Course materials

1. Assignment: Pilot Tests of Interventions
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PreviewChapter 28 Feasibility Assessments and Pilot Tests of Interventions Using Mixed
Methods Copyright © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins Question
Tell whether the following statement is true or false: The terms pilot study and feasibility
study are interchangeable. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams
& Wilkins Answer False Often, the terms pilot study and feasibility study are used
interchangeably. Recently, however, some experts are drawing a distinction between the
two. A feasibility study is research completed prior to a main intervention study to test
specific and discrete aspects of an emerging intervention or the anticipated trial. A pilot
study is an investigation designed to test the feasibility of, and to refinements of, the
protocols, methods, and procedures to be used in a larger scale trial of an intervention.
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Feasibility and
Pilot Studies Feasibility study • Tests specific and discrete aspects of an emerging
intervention • Using a fairly simple design Pilot study • A small-scale version of a full trial •
Assesses an entire set of procedures for implementing • Evaluates an intervention • Ideally
involves a randomized design Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Feasibility Study • Completed prior to a main intervention study • Tests
specific and discrete aspects of an emerging intervention or the anticipated trial • Do not
focus on the outcome of interest • Typically do not use a randomized design Copyright ©
2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Pilot Study • Goal is to avoid a
costly full study failure. • Questionable as to whether it should be used to test a hypothesis –
Sample size is too small. • Typically 30-40 subjects Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Question Tell whether the following statement is
true or false: An external pilot is a stand-alone study, whereas an internal pilot is an early
phase of a larger trial. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Answer True An external pilot is a stand-alone study, the findings from which
inform the design and implementation of a full randomized control trial. An internal pilot is
an early phase of a large trial, the findings from which are typically used to make
adjustments to sample size projections. Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins Pilot Study Objectives • Stated at the onset of study • Focus
on the: – Process – Resources – Management issues – Scientific issues Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Scientific Objectives • Focuses on

2. the substantive aspects of the intervention – Safety and tolerability – Clinical significance –
Preliminary evidence of efficacy • Focuses on the methodologic aspects of a trial –
Randomization – Sample size – Fidelity – Instruments Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Preliminary Effect Size Estimates • Assignment: Pilot
Tests of InterventionsOften computed with confidence intervals (CIs) – CIs need not be as
stringent as in full study results. Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Resulting Decisions Pilot study results are meant to inform the decision
about whether to: • Move forward with a full trial • Make revisions that require an
additional pilot • Abandon the project altogether Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins Mixed Method Designs • Especially well suited for a pilot
study • Quantitative data can be used to assess whether feasibility criteria were met. •
Qualitative data can elucidate why they were not met. – How the intervention of study
protocols could be improved Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Lessons Learned • Major product provides: – Information from which
protocols for a full trial can be created – If interventions have been found to be feasible,
acceptable, and promising – List of proposed outcomes • The findings will be published so
that others can benefit from learning about both the successes and the failures. Copyright ©
2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Critiquing Feasibility and Pilot
Studies • Provides descriptions of sample characteristics, design elements, instruments •
Intervention theory and development of the intervention • References should be provided
to any previously published papers on intervention development. • Researchers’
description of the pilot objectives, the criteria used to make decisions about feasibility, and
the methods associated with feasibility assessments Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Question What term is used to identify practical
information about the real-life application of a pilot study? A. Responder analysis B. Exit
interview C. Lessons learned D. Statement of purpose Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Answer C A major product from pilot work is a
description of “lessons learned” that inform the final protocols for a full trial as well as
providing information about the usefulness and achievability of the proposed
intervention(s) in the “real world.” Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Chapter 27 Developing Complex Nursing Interventions Using Mixed
Methods Research Copyright © 2012 Wolters Kluwer Health | Lippincott Williams &
Wilkins Question Tell whether the following statement is true or false: Nursing intervention
research refers to a distinctive process of developing, implementing, testing, and
disseminating nursing interventions. Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Answer True Nursing intervention research refers to a distinctive
process of developing, implementing, testing, and disseminating nursing interventions—
particularly complex interventions. Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Nursing Intervention Research • Distinctive process • Developing,
implementing, testing, and disseminating nursing interventions • Particularly complex
interventions Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins
Complex Intervention • Number of components • Number of outcomes targeted • Number
and complexity of behaviors required • Time needed for the full intervention to be delivered

3. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Framework
Phases • Phase 1: Strong development efforts at the onset • Phase 2: Pilot tests of the
intervention • Phase 3: Controlled trial to assess efficacy • Phase 4: Assess effectiveness of
interventions in real-world clinical settings Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins Question Tell whether the following statement is true or
false: Studies to assess effectiveness of interventions in real-world clinical settings (Phase
4) are common in nursing. Copyright © 2017 Wolters Kluwer Health | Assignment: Pilot
Tests of InterventionsLippincott Williams & Wilkins Answer False Studies to assess
effectiveness of interventions in real-world clinical settings (Phase 4) are rare in nursing.
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Framework •
Idealized model • Process rarely linear • Mixed methods research Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Question Tell whether the following
statement is true or false: An important product during Phase 2 is a carefully conceived
intervention theory from which the design of the intervention flows. Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Answer False An important product
during Phase 1 is a carefully conceived intervention theory from which the design of the
intervention flows. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Phase 1 • Conceptualization and in-depth understanding of the problem and the
target population • Intervention theory • Resources for developing an evidence-based
intervention and intervention strategies – Systematic reviews – Descriptive research –
Consultation with experts – Discussion with team Copyright © 2017 Wolters Kluwer Health
| Lippincott Williams & Wilkins Intervention Theory • Content • Dose and intensity • Timing
• Outcomes to target and when to measure them • Setting • Agents • Mode of delivery •
Individualization Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins
Phase 2 • Preliminary interventions tested • Simple quasi-experimental design • Pilots –
Qualitative components – Recruitment and retention Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Pilot Study • Feasibility of more rigorous testing •
Lessons – Refine the intervention – Improve its acceptance and appeal – Enhance delivery
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Question Tell
whether the following statement is true or false: A mixed methods approach can strengthen
the test of the intervention during the Phase 2 controlled trial. Copyright © 2017 Wolters
Kluwer Health | Lippincott Williams & Wilkins Answer False A mixed methods approach can
strengthen the test of the intervention during the Phase 3 controlled trial. The inclusion of
qualitative components can shed light on intervention fidelity, variation in effects, clinical
significance, and interpretive ambiguities. Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins Mixed Methods • Appropriate for all phases • Phase 1 QUAL
has priority. • Phases 2 and 3 QUAN is usually dominant. Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Chapter 28 Feasibility Assessments and Pilot Tests of
Interventions Using Mixed Methods Copyright © 2012 Wolters Kluwer Health | Lippincott
Williams & Wilkins Question Tell whether the following statement is true or false: The
terms pilot study and feasibility study are interchangeable. Copyright © 2017 Wolters
Kluwer Health | Lippincott Williams & Wilkins Answer False Often, the terms pilot study
and feasibility study are used interchangeably. Recently, however, some experts are

4. drawing a distinction between the two. A feasibility study is research completed prior to a
main intervention study to test specific and discrete aspects of an emerging intervention or
the anticipated trial. A pilot study is an investigation designed to test the feasibility of, and
to refinements of, the protocols, methods, and procedures to be used in a larger scale trial
of an intervention. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Feasibility and Pilot Studies Feasibility study • Tests specific and discrete aspects of
an emerging intervention • Using a fairly simple design Pilot study • Assignment: Pilot Tests
of InterventionsA small-scale version of a full trial • Assesses an entire set of procedures for
implementing • Evaluates an intervention • Ideally involves a randomized design Copyright
© 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Feasibility Study •
Completed prior to a main intervention study • Tests specific and discrete aspects of an
emerging intervention or the anticipated trial • Do not focus on the outcome of interest •
Typically do not use a randomized design Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins Pilot Study • Goal is to avoid a costly full study failure. •
Questionable as to whether it should be used to test a hypothesis – Sample size is too small.
• Typically 30-40 subjects Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Question Tell whether the following statement is true or false: An external pilot is a
stand-alone study, whereas an internal pilot is an early phase of a larger trial. Copyright ©
2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Answer True An external pilot
is a stand-alone study, the findings from which inform the design and implementation of a
full randomized control trial. An internal pilot is an early phase of a large trial, the findings
from which are typically used to make adjustments to sample size projections. Copyright ©
2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Pilot Study Objectives • Stated
at the onset of study • Focus on the: – Process – Resources – Management issues – Scientific
issues Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Scientific
Objectives • Focuses on the substantive aspects of the intervention – Safety and tolerability
– Clinical significance – Preliminary evidence of efficacy • Focuses on the methodologic
aspects of a trial – Randomization – Sample size – Fidelity – Instruments Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Preliminary Effect Size Estimates •
Often computed with confidence intervals (CIs) – CIs need not be as stringent as in full
study results. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins
Resulting Decisions Pilot study results are meant to inform the decision about whether to: •
Move forward with a full trial • Make revisions that require an additional pilot • Abandon
the project altogether Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Mixed Method Designs • Especially well suited for a pilot study • Quantitative data
can be used to assess whether feasibility criteria were met. • Qualitative data can elucidate
why they were not met. – How the intervention of study protocols could be improved
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Lessons Learned
• Major product provides: – Information from which protocols for a full trial can be created
– If interventions have been found to be feasible, acceptable, and promising – List of
proposed outcomes • The findings will be published so that others can benefit from learning
about both the successes and the failures. Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins Critiquing Feasibility and Pilot Studies • Assignment: Pilot

5. Tests of InterventionsProvides descriptions of sample characteristics, design elements,
instruments • Intervention theory and development of the intervention • References should
be provided to any previously published papers on intervention development. •
Researchers’ description of the pilot objectives, the criteria used to make decisions about
feasibility, and the methods associated with feasibility assessments Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Question What term is used to
identify practical information about the real-life application of a pilot study? A. Responder
analysis B. Exit interview C. Lessons learned D. Statement of purpose Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Answer C A major product from
pilot work is a description of “lessons learned” that inform the final protocols for a full trial
as well as providing information about the usefulness and achievability of the proposed
intervention(s) in the “real world.” Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins …Assignment: Pilot Tests of Interventions