SummaryAs part of the Indiana Cancer Pain and Depression (more commonly known as INCPAD) trial, 16 rural and urban oncology practices provided telephone-based care management and automated symptom monitoring to cancer patients suffering from pain and/or depression. A nurse care manager regularly called patients over a 3-month period to assess symptom response and medication adherence and provide pain- and depression-specific education. Throughout the year-long study, patients also responded to interactive voice-recorded telephone calls or Web-based surveys designed to gauge ongoing symptoms. With support from a specialist, the nurse care manager monitored the results, proactively called patients as needed, and contacted the patient's oncologist to make treatment recommendations as appropriate. The program significantly reduced the severity of both pain and depression, leading to improved quality of life in specific areas and to high levels of patient satisfaction.Strong: The evidence consists of a randomized controlled trial (RCT) comparing key metrics in program participants with those in a similar group of patients receiving usual care. Metrics include various measures of pain and depression severity, pain- and depression-related outcomes, quality-of-life indicators, and inpatient, outpatient, and emergency department (ED) utilization.
Developing OrganizationsIndiana University School of Medicine; Regenstrief Institute, Inc.
Date First Implemented2006
The INCPAD randomized controlled trial ran from March 2006 through August 2008.
Patient PopulationThe program serves cancer patients with at least moderately severe depression or moderately severe, persistent pain related to the cancer.
Problem AddressedCancer patients frequently suffer from—but often fail to receive treatment for—pain and depression, thus reducing quality of life and the ability to function.
- A common problem, leading to various symptoms and disabilities: Pain and depression are the most common physical and psychological symptoms associated with cancer, and they frequently lead to a variety of disabilities that have a negative impact on functionality and quality of life.1
- Often undiagnosed and untreated: Providers, including oncology specialists, often fail to diagnose and treat cancer-related pain and depression.1
Description of the Innovative ActivityAs part of the Indiana Cancer Pain and Depression (INCPAD) trial, 16 rural and urban oncology practices provided telephone-based care management and automated symptom monitoring to cancer patients suffering from pain and/or depression. A nurse care manager regularly called patients over a 3-month period to assess symptom response and medication adherence and provide pain- and depression-specific education. Throughout the year-long study, patients also responded to interactive voice-recorded telephone calls or Web-based surveys designed to gauge ongoing symptoms. With support from a specialist, the nurse care manager monitored the results of these calls and surveys, proactively called patients as needed, and contacted the patient's oncologist to make treatment recommendations as appropriate. Key elements include the following:
- Identifying eligible patients: Oncology clinic staff briefly screened patients during regular visits for depression and pain. Those who screened positive were referred to a central site, which then contacted the patient to conduct a more formal eligibility interview. Eligible patients with depression included those with a score of 10 or higher on the Patient Health Questionnaire 9-item depression scale (PHQ-9) who acknowledged having either depressed mood and/or anhedonia (a loss of interest or pleasure). Eligible patients with pain included those with a score of 6 or higher on the "worst pain in the past week" item on the Brief Pain Inventory (BPI) who had suffered this level of pain consistently despite trying at least one pain medication. The initial RCT excluded individuals who did not speak English; those with moderately severe cognitive impairment, schizophrenia, or other psychosis; those with a pending pain-related disability claim; and those pregnant or in hospice care.
- Telephone-based care management: A trained nurse care manager periodically telephoned patients to assess symptom response and medication adherence, provide pain- and depression-specific education, and make referrals as appropriate. During the first 3 months, regularly scheduled calls occurred at enrollment, 1 week later, and after 4 and 12 weeks. The initial call emphasized the importance of adhering to the prescribed treatment, while subsequent calls focused on assessing whether patients had improved and/or moved into a maintenance phase. Additional calls occurred whenever the automated symptom monitoring system so indicated (see below for more details); common triggers included inadequate symptom improvement, nonadherence to prescribed medications, adverse effects, suicidal ideation, or a patient request to be contacted. During the initial study, the average patient received 11.2 telephone contacts over a 12-month period, with the typical call lasting roughly 15 minutes. In addition, 11 of 154 patients with depression received a mental health referral, while 12 of 137 with pain received a pain-specific referral.1
- Automated symptom monitoring: Throughout the year-long study, the nurse care manager monitored patient responses to either interactive, voice-recorded telephone calls or Web-based surveys (with patients being free to choose their preferred method). Through these vehicles, patients answered a 21-item survey that includes the PHQ-9 depression scale, 8 items from the BPI (3 on pain severity and 5 on the degree to which pain interferes with life), and a single question on medication adherence, adverse effects, global improvement, and whether the patient would like the nurse care manager to call. Patients completed the survey twice a week during the first 3 weeks, weekly for the next 8 weeks, twice a month during months 3 to 6, and monthly during months 7 through 12. During the RCT, the typical participant had 20.5 contacts with the automated system.1 The nurse care manager proactively contacted any patient who did not complete his or her regularly scheduled survey.
- Weekly consultations with specialist: Each week, the nurse care manager met with a physician specialist with expertise in both pain and psychiatry to review and solicit advice on select cases. During these roughly 2-hour sessions, the care manager typically reviewed 10 to 12 patients with the specialist, including all new patients (usually 2 or 3 each week) and existing patients who had not progressed as planned. These sessions focused on developing a treatment and/or action plan to be recommended to the oncologist (see next bullet). Recommendations were based on existing algorithms and guidelines, with the antidepressant algorithm having been informed by several clinical trials and the analgesic algorithm having been adapted from the National Comprehensive Cancer Network Cancer Pain Guidelines (with simplifications based on other guidelines). Outside of these weekly meetings, the care manager had as-needed access to the specialist by telephone (although such contact seldom was necessary).
- Medication management recommendations for oncologist: As deemed necessary in the weekly meetings with the specialist, the nurse care manager contacted the patient's oncologist to provide treatment recommendations (typically related to medications). For those with depression, the recommendations were designed to achieve at least a 50 percent decline in the PHQ-9 score from baseline. For those with pain, the goal was at least a 30 percent decline in the BPI pain score, ideally to a score of 3 or below. For those with both pain and depression, treatment recommendations focused initially on the pain (unless the depression was quite severe, with a PHQ-9 score of 15 or above).
References/Related ArticlesKroenke K, Theobald D, Wu Jingwei, et al. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010;304(2):163-71. [PubMed]
Contact the InnovatorKurt Kroenke, MD
Professor of Medicine, Indiana University
Research Scientist, VA HSR&D Center for Implementing Evidence-Based Practice
Regenstrief Institute, 5th Floor
1050 Wishard Blvd.
Indianapolis, IN 46202
Phone: (317) 630-7447
Innovator DisclosuresDr. Kroenke has not indicated whether he has financial interests or business/professional affiliations relevant to the work described in this profile; however, information on funders is available in the Funding Sources section.
ResultsThe program significantly reduced the severity of both pain and depression, leading to improved quality of life in specific areas and to high levels of patient satisfaction.
Strong: The evidence consists of a randomized controlled trial (RCT) comparing key metrics in program participants with those in a similar group of patients receiving usual care. Metrics include various measures of pain and depression severity, pain- and depression-related outcomes, quality-of-life indicators, and inpatient, outpatient, and emergency department (ED) utilization.
- Less severe pain, improved pain-related outcomes: Pain severity levels, as measured by the BPI, improved significantly more in program participants than in a control group of similar patients receiving usual care. Among 137 participants with moderate to severe persistent pain at baseline, the average pain severity score fell from 5.23 to 3.62 after 12 months, a significantly larger decline than that experienced by the 137 patients in the control group (whose average score fell from 5.2 to 4.33). Participants also experienced larger improvements in other pain-related outcomes, including the degree of interference caused by pain and bodily pain scores as measured on the 36-item Short Form Health Survey (or SF-36). An analysis of the percentage of patients achieving the stated goal of a 30 percent or greater decline in BPI score found similar results.1
- Less severe depression: Depression severity, as measured by the Hopkins Symptoms Checklist 20-item depression scale (or HSCL-20), fell significantly more among program participants than among those in the control group. Mean scores among the 154 participants with moderately severe depression fell from 1.64 at baseline to 1.06 after 12 months, a much greater decline than that experienced by the 155 similar patients receiving usual care (whose average score fell from 1.64 to 1.32). In addition, the percentage of program participants meeting the criteria for a major depressive disorder fell from 61 percent at baseline to 21 percent after 12 months, a larger decline than among those in the usual care group (62 to 35 percent). An analysis of the percentage of patients achieving the stated goal of a 50 percent or greater decline in PHQ-9 score found similar results.1
- Improved quality of life in specific areas: Program participants experienced better outcomes on several health-related quality-of-life metrics than did those in the usual care group, including measures of mental health, vitality, anxiety, and physical symptom burden. Participants also experienced greater improvement on the Sheehan Disability Scale. However, self-reported disability days, physical health, and overall quality of life did not differ significantly among the two groups.1
- High satisfaction: Patients reported high levels of satisfaction with the program. In particular, they expressed appreciation for the opportunity to voice their concerns to the care manager (because busy physicians tend not to have time to discuss issues related to pain and depression) and for the peace of mind the program provided by having someone monitor them on an ongoing basis. They also spoke positively about the opportunity to report their symptoms at any time of day, and about the program's ability to address problems (e.g., poor pain management) without the need for an in-person visit. An upcoming study will provide more information on patient satisfaction with the program.
- Trend toward less utilization: Program participants used less health care resources than did those in the control group, including fewer hospital days (a mean of 3.6 vs. 5.8) and ED visits (1 vs. 1.4). These differences, however, were not statistically significant.1 An upcoming study will evaluate the program's impact on overall health care costs.
Context of the InnovationThe Regenstrief Institute is a private, nonprofit research institute affiliated with the Indiana University School of Medicine and the Health and Hospital Corporation of Marion County, IN. Regenstrief developed the INCPAD program in collaboration with 16 oncology practices, including 10 clinics operated by Community Cancer Care (a network serving rural and midsized communities throughout the state), 4 large hospital-affiliated clinics in Indianapolis, 1 public hospital-affiliated clinic providing care to underserved patients, and 1 clinic affiliated with a Veterans Affairs hospital. The program developed out of existing research conducted by Community Cancer Care in the area of symptom monitoring and management and palliative care. In response to a request for applications by the National Cancer Institute (part of the National Institutes of Health or NIH), Regenstrief and Community Cancer Care researchers approached other partner organizations about applying for grant funding to test a program specifically focused on two of the most common symptoms affecting cancer patients—pain and depression.
Planning and Development ProcessKey steps in the planning and development process included the following:
- Recruiting participating practices: The two principal investigators—one at Regenstrief and one at Community Cancer Care—approached the various partners to secure their willingness to participate. Each investigator focused on recruiting partners at practices where they had personal connections with organizational leaders. To maximize uptake, the investigators purposely designed the program to minimize the burden on participating practices, with the vast majority of program activities—including upfront screening, care management, and symptom monitoring—taking place outside the practice setting.
- Adapting guidelines: The two coinvestigators (both of whom have expertise in symptom management and in pain and depression) worked together to customize existing guidelines to the project's needs. For depression, this task was fairly straightforward, with the researchers relying on previous studies and an existing algorithm. For pain, the work involved adapting and refining several existing guidelines so as to provide more clear guidance on when to move from one class of pain medications to another (e.g., from basic analgesics to stronger medications).
- Creating automated monitoring system: The co–principal investigator had previously collaborated with a company (Interactive Performance Technology) with substantial experience in creating technology-based systems for physician practices, including automated symptom monitoring. This company also had previous experience working as part of NIH-funded projects.
- Training care manager: The care manager received roughly 8 to 12 hours of basic training on the algorithms and the automated symptom monitoring system. Most training occurred "on the job" during the weekly 2-hour meetings with the specialist (described earlier).
- Planning to refine and expand program: The program ended due to a lack of ongoing funding. The principal investigators hope to relaunch an expanded version of the program in future grant-funded trials, with a focus on a broader array of cancer-related symptoms, including fatigue, anxiety, insomnia, and nausea. They believe this comprehensive approach to cancer symptom management will have more value to real-world oncology practices, in which patients experience a wide array of symptoms beyond pain and depression. The investigators also hope to secure funding to test the potential benefits of a similar program that integrates behavioral health management with symptom/medication management.
Resources Used and Skills Needed
- Staffing: During the initial study, 1 full-time care manager handled approximately 60 patients at a time. However, in a real-world practice setting, a full-time care manager could likely handle more patients, with the difference being attributed to research-related work that would not be necessary in everyday practice and the potential to terminate symptom monitoring once the patient has improved. (The study design required 12 months of monitoring even if the patient's symptoms had resolved.) A registered nurse or nurse practitioner, ideally with experience in oncology and/or palliative care, can serve as a care manager. The program also requires a physician specialist for no more than one half day per week; ideally this physician should have experience or an interest in supportive and palliative care programs for cancer patients. Although the RCT used a psychiatrist in this role, an internist or family practitioner could also serve in this capacity.
- Costs: Upfront costs include the development, purchase, or lease/licensing of the automated monitoring system. This cost could potentially be shared among participating sites. Ongoing operating costs consist primarily of the salary and benefits for the care manager and specialist physician.
Funding SourcesNational Cancer Institute
Tools and Other ResourcesThe antidepressant algorithm used in this program was informed by the multicenter Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial and the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) trial. More information on these trials can be found in the articles cited below:
The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (also known as NCCN Guidelines™), which informed the analgesic algorithm used in this program, are available at http://www.nccn.org/clinical.asp.
- Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905-17. [PubMed]
- Kroenke K, Bair M, Damush T, et al. Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study design and practical implications of an intervention for comorbid pain and depression. Gen Hosp Psychiatry. 2007;29(6):506-17. [PubMed]
More information on Interactive Performance Technology can be obtained by contacting Mr. Josh Coburn at:
Interactive Performance Technologies LLC (IPT)
119 Mount Auburn Street, Suite 400
Cambridge, MA 02138-4946
Getting Started with This Innovation
- Create system to minimize oncologist burden: Oncologists often respond favorably to the idea of someone else helping monitor and manage symptoms, thus allowing them to focus more on treatment of the cancer itself. Their support depends, however, on creating a system that minimizes the burden on their practices. To that end, the INCPAD program used offsite staff to determine initial eligibility (requiring that practices conduct only a very brief screen) and provide program services.
- Let oncologists remain responsible for treatment changes: Oncologists may not react favorably to the idea of an outsider—particularly one who has not physically evaluated the patient—implementing treatment changes. Consequently, program developers decided to have the care manager provide recommendations to the oncologist, who remained responsible for all treatment changes. Also, neither the nurse care manager nor the supervising physician specialist saw patients in person in INCPAD, making them uncomfortable directly prescribing medications such as antidepressants and opioid analgesics. However, in clinical settings where the care management team has an initial in-person visit with the patient, the team might also prescribe medications, thereby further assisting the oncology practice.
- Offer care management and symptom monitoring: Nurse care management and symptom monitoring are designed to work in tandem. Offering either alone may lead to suboptimal results. For example, Community Cancer Care conducted an earlier study evaluating just automated symptom management and feedback to patients, with no involvement by a care manager. Oncologists and patients became frustrated with this program, as patients had no avenue (other than the overburdened oncologist) to get their concerns addressed and questions answered. Similarly, offering care management in isolation creates a significant burden on the nurses (who must proactively collect information on symptoms over the phone) while reducing flexibility for patients (who have no way to report symptoms during nonwork hours).
- Consider joining forces with other practices: A small oncology practice likely lacks the financial resources to launch and sustain this program on its own. However, they may be able to participate by sharing the upfront and ongoing operating expenses with a larger group of partners, such as a community-based cancer network or local cancer hospitals.
Sustaining This Innovation
- Approach payers about potential reimbursement: Third-party payers may be willing to provide reimbursement for program services once they understand its benefits, including enhanced quality and the potential to reduce inpatient admissions and ED visits. (As noted, data on the cost impact of the program are forthcoming.)
Use By Other Organizations
- At Michigan State University, the Given Institute (founded by William Given, PhD) has conducted several trials of a similar program serving cancer patients undergoing chemotherapy, with a focus on behavioral self-management rather than medication management.
Kroenke K, Theobald D, Wu Jingwei, et al. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010;304(2):163-71. [PubMed]
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Service Delivery Innovation Profile
Original publication: January 19, 2011.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: January 30, 2013.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.
Date verified by innovator: January 21, 2013.
Date verified by innovator indicates the most recent date the innovator provided feedback during the annual review process. The innovator is invited to review, update, and verify the profile annually.