Long-Acting Injectable Antipsychotics for Schizophrenia
Long-Acting Injectable Antipsychotics for Schizophrenia
Prescriber conversations (n = 60 with 14 psychiatrists; n = 9 with 2 NPs) averaged 11.5 minutes in total duration. Duration of interaction varied individually by type of HCP, averaging 12 minutes with psychiatrists, 9 minutes with NPs, and 16.6 minutes with social workers or therapists (4 conversations from 2 social workers and 2 therapists). Conversations between all types of HCPs and patients or caregivers comprised 2 phases: assessment and decision, which each covered approximately 70% and 30% of conversation time, respectively. During the assessment phase of the conversation, patients and/or caregivers dominated the conversation and then generally yielded to HCPs for the decision phase.
Multiple treatment goals were pursued for patients with schizophrenia and were addressed differently by each type of HCP. Social workers and therapists used open-ended questions ("What would you like to talk about?" "What would you like to work on?") and primarily focused on issues like social wellness and means of achieving daily structure, like work or school. Patients or caregivers sometimes discussed medications and compliance during these sessions but were not explicitly focused on this topic. Prescribers typically used a scripted check-list approach to ensure assessment for positive symptoms, deviating only if positive symptoms were detected and required further investigation. Figure 1 shows a breakdown of the types of topics discussed between prescribers and patients. Treatment discussion and behavior modification/counseling occupied just over 50% of the prescriber-patient visit. Psychiatrists and NPs spent a similar amount of time on treatment discussion while the time focused on behavior modification/counseling is attributed more to psychiatrists (25% vs 1% for NPs). Discussion on compliance occupied only 2% of the prescriber-patient visit. During conversations about medications, prescribers asked simple, direct questions when probing for patient medication compliance ("Are you taking your medications?" "Did you take any medicine last night…?"). Prescribers used direct and logical strategies when probing adherence but could become more authoritative upon discovering noncompliance. Overall conversation flow generally started with prescribers probing for compliance, symptoms, and assessing treatment, which may have included a subjective illness narrative by the patient. The second phase was led by patients where they could express any treatment preferences. The final phase consisted of prescriber-led treatment planning and LAI scheduling (if selected) based on learnings from the earlier phases of the conversation (Figure 2).
(Enlarge Image)
Figure 2.
Observed conversation flow between: A. patients and prescribers (n = 69); B. patients and social workers or therapists (n = 4).
A total of 20 unique HCPs (psychiatrists, n = 14; nurse practitioners, n = 2; case/social workers, n = 2; therapists, n = 2) from 16 unique institutions across the United States participated in the study.
Psychiatrists (n = 14) and their patients (n = 60) provided the most complete set of information for the study including recorded conversations, TDIs, and in-person CMHC observations. Psychiatrists' patients were being treated with oral antipsychotics (n = 22) or LAIs (n = 38). Psychiatrist could be treating individual patients with LAI or oral antipsychotic medications. Psychiatrist and patient characteristics by type of treatment are listed in Table 1. Median years in practice for psychiatrists treating LAI patients and those treating patients on orals were 25 and 18 years, respectively. Patients receiving oral treatment were predominantly female (59%) and LAI patients were mostly male (53%). The majority of patients across both groups (58% to 64%) were initially diagnosed with schizophrenia >10 years prior to the study. More than one fourth (27% to 29%) of the sample were diagnosed within 5 years.
Psychiatrists made antipsychotic treatment decisions without patient or caregiver input during 40 of 60 (67%) conversations. Patients with less severe impairment were more likely to be involved in treatment decisions (conversations with 13 of 36 [36%] mild or moderate patients vs 7 of 24 [29%] severe patients). Involvement in treatment decisions was greater when discussing LAIs: 15 of 60 (25%) with patients/caregivers vs decisions about oral antipsychotics, 5 of 60 (8%). However, there were no discussions of LAIs by psychiatrists in 11 of 22 (50%) patients taking oral antipsychotics (Table 2), despite the fact that participating patients were indicated for a change in treatment. Overall, only 6 of the 60 conversations (10%) involved patients actively making an antipsychotic treatment decision.
The conversation flow around introducing LAIs typically followed a number of steps that could be terminated by the prescriber or patient at several decision points (Figure 3). More than half (11 of 19 [58%]) of LAI-naïve patients offered LAIs by their psychiatrists agreed to start treatment although just three of those who agreed (3 of 11 [27%]) verbalized favorable responses to an LAI (Table 3). Adherence benefit was the major verbalized reason for accepting an LAI offer and fear of needles was most common for refusals. Almost half of patients offered an LAI were neutral or passive in the decision. During these conversations, a variety of techniques were used to encourage patient acceptance of LAI treatment, including: personal gain to the patient ("…not having to worry about where your pills are…"); sharing other patients' experience ("Sometimes, patients think that this is easier …"); or occasionally use of fear tactics ("…those voices, those paranoid thoughts are all going to come back. It's just a matter of time…I can guarantee…that it will happen"). When caregivers were present they were supportive of psychiatrists' choice of LAIs. However, this was only examined with a small sample, as caregivers were only present in 3 of 19 (16%) discussions with LAI-naïve patients.
(Enlarge Image)
Figure 3.
Observed conversation decision tree for prescriber interactions with patients regarding initiation of long-acting injectable antipsychotics.
If the decision was made to initiate LAI treatment, psychiatrists selected the specific LAI to prescribe with minimal patient input. Only 1 specific LAI was discussed in most of the "new start" conversations (7 of 11 [64%]). Patients and caregivers confirmed in TDIs that LAI selection had been made without their input and they were generally uninformed about choices ("I don't think there are that many choices with [the] shot.").
When the discussion about initiating LAIs was abandoned by prescribers, the main reason stated was to preserve a healthy, trusting therapeutic relationship with the patient rather than risk being perceived as coercive. Second, prescribers felt it was important to allow patients to retain autonomy to create treatment "buy-in". Third, prescribers felt that patients who initially rejected LAIs could become more receptive over time and chose to reintroduce the idea at a later date.
Patient obstacles to LAI use emerged as fear or hesitation about the injections. These perceived fears most consistently impeded LAI prescription choice. Patients who expressed strong concern about injections often did so repeatedly in the conversation ("I never did injections, I don't like needles…They freak me out, they scare me, they hurt and I don't like them."). Despite multiple tactics attempted by psychiatrists, the persistent refusal of patients who expressed a strong fear and concern about injections avoided use of LAIs. Of the 7 of 19 (37%) LAI-naïve patients who responded unfavorably to an LAI offer from a prescriber, only 2 of 7 (29%) received an LAI.
Another barrier to LAI use was the lack of patient insight into the disease and treatment (inability to reason regarding symptoms and treatment options). Patients generalized the negative treatment experience with a single LAI to the entire class of LAIs, even if there was a clear distinction between that past experience and currently available options.
Other examples of potential barriers to LAIs reported by individual patients included the requirement to go to the CMHC to receive injections and wishing treatment with medication was more effective. It is unknown to what extent these reasons ultimately prevented patients from receiving injections. In TDIs, the cost of medication as a barrier was reported in a very small number of cases as most patients received state or federal assistance (8 of 12 [67%]) or held private insurance (3 of 12 [25%]).
Among prescribers, possible side effects were among the chief concerns for LAI usage, specifically, with the long-acting effects of this administration method because treatment cannot be withdrawn rapidly if side effects suddenly occur. Despite this concern, conversations about side effects were rarely initiated by psychiatrists, typically being left for the patient to initiate. Even when specific side effects were explored (eg, with the use of general questions such as, "Have you been sleeping okay?" or "Is your appetite okay?"), they were not always directly attributed to the medication. Similar to psychiatrists, NPs tended to use very general questions about side effects, and during conversations did not always differentiate among side effects of LAIs vs. oral medications. However, LAI treatment changes were rare–only 4 of the 38 patients treated by psychiatrists switched or discontinued LAI treatment: 1 discontinued due to restless legs and other unspecified side effects, while 3 switches to a different LAI occurred due to fatigue/grogginess (n = 1) and high prolactin levels (n = 2). It should also be noted that psychiatrists' patients on an LAI at time of study had previously received an average of 2.7 injections, suggesting they had probably only recently begun treatment.
Prescribers were most successful in overcoming patient objections to LAIs by decomposing resistance to uncover the severity of resistance and investigate beyond the initially stated problem to address the root issue. Prescribers used several other logic-based approaches to overcome barriers during discussions. Emphasizing the benefits of newer LAIs, like the use of smaller needles with certain injections, or better therapeutic effects with LAIs than their oral counterparts helped patients commence LAI treatment. Empowering patients during the decision ("…just commit to one month of medicine, that's all, just one shot. If it's a disaster we'll switch gears"), emphasizing convenience ("one shot and we can pretty much minimize all medication"), or showing patients the needle and talking to the nurse were also successful approaches. In terms of decomposing resistance, one particular example included a patient who claimed to have a fear of needles, yet was actually resistant due to a 20-lb weight gain with a previous LAI. Digging deeper into the objection was successful. (Patient: "I actually, I have problems with needles. …last year, [my doctor was] giving me those [specific LAI medication] shots and it made me gain 20 pounds in 1 week", Psychiatrist: "So it wasn't the injection, per se, it was the side effect of the medicine. There is a different injection we can use. This is a once a month and I have several clients on it who have not gained weight.").
Twelve patients who received LAIs participated in TDIs; 9 of 12 (75%) believed they had improved over the 3 months during which the interviews occurred and attributed their success mainly to their LAI treatment. No patients reported a worsening condition. Individual patients mentioned benefits of LAIs that included: improvements in symptoms, better concentration, attention, alertness, and a more positive outlook. Patients also mentioned the medication working "faster" and "better" than oral formulations. Generally, strong support systems and an absence of barriers kept patients adherent to the LAI schedule. As with oral medications, stable home environments, involved family members, friends, and other such caregivers, and case workers helped contribute to adherence. Addressing logistical issues like transportation services to enable patients to reach a CMHC for treatment also encouraged LAI usage and adherence.
Information seeking and communication about LAIs may have contributed as another determinant for LAI usage, particularly by using the Internet. Most patients and caregivers reported using the Internet most commonly to search for information about schizophrenia, with most activity occurring around the time of diagnosis. Additionally, a few patients and caregivers reported social media sites (eg, blogs, message boards, chat rooms) to be the most useful source of disease information.
During TDIs, LAI patients reported willingness to share positive experiences with other patients including convenience, efficacy, and concerns about the injections/needles. The above may serve as future assistance for other patients considering LAI treatment.
Results
Patient and Prescriber (or Other Health Care Professional) Conversations
Prescriber conversations (n = 60 with 14 psychiatrists; n = 9 with 2 NPs) averaged 11.5 minutes in total duration. Duration of interaction varied individually by type of HCP, averaging 12 minutes with psychiatrists, 9 minutes with NPs, and 16.6 minutes with social workers or therapists (4 conversations from 2 social workers and 2 therapists). Conversations between all types of HCPs and patients or caregivers comprised 2 phases: assessment and decision, which each covered approximately 70% and 30% of conversation time, respectively. During the assessment phase of the conversation, patients and/or caregivers dominated the conversation and then generally yielded to HCPs for the decision phase.
Multiple treatment goals were pursued for patients with schizophrenia and were addressed differently by each type of HCP. Social workers and therapists used open-ended questions ("What would you like to talk about?" "What would you like to work on?") and primarily focused on issues like social wellness and means of achieving daily structure, like work or school. Patients or caregivers sometimes discussed medications and compliance during these sessions but were not explicitly focused on this topic. Prescribers typically used a scripted check-list approach to ensure assessment for positive symptoms, deviating only if positive symptoms were detected and required further investigation. Figure 1 shows a breakdown of the types of topics discussed between prescribers and patients. Treatment discussion and behavior modification/counseling occupied just over 50% of the prescriber-patient visit. Psychiatrists and NPs spent a similar amount of time on treatment discussion while the time focused on behavior modification/counseling is attributed more to psychiatrists (25% vs 1% for NPs). Discussion on compliance occupied only 2% of the prescriber-patient visit. During conversations about medications, prescribers asked simple, direct questions when probing for patient medication compliance ("Are you taking your medications?" "Did you take any medicine last night…?"). Prescribers used direct and logical strategies when probing adherence but could become more authoritative upon discovering noncompliance. Overall conversation flow generally started with prescribers probing for compliance, symptoms, and assessing treatment, which may have included a subjective illness narrative by the patient. The second phase was led by patients where they could express any treatment preferences. The final phase consisted of prescriber-led treatment planning and LAI scheduling (if selected) based on learnings from the earlier phases of the conversation (Figure 2).
(Enlarge Image)
Figure 2.
Observed conversation flow between: A. patients and prescribers (n = 69); B. patients and social workers or therapists (n = 4).
Health Care Professional and Patient Characteristics
A total of 20 unique HCPs (psychiatrists, n = 14; nurse practitioners, n = 2; case/social workers, n = 2; therapists, n = 2) from 16 unique institutions across the United States participated in the study.
Psychiatrists (n = 14) and their patients (n = 60) provided the most complete set of information for the study including recorded conversations, TDIs, and in-person CMHC observations. Psychiatrists' patients were being treated with oral antipsychotics (n = 22) or LAIs (n = 38). Psychiatrist could be treating individual patients with LAI or oral antipsychotic medications. Psychiatrist and patient characteristics by type of treatment are listed in Table 1. Median years in practice for psychiatrists treating LAI patients and those treating patients on orals were 25 and 18 years, respectively. Patients receiving oral treatment were predominantly female (59%) and LAI patients were mostly male (53%). The majority of patients across both groups (58% to 64%) were initially diagnosed with schizophrenia >10 years prior to the study. More than one fourth (27% to 29%) of the sample were diagnosed within 5 years.
Treatment Decisions and Conversations on Long-acting Injectable Antipsychotics
Psychiatrists made antipsychotic treatment decisions without patient or caregiver input during 40 of 60 (67%) conversations. Patients with less severe impairment were more likely to be involved in treatment decisions (conversations with 13 of 36 [36%] mild or moderate patients vs 7 of 24 [29%] severe patients). Involvement in treatment decisions was greater when discussing LAIs: 15 of 60 (25%) with patients/caregivers vs decisions about oral antipsychotics, 5 of 60 (8%). However, there were no discussions of LAIs by psychiatrists in 11 of 22 (50%) patients taking oral antipsychotics (Table 2), despite the fact that participating patients were indicated for a change in treatment. Overall, only 6 of the 60 conversations (10%) involved patients actively making an antipsychotic treatment decision.
The conversation flow around introducing LAIs typically followed a number of steps that could be terminated by the prescriber or patient at several decision points (Figure 3). More than half (11 of 19 [58%]) of LAI-naïve patients offered LAIs by their psychiatrists agreed to start treatment although just three of those who agreed (3 of 11 [27%]) verbalized favorable responses to an LAI (Table 3). Adherence benefit was the major verbalized reason for accepting an LAI offer and fear of needles was most common for refusals. Almost half of patients offered an LAI were neutral or passive in the decision. During these conversations, a variety of techniques were used to encourage patient acceptance of LAI treatment, including: personal gain to the patient ("…not having to worry about where your pills are…"); sharing other patients' experience ("Sometimes, patients think that this is easier …"); or occasionally use of fear tactics ("…those voices, those paranoid thoughts are all going to come back. It's just a matter of time…I can guarantee…that it will happen"). When caregivers were present they were supportive of psychiatrists' choice of LAIs. However, this was only examined with a small sample, as caregivers were only present in 3 of 19 (16%) discussions with LAI-naïve patients.
(Enlarge Image)
Figure 3.
Observed conversation decision tree for prescriber interactions with patients regarding initiation of long-acting injectable antipsychotics.
If the decision was made to initiate LAI treatment, psychiatrists selected the specific LAI to prescribe with minimal patient input. Only 1 specific LAI was discussed in most of the "new start" conversations (7 of 11 [64%]). Patients and caregivers confirmed in TDIs that LAI selection had been made without their input and they were generally uninformed about choices ("I don't think there are that many choices with [the] shot.").
When the discussion about initiating LAIs was abandoned by prescribers, the main reason stated was to preserve a healthy, trusting therapeutic relationship with the patient rather than risk being perceived as coercive. Second, prescribers felt it was important to allow patients to retain autonomy to create treatment "buy-in". Third, prescribers felt that patients who initially rejected LAIs could become more receptive over time and chose to reintroduce the idea at a later date.
Barriers to Initiation of Long-acting Injectable Antipsychotics
Patient obstacles to LAI use emerged as fear or hesitation about the injections. These perceived fears most consistently impeded LAI prescription choice. Patients who expressed strong concern about injections often did so repeatedly in the conversation ("I never did injections, I don't like needles…They freak me out, they scare me, they hurt and I don't like them."). Despite multiple tactics attempted by psychiatrists, the persistent refusal of patients who expressed a strong fear and concern about injections avoided use of LAIs. Of the 7 of 19 (37%) LAI-naïve patients who responded unfavorably to an LAI offer from a prescriber, only 2 of 7 (29%) received an LAI.
Another barrier to LAI use was the lack of patient insight into the disease and treatment (inability to reason regarding symptoms and treatment options). Patients generalized the negative treatment experience with a single LAI to the entire class of LAIs, even if there was a clear distinction between that past experience and currently available options.
Other examples of potential barriers to LAIs reported by individual patients included the requirement to go to the CMHC to receive injections and wishing treatment with medication was more effective. It is unknown to what extent these reasons ultimately prevented patients from receiving injections. In TDIs, the cost of medication as a barrier was reported in a very small number of cases as most patients received state or federal assistance (8 of 12 [67%]) or held private insurance (3 of 12 [25%]).
Among prescribers, possible side effects were among the chief concerns for LAI usage, specifically, with the long-acting effects of this administration method because treatment cannot be withdrawn rapidly if side effects suddenly occur. Despite this concern, conversations about side effects were rarely initiated by psychiatrists, typically being left for the patient to initiate. Even when specific side effects were explored (eg, with the use of general questions such as, "Have you been sleeping okay?" or "Is your appetite okay?"), they were not always directly attributed to the medication. Similar to psychiatrists, NPs tended to use very general questions about side effects, and during conversations did not always differentiate among side effects of LAIs vs. oral medications. However, LAI treatment changes were rare–only 4 of the 38 patients treated by psychiatrists switched or discontinued LAI treatment: 1 discontinued due to restless legs and other unspecified side effects, while 3 switches to a different LAI occurred due to fatigue/grogginess (n = 1) and high prolactin levels (n = 2). It should also be noted that psychiatrists' patients on an LAI at time of study had previously received an average of 2.7 injections, suggesting they had probably only recently begun treatment.
Overcoming Barriers to Treatment With Long-acting Injectable Antipsychotics
Prescribers were most successful in overcoming patient objections to LAIs by decomposing resistance to uncover the severity of resistance and investigate beyond the initially stated problem to address the root issue. Prescribers used several other logic-based approaches to overcome barriers during discussions. Emphasizing the benefits of newer LAIs, like the use of smaller needles with certain injections, or better therapeutic effects with LAIs than their oral counterparts helped patients commence LAI treatment. Empowering patients during the decision ("…just commit to one month of medicine, that's all, just one shot. If it's a disaster we'll switch gears"), emphasizing convenience ("one shot and we can pretty much minimize all medication"), or showing patients the needle and talking to the nurse were also successful approaches. In terms of decomposing resistance, one particular example included a patient who claimed to have a fear of needles, yet was actually resistant due to a 20-lb weight gain with a previous LAI. Digging deeper into the objection was successful. (Patient: "I actually, I have problems with needles. …last year, [my doctor was] giving me those [specific LAI medication] shots and it made me gain 20 pounds in 1 week", Psychiatrist: "So it wasn't the injection, per se, it was the side effect of the medicine. There is a different injection we can use. This is a once a month and I have several clients on it who have not gained weight.").
Determinants of Continued Use of Long-acting Injectable Antipsychotics
Twelve patients who received LAIs participated in TDIs; 9 of 12 (75%) believed they had improved over the 3 months during which the interviews occurred and attributed their success mainly to their LAI treatment. No patients reported a worsening condition. Individual patients mentioned benefits of LAIs that included: improvements in symptoms, better concentration, attention, alertness, and a more positive outlook. Patients also mentioned the medication working "faster" and "better" than oral formulations. Generally, strong support systems and an absence of barriers kept patients adherent to the LAI schedule. As with oral medications, stable home environments, involved family members, friends, and other such caregivers, and case workers helped contribute to adherence. Addressing logistical issues like transportation services to enable patients to reach a CMHC for treatment also encouraged LAI usage and adherence.
Information seeking and communication about LAIs may have contributed as another determinant for LAI usage, particularly by using the Internet. Most patients and caregivers reported using the Internet most commonly to search for information about schizophrenia, with most activity occurring around the time of diagnosis. Additionally, a few patients and caregivers reported social media sites (eg, blogs, message boards, chat rooms) to be the most useful source of disease information.
During TDIs, LAI patients reported willingness to share positive experiences with other patients including convenience, efficacy, and concerns about the injections/needles. The above may serve as future assistance for other patients considering LAI treatment.
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