A Randomized Controlled Trial using Brief Educational Messages Directed to Adults with Intellectual Disability and Hypertension or their Helpers Reduces Hospital Stays

Abstract

Purpose

We assessed an educational intervention to reduce the number of emergency department (ED) and inpatient stays for cardiovascular diagnoses, among South Carolina adult Medicaid Members with intellectual and developmental disability and hypertension (Members).

Design

This Randomized Controlled Trial (RCT) included Members or the person who helped them with their medications (Helpers). Participants, who included Members and/or their Helpers, were randomly assigned to an Intervention or Control group.

Setting

South Carolina Department of Health and Human Services, which administers Medicaid, identified eligible Members.

Sample

412 Medicaid Members - 214 Intervention (54 Members participating directly; 160 Helpers participating in lieu of Members) who received the messages about hypertension and surveys about knowledge and behavior and 198 Controls (62 Members; 136 Helpers) who only received surveys of knowledge and behavior.

Intervention

Educational intervention about hypertension included a flyer and monthly text or phone messages for one year.

Measures

Input measures - characteristics of the Members; Outcome measures - hospital emergency department (ED) and inpatient visits for cardiovascular conditions.

Analysis

Quantile regression tested the association of Intervention/Control group status with ED and inpatient visits. We also estimated models using Zero-inflated Poisson (ZIP) models for sensitivity analysis.

Results

Participants in the Intervention group with highest baseline hospital use (top 20% ED; top 15% Inpatient) had significant reductions in Year 1 (.57 fewer ED and 2 fewer inpatient days) compared to the Control group. For ED visits, improvement continued in year two.

Conclusion

The intervention reduced the frequency of cardiovascular disease-related ED visits and Inpatient days for participants in the Intervention group in the highest quantiles of hospital use, and the improvement was better for those who had a Helper.

Keywords

intellectual disability hypertension randomized controlled trial hospital visits helpers

Background

Cardiovascular disease (CVD) is the leading cause of death in the US for both the general population and among individuals with intellectual and developmental disability (IDD).^1,2 A major risk factor for cardiovascular disease is hypertension.³ IDD is typically present at birth and affects a person’s intellectual capabilities, and it often impacts both life tasks and social skills.⁴ There are numerous studies on hypertension rates in adults, but few have reported hypertension rates among adults with IDD.⁵ Most recently, a 2020 study of 33,122 adults with intellectual disability (ID) who participated in Special Olympics reported that 48.0% had hypertension, defined using guidelines from the American Heart Association in 2017 (≥130/≥80 mmHg). This rate is similar to that of the general US population.⁶

Hypertension is a preventable and treatable condition. There is substantial evidence that adherence to anti-hypertensive medication reduces the risk of cardiovascular events. One proxy of hypertension medication treatment efficacy is prescription days covered (PDC). A number of studies have shown that people who had at least 80% PDC also had lower use of hospital care, including both emergency department (ED) visits and inpatient (IP) stays.^7-10 Although lifestyle modifications such as diet, exercise and weight reduction have been shown to be helpful for lowering blood pressure, anti-hypertensive medications are often needed for effective management and reduction in risk for CVD.¹¹ In recent years, several studies have identified both risk and protective factors that have been associated with hypertension medication adherence in people with IDD. Reports have shown that rates of hypertension medication adherence are lower for Black or African American people and people with income at or below 185% of the federal poverty standard, especially those without insurance.^12-14 A study of adults with IDD enrolled in Medicaid in Kansas found that only 55% of those with IDD and hypertension were adherent to anti-hypertensive medication.¹⁵ In our previous work, we noted that only about half of adult South Carolina (SC) Medicaid members with IDD and hypertension were adherent to anti-hypertensive medication, defined as having at least 80% PDC, during the study period of 2000-2014.¹⁵ The SC study revealed that those who lived in a supervised residence, had a Medicaid waiver to provide supervised living, and had more frequent contact with a primary care provider were more likely to be adherent to hypertension medication.¹⁵ These findings are not surprising since staff in these situations are typically available to dispense and supervise the administration of medications as prescribed.

Adults with IDD are an important group for healthcare interventions; because, although they only represent only 1-2% of the adult population in the U.S,¹⁶ they have significantly higher rates of some adverse health conditions.^17,18 For example, in 2017, it was reported that adults aged 45-64 years with IDD had a prevalence of heart disease of 28.9% compared to 11.9% in the general population.¹⁹ Also, previous studies have reported higher utilization of healthcare services for people with IDD, compared to the general population;²⁰ and that high use of acute care services may be due in part to greater complexity of health needs in adults with IDD.^18,21 Further, a recent study of ED usage among people with IDD showed there was not substantial changes in ED visits during the period of Medicaid expansion,²² which implies that the issue involves more than the availability of health insurance coverage.

Research exists to demonstrate that antihypertension medications reduce the risk for hospitalization among the general population,^7-10 and people with IDD rely on caregivers to help them with medication refills and management.²³ Also, it has been shown that health interventions which include traditional caregivers have been successful in improving the health of people without IDD;^24-26 but randomized controlled trials (RCTs) have not been conducted to test the efficacy of targeting both adults with IDD and their self-identified helpers to reduce hospital use.

This study builds on the understanding that IDD is a continuum that includes individuals who can independently manage aspects of their healthcare services, while others need the support of helpers. The theoretical underpinning of this study rests on the fusion of the medical and social models of disability. The diagnosis of hypertension is a medical construct, but adults with IDD rarely identify with a diagnostic or disability label, or a group identity. Most adults with IDD know that they have the right to make choices and to decide if they want the support of a Helper. In this RCT, the study team let the Member decide if they wanted to function independently, or if they wanted their Helper to be the person that received the text or phone calls. Thus, the RCT included some Helpers in both the Intervention and Control group but the outcome of interest was the hospital usage by the Members, regardless of whether they directly enrolled in the study as a participant, or if they were represented by a Helper.

Purpose

This RCT trial sought to test the effectiveness of educational messages in reducing cardiovascular-related ED and IP visits, when delivered to adult Medicaid Members with IDD and hypertension (henceforth referred to as Members), or to their family or other caregivers (henceforth referred to as Helpers), about the importance of adhering to the medication. We partnered with the SC Department of Health and Human Services (SC DHHS), the administrator of the Medicaid program in SC, in anticipation that study findings would have direct implications for the services provided to Members.

Previous intervention studies have demonstrated the efficacy of text messaging and brief educational encounters about hypertension in helping participants to control blood pressure and improve medication adherence,^27-29 including one which showed that the text messaging intervention halved the odds of participants with hypertension having uncontrolled blood pressure after six months;²⁸ however, we could not find any previous RCT that included people with IDD. We conducted a RCT to assess the impact of a low-cost education and reminder system related to anti-hypertensive medication and lifestyle on the outcomes of CVD-related ED visits and IP stays. The education and reminders were directed to the Intervention group, which was comprised of Members or Helpers who assisted Members with prescription management. The Control group was similarly comprised of Members and Helpers, but they did not receive the education and reminders. The focus of this report is to present our findings from tests of the following hypotheses:

1. Regardless of whether they were self-represented or represented by a Helper, Members who were randomized to the Intervention group would have fewer CVD-related ED and IP visits one year after enrollment in the RCT, compared to Members randomized to the Control group.

2. Intervention group Members who were represented by a Helper would have fewer CVD-related ED and IP visits one year after enrollment in the RCT, compared to Control Members who were represented by a Helper.

Methods

Design

This study was a RCT with two parallel groups. Detailed study methods have been described in a previous publication about knowledge gain in the Intervention vs Control group with and without Helpers.³⁰ Here, we provide a brief overview of the study with more detail provided in the statistical methods section, as it related to the hypotheses described above.

Sample

Study participants were Medicaid Members who lived alone or with roommates or with family in the community. Potential participants were identified by SC DHHS in 2018 using Medicaid enrollment files. To be included, Members had to be ages 18-64 years, living in the community, enrolled in Medicaid for at least 12 months, and identified as having IDD and hypertension, using the International Classification of Diseases, ninth or 10th revision (ICD9 or ICD10): ICD9 317-319; ICD10 F70-F79 for IDD and ICD9 401.0, 401.1, 401.9; ICD10 I10 for hypertension. Initially, 2609 individuals were sent a recruitment letter to explain the study along with instructions about how to opt in or out of it. The letters explained that eligibility for participation in the RCT included either the Member OR a helper who assisted the Medicaid Member with obtaining and/or administering medication (Helper), but not both. Recruiters always initially asked to speak to the Member; but in many cases the person answering the phone connected the recruiter with a parent, friend or caregiver (ie, Helper) at the home, who stated that they handled communications on the Member’s behalf. Our approach to recruitment allowed for Members to decide who should participate, either the Member or their Helper who assisted with medication administration. We did not attempt to convince a Member that they should or should not participate directly. See Salzberg et al³⁰ (2022) for more recruitment details.

Inclusion/Exclusion Criteria: We only recruited English-speaking Members and Helpers.

The Recruiter asked whether the Member had been prescribed hypertension medication within the past two years. If the answer was no, then they were excluded from the study. Members were also excluded if the Member resided in a group home or other congregate setting where medication was administered by staff. This reduced the potential pool of applicants by 646 Members, resulting in a potential pool of 1963 eligible participants.

Informed Consent: For those who met the inclusion criteria, recruiters explained the study, answered any questions, and obtained verbal informed consent from the Member or Helper based on who elected to participate.

Human Subject Review: The study was approved by the appropriate IRB and conducted with a formal agreement with SC DHHS following all HIPAA privacy policies and procedures. Consent for participation was obtained orally by telephone.

Intervention and Control Group Assignment: A computer-generated random number system was used to make the Intervention and Control group assignment, stratified by the age group of the Member: either 18-45 years or 46-64 years, since age is associated with differences in overall health status and we did not have access to Members comorbid conditions.³¹ The age of the Helper was not considered in this process. The random assignment to age stratified Intervention and Control group was made regardless of whether the Member or the Helper was the participating study member. Each participant was assigned a unique Study ID.

Incentives: Participants received $25 upon study enrollment; $10 for completing a check-in call after six-, 12-, and 18-months, and $20 at 24-months.

Lost to Follow-Up: Throughout the two-year study some Members and Helpers became unreachable by telephone and US mail. We made several attempts in various ways to re-contact participants, eg, trying at different times of the day, sending multiple re-contact letters, and regularly obtaining updates in contact information from SCDHHS. Nonetheless, of the 412 people who enrolled in the study, 106 were lost in Year 1, and an additional 52 we lost to follow-up in Year 2. Figure 1 shows the numbers recruited and lost to follow-up at each stage of the study.

Figure 1.

Flow chart showing enrollment and lost to follow-up (LTFU) for Medicaid Members with IDD and hypertension in a randomized controlled trial (RCT).

Measures

Hospital ED and IP visits of the 412 Members (regardless of whether they or their Helper enrolled in the study): Our partnership with SC DHHS enabled us to link the dates of Medicaid coverage with the statewide all-payer hospital discharge data for the cohort. We obtained data about hospital stays, including cardiovascular-related ED visits and IP stays, from the SC Office of Revenue and Fiscal Affairs (SC RFA), which serves as the data center for many types of SC administrative data. The requested data only included ED and IP stays that had an ICD10 code for a cardiovascular condition (Table 1). The dataset that was queried was the SC All-Payer Hospital Discharge Dataset (HDD). SCDHHS provided support in this process by interfacing directly with SC RFA to identify the participants for whom the data was needed; and then SC RFA was able to develop the dataset and then they removed all HIPAA-protected identifiers and delivered it directly to the study biostatistics team, using the unique Study ID only.

Table 1.

Cardiovascular-related International Classification of Diseases, 10th Revision, Clinical Modification (ICD10) Codes used to Identify Hospital ED and IP Visits.

ICD10 Codes		Frequency	Percent, %
I10	Essential (primary) hypertension	1118	82.69
I110	Hypertensive heart disease with heart failure	74	5.47
I509	Heart failure, unspecified	51	3.77
I2510	Atherosclerotic heart disease of native coronary artery without angina pectoris	30	2.22
I5022	Chronic systolic (congestive) heart failure	13	.96
I5032	Chronic diastolic (congestive) heart failure	8	.59
I119	Hypertensive heart disease without heart failure	7	.52
I252	Old myocardial infarction	7	.52
I214	Non-ST elevation (NSTEMI) myocardial infarction	6	.44
I5033	Acute on chronic diastolic (congestive) heart failure	6	.44
I5031	Acute diastolic (congestive) heart failure	5	.37
I5030	Unspecified diastolic (congestive) heart failure	4	.30
I5042	Chronic combined systolic (congestive) and diastolic (congestive) heart failure	4	.30
I5043	Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure	4	.30
G459	Transient cerebral ischemic attack, unspecified	3	.22
I5023	Acute on chronic systolic (congestive) heart failure	3	.22
I159	Secondary hypertension, unspecified	2	.15
I213	ST elevation (STEMI) myocardial infarction of unspecified site	2	.15
I21A1	Myocardial infarction type 2	2	.15
I5020	Unspecified systolic (congestive) heart failure	2	.15
I25110	Atherosclerotic heart disease of native coronary artery with unstable angina pectoris	1	.07

The Intervention

After enrollment, we mailed an educational flyer about blood pressure and hypertension, including the definition of hypertension, symptoms, consequences for not taking medication, and adverse outcomes that could occur from not keeping hypertension under control to the Members and Helpers in the Intervention group. For the next 12 months, all Intervention participants received monthly messages, either personally delivered via telephone by a member of the study staff, or via text message, according to their preferred mode of communication. The messages addressed the importance of adhering to anti-hypertensive medication prescriptions and instructions from their healthcare provider, as well as some information and health tips related to managing hypertension. See Salzberg et al³⁰ (2022) for details about the educational flyer and monthly messages. The study staff was comprised of advanced social work and educational counseling graduate students, who were supervised by the study manager.

We delivered two distinct but very similar sets of messages – one to Intervention Members and the other to Intervention Helpers. The readability for the Member messages was no greater than grade six, as assessed with standard tools in Microsoft Word, and messages were direct, eg, “Take your blood pressure pills like your doctor said! Exercising, eating healthy, and taking pills as directed are important for your health.” The readability for messages directed to Intervention Helpers did not exceed grade seven, and they were indirect: eg, “Exercising, eating healthy, and taking blood pressure medicine as directed are all important for the health of the person in your care.” Control participants did not receive any educational materials or content during the RCT study period; but they received the educational flyer at the conclusion of their participation, about two years after enrollment.

Analysis

Baseline characteristics were summarized for Intervention and Control groups. The numbers of participants were tabulated for both groups, with a breakdown of number of Helpers and Members in each. All Members were included in an intention-to-treat analyses, regardless of whether they were directly participating or represented by their Helper or if the participant was lost to follow-up at any point. Approximately 38% of the participants were lost to follow up over the 24-month study period, with most dropping out in Year 1 (26%) (Figure 1).

Quantile regression (QR) models, for those who remained in the study, were used to assess the potential heterogeneity in the association between the exposure (ie, Intervention vs Control; Member with Helper vs Member without Helper) and different quantiles of the outcome (ie, ED visits and IP stays), adjusting for covariates.³² Participants’ age, race, sex, Intervention group identifier, Helper group identifier and an interaction term for Intervention group identifier by Helper group identifier were used in the regression models. We did not report ethnicity because this data field is often not filled in the South Carolina Medicaid dataset, and the survey was only done in English, so were not able to accommodate Spanish speakers. Quantile regression was chosen since there were a large number of zeros (ie, Members with no ED visits or no IP stays), combined with a few people with high numbers of ED visits and/or IP stays. By inspecting quantile regression results for quantiles from .05 to .95 (with increments of .05), we characterized the potentially different associations of participants' ER visits and IP stays to assignment to the Intervention group, with or without a Helper, at various quantiles in the conditional ER visits and IP stays distribution. All quantile regression analyses were adjusted for the demographic characteristics of age, sex, race, baseline year ED, baseline year IP stays, Intervention or Control identifier, and Helper group identifier. Adjustments ensure that the estimated treatment effect is adjusted for any imbalance that may have occurred between the groups. Data management, univariate tests and quantile regression were performed using SAS 9.4 (SAS Institute Inc, Cary). The statistical significance level was set at P = .05.

While we primarily report the quantile regression, we also estimated models using Zero-inflated Poisson (ZIP) regression models for sensitivity analysis. We also ran difference in differences, mixed effects, and population-averaged GEE, though significance was not always achieved because these models (including ZIP) focus on changes in average responses which are very small. Quantile regression, in comparison, focuses on associations with changes in responses at specific quantiles which allows us to focus on the higher demand sections of the distributions of ED and IP visits.

Results

The primary outcome of this clinical trial was a reduction in the number of ED and IP visits one year after the intervention was delivered. Given the fact that ED and IP visits are relatively rare events, we observed a statistically significant difference between the Intervention vs the Control group for those in the upper quantiles of the distribution of hospital utilizations. We enrolled 214 participants into the Intervention group and 198 into the Control group. Participants included 296 Helpers (160 Intervention and 136 Control) and 116 Members (54 Intervention and 62 Control). Table 2 shows the demographic characteristics of the participating Medicaid members with IDD and hypertension, regardless of whether the Member directly participated in the intervention, or their Helper was the participant. We note that age, race, sex, Member or Helper participation were not significantly different for Intervention and Control participants.

Table 2.

Characteristics of the Members, separated by who participated in the study – Helper or Member and Intervention or Control.

	Intervention	Intervention	Control	Control
	Helper	Member	Helper	Member	Total
	(N = 160)	(N = 54)	(N = 136)	(N = 62)	(N = 412)	P-Value*
Sex						.007
Female	62 (38.8%)	27 (50.0%)	49 (36.0%)	37 (59.7%)	175 (42.5%)
Male	98 (61.3%)	27 (50.0%)	87 (64.0%)	25 (40.3%)	237 (57.5%)
Race						.231
Black	86 (53.8%)	29 (53.7%)	86 (63.2%)	39 (62.9%)	240 (58.3%)
Unknown/Other	36 (22.5%)	13 (24.1%)	21 (15.4%)	16 (25.8%)	86 (20.9%)
White	38 (23.8%)	12 (22.2%)	29 (21.3%)	7 (11.3%)	86 (20.9%)
Age						.240
Mean (SD)	44.2 (13.5)	48.3 (11.8)	44.7 (13.0)	45.2 (11.3)	45.0 (12.9)
Baseline ED visit (days)						<.001
Mean (SD)	.431 (1.06)	1.37 (2.37)	.640 (1.80)	2.45 (5.01)	.927 (2.54)
Median [min, max]	0 [0, 7.00]	.500 [0, 12.0]	0 [0, 16.0]	1.00 [0, 29.0]	0 [0, 29.0]
Baseline IP stay (days)						.009
Mean (SD)	.556 (2.67)	3.17 (9.94)	1.87 (5.99)	3.87 (12.9)	1.83 (7.30)
Median [min, max]	0 [0, 28.0]	0 [0, 51.0]	0 [0, 38.0]	0 [0, 92.0]	0 [0, 92.0]
First year ED visit (days)						<.001
Mean (SD)	.381 (.875)	2.28 (7.31)	.728 (2.16)	2.29 (3.91)	1.03 (3.41)
Median [min, max]	0 [0, 6.00]	0 [0, 53.0]	0 [0, 18.0]	1.00 [0, 22.0]	0 [0, 53.0]
First year IP stay (days)						.233
Mean (SD)	.931 (3.97)	3.43 (14.4)	3.79 (18.4)	2.85 (8.58)	2.49 (12.5)
Median [min, max]	0 [0, 33.0]	0 [0, 98.0]	0 [0, 159]	0 [0, 57.0]	0 [0, 159]
Second year ED visit (days)						.002
Mean (SD)	.425 (1.73)	1.31 (3.23)	.669 (1.90)	1.61 (3.45)	.801 (2.38)
Median [min, max]	0 [0, 20.0]	0 [0, 21.0]	0 [0, 18.0]	0 [0, 19.0]	0 [0, 21.0]
Second year IP stay (days)						.538
Mean (SD)	.631 (2.81)	1.11 (4.23)	1.30 (5.37)	.984 (2.42)	.968 (3.97)
Median [min, max]	0 [0, 22.0]	0 [0, 22.0]	0 [0, 45.0]	0 [0, 11.0]	0 [0, 45.0]

- All variables are reported for Member with IDD and hypertension only, regardless of whether the Members directly participated or were represented by their Helper.

- P-values for categorical variables were calculated from the Chi-squared test, and for numeric variable they were calculated from the ANOVA test. Also, the P-values were calculated between four groups: Intervention and Helper, Intervention and Member, Control and Helper, and Control and Member.

Of the 412 total participants in the study, 132 participants (62 Intervention and 72 Control) had at least one ED visit in both the year before the study began and during the first year of the study. During the second year there were 110 ED visits. There were fewer IP stays, with a total of 67 in the year before the study started, 65 during the first year and 45 during the second year. The number of ED and IP visits are shown in Table 3.

Table 3.

Frequency of Emergency Department and Inpatient Visits during Year One and Year Two of the Study.

ER Visit	Frequency	Cumulative Percentile	IP Stay	Frequency	Cumulative Percentile
First Year of Study
0	283	68.69	0	347	84.22
1	57	82.52	1-4	24	85.68-90.05
2	26	88.83	5-10	20	91.99-94.9
3	13	91.99	11-159	21	95.15-100
4	11	94.66
5-53	22	95.63-100
Second year of study
0	302	73.3	0	367	89.08
1	50	85.44	1	4	90.05
2	25	91.5	2-6	21	90.78-95.15
3	12	94.42	7-45	20	95.63-100
4-21	23	95.63-100

In the quantile regression analysis (Table 4), being in the Intervention group and having a Helper were both statistically significant predictors of fewer visits in the 85th and 95^th percentiles of ED visits, compared to the Control group and those without a Helper during the first year of the study. In the second year of the study, being in the Intervention group was significantly associated with a reduction in the number of visits in the 80th and 90th percentiles of ED visits. Being in the Intervention group in the first year of the study was associated with a decrease in ED visits by .813 compared to being in the Control group for the 85th percentile of ED visits. Being in the Intervention group in the first year of study was associated with a decrease in ED visits by .984 compared to Control group for the 95th percentile of ED visits. In the upper part of the distribution of ED visits, there was a significant decrease in ED visits for Members with Helpers, regardless of Intervention/Control assignment, and there was also a statistically significant reduction in ED visits for those in the Intervention group, regardless of whether the intervention participant was a Member or a Helper.

Table 4.

Quantile Regressions^a for Emergency Department (ED) Visits (N = 412).

Parameter	Estimate	Std Err	95% Confidence Limits		P-value
First Year of Study
Quantile Level = 0.85
Baseline ER	1.1875	.0474	1.0943	1.2807	<.0001
Helper	−.8125	.2688	−1.341	−.284	.0027
Intervention	−.8125	.232	−1.2685	−.3565	.0005
Quantile level = 0.95
Baseline ER	1.5873	.0963	1.3981	1.7765	<.0001
Helper	−1.0317	.546	−2.1052	.0417	.0595
Intervention	−.9841	.4712	−1.9104	−.0579	.0374
Second year of study
Quantile level = 0.8
Baseline ER	.8125	.0364	.7409	.8841	<.0001
Helper	−.3125	.2065	−.7185	.0935	.131
Intervention	−.5	.1782	−.8503	−.1497	.0053
Quantile level = 0.9
Baseline ER	1	.0656	.871	1.129	<.0001
Helper	−1	.3723	−1.7318	−.2682	.0075
Intervention	−1	.3212	−1.6315	−.3685	.002

^aadjusted for Member’s age, sex, race, baseline year ED, baseline year IP stays, Intervention group identifier, and Helper group identifier.

Table 5 shows that Members from the Intervention group who had a high number of IP stays, at the 90^th percentiles, had a significantly smaller number of days in the hospital – on average there were two fewer days in the first year of the study – than those in the Control group in the same percentile range. During the second year of the study, participants in the Intervention group had 3.0 fewer days compared to the Control group in the 90th percentile for IP stays. The Intervention group had 2.8 fewer days compared to the Control group in the 95^th percentile for IP stays.

Table 5.

Results of Quantile Regressions^a for Inpatient (IP) Stays (N = 412).

Parameter	Estimate	Std Err	95% Confidence Limits		P-value
First Year of Study
Quantile Level = 0.9
Baseline ER	1	.0663	.8696	1.1304	<.0001
Helper	0	1.0937	−2.1501	2.1501	1
Intervention	−2	.9626	−3.8923	−.1076	.0384
Second year of study
Quantile level = 0.9
Baseline ER	.8	.0574	.6872	.9128	<.0001
Helper	.0001	.9459	−1.8593	1.8596	.9999
Intervention	−2.9953	.8325	−4.6318	−1.3588	.0004
Quantile level = 0.95
Baseline ER	1.2931	.0884	1.1194	1.4668	<.0001
Helper	.4167	1.4568	−2.4471	3.2805	.775
Intervention	−2.8333	1.2821	−5.3537	−.3128	.0277

^aadjusted for Member’s age, sex, race, baseline year ED, baseline year IP stays, Intervention group identifier, and Helper group identifier.

Sensitivity Analysis: We conducted a number of ancillary analyses to verify the results. We primarily focused on Zero-inflated Poisson (ZIP) regression models, but we also ran difference in differences, mixed effects, and population-averaged GEE. Overall, all these statistical methods provided similar results for the middle part of the distribution of outcomes,³³ but Quantile Regression also allowed us to observe significant differences among the high-demand parts of the distributions of ED and IP visits.

Discussion

The results suggests that for individuals with IDD and hypertension, who also have a history of high hospital use, the intervention was very successful. This finding should be understood in light of the fact that we gave Members, in both the Intervention and the Control groups, the option to have a Helper of their choice participate in the RCT. The use of Member selected Helpers is unique, in that most studies identify who will be assigned this role, typically a parent or a paid staff member. This is an important finding since Helpers were associated with a reduction in ED visits, where it is plausible that less severe signs and symptoms would be presented by both groups. In the Inpatient setting Helpers were associated with a smaller number of visits but not with predicting whether there would be a visit. And finally, independent of whether the Member had a Helper, people who were high end users in the baseline year, and who were randomly assigned to the Intervention group, experienced reduced ED and Inpatient stays.

This study was designed to test a brief, low-cost intervention for a population that is rarely provided the opportunity to participate in a RCT. The cost of providing the intervention, without the research elements, is estimated to be low, perhaps $10,000 per year for a part-time graduate student or staff to be able to be in contact monthly with 400-500 individuals with IDD and hypertension. The study design was selected since there is substantial documentation of the systematic exclusion of people with IDD from RCTs.³⁴ This is a particularly underserved population, as acknowledged by the disability community and researchers globally. This study was designed with the understanding of the challenges of obtaining consent from people with IDD, and thus we offered the option of having Helpers participate. Through its INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project,³⁵ which began in 2018, and the more recently updated INCLUDE Project Research Plan (2022), the National Institutes of Health (NIH) has prioritized the inclusion of people with Down syndrome in clinical trials and other research studies designed to improve their health and well-being.³⁶ Although this study was funded in 2017 by the Centers for Disease Control and Prevention (CDC), not NIH, it was designed to increase participation of people with Down syndrome, and other types of IDD, in RCTs, which is aligned with the current goals of the NIH.

The study team was imbedded in the South Carolina Medicaid agency (SC DHHS); and the partnership resulted in the ability to engage potential participants through recruitment letters initially sent by the agency on behalf of the study team. The study team recognized that if the trial was successful, then members would benefit by having better health and the Medicaid agency could benefit by having lower costs for ED visits and IP stays. The findings of the study have the potential to impact the health of Medicaid members with IDD by adding a simple education component via text and email messages. By working together, the study team and the SC DHHS professionals provided necessary safeguards to ensure adherence to HIPAA and IRB requirements for participant confidentiality. We were able to merge Medicaid enrollment and service data files with SC’s all-payer HDD and link them to the study records that included demographics, type of participant (Member or Helper), and Intervention vs Control assignment for all participants.

In accordance with previous studies, our results support the notion that a brief educational and prompting intervention can modestly reduce costly health services.³⁷ The present study is novel in that the target population was comprised of adults with IDD and their Helpers. The study findings also underscored the helpfulness of Helpers, who were identified by the Member with IDD or self-identified when recruiters called the Members’ home, rather than being identified or assigned by an agency. We were able to reach people who directly helped and assisted the Members, rather than focusing on legal guardians, who are not always the people who are actively involved in helping with care and everyday life tasks, when needed.

The study was designed to only include Members who lived outside of staff-supervised settings. Members lived in the community, either independently with or without support from family or friends, or other caregivers, or they lived in family homes. This study group was selected because previous research informed us that this was the high-risk group for low hypertension medication adherence.¹⁵ The focus on this subpopulation is important because the majority of adults with IDD live in these settings, yet most studies focus on group settings, where it is easier to administer an intervention, but where it is also much more likely that medications are provided and taken on schedule.³⁸

There were limitations to the study that should be considered. First, there was an issue of lost to follow-up (LTFU), as described in detail in our previous publication, with about 74% still participating after one year,³⁰ and another reduction down to 63% participating at the end of year two. We responded to the LTFU issue by doing Intention-to-Treat analysis as well as doing analyses for those who were followed throughout the two-year study period. Thus, even if a Member only completed one survey their Medicaid file was linked to the Hospital Discharge Data file and they were included in the analysis of ED and IP visits. Second, we were unable to obtain the prescription fill and refill records for Members with additional insurance. Medicaid is a “payer of last resort;” thus, if there is other insurance, typically Medicare, then Medicaid does not cover the medications. Finally, some of the Intervention participants chose to receive text messages and some preferred phone calls. Our analysis did not include the way the message was delivered to the Intervention group since some people changed their preference and received both text and phone messages. Therefore, our study findings did not identify which message mode was more effective.

This RCT demonstrated that brief, monthly contacts with Medicaid Members with IDD and hypertension and their Helpers, over a one-year period, can reduce the rates of ED visits and IP stays for cardiovascular complaints at the higher end of the distribution of visits/stays (we looked at 75% and higher for ED visits and we looked at 85% for IP stays). As with all RCTs, it is unknown how long the treatment effect will last, but the reduction in ED visits in this study was sustained at the two-year mark. It remains to be seen if “booster” contacts would prolong the treatment effect or if this intervention could be applied to other chronic conditions. It is possible that this project, conducted in collaboration with the SC Medicaid agency, could be sustained as a service provided to Medicaid Members with IDD.

We hope that future research will use the RCT design to incrementally expand the scope of this project. The addition of supports related to lifestyle modification, in the domains of physical activity and nutrition, that are associated with improved control of hypertension could be tested using this rigorous study design.

So What?

What is already known on this topic?

Hypertension is a preventable and treatable condition of which can lower risk for subsequent cardiovascular events.

What does this article add?

The current study shows the effectiveness of an educational intervention targeted to adults with IDD and hypertension. The target group for the intervention was adults with IDD and hypertension or that person’s self-identified Helper. Including both groups in the intervention is an important accommodation for people with IDD since it reflects their lived experience, and not the bias of the investigator who selects a parent or paid staff member to assist. The Intervention group had reduced rates of ED visits for those Members who were at the upper end of the distribution in terms of frequency of ED hospital visits.

What are the implications for health promotion practice or research?

The study found that an educational intervention about hypertension among adults with IDD and hypertension can aid in the reduction of ED visits due to cardiovascular complaints, if it is implemented by Medicaid agencies. The vision of the Centers for Medicare and Medicaid Services, which oversees all state Medicaid programs, is to strengthen the health care services and information available to Medicaid beneficiaries and the health care providers who serve them. This health promotion program, specific to adults with IDD and hypertension, has the potential to improve the health of a vulnerable population and reduce some high-cost health service utilization for state Medicaid agencies.

Footnotes

Acknowledgments

The authors thank all individuals who participated in the study.

Author Roles/Contributions

W. Zhang – Contribution to analysis and interpretation of data, drafting of manuscript and important revisions

S. McDermott – Contribution to concept/design of study, design of data collection, interpretation of data analysis, drafting of manuscript and important revisions

D. Salzberg – Contribution to concept/design of study, design and acquisition of data collection, creation of figure, drafting of manuscript and important revisions

N. Hollis – Contribution to drafting of manuscript and important revisions

J. Hardin – Contribution to design of study, analysis and interpretation of data, drafting of manuscript and important revisions

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the HHS CDC National Center on Birth Defects and Developmental Disabilities (5 U19DD001218).

Disclosures

This work was supported by the Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities (Cooperative Agreement).

Institutional review board (irb) approval

This study was approved by the University of South Carolina’s Institutional Review Board for Human Research, in an expedited review, with approval number CR00027819.

ORCID iD

Deborah Salzberg

Note

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