(46) One of the hurdles for any site is managing change that may come about as a result of new SOPs, QA findings, new studies, new sponsors, new employees or the evolution of the regulations. Negative reactions to change can be avoided thus it is important for professionals in this setting to understand the mechanisms of change theory.
Definition of the change
Determining the type of change required to improve performance (clear definitions)
Rate for change
Establishing the rate of change, incremental goals (depending on existing resources, other needs)
Buy-In
Developing an effective communications strategy to ensure “buy-in” on the part of employees
(47) There is a saying----- Change is inevitable. Those who cannot manage change successfully will vanish. That may sound harsh; but it is a truism. Consider what we now call “thinking outside of the box”.
(48) These are a few tips for managing change.
• Be open-minded for new ideas
• Protect new ideas from criticism
• Listen to suggestions, appreciate good ideas
• Eliminate “we have always done it this way” culture, move out of the “comfort zone”
• Learn from mistakes of the past
• Share risks
• Build on ideas, focus on the good aspects rather than on potential problems, be positive
• Don’t judge too early
• Get consensus, allow staff to participate in all phases of change process, build commitment
(49) Benjamin Franklin says that “When you’re finished changing, you’re finished.”
Well, it is a process.
(50) Metrics is a term that has evolved in business sectors, echoed through the pharmaceutical industry and now is a regular term used to conduct ongoing measurement of activities being performed.
Metric- In month “X” the site consented 8 participants. This is 10% less than all prior months since the study commenced. Action item: Investigate potential issues, constraints. Is training necessary?
(51) Typically, the parameters that are measured are related to:
Speed, quantity, quality and cost.
(52) Consider the metrics that a site might want to measure related to: administrative, clinical and regulatory activities- at the site or within a study.
(53) In terms of speed, a site may want to maintain records on the:
Time from final protocol receipt to IRB approval
Time from IRB approval to first randomization
Time it takes to complete a baseline visit
Time from study visit to CRF datafax
Time from receipt of queries to resolution and reporting
Time from SAE knowledge to reporting
What OTHER EXAMPLES could be listed?
(54) Examples of quantity metrics might be:
Number screened to obtain 1 randomized
Number refusals and why
Number screen failures and why
Number randomized, Number evaluable
Number lost-to-follow-up
Number of queries
Number in participant pools (sources)
Number of HIV vertical transmission
Number of endpoints, AEs, SAEs
(55) Quality metrics would certainly follow the principle indicators defined by a QA program. This may measure:
Quality of data – rate of errors
Number of evaluable compared to number randomized
Adherence to GCPs
Adherence to protocol and MOP
Adherence to IRB/EC requirements
Informed consent processes
(56) Cost metrics may be:
Cost of site operations (site budget, monthly costs)
Cost of study procedures
Cost to achieve one randomized participant
Comparing budget to actual costs
There may be other “costs” that a site may need to measure.
(57) One reason that a site might measure and compare metrics is because these give an accurate picture of the performance of the site. What metrics are routinely measured at your site?
(58) About Drug Accountability
(59) One of the key responsibilities of coordinators is maintaining drug accountability.
Things that should be tracked include…..
· Clinical trial drug orders
· Shipping forms
· Receipt and Inventory Logs
· Dispensing & Collection Logs
· Transfer of drug/materials between sites
· Return Logs
(60) Coordinators will be assessing studies and querying sponsors about drug accountability to determine what the protocol requires. Some sponsors require a pharmacy plan. A few of the essential questions to consider are:
• Can staff or is pharmacist required to dispense drug?
• Inpatient vs outpatient?
• Storage requirements
• Methods: bottles, blister-packs, labeling
• Sufficient supply for visits?
• Amount to dispense per visit?
• Complexity?
• Educational materials/aids?
(61) The FDA conducts routine inspection visits to site conducting IND studies. Drug accountability deficiencies seen by the FDA at their visits include:
Missing shipping forms
Incomplete or lack of drug accountability logs
Mistakes on accountability logs
Lack of source documentation
Large number of missed doses
Wrong drug dispensed
Wrong lot number recorded
Improper storage (secured, temp. control)
(62) Drug accountability involves a paper trail, just as any source documentation; with a few minor caveats:
· Logs (Pharmacy or study)
· Source Documents – should note that the study drug was dispensed, returned, re-dispensed, and a measure of “compliance” (e.g., taking the drug as prescribed).
· Prescriptions – some studies require a prescription be filled out and taken to the site or research pharmacy for dispensing. Inpatient studies (hospitalized) will also follow a similar procedure using medical orders.
· Pill Bottles/Labels- how the study drug is dispensed. Sometimes it is in a blister pack. Often specialized labeling is required.
· Shipping Invoices, Order Forms and Return Forms must be maintained
· Dosing Instructions, including Visual Aids and other educational materials may be used
· A sample drug accountability form is found on this slide.
(63) Once a participant is randomized – several adherence and retention issues must be addressed. Did they receive the assigned treatment? Some do not, some may be dispensed such treatment, but never ingest it or put it to use. Other participants are good about attending study visits, but are usually late or outside of visit windows. Others may “disappear” or refuse to return. Some withdraw, some are “lost to follow-up” meaning that they are unable to even be contacted to determine if they are alive or dead or to question about endpoints. However, the goal of every site is to have all enrolled participants complete the trial and be deemed fully evaluable.
(64) In this section, you are to consider the facilitators and barriers to participant activity in clinical trials- from intake, recruitment and completion. During this span, from intake to completion, what is the level of retention- numbers who remain in the trial. What are the various measures of adherence. What facilitates or blocks the process?
(65) Some of the facilitators of subject agreement in clinical trials may be:
Access to care
Assessments & testing
Assistance with other issues
Bridge for newly diagnosed health issues
New or Medications at no cost
Knowledge Access
Empowerment, Self-efficacy
Team building, being part of a solution to a medical problem- helping others with the disease
(66) And yet the barriers to subject agreement also are listed:
Fear, Superstitions, Customs, Cultural obstacles
Anonymity jeopardized
Confusion, lots of pills and instructions
Feeling helpless, coerced
Shame is treating sensitive issues
Counter to cultural norms
Side effects of new compounds
Research can be counter to standard of care
Potential adverse effects
Inconvenient, bothersome to daily routine
Each culture is going to have unique facilitators and barriers that may not even fall among the lists provided here. Consider those and share that among the group.
(67) Categorize and describe the facilitators and barriers to recruitment at your site through class discussion.
(68) Indeed, adherence is relative. Data has shown that 20% of participants may not keep an appointment they made themselves. 30% fail to take medication that is given to cure an illness. 50% fail to keep appointments made by the healthcare provider and 70% fail to follow preventive medication regimens. Coordinators strive for participant adherence and retention; however, this is a time-consuming challenge that is not always appreciated by management or in a budget. Discuss this among yourselves.
(69) What is meant by “adherence” In a clinical setting- this may mean:
· Attends scheduled appointments
· Takes medications as prescribed
· Uses other study materials as prescribed
· Concomitant medications and alternative remedies in concordance with protocol
· Maintains a health enhancing lifestyle
· Has self-efficacy
There are other parameters that may indicate adherence.
(70) There are also issues in the terminology used to describe this. What about the terms compliance, adherence and concordance? Which term is preferable? And consider, at your site, why do people agree and “adhere”. Perhaps also, staff should know a few things about not only the population pool and culture but also a few things about themselves and how they affect these issues.
(71) Social Cognitive Theory is a combination of social cues, environmental cues, physical and past experience cues- that impact behavior- and the behavior has consequences, based on the level of self-efficacy or the outcome expectations of the individual. All of this must be considered before any change in behavior can occur. All people react differently, based on these various cues. All people learn differently or “adhere” differently due to these cues as well.
(72) So as a staff member, what are the environmental, social, physical and past experiences that effect your decisions and actions. Likewise, for the culture and individuals in that culture (your participant pool)- what may be those parameters. Once you are encountering the individual, how can those be taken into consideration? Many of these theories are presented in clinical, educational and behavioral academics or training. They are very apt for clinical research participants and how staff relate to them.
(73) There is very little published on methods of retaining participants and enhancing participant adherence. Two methods recently described are the STEUCE Method and the 5 “As” of Adherence.
(74) The STEUCE method was described in an article published in medscape.com which described a method of managing side effects and promoting adherence in patients with HIV from the nursing perspective. Since literature by study coordinators remains limited, this article on the role of a nurse in the setting of promoting treatment adherence follows aspects of the participant, study coordinator relationship. This method is called STEUCE, because it is an acronym for the first letter of the key words used to describe the method. The method is:
· Simplify – decrease complexity
· Trust – being positive, do as you say, honesty, seeing the other person
· Education – methods, materials appropriate and personalized
· Understand – cultural competency
· Communicate- available, accessible, understandable, horizontal, not vertical
· Evaluate- frequent, timely, personalized assessments, check impact
This article may be found via the internet at: http://www.medscape.com/viewprogram/4573 . To access medscape articles you will need to create a user name and password. No subscription is required. This is a free online journal program.
(75) A second method, using the “5 As of Adherence” was published in 2003 is described by Egede, also found via Medscape.com http://www.medscape.com/viewarticle/457094?src=search This article focused on implementing behavioral counseling methods in primary care to reduce cardiovascular risk factors among diabetic patients. However, this method is something that also may be applied to the daily participant interaction in a clinical research site. Namely, this method focuses on 5 main actions, all starting with the letter “A”:
- Assess- “assess the behavioral health risk of the patient, determines the behavior that needs to change, then makes a decision about what methods to use to elicit change”.
- Advise – “discusses the harms and benefits of the target behavior, gives specific advice about what needs to change, and personalizes the advice to the unique needs of the patient”.
- Agree – “come to agreement about treatment goals based on what the patient thinks is feasible, and the extent to which the patient is willing to change the target behavior”
- Assist – “decide on the behavioral change technique that is applicable to the patient, and then provides the patient with the knowledge, skills, and social support needed to carry out the behavior change”
- Arrange- “Schedule follow-up, provide continuing support”
(76) When implementing any “adherence” technique, coordinators first should have a key understanding about cultural competence. United States universities and research entities have become more aware of this topic as studies have become more globalized. Cultural competence is about others (learning about and appreciating peoples history, culture and beliefs) and it is about self (having self-knowledge, understanding your beliefs from the context of your own personal history and culture). It is also about reaching the goal of effective, nonjudgmental communication, function and relationship.
(77) The cultural competence ladder describes the levels of cultural competence an organization or institution can achieve. The bottom rung is cultural destructiveness- this is an institution, clinic or group of people (or individuals) who actively belittle other cultures. Cultural incapacity is a term to describe a group without interest in or appreciation of other cultures. Cultural blindness- is that sitting on the fence behavior of “treating all cultures as if they were the same”. Often clinical research is criticized as treating all participants as if they came from a Western setting. While this is improving, the attitude indicates cultural blindness. Cultural competence is a belief that most people have the capacity to function within the context of cultural diversity. Reaching cultural competence is a level many institutions seek to achieve. Finally, cultural proficiency is developing positive, culturally diverse environments.
(78) A couple of main points that must be understood is that peoples traits and beliefs are influenced by culture. Also, people find it difficult to articulate beliefs of their own culture. “It is hard to explain”, “I don’t know why, this is the way it has always been done”, “I’m not sure why, but I know this is the way it is done” are all phrases that may be uttered when someone is trying to articulate a belief that is prevalent in their own culture.
(79) Clinical trials seek cultural competence in the spirit of the Belmont Report- “respect for persons- autonomy, beneficence and justice. The Nuffield Council on Bioethics conducted study groups that went into developing country sites and met with investigators and researchers there and immersed in the field as a way to gain insight and make better recommendations. Their report contains two chapters discussing social, cultural and ethical frameworks for conducting studies in the developing world, with its diverse cultures.