inclusion and exclusion criteria

AHRQ Health Care Innovations Exchange

Innovations Inclusion/Exclusion Criteria

INCLUSION – all must be met*	EXCLUSION – only one must be met*
Innovation focuses on how health care services are delivered to patients	Product or technical innovations
Innovation is intended to improve quality	Policy innovations
Service is truly innovative in context of setting and target population	Educational innovations
Innovation information can be made publicly available, if not already so	Clinical innovations
Innovator or rep will be active participant and share in Innovations Exchange	Health service delivery innovations without any evidence of effect
Innovation will be effective

* each is expanded on below

Inclusion criteria – ALL must be met for the innovation to be included:

• The innovation focuses on how health care services are delivered to patients during at least one particular stage of care and through at least one organizational and/or care process change

  • Stages of care are:

    • Preventive care (primary, secondary, tertiary)

    • Primary care

    • Acute care

    • Acute on chronic (i.e., an acute condition resulting from underlying chronic disease)

    • Chronic care

    • Urgent care

    • Emergency care

    • Intensive care

    • Rehabilitative care

    • Long-term care

    • End-of-life care

  • Care processes include:

    • Pre-care processes (e.g., gaining access to care, pre-visit history taking, waiting time management)

    • Active care processes (e.g., diagnosis)

    • After-care processes (e.g., handoffs and end of shift reports)

    • Care management processes (e.g., physician-physician communication)

    • Patient-focused processes (e.g., language and translation services)

  • Organizational processes include:

    • Cultural competence

    • Incentives

    • Management structure

    • Medical record keeping

    • Organizational culture change

    • Health records, personal

    • Physical environment modification

    • Policies and procedures

    • Public communication

    • Process improvement

    • Quality measurement, benchmarking, data feedback

    • Referrals

    • Staff scheduling

    • Staffing

    • Team building

    • Workflow redesign

• The innovation is intended to improve one or more domains of health care quality.

  • Safety

  • Timeliness

  • Effectiveness

  • Efficiency

  • Equity

  • Patient-centered

• The activity is truly innovative in the context of its setting or target population.

  • Settings may be:

    • Ambulatory

    • Ancillary service (e.g., freestanding laboratory)

    • Battlefield/military field hospital

    • Emergency

    • Home

    • Hospital inpatient

    • Mobile (e.g., van)

    • Residential

  • Target population covers:

    • Age, gender, geographic location, race and ethnicity, description of vulnerability (e.g., natural disaster victim)

    • Diseases/conditions

• Information about the innovation, even if proprietary, is publicly available.

• The innovator (or a representative) is willing and able to contribute information to the Health Care Innovations Exchange.

• There is reason to believe that the innovation will be effective. (This will be captured in an evidence rating, assigned by an editorial team:

  • Strong: The evidence of effectiveness is based on one or more rigorous evaluations using experimental designs that minimized bias and were based on random allocation of patients to comparison groups. The results of the evaluation(s) show consistent direct evidence of the effectiveness of the innovation in improving the targeted health care outcomes and/or processes.

  • Moderate: While there are no randomized, controlled experiments, the evidence of effectiveness includes at least one systematic evaluation of the impact of the innovation using a quasi-experimental design, which could include the non-random assignment of individuals to comparison groups, before-and-after comparisons in one group, and/or comparisons with a historical baseline or control. The results of the evaluation(s) show consistent direct or indirect evidence of the effectiveness of the innovation in improving targeted health care outcomes and/or processes. However, the strength of the evidence is limited by the size, quality, or generalizability of the evaluations, and thus alternative explanations cannot be ruled out.

  • Suggestive: While there are no systematic experimental or quasi-experimental evaluations, the evidence of effectiveness includes non-experimental or qualitative support for an association between the innovation and targeted health care outcomes or processes. This evidence may include non-comparative case studies, correlation analysis, or anecdotal reports. As with the category above, alternative explanations for the results achieved cannot be ruled out.)

Exclusion criteria – one criterion met renders the innovation excluded:

• Product or technical innovations, such as

  • Drugs

  • Devices (e.g, stents)

  • Software or hardware design, development, release, and promotion

  • Medical durable equipment (e.g., wheelchairs)

  • Supplies (e.g., gloves)

• Policy innovations, such as

  • Public policy (e.g., No smoking bans in public places)

  • Credentialing policy (e.g., physicians must acquire certain credentials in order to be granted hospital privileges)

  • Health plan policy (e.g., pay for performance)

• Educational innovations, such as

  • Curriculum redesigns (e.g., nursing program changes)

  • Continuing education certification (e.g., technology to track progress in reaching continuing education requirements)

  • Simulation

• Clinical (e.g., surgical, medical, dental) diagnostics and therapies and other professions’ techniques (e.g., robotics, new surgical procedures, new homeopathic therapies, new radiology tests)

• Health service delivery innovations without any evidence of effect (there is no quantitative or qualitative support for an association between the innovation and targeted health care outcomes or processes)