Informed Consent

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Chapter 12

Implementation: Strategies and

Associated Concerns

Defining Implementation

  • The act of converting planning, goals, and objectives into action through administrative structure, management activities, policies, procedures, and regulations, and organizational actions of new programs” (Timmreck, 1997, p. 328)

  • Setting up, managing, and executing a project (Keyser et al., 1997)

  • Program diffusion - adoption, implementation, sustainability (Bartholomew et al., 2006)

Implementation

  • Planners need to be flexible when implementing a program

  • Phases of implementation

Adoption of the program - a part of marketing (chapter 11)

Identifying and prioritizing the tasks to be completed

Establishing a system of management

Putting the plans into action

Ending or sustaining a program

Phase 2 - Identifying & prioritizing the tasks to be completed

  • Many tasks need to be completed when implementing a program (e.g., reserving space, ordering equipment, etc.)

  • Tasks need to be identified and prioritized

  • Planning timetables and timelines can help with this process

  • Types of timetables and timelines: key activity charts (McDermott & Sarvela, 1999), Task Development Timelines (Anspaugh et al., 2000), Gantt Charts, PERT charts, & CPM

Task Development Timeline

Gantt Chart

Program Evaluation & Review Technique (PERT)

00

10

20

23

25

27

30

40

50

60

70

80

90

1 wk

1 wk

5 wks

1 wk

1 wk

3 wks

0.5 wk

2 wks

1 wk

1 wk

3 wks

8 wks

3 wks

Time estimated 3 ways: optimistic (minimum possible time), pessimistic (maximum possible time), & probabilistic (best estimate time)

00. Start planning

10. Develop rationale

20. Needs assessment

23. Create instrument

25. Select sample

27. Collect & analyze data

30. Create goals/objectives

40. Create intervention

50. Pilot test

60. Identify & allocate resources

70. Marketing

80. Implement program

90. Evaluate (process, impact, & outcome)

Critical Path Method (CPM) or PERT/CPM

A

C

G

D

E

F

H

J

M

I

K

L

B

Items on critical path cannot be delayed without delaying the program; time is important estimates are made for earliest & latest start & finish times for each activity

A. Start planning

B. Develop rationale

C. Needs assessment

D. Create instrument

E. Select sample

F. Collect & analyze data

G. Create goals/objectives

H. Create intervention

I. Pilot test

J. Implement program

K. Identify & allocate resources

L. Marketing

M. Evaluate (process, impact, & outcome)

Phase 3 - Establishing a system of management

  • Management – “the process of achieving results through controlling human, financial, and technical resources” (Johnson & Breckon, 2007, p. 293)

  • “the efficient, satisfactory management of a health promotion program is vital to its long-term success” (Anspaugh et al., 2000, p. 124)

Phase 4 - Putting Plans into Action

  • Major ways of putting plans into action (Parkinson & colleagues, 1982)
  • Inverted triangle represents number of people involved

  • Pilot testing – trying the program out with a small group from the priority population to identify any problems

  • Phased-in – limiting the number of people who are exposed then gradually increasing the numbers; by offerings, by location, by ability, by number

  • Total program – all in priority population exposed at same time

Putting Plans into Action

First Day of Implementation

  • Also referred to as: program launch, program rollout, or program kick off

  • Decide on a first day; consider launching to coincide with other already occurring event (e.g., weight loss program and New Year’s resolution)

  • Kick off in style

  • Seek news coverage, if appropriate

  • Consider a news hook; e.g., day in history

  • Special event; use of celebrities

Phase 5 - Ending or Sustaining a Program

  • How long to run a program

  • Ending?
  • Goals and objectives met?
  • Resources available?
  • Need to re-focus?

  • Sustaining?
  • Work to institutionalize
  • Advocating for the program
  • Partnering with others
  • Revisiting and revising the rationale

Concerns Associated with Implementation

  • Safety & Medical Concerns
  • Most programs are to improve health, thus do not put participants in danger

  • Informed consent
  • Explain nature of program
  • Inform participants of risk and discomfort
  • Explain expected benefits
  • Inform of alternative programs
  • Indicate that they are free to discontinue participation at any time
  • Allow participants to ask questions

Example Informed Consent Form

Concerns Associated with Implementation (cont.)

  • Safety & Medical Concerns (continued)
  • Informed consent (waive of liability or release of liability) do not protect planners from being sued

  • Medical clearance signed by a physician

  • Ensure safety and health
  • Program location; appropriate security
  • Building codes met and facilities free from any hazards
  • Qualified instructors
  • Plan in case of emergency

Sample Medical Clearance Form

Checklist to Consider when Developing an Emergency Care Plan

  • Duties of staff...
  • Staff members are trained...
  • Participants instructed what to do in an emergency
  • Participants with high risks are known to staff
  • Emergency care supplies and equipment are available
  • Access to phone
  • Standing orders are available
  • Plan to notify others
  • Responsibility for transportation
  • Injury (incident) report form
  • Universal precautions
  • Responsibility for financial costs
  • Emergency plan is approved
  • Emergency plan is reviewed and updated regularly

Concerns Associated with Implementation (cont.)

  • Ethical Issues
  • Where competing values are at play and judgment must be made on what is the most appropriate course of action

  • Code of Ethics for the Health Education Profession to guide the work of health educators; highest standards

  • The Belmont Report: Ethical Principles & Guidelines for the Protection of Human Subject Research
  • Respect for persons
  • Beneficence – maximizing benefits and minimizing harm
  • Justice – fairness

Concerns Associated with Implementation (cont.)

  • Legal concerns
  • Negligence – failing to act in a prudent (reasonable) manner
  • Omission
  • Commission
  • Reducing liability – key to avoiding liability
  • Aware of legal liabilities
  • Qualified instructors
  • Good judgment
  • Informed consent
  • Medical clearance
  • Limit work to expertise
  • Safe environment
  • Insurance

Concerns Associated with Implementation (cont.)

  • Program Registration & Fee Collection – need a system

  • Procedures for Recordkeeping – HIPAA; anonymity/ confidentiality

  • Procedure and/or participants manuals – 1) make sure all understand, 2) standardize, avoid Type III error (failure to implement intervention properly), 3)ideas for facilitation, 4) provide additional background information, and 5) provide additional resources

Concerns Associated with Implementation (cont.)

  • Training of facilitators – if it is not possible to hire qualified instructors, may need to train

  • Dealing with problems – try to anticipate

  • Reporting and documenting – for 1) accountability, 2) public relations, 3) motivation of participants, 4) recruitment of new participants

Class Activity – Informed Consent

  • Develop an informed consent form for college freshmen to participate in a 12 week exercise program.