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Study Overview
Objective. To evaluate the effectiveness of a collaborative telecare intervention on chronic pain management.
Design. Randomized clinical trial.
Settings and participants. Participants were recruited over a 2-year period from 5 primary care clinics within a single Veterans Affairs medical center. Patients aged 18 to 65 years were eligible if they had chronic (≥ 3 months) musculoskeletal pain of at least moderate intensity (Brief Pain Inventory [BPI] score ≥ 5). Patients were excluded if they had a pending disability claim or a diagnosis of bipolar disorder, schizophrenia, moderately severe cognitive impairment, active suicidal ideation, current illicit drug use or a terminal illness or received primary care outside of the VA. Participants were randomized to either the telephone-delivered collaborative care management intervention group or usual care. Usual care was defined as continuing to receive care from their primary care provider for management of chronic, musculoskeletal pain.
Intervention. The telecare intervention comprised automated symptom monitoring (ASM) and optimized analgesic management through an algorithm-guided stepped care approach delivered by a nurse case manager. ASM was delivered either by an interactive voice-recorded telephone call (51%) or by internet (49%), set according to patient preference. Intervention calls occurred at 1 and 3 months. Additional contact with participants from the intervention group was generated in response to ASM trend reports.
Main outcome measures. The primary outcome was the BPI total score. The BPI scale ranges from 0 to 10, with higher scores indicating worsening pain. A 1-point change is considered clinically important. Secondary pain outcomes included BPI interference and severity, global pain improvement, treatment satisfaction, and use of opioids and other analgesics. Patients were interviewed at 1, 3, 6, and 12 months.
Main results. A total of 250 participants were enrolled, 124 assigned to the intervention group and 126 assigned to usual care. The mean (SD) baseline BPI scores were 5.31 (1.81) for the intervention group and 5.12 (1.80) for usual care. Compared with usual care, the intervention group had a 1.02-point lower BPI score at 12 months (95% confidence interval [CI], −1.58 to −0.47) (P < 0.001). Patients in the intervention group were nearly twice as likely to report at least a 30% improvement in their pain score by 12 months (51.7% vs. 27.1%; relative risk [RR], 1.9 [95% CI, 1.4 to 2.7]), with a number needed to treat of 4.1 (95% CI, 3.0 to 6.4) for a 30% improvement.
Patients in the intervention group were more likely to rate as good to excellent the medication prescribed for their pain (73.9% vs 50.9%; RR, 1.5 [95% CI, 1.2 to 1.8]). Patients in the usual care group were more likely to experience worsening of pain by 6 months compared with the intervention group. A greater number of analgesics were prescribed to patients in the intervention group; however, opioid use between groups did not differ at baseline or at any point during the trial period. For the secondary outcomes, the intervention group reported greater improvement in depression compared with the usual care group, and this difference was statistically significant (P < 0.001). They also reported fewer days of disability (P = 0.34).
Conclusion. Telecare collaborative management was more effective in improving chronic pain outcomes than usual care. This was accomplished through the optimization of non-opioid analgesic therapy facilitated by a stepped care algorithm and automated symptom monitoring.
Commentary
Chronic pain affects up to 116 million American adults and is recognized as an emerging public health problem that costs the United States a half trillion dollars annually, with disability and hospitalization as the largest burdens [1].The physical and psychological complexities of chronic pain require comprehensive individualized care from interdisciplinary teams who will facilitate prevention, treatment, and routine assessment in chronic pain sufferers [2]. However, enhancing pain management in primary care requires overcoming the high costs and considerable time needed to continually support patients in pain. Telecare represents an improved means by which doctors and nurses can provide primary care services to patients in need of comprehensive pain management. However, the effectiveness of interventions delivered to patients suffering from chronic pain, via telecare, is largely unknown.
This study had several strengths, including a distinct and well-defined intervention, population, comparator, and outcome. The inclusion criteria were broad enough to account for various age-groups, and therefore various pain experiences, yet excluded patients with characteristics likely to confound pain outcomes, such as severe mental health disorders. Participants were randomized in blinded fashion to 1 of 2 clearly defined groups. The stepped algorithm used in the study, SCOPE [3], is a validated and reliable method for assessing chronic pain outcomes. The statistical analyses were appropriate and included analyses of variance to detect between-group differences for continuous variables. The rate of follow-up was excellent, with 95% of participants providing measurable outcome assessments at 12 months. The scientific background and rationale for this study were explicit and relevant to current advances in medicine.
The study is not without limitations, however. It is unclear whether the 2 trial groups were treated equally. Data received through ASM from the intervention group prompted physicians to adjust a patient’s medication regimen, essentially providing caregivers updates on a patient’s status. This occurred in addition to the 4 monthly interviews that both groups received per protocol. The study did not elucidate exactly what care was provided to the usual care group and, therefore, does not allow for the disaggregation of the relative effects of optimizing analgesics and continuous provider monitoring. It is difficult to distinguish if additional care or the intervention was more effective in managing pain than usual care. Another limitation, noted by the authors, is the study’s use of a single VA medical center. Demographics reveal a skewed population, 83% male and 77% white, limiting the trial’s generalizability. Most clinical outcomes were considered, though cost-effectiveness of the intervention was not analyzed. As the VA is a cost-sensitive environment, it is important that interventions assessed are not more costly than usual care. Further cost analysis beyond health resource utilization reported in the study would provide a nuanced assessment of telecare’s feasibility as a replacement for usual primary care. Statistically, the study shows significant improvements in chronic pain in those who received the intervention via telecare, therefore, cost analysis is indeed warranted.
Applications for Clinical Practice
This study illuminates the need for a more intensive pain management program that allows for continuous monitoring. Though the intervention was successfully delivered via telecare, further research is needed to assess whether other programs would be as effective when delivered through telecare, and more importantly, to investigate what characteristics of interventions make telecare successful. Telecare has the potential to improve outcomes, reduce costs, and reduce strains on understaffed facilities, though it is still unknown which conditions would gain from this innovation. This study shows that chronic disease, a predominately self-managed condition, would benefit from a more accessible management program [4]. This, however, may not be the case for other health issues, which require continual testing and equipment usage, such as infectious diseases. Further studies should focus on populations that command a patient-centered intervention delivered using a potentially low-cost tool, like the telephone or internet. Finally, a significant cost driver with chronic pain is disability, and though change in disability days was not statistically significant in this trial, patients in the intervention group self-reported a decrease in disability days, where as patients in the usual care group self-reported an increase. A clinical improvement in pain management has the potential to shave millions of dollars from the U.S. economy, this hypothesis deserves further investigation.
—Sara Tierce-Hazard, BA, and Tina Sadarangani, MSN, ANP-BC, GNP-BC
Study Overview
Objective. To evaluate the effectiveness of a collaborative telecare intervention on chronic pain management.
Design. Randomized clinical trial.
Settings and participants. Participants were recruited over a 2-year period from 5 primary care clinics within a single Veterans Affairs medical center. Patients aged 18 to 65 years were eligible if they had chronic (≥ 3 months) musculoskeletal pain of at least moderate intensity (Brief Pain Inventory [BPI] score ≥ 5). Patients were excluded if they had a pending disability claim or a diagnosis of bipolar disorder, schizophrenia, moderately severe cognitive impairment, active suicidal ideation, current illicit drug use or a terminal illness or received primary care outside of the VA. Participants were randomized to either the telephone-delivered collaborative care management intervention group or usual care. Usual care was defined as continuing to receive care from their primary care provider for management of chronic, musculoskeletal pain.
Intervention. The telecare intervention comprised automated symptom monitoring (ASM) and optimized analgesic management through an algorithm-guided stepped care approach delivered by a nurse case manager. ASM was delivered either by an interactive voice-recorded telephone call (51%) or by internet (49%), set according to patient preference. Intervention calls occurred at 1 and 3 months. Additional contact with participants from the intervention group was generated in response to ASM trend reports.
Main outcome measures. The primary outcome was the BPI total score. The BPI scale ranges from 0 to 10, with higher scores indicating worsening pain. A 1-point change is considered clinically important. Secondary pain outcomes included BPI interference and severity, global pain improvement, treatment satisfaction, and use of opioids and other analgesics. Patients were interviewed at 1, 3, 6, and 12 months.
Main results. A total of 250 participants were enrolled, 124 assigned to the intervention group and 126 assigned to usual care. The mean (SD) baseline BPI scores were 5.31 (1.81) for the intervention group and 5.12 (1.80) for usual care. Compared with usual care, the intervention group had a 1.02-point lower BPI score at 12 months (95% confidence interval [CI], −1.58 to −0.47) (P < 0.001). Patients in the intervention group were nearly twice as likely to report at least a 30% improvement in their pain score by 12 months (51.7% vs. 27.1%; relative risk [RR], 1.9 [95% CI, 1.4 to 2.7]), with a number needed to treat of 4.1 (95% CI, 3.0 to 6.4) for a 30% improvement.
Patients in the intervention group were more likely to rate as good to excellent the medication prescribed for their pain (73.9% vs 50.9%; RR, 1.5 [95% CI, 1.2 to 1.8]). Patients in the usual care group were more likely to experience worsening of pain by 6 months compared with the intervention group. A greater number of analgesics were prescribed to patients in the intervention group; however, opioid use between groups did not differ at baseline or at any point during the trial period. For the secondary outcomes, the intervention group reported greater improvement in depression compared with the usual care group, and this difference was statistically significant (P < 0.001). They also reported fewer days of disability (P = 0.34).
Conclusion. Telecare collaborative management was more effective in improving chronic pain outcomes than usual care. This was accomplished through the optimization of non-opioid analgesic therapy facilitated by a stepped care algorithm and automated symptom monitoring.
Commentary
Chronic pain affects up to 116 million American adults and is recognized as an emerging public health problem that costs the United States a half trillion dollars annually, with disability and hospitalization as the largest burdens [1].The physical and psychological complexities of chronic pain require comprehensive individualized care from interdisciplinary teams who will facilitate prevention, treatment, and routine assessment in chronic pain sufferers [2]. However, enhancing pain management in primary care requires overcoming the high costs and considerable time needed to continually support patients in pain. Telecare represents an improved means by which doctors and nurses can provide primary care services to patients in need of comprehensive pain management. However, the effectiveness of interventions delivered to patients suffering from chronic pain, via telecare, is largely unknown.
This study had several strengths, including a distinct and well-defined intervention, population, comparator, and outcome. The inclusion criteria were broad enough to account for various age-groups, and therefore various pain experiences, yet excluded patients with characteristics likely to confound pain outcomes, such as severe mental health disorders. Participants were randomized in blinded fashion to 1 of 2 clearly defined groups. The stepped algorithm used in the study, SCOPE [3], is a validated and reliable method for assessing chronic pain outcomes. The statistical analyses were appropriate and included analyses of variance to detect between-group differences for continuous variables. The rate of follow-up was excellent, with 95% of participants providing measurable outcome assessments at 12 months. The scientific background and rationale for this study were explicit and relevant to current advances in medicine.
The study is not without limitations, however. It is unclear whether the 2 trial groups were treated equally. Data received through ASM from the intervention group prompted physicians to adjust a patient’s medication regimen, essentially providing caregivers updates on a patient’s status. This occurred in addition to the 4 monthly interviews that both groups received per protocol. The study did not elucidate exactly what care was provided to the usual care group and, therefore, does not allow for the disaggregation of the relative effects of optimizing analgesics and continuous provider monitoring. It is difficult to distinguish if additional care or the intervention was more effective in managing pain than usual care. Another limitation, noted by the authors, is the study’s use of a single VA medical center. Demographics reveal a skewed population, 83% male and 77% white, limiting the trial’s generalizability. Most clinical outcomes were considered, though cost-effectiveness of the intervention was not analyzed. As the VA is a cost-sensitive environment, it is important that interventions assessed are not more costly than usual care. Further cost analysis beyond health resource utilization reported in the study would provide a nuanced assessment of telecare’s feasibility as a replacement for usual primary care. Statistically, the study shows significant improvements in chronic pain in those who received the intervention via telecare, therefore, cost analysis is indeed warranted.
Applications for Clinical Practice
This study illuminates the need for a more intensive pain management program that allows for continuous monitoring. Though the intervention was successfully delivered via telecare, further research is needed to assess whether other programs would be as effective when delivered through telecare, and more importantly, to investigate what characteristics of interventions make telecare successful. Telecare has the potential to improve outcomes, reduce costs, and reduce strains on understaffed facilities, though it is still unknown which conditions would gain from this innovation. This study shows that chronic disease, a predominately self-managed condition, would benefit from a more accessible management program [4]. This, however, may not be the case for other health issues, which require continual testing and equipment usage, such as infectious diseases. Further studies should focus on populations that command a patient-centered intervention delivered using a potentially low-cost tool, like the telephone or internet. Finally, a significant cost driver with chronic pain is disability, and though change in disability days was not statistically significant in this trial, patients in the intervention group self-reported a decrease in disability days, where as patients in the usual care group self-reported an increase. A clinical improvement in pain management has the potential to shave millions of dollars from the U.S. economy, this hypothesis deserves further investigation.
—Sara Tierce-Hazard, BA, and Tina Sadarangani, MSN, ANP-BC, GNP-BC
Study Overview
Objective. To evaluate the effectiveness of a collaborative telecare intervention on chronic pain management.
Design. Randomized clinical trial.
Settings and participants. Participants were recruited over a 2-year period from 5 primary care clinics within a single Veterans Affairs medical center. Patients aged 18 to 65 years were eligible if they had chronic (≥ 3 months) musculoskeletal pain of at least moderate intensity (Brief Pain Inventory [BPI] score ≥ 5). Patients were excluded if they had a pending disability claim or a diagnosis of bipolar disorder, schizophrenia, moderately severe cognitive impairment, active suicidal ideation, current illicit drug use or a terminal illness or received primary care outside of the VA. Participants were randomized to either the telephone-delivered collaborative care management intervention group or usual care. Usual care was defined as continuing to receive care from their primary care provider for management of chronic, musculoskeletal pain.
Intervention. The telecare intervention comprised automated symptom monitoring (ASM) and optimized analgesic management through an algorithm-guided stepped care approach delivered by a nurse case manager. ASM was delivered either by an interactive voice-recorded telephone call (51%) or by internet (49%), set according to patient preference. Intervention calls occurred at 1 and 3 months. Additional contact with participants from the intervention group was generated in response to ASM trend reports.
Main outcome measures. The primary outcome was the BPI total score. The BPI scale ranges from 0 to 10, with higher scores indicating worsening pain. A 1-point change is considered clinically important. Secondary pain outcomes included BPI interference and severity, global pain improvement, treatment satisfaction, and use of opioids and other analgesics. Patients were interviewed at 1, 3, 6, and 12 months.
Main results. A total of 250 participants were enrolled, 124 assigned to the intervention group and 126 assigned to usual care. The mean (SD) baseline BPI scores were 5.31 (1.81) for the intervention group and 5.12 (1.80) for usual care. Compared with usual care, the intervention group had a 1.02-point lower BPI score at 12 months (95% confidence interval [CI], −1.58 to −0.47) (P < 0.001). Patients in the intervention group were nearly twice as likely to report at least a 30% improvement in their pain score by 12 months (51.7% vs. 27.1%; relative risk [RR], 1.9 [95% CI, 1.4 to 2.7]), with a number needed to treat of 4.1 (95% CI, 3.0 to 6.4) for a 30% improvement.
Patients in the intervention group were more likely to rate as good to excellent the medication prescribed for their pain (73.9% vs 50.9%; RR, 1.5 [95% CI, 1.2 to 1.8]). Patients in the usual care group were more likely to experience worsening of pain by 6 months compared with the intervention group. A greater number of analgesics were prescribed to patients in the intervention group; however, opioid use between groups did not differ at baseline or at any point during the trial period. For the secondary outcomes, the intervention group reported greater improvement in depression compared with the usual care group, and this difference was statistically significant (P < 0.001). They also reported fewer days of disability (P = 0.34).
Conclusion. Telecare collaborative management was more effective in improving chronic pain outcomes than usual care. This was accomplished through the optimization of non-opioid analgesic therapy facilitated by a stepped care algorithm and automated symptom monitoring.
Commentary
Chronic pain affects up to 116 million American adults and is recognized as an emerging public health problem that costs the United States a half trillion dollars annually, with disability and hospitalization as the largest burdens [1].The physical and psychological complexities of chronic pain require comprehensive individualized care from interdisciplinary teams who will facilitate prevention, treatment, and routine assessment in chronic pain sufferers [2]. However, enhancing pain management in primary care requires overcoming the high costs and considerable time needed to continually support patients in pain. Telecare represents an improved means by which doctors and nurses can provide primary care services to patients in need of comprehensive pain management. However, the effectiveness of interventions delivered to patients suffering from chronic pain, via telecare, is largely unknown.
This study had several strengths, including a distinct and well-defined intervention, population, comparator, and outcome. The inclusion criteria were broad enough to account for various age-groups, and therefore various pain experiences, yet excluded patients with characteristics likely to confound pain outcomes, such as severe mental health disorders. Participants were randomized in blinded fashion to 1 of 2 clearly defined groups. The stepped algorithm used in the study, SCOPE [3], is a validated and reliable method for assessing chronic pain outcomes. The statistical analyses were appropriate and included analyses of variance to detect between-group differences for continuous variables. The rate of follow-up was excellent, with 95% of participants providing measurable outcome assessments at 12 months. The scientific background and rationale for this study were explicit and relevant to current advances in medicine.
The study is not without limitations, however. It is unclear whether the 2 trial groups were treated equally. Data received through ASM from the intervention group prompted physicians to adjust a patient’s medication regimen, essentially providing caregivers updates on a patient’s status. This occurred in addition to the 4 monthly interviews that both groups received per protocol. The study did not elucidate exactly what care was provided to the usual care group and, therefore, does not allow for the disaggregation of the relative effects of optimizing analgesics and continuous provider monitoring. It is difficult to distinguish if additional care or the intervention was more effective in managing pain than usual care. Another limitation, noted by the authors, is the study’s use of a single VA medical center. Demographics reveal a skewed population, 83% male and 77% white, limiting the trial’s generalizability. Most clinical outcomes were considered, though cost-effectiveness of the intervention was not analyzed. As the VA is a cost-sensitive environment, it is important that interventions assessed are not more costly than usual care. Further cost analysis beyond health resource utilization reported in the study would provide a nuanced assessment of telecare’s feasibility as a replacement for usual primary care. Statistically, the study shows significant improvements in chronic pain in those who received the intervention via telecare, therefore, cost analysis is indeed warranted.
Applications for Clinical Practice
This study illuminates the need for a more intensive pain management program that allows for continuous monitoring. Though the intervention was successfully delivered via telecare, further research is needed to assess whether other programs would be as effective when delivered through telecare, and more importantly, to investigate what characteristics of interventions make telecare successful. Telecare has the potential to improve outcomes, reduce costs, and reduce strains on understaffed facilities, though it is still unknown which conditions would gain from this innovation. This study shows that chronic disease, a predominately self-managed condition, would benefit from a more accessible management program [4]. This, however, may not be the case for other health issues, which require continual testing and equipment usage, such as infectious diseases. Further studies should focus on populations that command a patient-centered intervention delivered using a potentially low-cost tool, like the telephone or internet. Finally, a significant cost driver with chronic pain is disability, and though change in disability days was not statistically significant in this trial, patients in the intervention group self-reported a decrease in disability days, where as patients in the usual care group self-reported an increase. A clinical improvement in pain management has the potential to shave millions of dollars from the U.S. economy, this hypothesis deserves further investigation.
—Sara Tierce-Hazard, BA, and Tina Sadarangani, MSN, ANP-BC, GNP-BC