**Transcript of Cyberseminar**

**Evidence-based Synthesis Program**

**Effects of Caregiver Interventions on Outcomes for Memory-related Disorders or Cancer**

**Presenter:  Joan M. Griffin, PhD**

**November 14, 2013**

*This is an unedited transcript of this session. As such, it may contain omissions or errors due to sound quality or misinterpretation. For clarification or verification of any points in the transcript, please refer to the audio version posted at www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm or contact Joan Griffin at Joan.Griffin@va.gov.*

*Moderator:*Today’s presenter is Joan Griffin.  She is a research investigator and director of post-doctoral fellowship program at the Center for Chronic Disease Outcomes Research at the Minneapolis VA Medical Center and an associate professor at the University of Minnesota Medical Center.  

She is joined by two discussants.  First is Meg Kabat, Deputy Director, VA Caregiver Support Program and VA Care Management and Social Work Services, and Julia Roland, Director, Office of Cancer Survivorship and the Division of Cancer Control and Population Sciences with the National Cancer Institute.  With that, Joan, I would like to turn things over to you.

*Speaker:*Thank you, Heidi, for that introduction, and thanks to Julia and Meg for agreeing to be discussants for today’s discussion.  I want to start off in thanking my co-authors who worked on this project with me and our team of reviewers and our expert panel that we worked with to help refine our research questions.  They also helped us work on the scope of the project and provided great feedback on our report.  

The expert panel also included Sonja Batten from the Office of Mental Health who nominated this topic to the Evidence Synthesis Program.  We’ll talk a little bit more about that nomination as we move on.  I don’t have any conflicts of interest to disclose.  

I wanted to just briefly talk about the Evidence Synthesis Program.  Those of you who are not familiar with the program, this is a program that’s sponsored by the VA’s Office of Research and Development and the Quality Enhancement Research Initiative, what we researchers called QUERI.  Its aim is to provide reviews of healthcare topics that are nominated by VA practitioners, managers or policymakers.  

This is an area that was of interest to the Office of Mental Health and it was nominated.  We took this on as a project within our center.  If you want more information about the Evidence Synthesis Program, there’s a link here at the bottom of the slide, and you can probably get that through the handouts as well.

Just because I can’t see anybody *[chuckles]* which is a little bit awkward, I wanted to get a chance to know who’s out there in the audience.  It would be helpful for me to know who’s on the call.  I’d like to start off with a question to the audience.  I’d like you to answer the question:  What is your position in the VA?  I believe that there are polling tabs that you can go ahead and answer that question.  

Once you have finished that question, if you can move to the next one which is what is your primary role in your position?  This might mean that there are multiple roles; everything from providing care to that you’re a researcher or that you’re a caregiver or that you help develop or manage caregiver programs.  

If you can take a look at those response categories and answer those, that would be great.  It would help me understand a little bit about who’s out there and how this information might be most useful for you.

*Moderator:*Great.  We’re actually only able to have one poll question up at a time, so we’re finishing up on the what is your position in the VA.

*Speaker:*Okay.

*Moderator:*It looks like we’re seeing around 20—it’s fluctuating 26 to 28 percent clinicians, about the same percentage of researchers, 13 percent managers, 13 percent other, 13 percent non-VA, and about 6 percent student trainee or fellow.

*Speaker:*Great.  Okay.  That’s helpful.

*Moderator:*Now I’m going to go ahead and open up our next poll question here.  Now this one you can select multiple answers, so feel free to click more than one if they do apply to you.  We’ll give you all a few second to respond there, and then we will read through those responses *[pause 04:08 – 04:25]*.

Okay, it looks like things are slowing down here a little bit.  We have around 47 percent who provide care or support for veterans’ families, around 30 percent who provide care to veterans with cancer.  Around 41 percent provide care to veterans with dementia or Alzheimer’s disease.  

Around 18 percent are researchers with interest in cancer.  Around 24 percent are researchers with interest in dementia.  Around 30 percent are researchers with interest in caregiving.  We have no caregivers caring for a veteran on the call.  Around 30 percent develop caregiving or family-focused support programs.  Around 35 percent manage caregiver programs.

*Speaker:*Okay.  We’ve got a really diverse audience out there.  Hopefully I will put this in a format that is applicable to most of you.  I think that we’ve got a lot of information.  For anybody who has looked at the full report, it’s very long, so I’m going to try and synthesize this in our short period of time that we have together and hopefully summarize it enough so that you have the major take home points.  

I wanted to talk today about why we did the review and then describe how we did it and then what we found and some of the limitations and then what some of the implications or future directions might be based on our findings.  The rationale for the project itself is really based on the fact that in the last five years there has been a legislation that has expanded the VA’s authority to provide family services and caregiver support services.  

This, along with the growing emphasis on patient-centered care and certainly on primary care we talk about the PAC teams, the patient aligned care teams.  Those programs aim to include not just the patients but their families into decision making and into the care process.  This has led to more interest in whether there are promising family and caregiver interventions that the VA can adopt or implement to improve patient outcomes.

Our overarching goal then was to examine if there are family or caregiver interventions that help patients maximize their health potential.  Last year in our first ESP report based on this nomination, that report was led by Dr. Laura Meis.  We examined the effect of family interventions on patients with mental health conditions.  That report was published earlier this year and then was also published in *Clinical Psychology Review* in 2013.

In this report, however, we concentrate on the effects of family or caregiver interventions on patients with physical health conditions.  As I’ll discuss in a minute, we limited our scope to dementia and cancer trials, which make up the majority of the trials that examine this question.  Unlike some of the reviews that have happened in the past, both in the literature and within the VA, we concentrated specifically on whether family interventions affect patient outcomes. 

Our first question was:  What are the benefits and harms of family and caregiver psychosocial interventions for adult patients with cancer or memory-related disorders compared to usual care or wait list?  We looked at interventions that had a family component and were comparing them to usual patient care or patients who were on a wait list for a certain program.  We had 18 cancer trials and 19 memory-related disorder trials that were included that addressed that specific question.

Our second question was, and there’s a typo here.  I apologize for that.  What are the benefits and harms of family and caregiver psychosocial interventions for adult patients with caregiver or memory-related disorders compared to either, and this is where the typo is *[laughs]*, to either another family intervention.  

This could be an attention-control condition, like education or a supportive phone call, or a less intense version of the intervention being studied.  It also could be compared to a patient-directed intervention, so going head to head between a comparison of the patient-only intervention to a family-involved intervention.  That was our key question number two.

We had an analytic framework which gave us an idea of how these relationships would work.  We proposed that the intervention would have a direct effect on patient outcomes compared to the control groups we outlined and that this relationship could be modified by the patient’s stage of illness, relationship to the patient and relationship quality.  

We used two electronic databases, MEDLINE and PsycINFO, to search for articles that fit a priority criteria that we had set out, which I’ll go over in just a second.  We used terms that we expected would capture families and caregivers and interventions that involved families and caregivers.

Our inclusion criteria are listed here.  Given the scope of the review, we included only articles that were published from 1996 to 2012 and in English and included adult patients.  One criteria that I inadvertently left out here is that trials were conducted—the trials that we picked were only conducted in the United States.  

We did this in hopes that we would capture trials that were most relevant to U.S. veterans and to the clinical and community practices that we have here in the U.S.  We also included only randomized control trials, those that had a clear family-involved psychosocial treatment, and had a physical condition of interest.

Here is a list of the different components in each article that we extracted.  I’ll talk a little bit more about that in a second, and then the analyses.  We knew that there might be a couple different ways of looking at the data and that there would be different constituencies so to speak so that there would be a different lens that we could examine the results in.  We knew that clinicians might be interested in what interventions are effective for improving certain symptoms, and then there might be policy or program managers that might be interested in adopting a broader intervention and interested in what would be the most efficacious intervention to put some muscle behind.  

For this reason, in addition to reporting just the patient outcomes, we also tried to categorize interventions into groups that had similar components.  We did that and came up with this list of interventions:  telephone or web-based counseling, behavioral couples therapy or adaptations of cognitive behavior therapy, training for family members to control patient symptoms, training for family members to control patient symptoms and family support or counseling, and then there was a group of interventions that were unique and had unique intervention targets that didn’t fit into the other four categories that we had.

We rated each trial for the quality of the trial.  We rated their efficacy.  To do that, what we really wanted to see is if the trial had been done in more than one site, and so whether the findings would be generalizable in more than one site.  We qualified our efficacy ratings in this way.

Efficacious and specific was that there was at least two randomized control trials conducted by different teams compared to an alternative intervention.  Efficacious was superior in at least two randomized control trials that were conducted by different teams compared to the usual care or wait list.  Possibly efficacious and specific was the same criteria except it was only met by one study.  Possibly efficacious was that it was the same as efficacious except it was only met by one.

In addition to efficacy, we also looked at study quality.  We categorized studies as having good, fair or poor quality based on the internal validity of the study and the study design.  We also wanted to look at treatment integrity to make sure that the intervention that was being delivered was indeed being delivered in the way that it was supposed to be or stated to be. 

We also looked at strength of evidence and did this in a number of different ways.  We had five criteria for the strength of evidence.  One was consistency in—so this was across all outcomes.  We looked at the consistency of the findings across all outcomes; the directedness, which was really whether the interventions were developed and designed to directly affect the health outcomes of interest; precision, the degree of certainty surrounding an estimate of effect for each outcome of interest.  This is where I think the power to detect differences is more likely to affect the precision of the estimate, so the power comes into—or the number of people in the trial comes into play right here for precision.  

Then, the risk of publication bias.  Using this criteria, we assumed that publication bias would be suspected if the evidence was derived from a small number of commercially funded trials with sample sizes and a small number of events.  Then, finally, risk of bias overall.  This plays into the study quality with study design limitations and potential biases of the estimates for the treatment effect.

Based on those five criteria, we categorized trials into either having high confidence, moderate confidence or low confidence.  High confidence meaning that we didn’t think that further research was likely to change our confidence of the estimate.  Moderate confidence meant that we thought that future research might change our confidence in the estimate of the effect.  

Low confidence meant that we really were unsure or had very little confidence that future research was going to impact the confidence of our statement.  Then, finally, insufficient meant that we didn’t—there wasn’t enough evidence to come to a conclusion about certain trials.

Based on our criteria and our search, we came up with 2,771 abstracts that we reviewed.  In full text, so we looked at 781 full text articles and reviewed those.  After reviewing those, we found a few more articles that we included.  Our final count was 59 articles that reflected 56 unique randomized control trials.  

It was during this screening process that we eliminated the trials that were not either cancer or dementia related.  That was 20 trials; 20 trials that captured mostly arthritis, cardiovascular and cerebrovascular disease, including stroke, so overall not a lot of trials.

The majority of them had to do with dementia and Alzheimer’s disease or cancer.  We limited our scope to just those trials in order to come up with more robust findings.  You’ll see here that we had a pretty even split between the cancer trials and the dementia/Alzheimer’s trials, but that overall few of them had veterans included or were trials with only veterans.  

I’m going to go through the results now, first with cancer and then with dementia or Alzheimer’s.  There’s a lot of information to get through, so I’m going to try and go through them relatively quickly in some places and in more detail in others.  This slide shows that the trials really varied in the number of patient/family dyads that were randomized and analyzed.  One trial had 12 patients, and another one had 476.  

They really varied in the number of people that were included in the trial and the number of people that were analyzed in the findings.  I’m pleased to report that most of them stated that they had a protocol or a manual that they used and stuck to, and they had some degree of fidelity to that protocol or some measure of fidelity to that program.  

Then you can see here that the different family members were targeted for different interventions.  This last section here was based on our key questions.  This is a summary of the baseline characteristics for the cancer trials.  

You can see again that they’re very heterogeneous trials.  There’s a lot of differences across the trials.  There’s significant variability both in the patient and family members, but also in the number of trials that reported certain characteristics.  Clearly it’s not a standard to report a lot of these baseline characteristics, but I think in the future it may be helpful to do so.

One thing I should note is that the stage of cancer was not always precisely reported.  Some studies included patients at any stage.  Some included patients only at early stages.  A good number of the trials were not very specific in including the stage of diagnosis or stage of disease.  

We found 18 cancer trials.  Five of those 18 showed a significant difference in the outcome.  The overall number of trials included prostate cancer patients, women with breast cancer, and then any type of cancer.  There was a specific type of cancer that made people eligible for a certain trial.  

As far as our comparatives go, we had 17 trials that compared the family intervention to usual care and one that compared it to a wait list.  The majority of the trials were fair quality, and three were poor, but we didn’t have any good quality trials for this key question one for cancer.

I think that the easiest way to present the findings for each question is just to get to the punch line, so that’s what I’m going to do here.  I’m going to present a summary of the results in this slide, and then I’m going to quickly review some of the findings in more detail.  As I mentioned earlier, five of the 18 trials showed a significant affect.  Three of those five showed significant effects across multiple outcomes.

Taken as a whole, the trials didn’t consistently improve any measured outcome.  None of the trials that we reviewed have been replicated, so we considered them to be possibly efficacious with some reservations.  The effect sizes that the papers reported were typically small to moderate, and the strength of evidence was low, meaning that we had low confidence that the evidence reflects the true effect.

None of the trials reported that the patients were harmed or had adverse effects from the intervention, but two trials did find that the family outcomes were worse in the intervention group than in the control group.  The reasoning for this the authors of these trials surmised that it might be that the intervention to retention to the concerns and fears about the patient’s cancer that families may have that otherwise may not have been discussed or considered, so it sort of raised the anxiety level about what the patient was facing.

In these next few slides, I’m going to go through each different outcome and discuss really briefly about the trials and some of the takeaway points for significant findings by outcome.  11 of the 18 trials assessed symptom control or management, so this was the most common outcome that was measured by these trials.  Four of those showed significant improvements in symptom control.  Those symptoms varied from symptom severity to day to day problems, rehabilitation needs and one on prostate cancer that looked at sexual dysfunction.  

The effect sizes were relatively small.  As you can see here, the quality of the trials was mixed between being poor and fair.  Really what we’re trying to look at as far as take home points would be good quality trials that were effective and showed significant differences between the family intervention and the comparator.  A number of the symptom control didn’t have any—none of the trials in this key question one were good quality trials, but a number of the fair quality ones might be of interest to some people.

Moving on to general psychological functioning, this is really around distress and wellbeing.  There were a lot of trials that also assessed psychological functioning for cancer patients.  Two of them showed significant improvements in psychological functioning.  Again, the overall risk of bias was moderate, and we had low confidence that the evidence that we reviewed reflects a true effect.  

One of these was a telephone counseling intervention for breast cancer patients and showed significant improvements in psychological wellbeing.  Interestingly enough, the effect was between post-surgery and adjuvant therapy, not right after the diagnosis.  There’s some interesting subgroups here that I think might be of interest to people at certain times in the course of treatment.  Then the other trial showed that training families in problem solving significantly reduced patient psychiatric symptoms and improved patient mood and distress.  

This trial, the Nezu trial, targeted patients who had high distress, and so it’s more likely that they were able to find an effect because they already had people who were distressed.  I think the take home point from this slide is that there may be subgroups within the trials where the effect is more prominent.  It may be that looking at subgroups as opposed to general populations may be a better approach than targeting interventions at everybody.  That theme I think will come through in a couple of the other ones.  

Again, for depression, very similar findings.  These were small to medium effects.  Only two of the nine trials it assessed, depression or anxiety showed significant improvements compared to usual care.  Then physical and social functioning, only one trial and it was the same trial, showed significant improvements in physical and social functioning for cancer patients.  Global quality of life and relationship adjustments in were assessed in a number of trials, but none of them showed any intervention effects.

Moving on to key question two which is the cancer intervention family-involved intervention compared to another intervention.  There were 13 trials that fit this criteria, and seven of those 13 showed a difference in outcome.  They varied across different types of cancer.  They were compared to different types of interventions.  

We had 11 trials, 11 of the 13, that compared the family-involved intervention to pscyhoeducation or just an educational component.  Three of the trials compared a patient-only intervention to a family intervention.  We had two good trials that we reviewed in this group.  The majority of the others were of fair quality.

Again, to cut to the chase, I’ll go through the summary slide and discuss a little bit about what we found.  We had two trials that showed effects across multiple outcomes.  These were possibly efficacious in specific trials, so they have not been replicated, and we don’t know if outside of their study setting if they would be effective in another setting.  

In general, we found that trials sometimes improved psychological functioning in depression/anxiety and symptom control management, but it was really inconsistent across those trials.  We found that overall the evidence was either low or insufficient to conclude that family-involved interventions were more effective than any other type of active control.  The same for looking at patients versus family interventions; we really didn’t see that patient interventions were any better than—or family-involved interventions were any better than patient-involved interventions.  Thankfully, we did not see that any of the patients or the caregivers were harmed in any of these trials.  

I’ll go into a few more details about the different outcomes like I did for the key question one for cancer and discuss a little bit more about some of the findings here.  We found three trials that showed significant differences in the family intervention compared to the comparator.  The first one was a problem solving intervention for patients versus a problem solving intervention for families.  This was a poor quality trial, and so although it has a significant effect, we raise caution about its overall impact on symptom control and management.

The Gustafson trial used an Internet-based education materials versus Chess, which is an online support group and materials.  They showed a significant effect, a small to medium effect, and it was a fair quality trial.  The last one, Stephenson, was a trial that trained family members how to do foot reflexology and compared training families to do foot reflexology versus just paying attention to the patient.  This was a hospital-based intervention.  That had a moderate effect on the intervention, although the sample size was relatively small.

For general psychological functioning, we found that three trials had significant differences in psychological functioning.  For the first trial, the values were actually not reported in the paper, but the authors reported that there was a significant difference between the intervention and control groups.  For the second trial, it was a problem solving intervention between the patients and the families.  It’s the Nezu trial that I mentioned briefly before.  Then, the third one was the Mokuau trial which was an intense patient education trial, but unfortunately only had ten participants, so we again raise caution about the findings there.

For depression and anxiety, we found two trials that significantly improved patient depression or anxiety compared to attention control, or in the Badger trial, they also had a second control arm which was exercise.  The Badger trial was a very small number of participants in each group.  They found that for depression, the intervention compared to attention control had medium effects, and the same for the exercise intervention.  The intervention compared to the exercise intervention had medium effects on reducing the risk for depression.  

For anxiety, the intervention compared to the attention control had large effects, and the same for the exercise.  The intervention compared to the exercise intervention also had large effects.  Again, we raise some caution with these because of the small number of participants and the overall risk for bias for the trial.

The Porter trial showed a significant improvement in relationship adjustment.  This is a good quality trial.  This is one that we wanted to pay a little bit more attention to because of the quality rating and because of the significant effect.  This was an education program about lung cancer and treatment for patient and family members.  It was delivered over the phone, and it was compared to a similar program that included coping skills where family members were sort of trying to coach the patient in improving their coping skills.  

The intervention was found to improve relationship adjustment, but especially among those who had stressed relationships.  People who went in and were having difficulty in their relationship at the beginning of the trial seemed to show the most effect with the intervention compared to just the education and support group.  

Then, for physical and social functioning, we had trials that assessed both of those outcomes, but neither showed any effect.  Then, the same for global quality of life; two of the 13 trials assessed global quality of life, but none of them reported any intervention effect.

Moving on to the memory-related disorders, you’ll see here that a lot of the heterogeneity of these trials is also strong just like the cancer trials.  We had a lot of participants, and we had a lot of variation in who was involved in the intervention.  If I go to the next slide here, you can see that the baseline characteristics really show the variation in age of family members and the patients.  Across the board we can see that these trials were somewhat different from each other.  

There were 19 trials that addressed the question of whether the intervention was effective compared to a usual care or wait list control group.  Ten of the 19 showed significant effects.  All of the trials in this memory-related disorders section of the report had to do with dementia and Alzheimer’s disease.  

In this specific area of looking at the intervention compared to usual care, 13 compared to usual care and six compared to wait lists.  They had a pretty broad range in the number of patients and caregivers in the trials, from 47 to 406.  We had three good quality trials, and then evenly split between poor and fair quality.

Again, I’ll get to the point here on the—the take home points for the dementia trials.  The targeted interventions to the groups of patients with specific symptoms like depression seemed to be more effective in managing and controlling the symptoms and reducing depression than usual care.  I’ll show you a little bit more about that in the subsequent slides.  Unique interventions that really looked at specific symptoms or specific problem behaviors seemed to be also more effective than interventions that sort of tried to target a whole battery of symptoms or outcomes.  

Significant trials were possibly efficacious because none of the trials that we examined have been replicated in more than one research group.  Overall, I would say that the magnitude of the effect sizes was small to moderate.  The overall strength of evidence was low for all outcomes with moderate risk of bias in precision of the effect sizes.  Again, we didn’t see that any of the—in any of the trials that there was any report of patients or caregivers being harmed.

Again, symptom management was the most commonly assessed outcome that we reviewed.  11 of the 19 trials assessed symptom management or control.  Five showed significant improvements over usual care or wait list.  One of these was a good quality trial, and that was the Gitlin from 2008 trial.  

This was a tailored activity program that included home visits and telephone support.  It showed significant improvements in symptoms compared to a wait list control group.  It had a large effect size in reducing the frequency of problem behaviors.  This may be one that we want to take a little bit more or that we would advocate for being replicated, but probably too early to have a wide rollout or adoption for that program.

Depression, we did not have any good quality trials that showed that depression was improved by one of the family-related interventions compared to usual care.  I know I’m running low on time, so I’m going to go through these relatively quickly.  The quality of life and overall functioning, we found two trials that showed significant improvements over the control conditions.  Again, these trials had small to moderate effects and had poor to fair quality ratings.  Very similarly, we found the same thing with physical functioning and cognitive functioning.  

This one, the Mittelman trial, I want to talk about just a little bit more too.  Six out of the 19 trials that we examined looked at healthcare utilization.  Most commonly that would be institutionalization.  The Mittelman trial is a good quality trial, and it’s been around for a long time.  It’s a longitudinal study that has been following up with patients and families for nearly 20 years.  

The intervention was this:  the loved ones of family members received sort of an adaptation of cognitive behavioral therapy or counseling and support.  What they found is that those who received this type of intervention had a longer period—there was a longer period before the patient was placed in a nursing home compared to the control condition.  This may be one again that we need to think about in more specific terms about replicating and figuring out if it’s efficacious and specific and possibly before we roll it out to a broader group.  It certainly shows more promise.

Then finally, the dementia trials that compared the family-involved intervention to another intervention.  There were 14 trials that fit into this criteria, and 4 out of the 14 showed a significant difference in outcomes.  12 of the 14 were another family intervention, and one was a patient intervention.  Most of the ones that compared a family intervention to another family intervention included an attention control condition.  They ranged in size just like the other trials.  We found three good quality trials in this category as well.  

Again, cutting to the chase with the findings, we found that studies that compared caregiver or family-involved intervention to an attention control condition showed few improvements on the outcomes.  We concluded that the evidence was not strong enough to suggest that interventions beyond controlling education or minimal support to caregivers were beneficial to patients and that the data were insufficient to suggest that any one type of intervention, whether it’s adaptive cognitive behavior therapy or cognitive behavior therapy plus coping skills, is superior to another at improving patient outcomes.

The significant trials were possibly efficacious and specific.  Again, they had not been replicated in other sites.  The strength of evidence was low for all the outcomes due to the moderate risk for bias.  Again, happy to report that no study reported that there were poor outcomes among patients or family members or that there were any adverse events.

Going through the symptoms very quickly here, symptom management again was the most commonly assessed outcome.  12 of the 14 trials assessed symptom management, and two of those showed significant improvement over the control conditions.  One of this, the Bourgeois trial, is a good quality trial.  This trial’s aim was to test strategy for improving coping for spouses of patients with Alzheimer’s disease.  

They had multiple contacts over the course of the intervention.  Families were trained to change patient behavior and provide—one arm was to change patient behavior.  The second arm was to train the caregiver in caring for themselves and coping with the problem behaviors.  Then, the third arm was an attention control support for the caregivers or family members.  

In the Bourgeois trial, they found that the training patients to change behavior, that group had significantly fewer—reported significantly fewer problem behaviors in the patient than those in the attention control group after adjusting for the baseline behaviors.  Interestingly enough, the effect continued over time, both at post-intervention and then also a long-term follow-up.  The trial was small; it had 42 participants over three arms.  I sort of have some caution about that trial.  Even though it was a good quality trial, it was relatively small.  

We had none of the trials looking at dementia and comparing one family intervention to the other show any improvement in depression or anxiety.  For quality of life, we had one trial.  This was the Reach trial, which a lot of people who are involved in caregiving research are familiar with.  VA has rolled out Reach to a certain degree.  In this trial they found that there was an overall improvement in quality of life for those who were in the Reach trial compared to an attention control condition.

Physical functioning, we found one trial also of good quality.  This was a bio-behavioral home-based intervention that targeted functional independence, quality of life and problem behaviors.  It was compared to a telephone support and education components.  It showed small yet significant effects and improvements in activities of daily living and instrumental activities of daily living and activity engagement for the patients when the family members received training in learning how to cope with some of the problem behaviors that dementia patients have.  

None of the trials found any improvements in the family-involved interventions at improving cognitive functioning of the patient.  There was one trial that assessed institutionalization.  That one did not show a reduction in institutionalization.

I want to leave some time for Julia and Meg to comment, so I want to go through some of my conclusions here.  There were some limitations to our report.  One is that we only included studies from 1996 to 2012, so there may have been earlier studies that had different findings that were not included in our review.  We did limit our review to the U.S.  We did this in order to be applicable to veterans, but we know that there’s a lot of work that’s done outside of the U.S. that may change the findings or change the strength of evidence that we report.

We only included randomized control trials.  We know that there are numerous observational studies in family interventions that are out there and being developed and being evaluated, but given the scope of the trial and we wanted to make sure that these were tested in a gold standard way, so we used only randomized control trials.  

We limited our set of outcomes to ones that we thought were clinically significant, but there may be other ones that were important.  I think it’s also very difficult to disentangle some of the caregiver outcomes from the patient outcomes, and that certainly is a limitation to looking only at patient outcomes.

A lot of our trials were fair to poor quality and had moderate risk of bias.  I think we would overall say that we have low confidence that the evidence that we reviewed reflects the true effect and that other studies may significantly change our findings over time. 

Overall, I think that what we found is that tailored interventions that target specific behaviors or problems may have a limited effect on the outcomes.  Certainly we found that interventions that are targeted to certain subgroups, such as those that are distressed or under—that have certain degrees of depression, may benefit more from the interventions than other groups.  

We didn’t find that one trial was more efficacious or efficacious and specific and that there’s insufficient data to actually look at some of the moderators that we set out to look at, such as the state of disease or the relationship with the patient or the relationship quality.  Those are things that I think that we really need to in the future pay attention to.

A lot of the data was either not reported at post-intervention or there was insufficient data reported.  There were a lot of methodological problems with the trials that we reviewed.  Another thing that I think is not brought up in a lot of the trials that we looked at was that there may have been clinical significance, and they may not have shown statistical significance, but there may have certainly have been clinical significance.  The difference between those was really not brought up in a lot of the discussion sections that we reviewed.  

What do I think we need to do as we move forward?  I think we need to start promoting higher quality research.  We need to make sure that the trials, the randomized control trials, sort of follow the standard procedures of making sure that the allocation into a certain intervention arm is concealed and that at the very least that the intervention is the one that’s providing the intervention, or the assessor, I should say.  The one who’s assessing the outcomes is blinded to the intervention group that the patient is in or the family is in.  I think we need to promote more consistently across studies, both with the measures that we use and how much of an intervention we give and how frequently we follow up.

I think you’ve heard me say numerous times that none of these trials had been replicated.  If we want to take the good quality trials and replicate them and get more data on whether these findings would be applicable in other settings, I think that would improve the field tremendously and give us a little bit more information on what would be effective at improving patient outcomes.

Finally, I think that we need to figure out ways to link caregiver and care recipients, the outcomes.  I think that this is a difficult problem conceptually.  We know that—I mean we all make these assumptions that having a caregiver around is going to improve care recipient outcomes, but the data is not really showing that.  There may be things that we’re missing or we’re not measuring or we’re not really taking into consideration that we need to.  We need to kind of think of those things and measure them precisely.

Then, just a couple closing points.  I think that we might be better off at targeting subgroups that are at risk than targeting broader groups of caregivers for these two conditions.  I think that you’ve seen that we have few studies that specifically address some of the—that address veterans specifically.  

I think none of the trials that we looked at address a lot of the programs and benefits that have been rolled out to caregivers through the VA in the last few years.  We don’t really know if those programs are effective, and they certainly were not included in this report.  Those would be areas that we really need to pay attention to as well to see if the programs that we have developed and that caregivers are benefiting from actually improve patient outcomes in the long run.

With that, I will open it up to Julia and to Meg and to anyone who has questions for me as well.  It was a huge report.  I apologize for going through things so quickly, but hopefully I synthesized things in a way that will either elicit some more questions or clear things up for the participants today.  I’ll pass it on to, I think, Julia first.

*Speaker:*Great.  Thanks so much.  My special thanks to Joan for the invitation to comment on this huge report as she indicated and to Heidi for the opportunity to be with you to discuss this.  I’d like to launch our discussion today by articulating why the evidence-based review and synthesis that you just heard Dr. Griffin deliver and today’s larger dialogue is so important right now.

Some years back Rosalynn Carter, wife of former president Jimmy Carter and a big proponent of caregiving issues and supporting families, was quoted as saying, “There are only four kinds of people in the world:  those who have been caregivers; those who are currently caregivers; those who will be caregivers; and those who will need caregivers.”  Caregiving is very much a part of the fabric of our lives today.

What are the actual numbers?  It’s currently estimated that there are 65.7—65.7 million family caregivers in the U.S. alone, approximately 29 percent of the population.  These are figures based on a study released November 2009 by the National Alliance for Caregiving and the American Association of Retired Persons, or AARP.  This study found that Alzheimer’s or memory problems and cancer care, respectively, are the second and third leading reasons for a person needing care after simply old age.

At least in the context of cancer, which I’m going to talk about now, caregiving figures are going to be rapidly on the rise.  Why?  Because the number of survivors is rapidly on the rise.  Currently, there are 13.7 million cancer survivors in the United States, 60 percent of whom are age 65 and older.  By 2022, the number of survivors will rise to 18 million.  That increase is going to be driven largely by the aging of the population, specifically the aging of the baby boomer population.

The U.S. Census Bureau reports that almost 38 million Americans are currently over the age of 65 and that by 2030 that number will nearly double.  Even if we make a conservative estimate that only a third, let’s say, of survivors need assistance at some point in time for their cancer, that figure today would lead to there being over 4.6 million cancer caregivers, a stunning number when we think of what we need to be doing.  

Importantly, the message today I think should be that identifying and delivering interventions that will help these caregivers provide optimal care to their loved ones or care recipients, while importantly maintaining their own good health, matters.

One could take a look at this report and come away and be very dismayed.  I hope that is not going to be the response of either any of the listeners or anybody who takes importantly the time to read through this documentation.  The implications for practice are more limited as Joan pointed out.  

There is no clear evidence that any one intervention is going to benefit, but there are some tantalizing indications about the kinds of interventions that may be helpful.  In particular, those that target individuals who are at high risk for vulnerability, as was demonstrated in the Nezu study and then Porter and colleagues work with their two studies.  

It’s important to note too that you need to understand what the issues are for caregivers and their care recipients.  In this regard, I think one of the challenges that we have is trying to figure out how we are going to define what quality caregiving should look like.  I would posit for us to consider that there are multiple perspectives to this.  

The care recipient, so if I’m going to be the beneficiary of this care, what is that I need from my caregiver?  From the care provider, what I need to be delivering to my loved one.  From the healthcare team, what are we expecting these individuals to do to help in the wellbeing or management of the disease trajectory?  For other family members, what are we expecting a child to believe that a spouse should be doing for a sick parent?  Also the public, what do we think we should be paying for and obtaining from this body of research?

When we sit down and try and map that out, we may have a better idea of how we’re going to target some of the issues that have come up and begin to identify interventions to address those.  The implications for research design from this are huge.  I think that Joan has very nicely gone through some of those, but I’m going to highlight these again from a slightly different perspective.

In particular, when we think about cancer, cancer is not a single disease.  It is many diseases and it has a variable trajectory for each person diagnosed that depends on the type of cancer, the nature and stage of the disease, the treatments needed or received, the age or developmental stage of the person diagnosed.  A woman diagnosed with breast cancer in her 20’s is going to have a very different challenge than someone diagnosed in her 80’s.  The pre-existing health of the individual, pre-cancer health and function of the patient, the resources available to the patient, both physical, emotional, social, financial.

Importantly, where that person is on the trajectory.  All too often what we see in these studies, including the 27 that were reviewed here, is that patients are taken at variable stages in the trajectory.  They may be earlier in their course, and they may be in the middle of treatment or transitioning off treatment or post-treatment.  

Those areas on the care trajectory have very different need components.  If we aren’t looking at that and trying to match up what someone needs at that point in time, we’re likely to miss the mark in having an impact on those care recipients’ outcomes.  At a minimum, we need to be thinking about that.

Also *[audio cuts out 57:43]* although it may have been contained in some of these papers is, is there a model or a theory that’s driving some of the science?  Are the researchers trying to say, “What do I need to be asking?”  If I think it’s a coping skills, how do I think that training someone in coping skills management is going to affect an outcome?  

Further, building into the research design a measure of that.  Did I improve the skills training or did I just deliver a program and expect that it worked?  I think that’s a very important question for us because it may clue us in to why something is or isn’t working.

I think we clearly need to develop and support more rigorous methodology.  Many of the studies that were reviewed here are reported as fair or poor; very few good.  There’s only two good studies classified as good, the two Porter studies in the cancer set of literature.  

One has to ask the question:  Was it that the study wasn’t good or the reporting was so terrible that it doesn’t look like it was good?  I think that is a wake-up call again to how we’re reporting this.  Are people following the concert guidelines and putting all the elements when they write the paper?  I think that’s very important.

Sometimes the question we often don’t ask is:  Is there a good match between the caregiver’s skills training, etcetera, and what he or she is supposed to deliver?  I worry about this in caregiver research because we’re expecting a lot of caregivers, and caregivers sometimes are not well matched to the task we’re asking them to do.  I

t could account for why the intervention fails because if you don’t feel you’re good at giving medications or monitoring medications, even if we train you to do that and you don’t feel self-efficacious in it or don’t want to, it’s going to be a mismatch, and likely you’re going to have a worse impact for the individual receiving that care.

I think important in this review and something we need to be considering are the harms.  Interestingly again, in the cancer literature, a couple of the studies found that the caregiver was more distressed because he or she learned perhaps some of the challenges to this care and the symptoms that she or he may experience or their care recipient were that were news to them and it caught them unawares.  I think looking at potential harms is something we really need to support.

Finally, I think we need to be thinking also about designing studies for implementation.  I think many of these studies tried to do a good job of that.  They tended to be shorter term, although there were some quite intensive studies that were covered in here, what’s quote/unquote deliverable.  Importantly, we do need to be adding in that health services component.  Healthcare utilization or cost of delivery of this, particularly if we’re expecting systems like the VA, for example, or an insurance framework to pick these up and run with them or a clinical practice.  

I think as an overall statement in here we have a lot of work to do.  The important message from this:  It’s a wake-up call.  We simply cannot keep doing this type of research as usual.  We need to take a short step back here, look at where we’re heading and begin to think where are the real gaps.  What do we know?  What should we be doing better to really support this research?  

Because it’s worrisome that we have 27 unique studies, at least in cancer, thousands of individuals who participated, and very little to show as clear evidence of something that works.  That we need to change.  I think with this review it’s going to help us guide our movement forward in a direction that will help us address this.

Thank you.  I’ll turn it over now to Meg for her comments.

*Speaker:*All right.  Thank you so much.  I too want to thank both Dr. Griffin and Heidi for inviting me to participate.  I also want to thank Julia for her comments.  Because she did such a nice job of expressing why this is so important, I’m going to skip over my thoughts about that because I agree with her completely.  She certainly provided a nice sense of the impact.  

I will add that in my work within the VA’s caregiver support program, I do want to make everyone aware that caregiving is a very hot topic across many, many different programs and institutions.  There is a lot of work being done outside of VA.  Luckily, and in a very good, positive way, VA is being asked to participate in a lot of work that’s going on across different communities around supporting caregivers.  I’m thrilled to be a part of all that.

I too want to echo some of Julia’s comments.  I agree, you heard Joan talk over and over, say different things, like evidence not strong enough, data were insufficient.  I think too, while this could be a very disheartening discussion, I think that we really need to think of it more as, as Julia said, as a wake-up call and that we really need to take a look at what we’re doing to support caregivers in order to support folks with chronic illness.  

Certainly, I think in many ways, like cancer, dementia is not one disease as well.  Certainly, it’s most often diagnosed at an older age, but it can look very different from one individual to the next.  Certainly, the cause of the cognitive issues can be very different from one another, and therefore lead to all sorts of other concerns and issues.  

Often, a diagnosis of dementia is a co-morbid condition with some kind of a physical health problem that can really add to the caregiving issues.  Someone who may have been able to manage their own diabetes prior to diagnosis of dementia may no longer be able to do that.  It’s sort of a double blow to that individual caregiver.

I just want to touch on a couple of thoughts as we move through this.  You’ll note that Joan talked a lot about the targeted interventions at a specific stage in cancer, for example, or a specific stage in dementia.  

You’ll note that none of the studies really talked about targeting the intervention on the status of the caregiver themselves.  Certainly, I know from talking to hundreds and hundreds of caregivers of veterans *[chuckles]*that really often it’s not so much the work that they’re doing, it’s what they think about the work that they’re doing and how they feel about the work that they’re doing.

We have many caregivers who are quote reluctant caregivers.  This is not what they intended.  This is not what they imagined when they married their spouse or when they sent their son or daughter off to war.  Certainly, to quote many of them, “It’s not what I signed up for.”  I think that the piece around where the caregiver is in their particular journey of acceptance of their role or maybe in their journey of removing themselves from that role has a huge impact on what’s going on with that individual patient.

I think if we can also look at targeting interventions to where a caregiver is at.  Someone may be doing very intense physical hands-on work for someone at the end stages of dementia and be perfectly fine and not really need a lot of assistance.  Whereas, someone maybe doing only some minimal work, some supervision of what’s going on in the home, and yet really be struggling with their own mental health issues, their own physical issues, or their relationship that they have with that patient.  That may have more of an impact on what’s going on than really the stage of that disease.

The second point that I want to make is really this issue of who is our patient, who is our concern, who is our focus when we do these kinds of interventions.  I think this study looks at the impact of the patient on supporting that caregiver.  I think for a system like VA that’s an important point because we have the charge to take care of the nation’s veterans.  Certainly, there’s been more and more legislation passed recently around supporting family members and caregivers who are not that individual veteran.  

I think that question—VA is not unique in that, however, because certainly when Medicare looks at supporting folks that they’re responsible for through Medicare, the individual who’s doing the caregiving may not be a Medicare recipient.  I mean often I think the average age of someone taking care of someone with dementia is in their mid to late 40’s, and they’re taking care of their aging mother.  That mother’s probably a Medicare recipient, but the daughter is mostly likely not.  Medicare may not be as concerned with the outcomes for that caregiver.  They may be more focused on the outcomes of the individual who’s being served with Medicare.  

I think that from the holistic perspective, if we’re not supporting that caregiver at the same time, eventually there’s going to be significant impact on her health and wellbeing as well.  I think we need to take really the broad look at this around who is our patient.  The patient outcomes, although they are certainly significant and important, they’re not the only thing we need to look at.  Because if that caregiver cannot continue what they’re doing over a long period of time, then that’s going to have a significant impact down the road.  

I really want to make sure that that’s something that people really take away from this conversation is this idea of who we’re supporting, who we’re looking at, and that the needs, the physical health, the emotional health of that caregiver may be more important at times in the progression of a disease than what’s going on with the patient who’s being cared for.  I think that that’s an important part of the conversation.

Those were really my comments.  I’m hoping that we’ll hear from some folks who are online as well.  I guess I’ll turn things back over to Joan and to Heidi.

*Moderator:*Fantastic.  We do actually have one pending question out here.  For the audience, if you do have any questions for any of our speakers today, please feel free to type those into the Q&A box in the lower right-hand corner of your screen.  We’re just going to start with the first one here.  Joan, this came in while you were speaking.  Did the studies assess outcomes to caregivers, suggesting perhaps lowered caregiver burnout or stress?

*Speaker:*There was a split between the trials, between those that were specifically looking at patient outcomes only and those that looked at both caregiver and patient outcomes.  We didn’t look at the caregiver outcomes in those trials that looked at both patient and caregiver outcomes, but some of them did.  Their primary focus may have been improving caregiver outcomes, but they also included patient outcomes in addition to, as sort of a sub-analyses.  It was kind of a combination, but that wasn’t part of our scope, and so we didn’t include the caregiver outcomes in our review.

Having said that, I should direct people to Elizabeth Goy’s Systematic Review that was done about a year ago on dementia caregivers that looked at both patient and caregiver outcomes.  If people are interested in that work, she did include some of those trials in her review.

*Moderator:*Great.  Thank you.  That is actually the only question we have received in—oh, here we go.  What tools were used to assess depression and anxiety, also for quality for life?  Was the Lawton and Katz used for IADLs?

*Speaker:*We tried to cast a wide net and included any measure or instrument that was a validated measure.  For depression and anxiety, we had probably 15 or 18 different measures of depression, and also a number for anxiety.  There were quite a few different assessments for ADLs and IADLs.  

We included any trial or any—we included any assessment if it was a standardized or validated measure.  If it was sort of a homegrown one where they asked one question or a series of three questions that they made up, those were not included.  

We did have the Lawton for depression.  I think for cancer it was mostly the CESD that was used.  We didn’t have enough across outcomes, so there wasn’t enough consistency across the outcomes for depression and quality of life that we were able to group the data and then do a meta-analysis where we looked at the data that used that consistent measure.  

That was one of the limitations of the review was that the measures that were used across trials were inconsistent enough that we weren’t able to really pool any data and look at effect sizes across a number of different ones because they used different measures.  I think that the questioner hit on something that I think is a limitation of the trials.

*Speaker:*This is Julia, and I’ll just comment on that in terms of tool use.  Tools are important.  It’d be nice to have some set from which people were all drawing in some way or there’s some cross-scoring that you know on the ADSIS, the CSD and stat 01:11:57.  

I would also point out that because so many of these studies didn’t take high risk people, so they didn’t use a criterion cutoff for depression or physical problems or symptoms to intervene that you have kind of an issue of really deflating potential impact of your intervention because you’re delivering it to all comers.  

I think that really is an important point for us to be considering, particularly if we’re thinking of tools.  What tools can we use for cutoff and where we can show some kind of movement over time when we develop these interventions?

*Moderator:*Great.  Thank you.  The next one here is more of a comment.  Excellent presentation today.  Thank you for your thoughtful work.  Would like to mention that there are many similar issues for unlicensed caregiving nursing staff at our nation’s nursing homes and the VA community living centers.  This issue also affects discharge planning and care transitions when we don’t address the caregiver needs in the community especially for our non-service connected, low-income veterans.

*Speaker:*That’s a really interesting comment.  As far as the research around that world, I’m not as familiar with the nursing care and the nursing home care workers.  Although those were excluded from our study because they weren’t family caregivers, but I think the commenter makes some really interesting points and things that we really need to pay attention to.

*Speaker:*This is Meg.  I’d like to comment as well.  I agree that it’s a very important component.  I mean often family caregivers with someone who requires more physical hands-on care, a veteran with ALS or MS or Parkinson’s or even advanced stages of Alzheimer’s, there may be that family caregiver who requires assistance intervention, but there’s usually also a paid caregiver at that point, whether that person’s being paid through the VA or in other ways.  

That person often becomes an integral part of that family and requires support and assistance and training and education in the same way that the family caregiver does as well.  I agree that that is something that we really need to be paying attention to as we move forward as well.  It’s often not just one family caregiver in isolation taking care of someone, but there’s a whole system going on that needs to be impacted in different places.  I think that’s an excellent point.  Thank you.

*Moderator:*Great.  Thank you.  We have one last comment here, and then we’ll wrap things up today.  We have here home telehealth has a great intervention for caregivers.  We really need studies on the efficacy of this intervention.

*Speaker:*Great.  I am not as aware—I think that there’s—I think that one of the things that came through in our review is that there, especially when we sent it out to the reviewers, is that there is a lot going on.  Meg alluded to this as well.  

There’s a lot that’s beginning to bubble up.  There are a lot of trials that are right now in the field.  I think that results are coming out.  We’ve been trying to update our results every three months or so, four months.  It seems like we are on the verge of a lot of new research coming out.  

Just to echo back to what Julia was saying is that I hope that as these new trials come out, it’s not that the trial is maybe a poorly designed trial.  It may not be that they are poor trials; it may just be that they’re poorly reported trials.  

I think that there’s a lot of opportunities.  Anybody who’s interested in caregiving research, there’s a lot of opportunities that are coming up.  I think that there’s a lot more attention to the area overall, especially as we move towards more patient-centered care and trying to figure out how to deliver better and more effective patient-centered care.

*Speaker:*This is Julia just to add on to that.  I think the person who sent in that question, it’s a great question.  Telehealth, using social media, using other digitized kinds of ways to support people, particularly if they are remote and can’t get into face to face kinds of encounters or interactions.  It’s a whole new way that the technology is moving.  It’s also a new way to track it.  

I think of Barbara and Bill Gibbons at Michigan State work with symptom management in the cancer arena where it’s done by phone.  Caregivers phone in and then a nurse can respond if they see that the patient is really struggling with symptoms.  They can help with the management of that without a patient ending up in the ER.  

I think there’s some very dynamic things, as Joan said, going on right now.  Some of them are already in the middle of being conducted, but stay tuned because I think this is another platform, another way that we can push out effective interventions.

*Moderator:*Fantastic.  Great.  Thank you so much.  I really want to thank Joan, Meg and Julia, all three of you, for taking the time to present today.  We really appreciate the time that you put into this.  For our audience, we really want to thank you all for joining us for today’s session.  

As I close out the meeting today, you will be prompted with a feedback form.  We would appreciate if you would take a few moments to fill that out.  We really do read through all of that, and we will be passing all of that information along to our speakers from today’s session.  

Thank you everyone for joining us for today’s Evidence-based Synthesis Program cyber-seminar.  We hope to see you at a future session.  Thank you.

*[End of Audio]*

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