without which the intervention will not

have its intended effect – Balancing fidelity and adaptation: 100% fidelity may be unrealistic

18 Source: Dusenbury et al 2003, Rabin et al. 2008

Fidelity – a Multi-domain Construct

• May consist of the following domains:

19 Source: Dane & Schneider, 1998; Dusenbury et al 2003; Carroll et al. 2007; Durlak and Dupre 2008; Proctor et al 2011

Dane & Schneider, 1998

Carroll et al. 2007 Proctor et al. 2011 Durlak and DuPre 2008

Adherence Adherence Adherence Adherence

Dose Exposure or dose Dose

Quality of delivery Quality of delivery Quality of delivery

Participant responsiveness

Program differentiation

Intervention complexity

Facilitation strategies

Fidelity – Domains of Interest

• Adherence – an intervention is being delivered as it was designed or written

• Dosage or exposure - frequency and duration of the intervention is as full as prescribed by its designers. Could mean amount of intervention that the recipient received

• Quality of delivery - the manner in which an intervention worker (e.g. teacher, volunteer, or staff member) delivers a program

– Based on techniques prescribed by developer – Based on a theoretical ideal

• Participant responsiveness - how far participants respond to, or are engaged by, an intervention

• Program differentiation - identifying unique features of different components of an intervention, and identifying the core components

20 Source: Mihalic 2004, Carroll 2007

Fidelity – Perspectives in Measurement

• Perspectives in measurement:

– Representative (commonest approach): to measure fidelity using estimates from a single domain (as a representation of all domains involved)

– Comprehensive: to measure fidelity using estimates aggregated across multiple domains

– Complex: to measure fidelity using estimates aggregated across multiple domains while also capturing the interactions between the different domains

Measuring Fidelity – Example from Literature

23 Source: Horwood et al. 2009 An Evaluation of quality of IMCI PloS One

Summary

• Implementation research is the scientific inquiry into questions concerning implementation

• Implementation outcomes (IO) describe effects (results) of a deliberate and purposive action to implement an intervention

• IO are mediators of health outcomes

• IO could comprise multiple domains or a single domain, are defined and measured in context across single or multiple socioecological levels

• They could be measured using quantitative, qualitative and mixed method approach