Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

What is the comparative effectiveness of the MIST low-frequency ultrasound therapy with or without debridement and cleaning versus negative pressure wound therapy (Wound V.A.C.).

If one modality is more effective than the other, what are the conditions and parameters associated with the better outcomes including co-morbidities, wound size, treatment setting, caregiver training, etc.?

Are there significant cost differences associated with one therapy versus another based on healing times, adverse events, nursing care burden, etc.?

What are the common and serious risks and harms associated with MIST versus negative pressure wound therapy (Wound V.A.C.) ?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

MIST low-frequency, non-contact ultrasound system with or without debridement and cleaning versus negative pressure wound therapy (Wound V.A.C.).

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Patients in long term care settings with open wounds. Patients in outpatient, community health care and home health settings with open wounds

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

• Patients with disabilities
• Patients with diabetes
• Patients with co-morbidities
• Frail elderly with mobility issues
• Stroke patients

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

• Shorter wound healing times
• Decreased morbidity and mortality including fewer progressions to Stage IV wounds, amputations and sepsis

Describe any health-related risks, side effects, or harms that you are concerned about.

• Slower healing times
• Progression to Stage IV wounds
• Sepsis
• Amputation
• Death

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Arthritis and nontraumatic joint disorders
• Cardiovascular disease, including stroke and hypertension
• Diabetes mellitus
• Functional limitations and disability

AHRQ Priority Populations

• Low income groups
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Chronic wounds constitute significant morbidity and mortality in Medicare and Medicaid populations. Treatment of chronic wounds is both common and costly for these programs. Treatment of chronic wounds is common in both community healthcare and acute care settings but patients in long term care are particularly prone to chronic wounds from diabetic ulcers, pressure ulcers and venous ulcers. Traditional management includes special bedding and mattresses for pressure wounds, compression therapy for venous ulcers and a wide range of other therapies including debridement, negative pressure wound therapy and various ultrasound therapies for other types of ulcers. One of the newer ultrasound therapies is the MIST Therapy System 5.0, a low-frequency, non-contact ultrasound device that was approved for wound cleaning and maintenance debridement of wounds in August 2004.

Given the populations affected by chronic wounds, treatment is costly to state and federal public assistance programs like Medicaid and Medicare. The state of Arizona is piloting the use of MIST among its Fee for Services population (N= 92,000) and is getting pressure from Health Plan medical directors to use MIST in its managed care population. However, to date, limited evidence exists to support the superiority of MIST over other standard treatments of care. What evidence does exist is largely industry sponsored or has other limitations such as small sample size. Without less biased evidence to suggest greater effectiveness or cost savings, the state is reluctant to cover this newer treatment. So although ultrasound technologies are being used clinically to aid healing of chronic wounds there is no consensus regarding their effectiveness.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

There is uncertainty regarding best practice based on evidence for the treatment of chronic wound healing therapies. Comparative effectiveness research on which treatment modality is most effective under what conditions and parameters would assist state policymakers in making coverage determinations.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

It is not clear when MIST might be the preferred treatment over negative pressure wound therapy (Wound V.A.C.) and whether or not it is more or less effective and under what conditions (i.e. size of wound, relative health of patient, inpatient vs. outpatient, etc.). MIST is marketed as a less expensive alternative than Wound V.A.C. and can be used in an outpatient or home setting. Some analysis though, indicates that use of trained health care personnel is still required when wound size is greater than 5cm in diameter thus making the total cost equal, if not higher than other treatments. In considering when, or if, to cover MIST ultrasound therapy, policymakers need to consider both outcomes and overall cost of treatment. Information on the comparative effectiveness of wound healing treatments would be very helpful to policymakers in making coverage determinations.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

State policy makers will use this information in making coverage determinations for recipients of the State’s Fee for Service populations.

Describe the timeframe in which an answer to your question is needed.

As soon as possible.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

N/A

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

State policy makers will use this information in making coverage determinations for recipients of the State’s Fee for Service populations.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

EHC Stakeholder