Evaluating the Efficacy of a Bundled Chronic Condition Management Program

A chronic disease management company presents promising preliminary results from their remote intensive behavioral counseling intervention, aimed at addressing type 2 diabetes.
Published Online: December 16, 2016
Sean Bowman, MPH; Mazi Rasulnia, PhD, MBA, MPH; Dhiren Patel, PharmD, CDE, BC-ADM, BCACP; David Masom, BSc; Margaret Belshé, BA; and William Wright, MBA, MPH
ABSTRACT

Objectives: Chronic disease management solutions have been difficult to implement at scale and in real-world clinical settings. We report on the preliminary results of an intervention designed to address these issues.

Study Design: We performed a prospective analysis on data collected during the early trials of our intervention to assess its effectiveness and feasibility.

Methods: We partnered with 2 physicians to recruit adults with diabetes or prediabetes.  A health advisor from our team engaged each participant for 12 weeks with print information and individually tailored telephonic and text message–based counseling according to the participant’s preference(s). The primary measure recorded was glycated hemoglobin (A1C), in addition to several secondary clinical and behavioral measures and participant satisfaction. All measures, except participant satisfaction, were recorded at baseline and 12 weeks, and changes were measured with non–variance-assuming t tests.

Results: We recruited 167 participants and received participant-reported data from 122 (73%). For A1C, we recorded data for 56 participants (34%); of these, we saw a mean decrease in A1C of 0.91% (95% confidence interval [CI], 0.44%-1.38%; P = .0053). For participants with diabetes, the decrease in A1C was 1.53% (95% CI, 0.77%-2.28%; P = .0009), and for participants with prediabetes, we saw no progression toward diabetes (P = .2282). We saw significant improvements in most secondary measures (for most, P <.0001) and favorable participant feedback (mean satisfaction rating = 2.97 of 3 [95% CI, 2.91-3.00]).

Conclusions: This management model shows some promise in improving disease management in a scalable manner.

The American Journal of Accountable Care. 2016;4(4):16-20
Chronic disease in the 21st century United States has increased in prevalence for the past 15 years, and its management and treatment now consume the majority of healthcare spending.1-3 Intensive behavioral counseling is one strategy that has been deemed both necessary and cost-effective in the effort to combat this trend. Per the guidelines of the US Preventive Services Task Force and the Affordable Care Act, intensive behavioral counseling can be covered as a preventive measure against cardiovascular disease for obese or otherwise at-risk individuals.4,5 Although cost-effectiveness estimates vary widely, they are all well within the commonly accepted intervention threshold of $50,000 per quality-adjusted life-year added—below which, an intervention is considered to be worth the cost.6,7

However, several issues threaten its scalability and efficacy. One, is availability of time on the part of physicians and patients. Team-based coordination has been suggested as a solution to increase the time available to physicians, but only the most qualified clinicians (ie medical doctors, physician assistants, certified registered nurse practitioners, certified clinical nurse specialists) can be reimbursed for counseling; furthermore, patient time constraints remain a barrier even when clinician time constraints are accounted for.8-12 Telephonic counseling has also been suggested as an option, but recent results have not shown promise.13

To address this issue, we set out to develop, implement, and test an innovative remote intensive counseling intervention for type 2 diabetes (T2D) as a model for other chronic disease management interventions. Utilizing “processes of change” from the Transtheoretical model and motivational interviewing techniques, we delivered a multi-channel (mail, phone, text, and/or e-mail), 12-week intensive behavioral counseling intervention to individuals with diagnoses of diabetes or prediabetes. The aim was 4-fold: 1) deliver the intervention to the participant in a comfortable environment and timeframe to improve participant engagement, 2) act as an extension of the patient’s primary care provider to provide a coordinated care intervention (not an intervention delivered in parallel), 3) deliver an intervention that produces lasting results in value-based outcomes, and 4) deliver an intervention that is scalable to a large patient-per-advisor ratio.

Here, we present our preliminary results and implications to those attempting similar interventions or to those searching for novel management interventions.

METHODS

Study Design

Our design was prospective and followed a cohort receiving the intervention over 12 weeks. We had 3 main hypotheses: 1) participants would engage and find the experience favorable due to their ability to select the time and method of engagement; 2) clinicians would find the experience favorable due to our ease of enrollment, maintenance of contact with them, and our contributions to their patients’ value-based outcomes; and 3) it would produce significant positive results in clinical and behavioral measures of diabetes management.

Setting, Participants, Enrollment

Participants receiving the intervention were being served by 2 Alabama primary care physicians—one in an urban center and the other in a rural area—so as to test the intervention independent of geography. The physicians served as the enrollers and recruiters, and eligibility criteria for participants were as follows: 1) the clinician felt that the participant would benefit from intensive behavioral counseling for diabetes management or prevention; 2) the participant felt that he or she would benefit from intensive behavioral counseling for diabetes management or prevention; 3) the participant’s last glycated hemoglobin (A1C) measurement was at, or above, 5.7; and 4) the participant was aged at least 18 years. The principle of participant opt-in was paramount, as we hypothesized that individuals who wanted intensive behavioral counseling would benefit more than those who simply followed the advice of their clinicians. All identifying information was stored in a HIPAA-secured database. Enrollment for this sample began on June 16, 2014, and ended June 17, 2015, with the last postintervention assessment occurring on September 29, 2015. In all, 167 individuals were identified and consented to participate in the intervention.

Intervention

The duration of the intervention was 12 weeks. Every participant was given standard print information and management-assisting tools in addition to being assigned to a personal health advisor, who was in weekly communication with the participant to provide support, motivation, additional education, and accountability.

The provided print material and tools were as follows: 1) 2 informational booklets—1 on diabetes self-management and 1 on healthy eating principles; 2) 1 interactive booklet encouraging participants to contemplate their goals, external facilitators, and external barriers; 3) booklets in which individuals were asked to track medication adherence, diet, and physical activity for personal and clinician viewing; 4) a blood glucose logbook; 5) a pedometer; 6) an informational card (to be carried in a purse or wallet) on suggested procedures for others to follow in the event of hypoglycemia; 7) a refrigerator magnet reinforcing healthy eating principles discussed throughout the program; and 8) 1-page informational cards, termed “mailers,” focusing on individual topics of diabetes management, sent once every 1 to 2 weeks depending on the depth of the topic.

The health advisor engagement procedure was as follows. First, the participant would be engaged through mail and phone, and could choose text message and/or e-mail based on availability and preference. The participant would receive telephone sessions once per week, at a time chosen by the participant, to discuss the topic of the week, in addition to the information they had already received. The health advisor would use motivational interviewing techniques to discover participant barriers and foster the participant’s creation of solutions that worked for them.14 Various processes of change from the Transtheoretical model would be taught and/or suggested as strategies to overcome barriers and achieve health behaviors, as needed.15

One small goal for the upcoming week would be decided by the participant at the end of each session. In order to assist participants in staying on track, 3 text messages would be sent to the participant per week; all of which would be based on standard aspects of the week’s topic or on personal matters discussed with the health advisor in the previous counseling session. The aim was usually to encourage, remind, or hold the participant accountable to their goal for the week and in the long term. Alternatively, if the participant chose e-mail but not text message as their preferred method of communication, 2 to 3 e-mails would be sent each week to accomplish the same purpose as the text messages. Any inbound communication (eg, an additional question outside of the scheduled interactions) from the participant to their health advisor was received and responded to. For matters potentially of clinical concern, the participant was encouraged to contact their enrolling clinician, and the health advisor followed up on the matter the following week.

Measures

All primary and secondary measures were recorded via participant report at baseline and again at the 12-week program completion date. The primary measure used to assess the efficacy of the intervention was A1C, measured in percent glycation.

Secondary measures were based on individual aspects of diabetes management, which were covered throughout the intervention. We were interested in testing whether comprehensive education and counseling on diabetes management made a clinically relevant difference, as well as whether counseling on individual management behaviors changed those behaviors. There were 12 secondary measures, with the first 2 being: 1) body mass index (BMI) and 2) knowledge regarding diabetes management. Knowledge was identified by our team in 4 key components of diabetes understanding: that diabetes involves higher than normal blood sugar, that diabetes is a chronic condition, the causes of elevated blood sugar, and the potential complications if left unmanaged. Participants were asked to describe their understanding of diabetes at baseline and 12 weeks, and whether a participant accurately understood all 4 concepts was measured binarily.

Other secondary measures included: 3) health self-efficacy, which was measured—for participant convenience—by 1 item, which read thus: “On a scale of 1-5, with 5 being the highest, how confident are you in your ability to improve your health?” We measured binarily whether a participant rated their confidence as 5; 4) skipped doses of medication per week (number); 5) if a participant skipped any number of doses of medication per week (binary: 0 times per week or ≥1 time per week); 6) if a participant was engaging in moderate to vigorous physical activity 2 or more times per week; 7) if a participant was eating at least 7 healthy meals per week, defined as half nonstarchy vegetables, a quarter starchy vegetables and/or grains, a quarter protein, an optional small portion of fruit, and an unsweetened beverage; 8) whether a participant had received at least 1 formal eye exam in the past 12 months; 9) whether a participant had received at least 1 formal foot exam in the past 12 months; and 10) the number of emergency department (ED) visits a participant had in the past 3 months.

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