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BRIEF INTERVENTIONS BY PHARMACISTS TO MOTIVATE PATIENTS

TO UNDERSTAND AND PREVENT DRUG MISADVENTURES

College of Pharmacy, University of New Mexico

David A. Gettman, R.Ph., M.B.A., Ph.D.

Carol Kengott-Hickey, Pharm.D.

Barbara Armstrong, Pharm.D.

Barbara Colaianni, Pharm.D.

Christine Sandoval, Pharm.D.

Roger Ly, Pharm.D.

Funded by: The American Society of Health-System Pharmacists (ASHP) Research and Education Foundation

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INTRODUCTION

1980’s More than 1.3 million people in the United States are

injured annually by adverse drug events. Some 180,000 die because of these injuries. Total cost of adverse drug events in the United States

was $59 billion - 10% of all health costs.

Leape, L.L. Preventing adverse drug events. American Journal of Health-System Pharmacy. 52: (Feb 15):379-382. 1995.

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INTRODUCTION

1990’s Drug misadventuring is a significant problem in this

country: for every dollar spent on a medication, another dollar is spent on problems directly associated with drug misadventuring, such as drug reactions and medication errors.1

Efforts to curtail these problems have focused on coordinating efforts among health care professionals.2

1Johnson JA and Bootman L. Drug-related morbidity and mortality: cost-of-illness model. Journal of Managed Care Pharmacy. 2(Jan-Feb): p 39-47. 1996.

2 e.g., the IMPROVE study: Carter BL, Malone DC, Valuck RJ, Barnette DJ, Sintek CD, and Billups SJ. The IMPROVE study: Background and study design. American Journal of Health-System Pharmacy. 55 (Jan 1): p 62-67. 1998.

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“There is a need to emphasize the patient’s role as the director of her or his own health care rather than the recipient of health care.”

Dole, E.J. (1994) Beyond Pharmaceutical Care. American Journal of Health-System Pharmacy. 51(Sep 1): p2183-4.

AREN’T WE (INAPPROPRIATELY) LEAVING OUR PATIENTS OUT OF THIS “COORDINATED EFFORT” ?

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"Tell me, and I forget

Teach me, and I may remember

Involve me, and I learn."

-- Benjamin Franklin

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PROBLEM STATEMENT

2000’s A new approach to drug misadventuring should be investigated

that focuses on empowering each patient to help herself or himself recognize and prevent these problems.

This new approach might be described as a periodically administered “defensive driving course” tailored to each patient’s specific needs so s/he will remain vigilant about anticipating drug misadventures in both inpatient and outpatient health care environments.

Pharmacists might be in the best position to administer this course to patients on an ongoing basis. They might be reimbursed utilizing some fraction of a realized decline in health care dollars spent on problems directly associated with drug misadventuring.

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STUDY OBJECTIVES

1. Develop and validate a new Precautionary Medication-taking Behaviors and Beliefs (PMtBB) inventory;

2. Develop an intervention termed the Medication Misadventuring Check-up (MMCu);

3. Conduct a prospective controlled randomized experiment to determine if there is a statistically significant difference in PMtBB inventory scores (after three months) between a control group and a study group given the MMCu; and

4. Determine if there is a differential impact of the MMCu on PMtBB inventory score improvements that can be explained by certain patient characteristics (i.e., age, gender, ethnicity, income, locus of control).

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METHODOLOGY

1. Develop and validate a new Precautionary Medication-taking Behaviors and Beliefs (PMtBB) inventory

The PMtBB inventory is a multidimensional self-report instrument that assess “a patient's watchfulness for an array of possible drug misadventures”

Content validity - an examination of the extant literature, discussion among the investigators, and initial administration to patients in a clinic setting. Patterned after a recently developed inventory that measures precautionary behaviors in the domains of hazard preparedness, crime prevention, vehicular safety, and health maintenance.1

Construct validity - factor analysis(Varimax Rotation with Kaiser Normalization) & (alpha) reliability analyses

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METHODOLOGY

Concurrent validity - anticipated that higher scores on the health maintenance domain of the previously developed instrument for precautionary behaviors, lower perceived medication stress,medication adherence and better health status might be associated with higher PMtBB inventory scores.

Predictive validity - anticipated that age, gender, ethnicity, income, and multidimensional health locus of control might predict higher PMtBB inventory scores.

1 Gettman DA. An Exploratory Investigation of a Stress Model of Medication Adherence Among Elderly Outpatients. Doctoral Dissertation. Gainesville, Florida: University of Florida. 1997.

2 Morisky DE, Green LW, and Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Medical Care. 24(1):67-74. 1986.

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METHODOLOGY

2. Develop an intervention termed the Medication

Misadventuring Check-up (MMCu)

Currently the most influential research model of motivation of change in addictive behaviors is “transtheoretical approach.1

In clinical trails to date, Motivational Enhancement Therapy (MET) has used the findings from psychometric instruments as feedback to the patient as part of a 20 to 30 minute interventions

1 Prochaska JO and DiClemente CC. The transtheoretical approach: Crossing traditional boundaries of therapy. Homewood, IL: Dow Joines/Irwin. 1984.

2 Bien TH, Miller WR, and Tonigan JS. Brief interventions for alcohol problems: a review. Addiction. 88:315-336. 1993..

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Figure 1. When using G-Power ProgramR for two-tailed test when effect size d= 0.333, alpha = 0.05, and power = 0.8, the total sample size is 286 (143 control group, 143 intervention group), critical t(284) =

1.9684, and Delta = 2.8158.

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METHODOLOGY

Confidential Information Form

Control GroupPMtBB inventory

Intervention GroupPMtBB inventory

Control GroupPMtBB Inventory

Intervention GroupPMtBB inventory

3-months later

3. Conduct a prospective controlled randomized experiment to determine if there is a

statistically significant difference in PMtBB inventory scores (after three months) between a control group and a study group given the MMCu

4. Determine if there is a differential impact of the MMCu on PMtBB inventory score improvements that can be explained by certain patient characteristics (i.e., sociodemographic variables, locus of control, and morbidity).

Sociodemographicslocus of controlmorbidity

MMCu

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RESULTS

Performance

Usefulness – “Readiness Rulers” (Importance/Confidence)

Lifestyle Instrumental

Asking Telling

Types of PrecautionaryMedication-taking Behaviors and Beliefs

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RESULTS

Table 1: SocioDemographicsControl Group (Intervention Group)

Self-Reported Chronic DiseaseSubject Characteristic Age Gender Ethnicity Income Health Status Score

< 9 yrs. 1 (0)10 to 19 yrs. 5 (9)20 to 29 yrs. 20 (14)30 to 39 yrs. 32 (28)40 to 49 yrs. 41 (45)50 to 59 yrs. 26 (28)60 to 69 yrs. 17 (16)> 70 yrs. 1 (3)

Male 25 (31)Female 118 (112)

Black 8 (5)Hispanic 64 (66)White 70 (69)Asian 1 (3)

< $ 5,000 32 (30)$ 5,000 - $9,999 43 (45)$ 10,000 - $14,999 20 (22)$ 15,000 - $19,999 18 (15)$ 20,000 - $ 24,999 8 (9)$ 30,000 - $ 34,999 6 (7)$ 35,000 - $ 39,999 4 (5)> $ 40,000 12 (10)

Poor 35 (32)Fair 26 (27)Good 54 (56)Very Good 18 (21)Excellent 10 (7)

0 37 (32)1 to 3 45 (44)4+ 61 (67)

Note . p -values for between group differences were not significant (not shown here).

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RESULTS

Table 2: Psychometrics

Mean sd Mean sd

MultidimensionalHealth Locus of Control Internal (min=6, max=36) 25.1 4.89 23.22 4.51 Powerful Others (min=6, max=36) 19.89 5.22 20.91 4.97 Chance (min=6,max=36) 16 5.75 18.46 5.33

Precautionary BehaviorsHealth Maintenance Avoidance (min=4,max=16) 11.55 2.81 12.1 2.96 Everyday (min=2,max=8) 4.51 1.43 4.75 1.54 Seek ing (min=4,max=16) 12.13 2.9 12.08 2.71 Usefulness (min=4,max=16) 15.09 3.56 14.93 3.24

Medication-takingBehaviors (min=4,max=8) 6.31 0.9 6.54 0.98

Perceived MedicationStress (min=0,max=24) 8.23 5.05 7.59 5.36

w ere not signif icant (not show n here).

BEFORE Medication Misadventuring Check-up only

Note . p -values for betw een group differences for all variables

Control Group Intervention Group

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RESULTS

Mean sd Mean sd t Sig.

Precautionary BehaviorsMedication-taking Lifestyle (min=5, max=20) 13.3254 2.6312 13.8605 2.3533 -2.388 0.017 Instrumental (min=12, max=48) 37.8483 5.3391 39.9688 5.0252 -2.078 0.039 Asking (min=22, max=44) 35.4554 5.2182 36.8792 4.9483 -2.081 0.038 Telling (min=7, max=28) 10.4537 2.4537 11.0444 2.1296 -2.368 0.019 Performance (min=6, max=24) 20.4921 4.1172 21.3151 3.8543 -2.232 0.024 Usefulness (min=4,max=16) 14.6355 2.7641 15.2224 2.4251 -2.371 0.018 (Readiness Rulers)

Table 3: Independent Samples t-Tests

AFTER Misadventuring Check-up Control Group Intervention Group

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RESULTS

For lifestyle precautionary medication taking behaviors and beliefs there are five different items.

I would ask the health care provider if I could do the following while taking my medication:

  Q5: drink alcohol Q6: smoke Q7: use an unlawful drug Q16: consume an herbal product Q25: take another person's medication

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RESULTSFor instrumental precautionary medication taking behaviors and beliefs there are twelve different items.

I would ask the health care provider what to do if I needed the following: Q29: if I wanted easy to read information about the medication I take Q30: an easy-to-open medication containerQ31: something to help remind me to take my medication on timeQ32: an up-to-date list of my medicationsQ33: an easy-to-swallow medicationQ34: help remembering to have my medication refilled on time Q35: transportation to a healthcare providerQ36: an aid (or device) to help me administer my medication Q37: an identification bracelet for medicationQ38: an identification bracelet for medical conditionQ40: uncommon medication refilled on time Q41: paying for unaffordable medication  

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RESULTS

For asking precautionary medication taking behaviors and beliefs there are eleven different items.

I would ask the health care provider the following: 

Q1: what to do if I missed a dose of medicationQ3: about side effects from my medicationQ8: how to determine if my medication is workingQ9: how to take my medication correctlyQ11: taking my medication with non-prescription medicationQ14: how to store my medication Q15: about drug interactions with my medicationsQ17: why I am taking my medicationQ19: how long I will take my medication Q28: how to obtain devices to keep track of how well my medication is workingQ43: ask if not sure what medication looked liked 

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RESULTS

For telling precautionary medication taking behaviors and beliefs there are seven different items.

I would tell the health care provider the following: 

Q2: if I wasn't feeling "right" and thought it might be due to my medication

Q4: about all the different medications I was takingQ10: if I experienced an unusual side effect from my medicationQ12: if I noticed my medication looked differentQ21: about all my health conditionsQ23: about all my known allergiesQ42: if I discovered something alarming about my medication

 

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RESULTS

For performance precautionary medication taking behaviors and beliefs

there are six different items.

Q13: I would take my medication as directed on the label.

Q18: I determine what strength my medication(s) are.

Q20: I take my medication for the full duration that it is prescribed for me.

Q26: I read the label of my medication before I take it.

Q27: I keep my medication in the original container it comes in unless told otherwise.

Q39: I keep a list of the different medications I take to show all my health care

providers.

 

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RESULTS

For usefulness precautionary medication taking behaviors and beliefs there are the four last items.

• How useful do you think it is to take extra steps (like asking questions about your medications) to guarantee that you take your medication without making mistakes?

• All in all, how much would you say that the effectiveness of your medication depends on what you do to insure that it is taken right?

• How confident are you that you could learn new things to make sure you take your medications right?

• How confident are you that if you could learn new things to make sure you take your medications right you would continue to do those things?

 

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RESULTSAn intervention termed the Medication Misadventuring Check-up (MMCu):

A. READINESS RULER: Determine if the patient thinks it is BOTH important to adapt certain behaviors and if s/he is confident s/he can adapt certain behaviors.

B. MOTIVATIONAL INTERVIEWING: Summarized by the acronym READS: roll with resistance, empathy, avoid argumentation, develop discrepancy, and support self-efficacy.

C. BRIEF INTERVENTION: Summarized by the acronym FRAMES: feedback, responsibility, advice, menu, empathy, and self-efficacy.

1 Miller WR and Sanchez VC. Motivating young adults for treatment and lifestyle change. In G. Howard (Ed.) Issues in Alcohol Use and Misuse by Young Adults. (pp. 55-82). Notre Dame. IN: University of Notre Dame Press. 1994.

2 Stott NC, Rollnick S, Pill R, and Rees M. (1995). Innovation in clinical method: diabetes care and negotiating skills. Family Practice. 12(4): 413-8. 1995.

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RESULTS CORRELATIONS BETWEEN PMTBB FACTOR SCORES, HEALTH

MAINTENANCE SCORES, PRECEIVED MEDICATION STRESS, AND

MEDICATION ADHERENCE

It was thought that all of the new PMtBB inventory factor scores would be positively correlated with the factors of the health maintenance domain of the previously developed instrument for precautionary behaviors (Norris, 1997). It was clear from the correlations that most PMtBB factors were not only positively correlated with the health maintenance domain, and medication adherence, but they were also significantly associated.

There are a few notable exceptions that will need to be addressed when further data is collected and analyzed.

Both lifestyle and instrumental PMtBB inventory factor scores seemed to be negatively associated with the health maintenance factor. It was anticipated that those patients with higher PMtBB inventory scores would have lower PMS scale scores. This appeared to be true except for the usefulness PMtBB score.

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RESULTS

CORRELATIONS BETWEEN PMtBB INVENTORY FACTOR SCORES, MULITDIMENSIONAL HEALTH LOCUS OF CONTROL FACTORS, CHRONIC DISEASE SCORE, AND SOCIODEMOGRAPHIC PROFILE

The internal HLC factor score had positive correlations with all PMtBB inventory factor scores. The chance HLC factor score had negative correlations with all PMtBB inventory factor scores. The powerful others HLC factor score had positive correlations with i-PMtBB, a-PMtBB, t-PMtBB, and u-PMtBB and negative correlations with l-PMtBB and p-PMtBB scores. The CDS had positive correlations with all PMtBB inventory factor scores. Higher income had negative correlations with all PMtBB inventory factor scores Advanced age had positive correlations with all PMtBB factor scores.

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CONCLUSIONS

IMPLICATIONS FOR PHARMACY PRACTICE & SCHOOLS O F PHARMACY

1. Pharmacists will probably adopt all or part of this stepwise procedure to motivate their patients to understand and prevent drug misadventures as a part of their daily practice at some future point in time.

2. Pharmacists will probably adopt and refine the core set of skills that includes the use of readiness rulers, READS and FRAMES to help their patients to understand and prevent other medication-related problems.

3. Schools of Pharmacy will probably start to teach their professional students to use this core set of skills as part of problem-based learning and/or communication courses.

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CONCLUSIONS

IMPLICATIONS FOR PHARMACY RESEARCH SHORT TERM 1. Study replications to test for external validity (e.g., community pharmacy rather than a clinic

setting). 2. Cost-benefit analysis to determine possible cost savings. Would need to include a sensitivity

analyses to determine if cost savings would be realized a with different patient case mixes. 3. Development of computerized or written self-help materials that utilize these concepts.

LONG TERM 1. Develop other types of “inventories” using the same methodology used to develop the

Precautionary Medication-taking Behaviors and Beliefs (PMtBB) inventory. 2. Apply the framework used to develop the Medication Misadventuring Check-Up (MMCu)

intervention (readiness ruler, READS, FRAMES) to develop other interventions that might improve scores on other “inventories.”

3. Explore how patient characteristics might help predict differential reponse to these new interventions. (beyond sociodemographics, locus of control, comorbidity).