News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
Feb. 4, 2005 — A Pro-Active Call Center Treatment Support (PACCTS) intervention can improve glycemic control in type 2 diabetes, according to the results of a randomized trial published in the February issue of Diabetes Care. A second article in the same issue established that this intervention, using trained nonmedical telephone operators supported by specially designed software and a diabetes nurse, was well received by the patients.
"Diabetes educator-led PACCTS for diabetes care is well established as a health care delivery vehicle in the US," write Robert J. Young, MD, from Hope Hospital in Salford, U.K., and colleagues. "It seems to offer service delivery characteristics that might enhance effectiveness, such as continuity, convenience, and risk-stratified intervention. However, it has not been subject to rigorous or large-scale clinical trial assessment of its effectiveness or efficiency."
Of 591 randomly selected individuals with type 2 diabetes in Salford, U.K., 197 individuals were randomized to the usual care (control) group and 394 to the PACCTS (intervention) group. Both groups received lifestyle advice and drug treatment according to local guidelines, but only PACCTS patients were telephoned according to a protocol in which the frequency of calls was proportional to the patients' last glycated hemoglobin (HbA1c) level. The primary outcome measure was absolute reduction in HbA1c level, and the secondary outcome was the proportion of patients in whom HbA1c level decreased by at least 1%.
The one-year study was completed by 332 patients (84%) in the PACCTS group and 176 patients (89%) in the control group, and final HbA1c values were available in 374 patients (95%) in the PACCTS group and 180 patients (92%) in the usual care group.
Compared with the usual care group, HbA1c level improved by 0.31% overall (95% confidence interval [CI], 0.11-0.52; P = .003) in the PACCTS group. However, for patients with baseline HbA1c level less than 7%, there was no change, and for patients with baseline HbA1c level of more than 7%, improvement increased to 0.49% (95% CI, 0.21-0.77; P < .001). The difference in the proportions of patients achieving at least a 1% reduction in HbA1c level was 10% overall (95% CI, 4-16; P < .001) and 15% (95% CI, 7-24; P < .001) for patients with baseline HbA1c level of more than 7%, favoring the PACCTS intervention.
"In an urban Caucasian trial population with blood glucose HbA1c > 7%, PACCTS facilitated significant improvement in glycemic control," the authors write. "Further research should extend the validity of findings to rural communities and other ethnic groups, as well as to smoking and lipid and blood pressure control."
GlaxoSmithKline funded the staff, data management, and analysis costs of this study. British Telecom acted as technology partners funding call center equipment, development, and maintenance costs. One of the authors was indirectly funded by GlaxoSmithKline.
An accompanying article by Andrew F. Long, MSc, MPhil, and colleagues from the PACCTS Team describes the results of a questionnaire survey designed to examine patients' views of the acceptability of and satisfaction with PACCTS.
Using the Diabetes Satisfaction and Treatment Questionnaire (DTSQ), the investigators determined satisfaction with care in all 591 patients at baseline and at the end of the study. In addition, 394 intervention patients received an acceptability questionnaire after at least three proactive calls from the call center and at the end of the trial, and a sample of 25 patients participated in in-depth, semistructured interviews.
Response rates were 79% for the DTSQ and 65% for the acceptability questionnaire. Individuals receiving the PACCTS intervention continued to report high levels of satisfaction with their treatment (95% CI, 32.3-33.2 at one year), and more than 90% strongly agreed or agreed that the telecarer approach was acceptable.
Based on qualitative comments, the patients expressed satisfaction with having a personalized service; improved feelings of well-being, such as confidence and self-control; assistance with problem solving; and developing rapport and a strong bond with the telecarers.
"A personalized PACCTS approach is acceptable to patients," the authors conclude. "A service giving priority to the interpersonal dimension leads to increased commitment from patients to improve long-term glycemic control."
Study limitations include potential bias in the measurement of satisfaction; a possible "expectation" effect with behavior change arising from the expectation of a call and the monitoring of glucose control; differences between PACCTS and other telecare systems; and limited one-year follow-up.
"These results suggest that several processes can contribute to a successful patient-centered telephone-supported disease management, [including] listening to and focusing on the concerns of patients, individualized problem solving, and continuity of care over time," the authors conclude. "It may not be the information provision per se that is important (raising awareness and knowledge), but its provision in a context of enablement and support aimed at self-efficacy."
GlaxoSmithKline and British Telecom funded this study, and GlaxoSmithKline indirectly funded some of its authors.
Diabetes Care. 2005;28:278-289
Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to:
* Describe the PACCTS intervention for diabetes care.
* Evaluate the impact of PACCTS with usual care vs usual care only on diabetic outcomes at one year.
Clinical Context
The U.K. Prospective Diabetes Study demonstrated the effort required to obtain and maintain improved glucose control, and the importance of tight control in preventing long-term adverse outcomes of diabetes. Telephone diabetes education has been advocated and delivered by nurses and dieticians as part of a patient education strategy in chronic disease management. PACCTS was developed as a health care model in the U.S. and offers continuity, convenience, and access to patients as a risk-stratified intervention. However, according to the current authors, the strategy has not been tested for its efficacy in diabetes management in large, rigorous clinical trials.
The current authors conducted a randomized, open controlled trial to compare the outcomes of diabetes control at one year for an unselected group of patients with diabetes who were offered either usual care or usual care with PACCTS intervention modified for that community. The patients were from among 22 group practices in one U.K. community.
Study Highlights
* Patients were from an inner city, and 95% were white. More than 80% were in the lowest 2 socioeconomic strata. 22 practices with 591 patients agreed to participate.
* Exclusion criteria were diabetes duration less than one year, terminal illness, and inability to use the telephone.
* Patients were randomized to receive either usual care (n = 176, control) or usual care and PACCTS (n = 332, PACCTS) stratified by baseline HbA1c level (< 7, good; 7-9, moderate; and > 9%, poor).
* Usual care consisted of following the English National Guidelines for managing glucose control in type 2 diabetes, using a standard stepped-care protocol for patients, continuing medical education to primary care providers, and annual review. The guidelines are available at: http://www.NICE.org.UK.
* PACCTS was delivered by call center operators (telecarers) trained for 3 months by a diabetes specialist nurse with a focus on listening skills, motivational interviewing, and database methodology.
* The PACCTS application consisted of four main domains: knowledge, readiness to change (lifestyle intervention), medication adherence, and blood glucose control (self-testing and clinic follow-up reminders).
* Telecarers (working part-time) made calls once every 3 months if HbA1c level was 7% or less, every 7 weeks if HbA1c level was 7.1% to 9.0%, and monthly if HbA1c level was more than 9%. Each call lasted 20 minutes. If supplemental counseling was required, a referral was made to the specialist nurse.
* Primary outcome was HbA1c level at one year.
* Secondary outcome was proportion of patients reducing HbA1c level by at least 1% at one year.
* The study was powered at 90% to detect a reduction of 1% in HbA1c level in the PACCTS group at a significance level of 5%. Analysis was by intent-to-treat, using last observation carried forward for missing data.
* Mean age was 67 years, 58% were male, mean body mass index was 30.3 kg/m2, and mean duration of diabetes was 6 years. At baseline, a quarter of patients used lifestyle intervention only for control, 30% used one oral hypoglycemic agent (OHA), 25% used two OHAs, and 20% used insulin with or without OHA.
* There were more than 4,000 telephone consultations, with 90% outbound and 10% inbound.
* 10.7% of the control and 15.7% of the PACCTS group withdrew.
* Medication use in the control group increased overall, with no change in 91% and step-up in 9%.
* In the PACCTS group, medication decreased in 3%, did not change in 75%, and increased in 22%.
* Medication use increased more in the PACCTS than in the control group (P = .002).
* Mean HbA1c level improved by 0.3% in the PACCTS vs the control group (P < .003). The improvement was greater for patients with HbA1c level of 7% or more at 0.49% (P < .001), and there was no change in patients with baseline HbA1c level less than 7%.
* Significantly more patients in the PACCTS group had improvement of at least 1% in HbA1c level (overall 10%; P < .001). For patients with baseline HbA1c level of more than 7%, the proportion with improvement of at least 1% in HbA1c level was 15% (P < .001).
* The results were independent of age, sex, or practice (group vs single handed).
* In a separate article, patient surveys with 79% response rate for the PACCTS and 65% response rate for the control group indicated that PACCTS was well accepted by patients and offered increased feelings of well-being, confidence, and self-control.
Pearls for Practice
* The PACCTS intervention for diabetes management consists primarily of trained telecarer-initiated calls to patients focusing on the domains of knowledge, readiness to change (lifestyle intervention), medication adherence, and blood glucose control.
* Compared with usual care, patients with diabetes with a baseline HbA1c level of more than 7% who were offered PACCTS for one year had improved HbA1c control, with a higher proportion showing improvement of at least 1%.