Evidence Review

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•ƒƒ Based on moderate to high quality evidence, exposure to a decision aid for a treatment or screening decision is consistently associated with improved knowledge, risk perception, and reduced decisional conflict for participants.
•ƒƒ The use of decision support tools is also associated more patient-controlled and less provider-controlled decision making.

Many of the decisions faced by patients and clinicians are complicated by equivalent options, each with its own harms and benefits that will vary in importance by individual values and preferences. Patient decision support tools strive to aid people in making high-quality decisions in the face of uncertainty; facilitating shared decision making conversations to supplement patient-provider consultations.

Shared decision making braids evidence-based medicine and patient-centered communication together, helping patients and providers reach a decision when facing equivalent options (Hoffmann, Montori, & Del Mar, 2014).

Decision aids are “evidence-based tools designed to help patients to participate in making specific and deliberated choices among health care options” (Stacey et al., 2014). Formats include handheld pamphlets, booklets, videos and web-based aids used during the consultation or provided before or after the visit.
The three core components to shared decision making include (Legare & Witteman, 2013):

  • Explicit acknowledgement of the decision to be made and the available options
  • Presenting the evidence for potential harms and benefits of each option
  • Blending the patient’s values and preferences with the providers guidance to ultimately make a high quality decision

Implementing decision aids in practice can be fraught with challenges. Providers, clinics, and health systems can address these issues to most effectively implement robust patient decision support.

Evidence on Patient Decision Support Tools

The Cochrane Collaboration published the first systematic review of patient decision aids and their effects in 1999. At that time they identified 17 eligible trials. In the latest Cochrane review from January 2014, including publications though June 2012, the eligible trials blossomed to 115 and included over 34,000 participants (Stacey et al., 2014). Their work provides a systematic review and meta-analysis on the impact of decision aids for patients facing treatment or screening decisions. The primary outcomes studied are patient-centered attributes of the choice-made and decision making process for decision aid recipients compared to usual care.

Based on moderate to high quality evidence, exposure to a decision aid for a treatment or screening decision is consistently associated with improved knowledge, risk perception, and reduced decisional conflict for participants. The use of decision support tools is also associated more patient-controlled and less provider-controlled decision making. In trials that observed the length of consultation the median increase in visit time was 2.5 minutes for those with decision aid involvement (range: 8 minutes shorter to 23 minutes longer). Notably, the trials in the Cochrane review do not find consistent evidence on patient choices, adherence, or costs (Stacey et al., 2014).

Table 1 provides the primary outcome, estimate of comparative benefit (e.g. mean difference)
or relative effective (e.g. relative risk), and the quality of the evidence. The quality of the
evidence was assessed using the Grading of Recommendations Assessment, Development and
Evaluation (GRADE) framework (GRADE Working Group, n.d.).

In the past decade, publications on shared decision making and decision support interventions
grew exponentially (Blanc et al., 2014). Recent additional systematic reviews on decision
aid effectiveness include sub-analysis of the original Cochrane review trials evaluating
heterogeneity of effects, investigations on the role of gender in the patient-provider dyad, and
narrowing the focus to decision aids in certain fields (e.g. cancer screening or treatment).
In their 2013 sub-analysis of the Cochrane review, Gentles and colleagues found participants
with lower baseline knowledge of risks and outcomes demonstrated greater gains from the use
of a decision aid than those with high baseline knowledge (Gentles, Stacey, Bennett, Alshurafa,
& Walter, 2013).

Wyatt and colleagues investigation into the role of gender dyads (i.e. gender of patient and
provider) on shared decision making did not identify any differences in outcomes across gender
congruent or disparate patient-provider dyads (Wyatt et al., 2014).

A 2014 comparative effectiveness report from the Agency for Healthcare Research and Quality
(AHRQ) on decision aids for cancer screening or treatment found similar effects to those in the
Cochrane analysis. Patients demonstrate increased knowledge without concomitant increased
anxiety or decisional conflict, have more accurate risk perception, and make more value consistent
decisions (Trikalinos, Wieland, Adam, Zgodic, & Ntzani, 2014).

Table 1: AHRQ Comparative Effectiveness Report
Outcome Comparative Benefits Relative Effect GRADE Quality of the Evidence
Knowledge Higher scores reflect better knowledge. Scale 0-100 Mean knowledge score 13.34 points higher (11.17-15.51) for decision aid recipients N/A High
Accurate Risk Perception N/A RR: 1.82 (95% CI 1.52-2.16) Moderate
Congruence between chosen option & their values N/A RR 1.51 (95% CI 1.17-1.97) Low
Decisional Conflict: feeling uninformed Lower scores better, less feeling uninformed. Scale 0-100 Mean score 7.26 (9.73-4.78) points lower for decision aid recipients N/A High
Decisional Conflict: unclear values lower scores better, values clearer. Scale 0-100 Mean score 6.09 (8.5-3.67) lower for decision aid recipients N/A High
Participation in decision making: practitioner controlled decision making N/A RR: 0.66 (95% CI 0.53-0.81) Moderate
N/A = not applicable, RR = relative risk

Federal & State Policies for PDSTs

State and Federal Efforts to Promote the Use of Patient Decision Support Tools through Promotion of Shared Decision Making

Shared Decision Making (SDM) appears in multiple areas of federal and state health policy. At the federal level, Affordable Care Organizations are evaluated on their ability to integrate SDM through quality metric monitoring (i.e. the Consumer Assessment of Healthcare Providers and Systems survey). At the state level, SDM is a common component of patient-centered medical home (PCMH) certification.

Efforts in Washington, Maine, and Minnesota highlight the array of early state-based initiatives promoting SDM. Efforts include private-public partnerships, informed consent laws, implementation pilot programs, and provider education on best practices in SDM and PDST implementation. While federal and state efforts have encouraged the spread of SDM, there remains work to be done to unify definitions, establish best practices, and standardize efforts across health systems.

Federal Legislation: The Patient Protection and Affordable Care Act of 2010

Section 3506
Section 3506 of the Affordable Care Act (ACA) defines Patient Decision Aids, Preference Sensitive Care, and other significant terms related to SDM. Furthermore, the ACA compels the Department of Health and Human Services (HHS) to contract with eligible entities to establish standards and a certification process for Patient Decision Aids. The legislation also established a grant process to develop and test Patient Decision Aids, and educate providers, however, these grants have not been implemented due to lack of appropriated funds.

Section 931
Section 931 of the ACA promotes the development of quality measures for the “experience, quality, and use of information…to inform decision making about treatment options, including the use of SDM.” This language authorizes the HHS Secretary to prioritize funding to entities working on this effort. As with Section 3506, this section was affected by the lack of appropriated money for grants.

Section 3022
Section 3022 of The Affordable Care Act created the Shared Savings Program, in which Accountable Care Organizations (ACO) can be financially rewarded for lowering their growth in health care costs while meeting performance standards on quality of care and putting patients first. One way those performance standards are measured is the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey, which queries patients on their experience with health care team. The Medicare CAHPS survey has included questions relating to SDM for ACOs since 2014. The CAHPS survey gauges patient perception and experience of decision making, but the data is unlikely to reflect the in-depth evaluation and stringent standards of research studies on the topic . The benchmark for whether patients thought SDM was used in ACOs ranges from 72.87%-76.71% for the 30th – 90th percentile respectively. New data on SDM for ACOs participating in the Shared Savings Program will be published later in 2016.

Section 3021
In 2011, using authority from Section 3021 in the ACA, the Centers for Medicare and Medicaid Services (CMS) issued the Health Care Innovation Challenge, making grants available to providers, payers, local government, public-private partnerships, and multi-payer collaboratives to “accelerate system transformation toward better care, better health, and lower costs through improvement.” Three grants have been awarded to 3 entities conducting SDM research and pilots, though quantitative data is currently available on only two.
The largest of the Health Care Innovation Challenge grants is the High Value Healthcare Collaborative’s $26.17 million from CMS’ Center for Medicare & Medicaid Innovation (CMMI) to hire and train 48 health coaches across 15 member organizations. The project, administered by Dartmouth College, focuses on the use of SDM in sepsis care for patients and their families. Health coaches help organizations undertake process improvement strategies to implement services for sepsis patients at three and six hours post diagnosis. The goal is to increase optimal adherence to sepsis bundled care by 5%, reduce the burden of chronic morbidity from sepsis-associated chronic organ dysfunction, and achieve a 5% rate reduction in sepsis patients requiring long term care.

Federal Regulations

Long-Term Care Facilities
A rewrite of Medicare rules for long-term care facilities proposed in 2014 and taking effect in 2017 includes provisions for the use of SDM. Under the “Plan of Care” rule rewrite, all home health services must follow an individualized written plan of care. The standard requires that “each patient’s home health services be furnished under a written, patient-specific plan of care that would identify patient-specific measurable outcomes and goals selected jointly by the Home Health Agency and the patient.”

SAMHSA Certification of Behavioral Health Integration Efforts
The Substance Abuse and Mental Health Services Administration (SAMHSA) uses SDM as one of the standards to certify a patient-centered medical home (PCMH) for behavioral health integration. Use of shared decision making accounts for five points, out of a possible 100, towards PCMH certification.

Physician Quality Reporting System Measures – Hepatitis C
Shared decision making is included in the 2015 Medicare Part B Physician Quality Reporting System (PQRS) measures. The PQRS is a quality reporting program that encourages practices to report information on the quality of care to Medicare, and allow practices to assess the quality of care provided. Starting in 2015, practices that fail to report PQRS data will have a negative payment adjustment. The PQRS has tables for individual procedures to evaluate physicians, and one of the tables evaluates providers on the percentage of patients aged 18 years and older with a Hepatitis C diagnosis who review the range of treatment options with their provider. Physicians document the shared decision making in the patient record as follows: “treatment choice appropriate to genotype, risks and benefits, evidence of effectiveness, and patient preferences toward treatment” were discussed.

Physician Quality Reporting System Measures – Total Knee Replacement
The PQRS Total Knee Replacement Measures for 2015 table includes a question on shared decision making. The question pertains to a patient and provider discussion of a trial of non-surgical therapy prior to the procedure.

Medicare Regulations – Lung Cancer Screening
In 2015, CMS issued a Decision Memo to include lung cancer screening counseling and related SDM as a preventive service benefit. These benefits are only available if patients and providers meet specific criteria, such as the use of one or more decision aids that include information on the benefits and harms of screening, follow up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure. The memo did not specify a required provider type or tool.

Future Regulations

Future Medicare Regulations – Lower Extremity Joint Replacement
CMS is considering a measure to capture SDM discussions as a possible new outcome for future measures regarding elective total hip and/or knee arthoplasty.

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