Disclaimer

Some of the facts in this example have been fictionalized for instructional purposes.

Step 1.1 Write a problem statement.

Step 1.2 Assess the problem's relevance to your program.

In February 1994, at the National Institute of Health (NIH) Consensus Conference on H.pylori, the expert panelists concluded that a causal relationship between the bacterium and peptic ulcers was well established. They recommended treating all infected peptic ulcer patients with antibiotics, stating that eradicating the bacteria reduced the risk of ulcer recurrence to less than 10% (NIH, 1997).

Following the recommendations of the Consensus Conference, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) convened an advisory meeting of experts. This group developed a strategic plan to guide future research. The plan was presented to both the House and the Senate Committees on Appropriations (NIH, 1997).

In the Conference Report on the Fiscal Year (FY) 1997 budget for the Department of Health and Human Services (DHHS), the Conference Committee stated: "The conferees concur in the recommendation of the Senate report the CDC initiate a trans-department public education campaign to foster more effective communication between consumers and physicians on H.pylori and its link to ulcer disease. The conferees expect this effort to include a collaboration between the public and private sectors, including the pharmaceutical industry" (CDC, 1997).

Because of the infectious nature of H.pylori, the National Center for Infectious Diseases (NCID), Division of Bacterial and Mycotic Diseases (DBMD) of the CDC was chosen as the lead agency for this campaign. NCID’s explicit mission was to plan, direct, and coordinate a national program to improve the identification, investigation, diagnosis, prevention, and control of infectious diseases.
http://www.cdc.gov/maso/ncidfs.htm

Step 1.3 Explore who should be on the planning team and how team members will interact.

Planning team members that were suggested follow:

• American Digestive Health Foundation (ADHF)
• American Gastroenterological Association (AGA)
• Food and Drug Administration (FDA)
• Health Care Financial Administration (HCFA)
• Healthcare providers
• National Institute of Diabetes and Digestive Kidney Diseases (NIDDK)
• National Institute of Health (NIH)
• Pharmacists associations
• Pharmaceutical representatives
• State Health Departments
• University Researchers

Step 1.4 Examine and/or conduct necessary research to describe the problem.

Step 1.5 Determine and describe distinct subgroups affected by the problem.

The subgroups that were affected by the presence of H.pylori or needed to be aware of the effects of the bacterium as a cause of peptic ulcers were:

• African American and Hispanic populations
• People of lower socioeconomic status (SES)
• People over 35 years old
• Peptic ulcer sufferers

Step 1.6 Write a problem statement for each subgroup you plan to consider further.

The prevalence of infection with H.pylori was higher among persons over 35 years of age, persons of lower socioeconomic status, and among certain ethnic groups, such as persons of African American and Hispanic descent (CDC, 1997).

Ulcer disease was more common in urban areas, and sites with sanitation problems and/or poor living conditions.

Step 1.7 Gather information necessary to describe each subproblem defined in new problem statement.

Step 1.8 Assess factors and variables that can affect the project's direction.

Strengths

• Testing for H. pylori was once complicated and invasive, but new techniques made it possible to detect the infection by drawing a small amount of blood or by giving patients a simple breath test. Recently, the FDA approved several different antibiotic regimens for eradicating H.pylori infection. All treatment regimens are 10 to 14 days in length with cure rates of 70-90%.

Weaknesses

• Unfortunately, the idea was slow to catch on. In 1995, one study showed that only 5 % of ulcer patients were being treated with antibiotics (Slvakumar & Sonnenberg, 1997).
• Health professionals were not aware of the new advances. Although 74% of physicians and self-diagnosed ulcer sufferers had made a specific trip to the doctor to inquire about their condition, very few had asked their physician about H.pylori infection and its link to ulcer disease (Abbott, 1997).

• Congress allocated funds in the FY 1997 budget to the Centers for Disease Control (CDC) to launch a trans-department public education campaign that fostered more effective communication between consumers and physicians on H.pylori and its link to ulcer disease (CDC, 1997). With the Congressional mandate and the allocation of funds, political support for the program was strong. There was no known resistance to the campaign.
• Work already underway by the American Digestive Health Foundation (ADHF), the American Pharmaceutical Association (APhA), and Abbott Laboratories provided good background on this issue. In an ADHF educational program for consumers, Dr. Dan was an animated character who educated his ulcer patients about H.pylori and treated them with antibiotics. This campaign had an 800 number that provided more information and directed callers to discuss individual questions with their doctor. ADHF’s message mix also included a Public Service Announcement, media relations, special events, and support materials for health care providers.
• The APhA developed a continuing education program for pharmacists on treatment options for eradicating H.pylori in peptic ulcer disease. Abbott Laboratories had a public education campaign consisting of print ads in widely circulated magazines such as Time, Newsweek, and Parade Magazine. An 800 line gave callers additional information and directed them to talk with their doctors. The Health Care Financing Administration also developed a program to improve the medical treatment of Medicare beneficiaries hospitalized with Peptic Ulcer Disease (PUD).

• Health professionals could have been skeptical of the CDC partnering with pharmaceutical companies to promote antibiotic use and diagnostic procedures that the health care providers were not familiar with.

Step 2.1 List the direct and indirect causes of each subproblem that may require intervention(s).

Some peptic ulcer sufferers did not seek treatment because they were unaware that their ulcer was caused by a bacterium and that it could be cured with antibiotics. The majority of ulcer sufferers believed that stress and/or spicy or fried foods were the cause their ulcer.

Some peptic ulcer sufferers did not seek treatment, finding symptomatic relief in several acid-reducing over-the-counter medications such as Pepcid®, Zantac®, Axid®, and Tagament®. These sufferers, therefore, were not actively looking for a cure.

Some ulcer sufferers did not seek treatment because their belief that ulcers were caused by stress and/or diet was so firmly entrenched, it was difficult to convince them that they had an infection that was curable.

Some ulcer sufferers who had heard of the link between peptic ulcer disease (PUD) and H.pylori did not seek treatment because they believed that the diagnostic procedures were too invasive and uncomfortable. Among those sufferers who were diagnosed with H.pylori and began treatment, some did not complete treatment because they found it too difficult to comply with the 10 to 14-day antibiotic regimen.

Some ulcer sufferers were neither tested nor treated because their primary care physicians (PCPs) had been hesitant to accept the bacterial cause of ulcers, and as a result, did not pass the word on to their patients. Other PCPs accepted the causal link but took a conservative approach to medicine and treated their ulcer patients for H.pylori only when more conventional treatments had failed.

Some ulcer sufferers did not receive treatment for H.pylori because some health insurance companies and managed care organizations (MCOs) did not cover the diagnostic procedures or antibiotics that were needed to test and treat H.pylori.

Step 2.2 Prioritize and select subproblems that need interventions(s).

A priority list of subproblems placed the sufferer above their PCP:

• The lack of knowledge among ulcer sufferers that most peptic ulcers were caused by H.pylori infection and not by stress or diet.
• The belief among ulcer sufferers that continual use of over-the-counter medications to treat the symptoms of a peptic ulcer was acceptable even though a permanent cure was available.
• The belief among ulcer sufferers that diagnostic procedures to detect H.pylori were necessarily unpleasant.
• The lack of self-efficacy on the part of ulcer sufferers to complete the antibiotic regimen necessary to eradicate H.pylori.
• The reluctant attitude on the part of some personal care physicians to accept fully the causal link between ulcers and H.pylori.
• The belief of some primary care physicians that treating H.pylori should be a course of action only after other more traditional treatments had failed.

Step 2.3 Write goals for each subproblem.

Goal: Significantly increase the following within one year of the campaign kickoff:

• The number of ulcer sufferers who inquired about testing and treatment for H.pylori.
• The number of personal care physicians who regularly tested and treated their ulcer patients.

Goal: Increase the number of ulcer sufferers who knew that most peptic ulcers were caused by H.pylori infection. There was a lack of knowledge among ulcer sufferers that most peptic ulcers were caused by H.pylori infection and not by stress or diet.

Goal: Increase the number of people seeking a permanent cure for their ulcer. There was a belief among ulcer sufferers that continual use of over-the-counter medications to treat the symptoms of a peptic ulcer was acceptable even though a permanent cure was available.

Goal: Increase the number of ulcer sufferers who were informed about the diagnostic procedures used to detect H.pylori. There was a belief among many ulcer sufferers that diagnostic procedures to detect H.pylori were necessarily unpleasant.

Goal: Increase the number of ulcer sufferers who believed that they were capable of completing the treatment. There was lack of self-efficacy on the part of some ulcer sufferers to complete the antibiotic regimen necessary to eradicate H. pylori.

Goal: Increase the number of physicians who accepted the causal link between ulcers and H.pylori. There was a reluctant attitude on the part of some personal care physicians to accept fully the causal link between ulcers and H.pylori.

Goal: Increase the number of physicians who treated H.pylori immediately, instead of trying other alternatives. There was a belief of some primary care physicians that treating H.pylori should have been a course of action only after other more traditional treatments had failed.

Step 2.4 Examine relevant theories and best practices for potential intervention(s).

Health communication/education

A health communication strategy was one way to address this problem because it could increase knowledge and awareness and influence attitudes and beliefs. Congress also appropriated funds to implement a communication campaign. Stages of Change, entertainment education, Social Marketing and adult learning theory could all be incorporated into a health communication campaign.

The CDC’s activities could compliment on-going campaigns from American Digestive Health Foundation, Health Care Financial Administration (HCFA) Medicare PRO PUD Project, and pharmaceutical campaigns.

Health policy/enforcement

A health policy strategy might have included approving different antibiotic regimens so that patients resistant to certain treatments would have more choices.

Media Advocacy

Media Advocacy could be useful in changing social norms as they relate to ulcers and ulcer sufferers.

Health Engineering

An engineering strategy, such as designing less invasive diagnostic procedures that lead to increased screening, might be used.

Health-related community services

A medical intervention strategy could involve mass screenings of all patients with gastrointestinal (GI) problems using one of the less invasive diagnostic procedures. Healthcare providers, as well as insurance companies and health care organizations, would then be better informed about ulcers and ulcer sufferers.

Step 2.5 Consider SWOT and ethics of intervention options.

Health Communication/Education

Strengths

• The CDC had been given funding for this activity. The knowledge and attitude changes that needed to be made were tailored to health communication activities.

Weakness

• There was a large group of ulcer suffers and health care providers who were not aware of the new findings.

Opportunities

• Other organizations were developing health communication campaigns around this issue.

Threats

• The antibiotic regiment may have been hard for some patients to follow.
• Cost may have interfered with treatment.

Ethics

• Because pharmaceutical companies were involved and these companies manufactured the antibiotics that were a part of the treatment, the CDC had to avoid the appearance of a conflict of interest.

Health Policy/Enforcement

Strengths

• Limited

Weakness

• People first need to be made aware of H.pylori before they could consider options.

Opportunities

• Public health and health care professionals' knowledge of H.pylori would support these efforts.

Threats

• This intervention may face limitations due to low awareness levels of H.pylori.

Ethics

• The CDC kept a safe distance from the pharmaceutical companies to avoid what might have appeared to be a conflict of interest.

Media Advocacy

Strengths

• This intervention strategy had the advantage of impacting social norms and addressing a wide audience.

Weakness

• The audiences could not be precisely targeted. The CDC could prompt the media but had little direct power over the messages sent.

Opportunities

• There were a number of newspaper columns, and radio and television shows that focused on health issues.

Threats

• Other health topics could have over shadowed H.pylori.

Ethics

• The CDC could not be responsible for misinformation other writers produced.
• The CDC had to avoid conflict of interest when advocating pharmaceuticals used in the treatment of H.pylori.

Health Engineering

Strengths

• A two-week oral antibiotic treatment should be standard procedure.

Weakness

• Antibiotics can be costly especially among low SES populations.

Opportunities

• Partnerships in this endeavor are possible between the pharmaceutical companies and the CDC.

Threats

• Government intervention with pharmaceutical companies could raise objections.

Ethics

• Pharmaceutical companies have been perceived as overmedicating Americans and having close ties to insurance companies. By supporting this industry ethical questions are raised.

Health-related Community Services

Strengths

• Once educated, healthcare providers can routinely treat H.pylori with antibiotics.

Weaknesses

• Healthcare professionals and organizations had to be made aware of H.pylori. If they were not informed, patients would not have been tested and their insurance would not have covered the costs.

Opportunities

• Healthcare professionals were accustomed to being communicated with in this manner.

Threats

• Certain people will not be willing to spend money for treatment.

Ethics

• The manufacturing of antibiotics by pharmaceutical companies raised an ethical question.

Step 2.6 For each subproblem, select the intervention(s) you plan to use.

For the intervention, it was clear that communication was the only appropriate strategy. The mandate was specific in its purpose and did not suggest or imply that the agency had the authority to change policy, engineer treatments and procedures, or engage in medical intervention. Thus, only target population and factor-specific strategies that related to communication were explored.

A health communication strategy also made sense for the following reasons:

• Communication can be very effective in increasing awareness or changing attitudes and beliefs.
• Ulcer sufferers and primary care physicians are accessible through a variety of communication channels.
• The CDC and its divisions have considerable experience with a wide variety of communication programs for both consumers and professional populations, and the National Center for Infectious Diseases (NCID) had the support of the CDC’s Office of Communication (OC).

Logic Model

Step 2.7 Explore additional resources and new partners.

From the start of the campaign, and as resources became available, NCID sought a variety of partners for the campaign. In its mandate, Congress specifically stated that CDC’s intervention would "include a collaboration between the public and private sectors, including the pharmaceutical industry" (CDC, 1997).

NCID looked for partners in several different areas, including academia, other related government agencies, associations and foundations, and profit-making entities such as pharmaceutical companies. People or organizations already working in the area of H.pylori were strongly desired.

Suggested partners included:

• Abbott Laboratories
• American Digestive Health Foundation (ADHF)
• American Gastroenterological Association (AGA)
• Astra Merck
• Food and Drug Administration (FDA)
• Health Care Financial Administration (HCFA)
• Meretek
• National Institute of Diabetes and Kidney Diseases (NIDDK)
• National Institutes of Health (NIH)
• Proctor and Gamble
• University based H.pylori – ulcer researchers (one from Howard University, the University of New Mexico and Emory University)

Step 2.8 Acquire funding and solidify partnerships.

Step 3.1 For each subproblem, determine if intervention is dominant.

Communication was the primary intervention.

Because of their unique link to the problem as defined by the contributing factors, four possible target populations were identified. They included:

• Health insurance companies
• Managed care organizations (MCOs)
• Primary care physicians (PCPs)
• Ulcer sufferers

The following were possible target populations based on the contributing factors:

• Companies and managed care organizations.
• Employers
• Older women
• Public officials
• Women with dependent children

Step 3.2 Determine whether potential audiences contain any subgroups (audience segments).

Possible ways of segmenting the population who suffered from ulcers included:

• Those 35 and older versus those younger than 35
• Those who spoke English as their primary language versus those who spoke Spanish as their primary language
• Those who already had been tested and or/treated for H.pylori versus those who had not

Possible ways of segmenting the PCP population included:

• Those who practiced in urban locations versus those who practiced in rural locations
• Those who practiced in a managed care organization (MCO) environment versus those who had privately owned practices
• Those who had been practicing for many years versus those who had practiced just a few years

Because the goal of the campaign was to create awareness and encourage all ulcer sufferers to discuss possible H.pylori diagnosis and treatment with their physicians, little emphasis was placed on targeting them according to specific audience segments. They were segmented only by language. The National Center for Infectious Diseases (NCID) wanted to make certain that they could reach those whose primary language was Spanish.

Step 3.3 Finalize intended audiences.

The populations chosen for intervention were ulcer sufferers and primary care physicians. Health insurance companies, and managed care organizations were dropped from consideration because they were not included in the original mandate.

A profile of ulcer sufferers as a primary target audience follows:

• The average age was 47 years (Abbott, 1997).
• Data consistently showed that peptic ulcer disease (PUD) prevalence was associated with low-income and low-education levels and with older age (Sonnenberg & Everhart, 1996; Abbott, 1997).
• Older PUD sufferers were more likely to have been diagnosed by a doctor than those in younger age groups. Seventy percent of ulcer sufferers who had been diagnosed by a doctor are 35 years of age or older (Abbott, 1997).
• Data are conflicting as to whether PUD is more prevalent among men or women (Sonnenberg & Everhart, 1996; Abbott, 1997).
• As with the general public, a large majority of individuals with gastrointestinal (GI) problems believe that stress can cause ulcers (Porter Novelli, 1997; ADHF, 1995b; ADHF, 1995c).
• When asked in an open-ended format, only a small percentage of PUD sufferers identify a bacterial cause of their own condition (Abbott, 1997).
• Ulcer sufferers consider both physicians and pharmacists credible sources of medical information. Individuals with GI problems often feel more comfortable asking their pharmacists about treatments and prescriptions than they do asking their physicians (ADHF, 1995a).
• When presented with information about H.pylori and its treatment, individuals with PUD generally were very enthusiastic about the news (ADHF, 1995a).
• Over-the-counter (OTC) medications were the most common treatment that PUD sufferers used for their ulcers (ADHF, 1995c; Abbott, 1997; Synergy Health Care, Inc., 1997).

Concerns about the H.pylori antibiotic treatment included:

• the need to ingest up to 20 pills per day for 10 to 14 days
• the need to keep track of their dosing schedule
• the concern about cost, and the side effects of large doses

Data strongly suggested that a large number of PUD sufferers viewed their condition as chronic. Many treated their ulcers for years without any regular consultation with their physicians (Abbott, 1997).

Although primary care physicians as a target audience could be segmented in a number of ways, the NCID had no compelling data to suggest that one or more segments of the population were more likely to diagnose and treat H.pylori than any others.

PCPs as a target audience are profiled below:

Over 30 different regimens had been suggested to treat H.pylori, yet the FDA had approved a much smaller number. Physicians questioned which regimen was best because there was a lack of efficacy studies for the different regimens.

PCPs could benefit from additional education about H.pylori and various treatment regimens, especially those who took a "wait-and-see" approach to treatment (Mowen, 1996; Fendrick, 1996).

PCPs viewed peer-reviewed literature as a reliable source of important information (Fendrick, 1996).

Many PCPs initially treated their ulcer patients with H-2 blockers and antacids and referred all complicated cases, or instances where conventional therapy failed, to a gastroenterologist (GE). Once they referred patients, they turned over full responsibility to the GE for diagnosis, treatment, and management of the patients' conditions (Mowen, 1996)

Step 3.4 Write communication goals for each audience segment.

Objectives for the H.pylori campaign included:

• Increase the number of ulcer sufferers who were aware of the link between H.pylori and peptic ulcer disease.
• Increase the number of ulcer sufferers who thought that stress and/or the foods that they ate were not the primary cause of ulcers.
• Increase the number of PCPs who believed that their patients with peptic ulcers should be tested and treated for H.pylori.

Step 3.5 Examine and decide on communication-relevant theories and models.

Sample communication-relevant theories and models are listed below:

• Adult Learning Theory
• Mass media campaigns that use Social Marketing
• Stages of Change

Special attention will be paid to news media and education entertainment.

Step 3.6 Undertake formative research.

From focus groups and data from partners, the NCID knew that ulcer sufferers:

• Believed ulcers were a chronic condition
• Self diagnosed their condition from onset
• Stop seeing a doctor and self treated
• Took a fatalistic view
• Treated ulcers for pain relief

The NCID considered pharmacists as a possible secondary audience because of their potential to interact with and influence ulcer sufferers. They were not identified as a primary audience because they were not uniquely linked to the problem as defined by contributing factors.

The NCID conducted telephone focus groups with retail chain and independent pharmacists to help make a decision. The findings indicated that pharmacists should be included in the campaign as a secondary audience.

Highlights from a series of CDC telephone focus groups, which produced qualitative data on pharmacists, led to the decision to include pharmacists as a secondary target audience. The reasoning for their decision follows:

• Although they acknowledged their time for interaction was limited, the pharmacists agreed that it was important to talk to patients about their medications, especially because so few asked questions (CDC, NCID, 1997a).
• Even when general awareness of the link between H.pylori and ulcers was high, the pharmacists said they could use more information on the efficacy of various combination therapies (CDC, NCID, 1997a).
• Focus group participants welcomed continuing education programs to learn more about H.pylori and ulcers (CDC, NCID, 1997a).
• The pharmacists said their primary source for new or additional information was professional literature, such as the Pharmacist's Letter (CDC, NCID, 1997a).

Step 3.7 Write profiles for each audience segment.

Key Messages

• Antibiotics cure the infection and the ulcer
• Most ulcers are caused by an infection
• Talk to your physician about a cure for your ulcer
• The infection is caused by the bacterium H.pylori

Settings

Ulcer Sufferers

• Buses/bus stations
• Car (radio)
• Grocery stores (stomach remedy aisles)
• Health clinics
• Home (via television, radio, telephone, magazines, newspapers)
• Hospitals
• Internet
• Libraries
• Magazines, newspapers
• Malls
• Pharmacies
• Physicians' offices

Health professionals (physicians/pharmacists)

• Automobile
• Classroom
• Conferences/meetings
• Home
• Internet
• Workplace

Activities

Interpersonal

• Placed a list of questions near stomach medicine displays at pharmacies for ulcer sufferers to ask their pharmacists.
• Provided ulcer sufferers with question lists to help them remember all of the relevant issues to discuss with their PCPs.

Small Group

• Created an outline that could be used at a conference to facilitate a workshop made up of PCPs discussing treatment options for H.pylori infection.
• Provided an expert to hold H.pylori sessions during grand rounds at area hospitals.

Organizational

• Added an informational "stuffer" to the pay envelopes of company employees encouraging them to see a doctor for H.pylori testing if they had symptoms of an ulcer.
• Broadcasted in-house television health news flashes for corporate communication.

Community

• Established an ulcer booth at local health fairs, staffed by local health care providers.
• Placed displays in pharmacies, bus stations, grocery stores, and doctors' offices throughout the community.

Mass Media

• Aired radio and television PSAs intended to motivate ulcer sufferers to see or call their health care provider for more information.
• Arranged for NCID staff to appear on talk shows to discuss the link between H.pylori and ulcers.
• Contacted radio and/or television station program managers and persuaded them to include a story/feature on H.pylori and ulcers.
• Published print ads that advised patients to see their physicians about getting tested and treated for H.pylori.
• Sent a packet of materials to pharmacists that contained a fact sheet, a poster, and educational brochures for consumers.
• Sent informational packets to physicians across the country that included a fact sheet, waiting room poster and educational brochures for patients.

Step 3.8 Rewrite goals as measurable communication objectives.

• By September 1998, increase by 50% the number of ulcer sufferers who were aware of the link between H.pylori and peptic ulcer disease.
• By September 1998, increase by 40% the number of ulcer sufferers who believed that stress and/or the foods they ate were not the cause of their condition.
• By September 1998, increase by 30% the number of PCPs who believed that their patients with symptoms of a peptic ulcer should be tested for H.pylori and treated with the appropriate antibiotic regimen if the test was positive.

Step 3.9 Write creative briefs.

As stated in Step 3.3, two different audiences were targeted. The first were ulcer sufferers, and the second were the primary care physicians that treated them.

Target Audience – Those with PUD, especially individuals 35 years of age and older (both long-term sufferers and newly diagnosed patients), and those of low socioeconomic status and education levels.

Objective(s)

• Inform the audience that ulcers are an infectious disease, which can be permanently cured.
• Convince the audience to talk to a health care provider about a permanent cure for their ulcers.

Obstacles

• Many sufferers believed that ulcers were a chronic condition, rather than an infectious disease.
• There were many misperceptions about the cause of ulcers:
• Many people believed ulcers were caused by stress.
• Many people believed ulcers were caused by spicy foods.
• Few people knew/believed that bacteria could cause ulcers.
• There was a firm belief that you treated ulcers to relieve pain, but not permanently cure them.
• Many ulcer sufferers self-diagnosed their condition from on-set; self diagnosed sufferers were more likely to be younger individuals than those diagnosed by a doctor.
• Many ulcer sufferers stopped seeing a doctor about their condition and self treated with the latest heavily-promoted OTC drugs (i.e. Pepcid®, Zantac®), which were very effective at relieving pain, but not at permanently curing the ulcer.
• Many ulcer sufferers took a fatalistic view of their condition; they learned to live with their pain and became resigned to a recurring cycle of flare-up, treatment and relief.
• There was public confusion about the differences between types of ulcers and dyspepsia/heartburn/reflux.

Key Promise

If I cure my peptic ulcer infection, I can avoid a lifetime of suffering and pain by ‘curing the real cause.’

Support Statements/Reasons Why

• Peptic ulcer disease is an infectious disease – not a chronic condition.
• The infectious bacteria, H.pylori, causes about 9 out of every 10 peptic ulcers.
• The disease is curable: for peptic ulcer sufferers, combination therapy (antibiotics and acid reducers) used to eliminate the H.pylori bacteria has been proven highly effective in preventing recurrence of the ulcer.
• A number of new diagnostic tests and treatment regimens are now available which offer easier diagnosis of the disease and a permanent end to ulcer pain.

Tone

In order to overcome the history of misperception, cynicism and disbelief about the permanence of a cure, we suggested communicating in an optimistic, positive, authoritative, attention-getting and/or motivating tone.

Media

• A series of 2 (or more) television, radio and print PSAs
• Brochure for consumers and health care professionals
• Local implementation kit
• Media kit

Openings

Campaign members could reach target audiences through the following channels/at the following places:

• Situations related to food-particularly social occasions, i.e. weddings, anniversaries, birthdays, parties, holidays-Thanksgiving/New Year’s, eating out
• Situations where audience was under stress, i.e. commuting in rush hour traffic, work, pressures at home/noise of kids/neighbors, tax time, etc.
• Visits to clinics/hospitals/doctors’ offices/pharmacies- at the onset of the disease or during flare-ups
• Watching television, listening to radio talk shows, reading newspapers

Creative Considerations

Below are issues that needed to be considered before/as the communication plan was designed and implemented:

• Broadcast and print PSAs needed to be in Spanish and English
• First wave of PSAs aired in the Fall of 1997 following National Infectious Disease Week, the second wave aired in the Spring of 1998 following Digestive Disease Week
• PSAs tagged with ‘talk to your doctor/health care provider’ or ‘for more information, call 1-800-…‘

Target Audience – Primary care physicians

Objective(s)

• To enable physicians to effectively cure their patients’ ulcers (i.e. diagnose H.pylori and treat it with antibiotics)
• To facilitate better communication between doctors and patients about ulcer treatments

Obstacles

• Consumers in managed care settings lacked the ‘family doctor’ and often saw different doctors; they no longer had a one-on-one relationship, which made for inconsistent delivery of information
• Physicians tended to treat the symptoms of ulcers as a chronic condition
• Primary care physicians tended to be the last to prescribe new therapies
• Some physicians were not convinced that H.pylori caused ulcers
• There were some financial deterrents for some physicians which encouraged them not to cure their patients

Key Promise

By providing accurate information and a clear course of treatment, physicians will manage their time more efficiently, cut down on unnecessary office visits and preventable hospitalizations, reduce the need for specialist consultation, and place more focus on patients who need their attention.

Support Statements/Reasons Why

• Antibiotic treatments were cost-effective in terms of manpower and medicines.
• More than 25 million Americans suffered from ulcers.
• New diagnostic tests and treatment regimens that offered easier diagnoses and a permanent end to ulcer pain were available.
• Ninety percent of ulcers are caused by H.pylori and are curable.
• Ulcers lead to more than one million hospitalizations each year.

Tone

We suggested communicating in a credible, informative, straightforward, compelling, and/or encouraging tone, when targeting physicians.

Media

• Audio cassettes (for physicians’ use)
• Information leaflets (for physicians)
• Prescription pads
• Waiting room posters

Openings

Campaign members could reach target audiences through the following channels/at the following places:

• Annual association meetings.
• Continuing Medical Education (CME) programs conducted on a national, regional and community level.
• Direct mailing to group primary care practices.
• Teaching hospitals and medical schools.

Creative Considerations

Below are issues that needed to be considered before/as the communication plan was designed and implemented:

• A ‘treatment tips’ sheet needed to be created and used as a resource for physicians working in areas that were heavily populated by Hispanic Americans.
• Input from female and male physicians needed to be solicited.
• Print materials were the number one source of information.
• Two versions of the physician waiting room poster needed to be created in order to include the Hispanic Americans population.
• We were not advocating large-scale screening or an eradication program.

Step 3.10 Confirm plans with stakeholders.

A meeting with stakeholders was held to reveal the results of the formative research. They were also asked what information they hoped to attain by implementing this campaign, and what their desired outcomes were. A campaign timeline was discussed and the program and first phase launch was scheduled for June of 1997. The second phase was planned to begin in January of 1998 and end in May of 1998, which meant that some overlap of first and second phases would occur. Evaluation of these phases was stressed to be essential.

Step 4.1 Draft timetable, budget, and plan for developing and testing communication mix.

A time table was developed for Task Wave 1; to view it click here.

A milestone table was developed for Task Wave 2; to view it click here.

Step 4.2 Develop and test creative concepts.

For the H.pylori campaign, four concepts were developed based on the information gathered on ulcer sufferers. The concepts used different "hooks" that might sound familiar to ulcer sufferers. Brief explanations of the concepts were:

"Sadie/Eloise" – Using two characters (Sadie and Eloise), this approach was designed to get sufferers to realize that ulcers do not have to be chronic. If they are treated for the infection, chronic complainers will have nothing left to complain about.

"Good News" – The main idea of this concept was to cause people to think of the H.pylori infection in a positive way and to welcome the diagnosis. Infections are curable, and an alternative to chronic pain in this particular instance.

"Goodbye Ulcer, Hello Life" – This concept played on the ulcer sufferer’s belief that she/he must give up certain aspects of their life because of their condition. Curing one’s ulcer allowed a person to enjoy life instead of avoiding behaviors commonly believed to cause ulcers.

"Not What You Thought" – The concept focused on the causal factors associated with ulcers. The message tried to dispel the myth that stress and spicy foods cause ulcers.

Twelve focus groups were conducted targeting three population subgroups that suffered from peptic ulcers (four addressing Hispanic Americans, four addressing African Americans, four addressing non-Hispanic white Americans). The objective was to obtain responses to the following questions:

• How do ulcers affect your life?
• What would a cure mean to you?
• What do you know about H.pylori/Its association with peptic ulcer disease?
• What did you think of the four creative concepts?

Most of the focus group time was used to test the four concepts. The purpose was to have the participants react to visual and verbal representations of the concepts. This was intended to be a starting point for developing a specific message, but the words and images were not intended to be viewed as finished products.

Examples of questions the moderator asked the group included:

• What is the main idea of "Good News"?
• Who would you say they are hoping to reach?
• As an ulcer sufferer, would you take any particular action after seeing this message?

• Were certain words or phrases relevant to you? Did you relate to the words/phrases/messages presented in the PSA?
• Were the images attention-getting, appealing and/or motivating?
• What did you like or dislike?
• What would you change to make the concept more motivational, believable and/or appealing?

The moderator also asked the participants to expand on why certain concepts did or did not appeal to them. That part of the focus group was particularly important to the creative team, who were sitting behind a two-way mirror. It allowed the team members to hear and watch the participants and better understand their feelings and reactions to the messages/concepts tested.

Highlights of the focus group findings are outlined below:

• Participants were pleased to hear that a cure for ulcers existed and that antibiotics could eliminate the pain and inconvenience of controlling an ulcer. Details about the actual cause were less important to participants than the fact that there was a cure (CDC, 1997b).
• Most participants chose "Good News" as the best attention-getting concept because of its focus on a cure. Emphasizing that the cure was based on what caused ulcers helped to address the barrier posed by former incorrect beliefs that food and stress caused ulcers (CDC, 1997b).

To reach ulcer sufferers, the H.pylori campaign used a multi-layered communication approach (print, television, PSAs, brochures, and posters). Much of the campaign was based on humor because it had proven successful in the past (e.g., Alka Seltzer ads).

The program planner decided to convey humor with live actors in the PSAs and with caricature drawings in printed materials.

Step 4.3 Develop and pretest messages.

Twenty one-on-one interviews (11 English, 9 Hispanic) were conducted in Washington, DC and Miami, FL to pretest the television PSA scripts and storyboards and the radio PSA with ulcer sufferers. The interviews, held in focus group facilities, were conducted by a trained interviewer and averaged 10 to 15 minutes in length.

After showing the television PSA and playing the radio PSA, the interviewer probed for in-depth responses to the ads. Interviewers wanted to know if the ads were motivational, whether the individuals liked or disliked the spots, and if they liked or disliked the humorous approach used in the television PSA.

Overall the results were quite positive. Highlights included:

• The spot motivated them to see a doctor.
• They understood the overall message.
• They liked the humor.

Step 4.4 Pretest and select settings.

Through focus groups conducted in the formative research and pretesting phases the following data was gathered on settings and channels:

• People expected to hear this news from their physicians.
• Non-physician settings (pharmacists and consumer media) were important because many sufferers no longer visited their physicians to treat ulcers.
• 1-800 number and website were mentioned as an important means of communicating the message.

Ways to reach the target audience varied somewhat between African Americans, Hispanic Americans and non-Hispanic white Americans:

• African-Americans- medical offices and health professional buildings, libraries, senior citizen centers, public transportation, billboards, grocery stores, liquor stores, BET and UPN programming, music video channels, magazines, local newspaper, website (strongly recommended), direct mail
• Hispanic Americans- church bulletins, Spanish language newspapers, medical offices, pharmacies, hospital and clinics, health fairs, Spanish-language television, schools and children’s recreation sites, restaurants, bars and airports, DO NOT use direct mail
• Non-Hispanic white Americans- doctors’ offices, medical/science journals, 1-800 number, print materials in doctors’ offices, on prescription drug bags, coupons for drugs, consumer magazines, bus ads, Wall Street Journal, radio during drive time

Step 4.5 Select, integrate, and test channel-specific communication activities.

The National Center for Infectious Diseases (NCID) chose a mass media approach for the H.pylori campaign because it worked well for creating and building awareness and changing attitudes and beliefs. A list of materials the CDC developed that could reach a large audience through various settings and media follows:

• A local implementation kit
• A pharmacist packet of materials
• A physician packet of materials
• A press kit
• A web page
• Brochures
• Fact sheets
• Print, television and radio PSAs

Step 4.6 Identify and/or develop, pretest, and select materials.

Step 4.7 Decide on roles and responsibilities of staff and partners.

Step 4.8 Produce materials for dissemination.

After organizational clearance was obtained, four major tasks were accomplished:

• Coordination with the phone company to set up the toll free 1-888 number.
• Creation of the CDC H.pylori web page.
• Duplication of the print campaign materials, including the print PSAs, cover letters for the physician packet, cover letters for the pharmacist packet, physician fact sheets, consumer brochures, and posters.
• Duplication of the television and radio PSAs.

Examples of public relations and marketing activities are listed below:

• Developed a media policy sheet identifying point persons to whom media inquiries should be directed. These people followed the policy sheet, keeping comments focused on the main message(s) of the campaign.
• Developed talking points and made them available to those who were called upon to speak publicly. These points were things such as the central messages, the medical facts, and the tips for obtaining more information.
• Provided technical assistance upon request in the form of interviewer training for physicians and pharmacists.

Step 4.9 Finalize and briefly summarize the communication plan.

Step 4.10 Share and confirm communication plan with appropriate stakeholders.

Step 5.1 Identify and engage stakeholders.

Step 5.2 Describe the program.

The goals of the campaign were:

• By September 1998, increase, by 50%, the number of ulcer sufferers who recognized the link between H.pylori and peptic ulcer disease.
• By September 1998, increase, by 40%, the number of ulcer sufferers who believed that stress and/or the foods they ate were not the cause of their ulcers.
• By September 1998, increase, by 30%, the number of PCPs who believed that their patients with symptoms of a peptic ulcer should be tested for H.pylori and treated with the appropriate antibiotic regimen.

In order to achieve the outlined goals, the following intervention was designed:

• Mass media communications: To address the public’s misconceptions, a mass media strategy that combined media relations, public service advertising and entertainment education was designed.
• Outreach to Pharmacists: Because many ulcer sufferers self-medicated with over-the-counter products, pharmacists were targeted as a primary information source for consumers.
• Outreach to Physicians and Health Care Providers: To improve communication between ulcer sufferers and physicians, special information kits were created. The kits included a physician fact sheet, waiting room posters and consumer brochures.

Step 5.3 Determine what information stakeholders need and when they need it.

Stakeholders were interested in discovering the answers to these questions:

• Was the intervention delivered and implemented as planned?
• Was the intended audience exposed to the messages? Did the messages reach the intended audience(s)?
• Did the campaign have the intended effects? Were the objectives reached?
• Was the campaign cost-effective?

Step 5.4 Write intervention standards that correspond with the different types of evaluation.

• By September 1998, increase, by 50%, the number of ulcer sufferers who recognized the link between H.pylori and peptic ulcer disease.
• By September 1998, increase, by 40%, the number of ulcer sufferers who believed that stress and/or the foods they ate were not the cause of their ulcers.
• By September 1998, increase, by 30%, the number of PCPs who believed that their patients with symptoms of a peptic ulcer should be tested for H.pylori and treated with the appropriate antibiotic regimen.
• The intervention was delivered and implemented according to the communication plan.
• The cost of the campaign was in relation to the benefits.

Step 5.5 Determine sources and methods that will be used to gather data.

Click here to see the chart.

Because several sources of baseline data were available, new data would not be needed. The following data sources provided a baseline:

Ulcer sufferer data

• Abbott Laboratories (1997) - Abbott conducted a telephone survey with self-and doctor-diagnosed ulcer sufferers. Questions were asked about knowledge, beliefs, attitudes, perceptions and practices.
• American Digestive Health Foundation (ADHF) (1995-1997) - The organization conducted a mall intercept study, a focus group study, and a telephone survey. The mall intercept study provided data from the general public. The focus group study and the telephone survey yielded data from people with gastrointestinal (GI) problems. The ADHF obtained knowledge, beliefs, attitudes, perceptions, and practice data.
• Porter Novelli (Healthstyles) (1997) - These data came primarily from six items that directly related to H.pylori. Healthstyles is an annual telephone survey that relies on a national probability sample to provide knowledge and behavioral data on various health topics.

Physician Data

• Abbott Laboratories (1996) - Abbott administered a telephone survey to 300 physicians from the top 40% of prescribers of H-2 blockers. The survey was administered in four phases.
• Astra Merck (1996) - Astra Merck conducted a telephone survey with 150 physicians. Questions were asked about knowledge, beliefs, and practices.
• Fendrick/University of Michigan (1996) - This article, published in the American Journal of Gastroenterology, reported the results of a survey of gastroenterologists and primary care physicians and their level of awareness and practice patterns.

Step 5.6 Develop an evaluation design.

Step 5.7 Develop a data analysis and reporting plan.

A data analysis plan for the H.pylori campaign incorporated the following types of analysis:

• 1-888 logs - Percentages and cross tabulations were calculated to analyze variables such as age, gender, ethnic/racial group, state, type of questions, and responses provided to callers. Descriptive analysis was used to summarize the main findings.
• Focus groups - Analysis was done by using data immersion.
• Survey data - Data was analyzed using basic descriptive statistics.
• Television and radio PSA logs - Percentages and cross tabulations were performed to analyze variables such as the number of times aired, in which States, at what times during the day, and the increase in calls to the 1-888 number.
• Web page - Analysis was included counting the number of hits and writing up weekly summaries of access. Descriptive data was used to summarize the findings. Researchers looked for trends such as whether there were more hits to the page immediately after campaign kickoff or if there was lag time.

Step 5.8 Formalize agreements and develop an internal and external communication plan.

Daily internal communication included e-mail, telephone, print, and face-to-face interviews. Holding regularly scheduled biweekly meetings also facilitated communication. Participants included the creative director, the research task leader, and other interested agency staff. On occasion, a partner(s) or two participated. Minutes were prepared and distributed with some content extracted to help develop the Partner Update newsletter.

External communication with external project staff included e-mail, telephone, face-to-face meetings, and The Partner Update. The Partner Update was used periodically to disseminate the latest developments in the campaign. A sample of headlines from one issue included: "Last Call for Research" and "Pharmacists Focus Groups."

Step 5.9 Develop an evaluation timetable and budget.

The campaign was kicked off in October of 1997, and all evaluation was completed within the year.

Budget information was not available.

Step 5.10 Summarize the evaluation implementation plan and share it with staff and stakeholders.

Step 6.1 Integrate communication and evaluation plans.

Step 6.2 Execute communication and evaluation plans.

Step 6.3 Manage the communication and evaluation activities.

Step 6.4 Document feedback and lessons learned.

Lessons learned included:

• For future programs, it is imperative that program planners/members make certain that the target audiences are composed of individuals who suffer from stomach ulcers. During the first night of concept testing focus groups, some participants had foot and mouth ulcers, not stomach ulcers. For the remaining groups, participants were re-screened at the door to make certain they had a stomach ulcer.
• Some partners were receptive and willing to share information in the beginning but became less involved as the campaign continued. The campaign could be analyzed to find out why this happened, if it affected the campaign, and how to form more effective partnerships.

Step 6.5 Modify program components based on evaluation feedback.

Step 6.6 Disseminate lessons learned and evaluation findings.

• An academic journal article highlighting the process of the campaign was written.
• An executive summary was sent to all partners.
• Examples of organizations and individuals who received the H.pylori campaign findings and lessons learned through the full report, the executive summary, or the journal article included:
  • All partners (ADHF, Procter and Gamble, HCFA, etc.)
  • APHA and other relevant associations
  • Journals targeted to physicians and pharmacists
  • Web pages that have information about ulcers/GI problems
• Presentations were delivered at conferences held by the American Gastroenterology Association, the American Public Health Association, and similar groups, to report findings. They were also presented to interested parties at the CDC, HCFA, NIH, and FDA. Articles were submitted to newsletters, which circulated to health and medical association members.
• The Centers for Disease Control and Prevention (CDC) created a full report detailing all the aspects of the research and the campaign. The report was available to anyone who contacted the CDC project officers.