# Presentation: 100444

## Cardiovascular Risk Education and Social Support (CaRESS) 

**Kevin A. Pearce, MD, MPH**
**Margaret M. Love, PhD**
**Brent J. Shelton, PhD**
**Nancy E. Schoenberg, PhD**
**Mary A. Williamson, RN, BSN**
**Mary A. Barron, RN, BSN**
**Jessica Houlihan, MPH**
**Jenny Carey**
**Supported by a grant from the**
**Agency for Healthcare Research and Quality**

## Cardiovascular Risk Education and Social Support (CaRESS)Participating Primary Care Practices

- Family Practice Associates
- Georgetown Internal Medicine
- Gus Bynum M.D., P.L.C.
- Georgetown Family Physicians
- Family Medicine Clinic of Danville
- Capital Family Physicians, P.S.C.
- Berea White House Clinic
- Central KY Medical Group
- Kentucky Clinic North

- Kentucky Clinic South
- Bluegrass Clinic Stanford Family Medicine & Obstetrics, P.S.C.
- Scott County Family Physicians
- Dartt & Hurt, P.S.C.
- Berea Primary Care Clinic
- Central Internal Medicine
- Bluegrass Medical Group
- Capital Medical Group
- UK Family Medicine Center

## CaRESS Rationale 

- Type 2 DM triples CV risk
- Two-thirds of adult diabetics die from CVD
- Medications and improvements in health habits reduce the rates of disability and premature death due to CVD in diabetics
- But -- many diabetic people still succumb to preventable CVD

## The challenge we addressed

**How can primary care practices foster sustained positive health behaviors in patients with mainly asymptomatic but dangerous conditions?**

## CaRESS Aims

- Test the effectiveness of a primary care practice-based intervention designed to foster supportive involvement of a friend or relative in CV risk reduction for adult diabetic patients
- Evaluate the relevant cognitive and behavioral mechanisms of action of the intervention

## Patient Behaviors/beliefs targeted in CaRESS

- Adherence to prescribed Txs, and recommended follow-up
- Diet and exercise habits
- Underlying health beliefs that affect these health behaviors

## Basic CaRESS Approach

- Educate and motivate patient _and support person (SP)_ to work together to improve CV risk through improved adherence to prescribed Txs, F/U and healthy lifestyle

## CaRESS Study Design

- Clustered Randomized Controlled Trial
- Approx 1 year of follow-up
- All study visits done at PCP practices
- Main Outcomes:
**SBP****	****	****- HRQL**
**LDL****	****	****- Patient satisfaction**
**HbA1C**

## CaRESS Intervention 

- Patient chooses SP with advice from CaRESS program
- Patient** and SP together** attend a 30-minute session with CaRESS RN held at the patient’s PCP office
- Patient** and SP each** receive quarterly newsletters in mail that reiterate and expand upon topics covered in ed. session

## Primary Care Target Population

- Consenting adult patients with type 2 DM
- Suboptimal control of BP (SBP _>_ 130 mmHg)
- Subset also with suboptimal LDL (> 100 mg/dl)
- Willing and ready to involve one particular relative or friend as a support person
- Not pregnant or planning pregnancy in 12 mos
- Expect to be avail for study visits for 12 mos.

## CaRESS Study Schematic

**1,318 **
**Primary care****patients w/ DM plus HBP**
**(some **
**w/  high LDL)**
**Based on Chart****Reviews**

**Recruitment****letters****&****phone calls**

**336 ****Pts****@ 18 practices completing screening****visit**

**Unmask****random****group****assignment**

**43 -Not eligible****64- Declined****30- Drop Out**

** ****Control Group **
**91**** patients**

**Intervention Group**
**108**** pts. and SPs**

**CaRESS ****Study Schematic**

## CaRESS Study Schematic

**Control Group  **
**91 Patients **

**Intervention Group**
**108 Pts. & SPs**

**Pt. Educ.****Session****(no SP)**

**Pt. Educ.****Session****with SP**

**Data****Collection****Visits**
**n = 74**

**Data ****Collection****Visits**
**n = 60**

**Data****Collection****Visits**
**n = 92**

**Data****Collection****Visits**
**n = 81**

**6**

**6**

**mos**

**mos**

**mos**

**mos**

**3 - 6**

**3 - 6**

**Quarterly Newsletters for patients and SPs**

**Quarterly  Newsletter  for  patients  only**

## CaRESS   Main Results 

## Baseline Characteristics ~ Equal

- Age
- Gender
- Race
- Education
- Employment
***Insurance***
- Hx CVD
- Smoking
- Alcohol use

- SP relationship and qualities
- Health competence
- Rx adherence
- BP levels
- LDL level
- HbA1C
- SF-36
- Pt satisfaction

##    Outcome:  Systolic BP (ICC = .105) 

**p = .47**

**p = .18**

## Outcome:  HbA1C level (ICC = .044)

**p = .06**

**p = .88**

## Outcome:  LDL Cholesterol (ICC = .103)

**p = .34**

**p = .67**

**n = 40**

**n = 29**

**n = 29**

## Outcome: SF-36 HRQL  (ICC = .0274)

**p = .41**

**p = .41**

## Outcome:  Satisfaction with health care(ICC = .011)

**p = .63**

## Outcome:  Satisfaction with doctor(ICC = .026)

**p = .06**

## Perceived Health Competence(Self-Efficacy) (ICC = .001)

**Perceived Health Competence****(Self-Efficacy) ****(ICC = .001)**

**p = .17**

## Medication Adherence

**Medication Adherence**

- Baseline

- 9 – 12 Months

**p = .68**

## CaRESS Conclusions

**Our intervention to foster supportive involvement of a relative or friend to reduce CV risk among diabetic adults had no significant impact on the targeted CV risk factors, HRQL or pt. satisfaction.  Power to detect an effect on LDL was too low.**

## CaRESS Conclusions (cont’d)

**   ****The intervention also had no significant impact on self-reported **_**medication adherence**_** or **_**perceived health competence**_**.**

## Plausible explanations for results

- Intervention not robust enough
- Intervention misguided
- Ceiling or floor effects (SBP and HbA1C were pretty low at baseline; Pt. satisfaction high at baseline)
- Sampling bias  (were people who would have benefited systematically excluded by strict efficacy RCT? )

## Challenge remains

**	****How can primary care practices foster sustained healthy behaviors for patients with largely asymptomatic but dangerous chronic disease?**

## APPENDICIES

## Adjusting for following baseline values had no significant impact on Tx effect

- Age
- Gender
- Race
- Education
- Employment
- Health insurance
- SP friend vs relative
- SP involvement

- Rx adherence
- Perceived health comp.
- Pt report Hx HBP
- Pt report Hx high chol
- Pt report CVD score
- Smoking status
- Alcohol use

## Baseline Characteristics 

| Value | Control Group         n = 91 | Interv. Group  n = 108 | p for 
Diff |
| --- | --- | --- | --- |
| Age       mean (SD)  |     63.1 (11.0) |    61.2 (10.6) | 0.26 |
| % Female |           52.8 % |        57.4 % | 0.56 |
| % African American |           11.0 % |        14.8 % | 0.53 |
| % SP is Relative |            83.5% |        82.2% | 0.85 |

## Baseline Characteristicsmean (SD)

| Value | Control Group | Interv. Group | p for            Diff |
| --- | --- | --- | --- |
| SBP mmHg |        139 (10.8)  |       141 (10.9)  | 0.54 |
| DBP mmHg |          76  (8.7) |          78 (9.2) | 0.48 |
| LDL mg/dl |         137 (24.3) |        137 (24.0) | 0.94 |
| HbA1C % |           7.6 (1.4) |         7.5 (1.6) | 0.69 |

## Baseline Characteristics

| Value | Control Group | Interv. Group | p for            Diff |
| --- | --- | --- | --- |
| Employed |        33.3% |       41.2% |  |
| Retired |        54.4%  |       42.2% | 0.23 |
| Unempl. Or disabled |        12.3% |       16.7% |  |
| Not HS grad |        16.5% |      16.7% |  |
| HS grad |       40.7% |        41.7% |  |
| Some college |       24.2% |       21.3% | 0.97 |
| > 4 yrs coll |       18.7% |        20.4% |  |

## Baseline Characteristics

| Value |  Control Group |  Interv. Group | p for    Diff |
| --- | --- | --- | --- |
| Perceived hlthcompet |        3.2 (0.85)
        mean  (SD) |    3.3 (0.77)
      mean  (SD) |  0.23 |
| High Rx Adherence |        41.8% |      39.3% |  |
| Med Rx Adherence |        49.5% |      53.3% |  0.43
 |
| Low Rx Adherence |          8.8% |       7.5% |  |

## Baseline Characteristics

| CV Health History | Control Group | Interv. Group |  p for        diff |
| --- | --- | --- | --- |
| Pt gave   Hx HBP |        86.7% |        87.0% |  1.00 |
| Pt gave Hx high chol |        80.0% |        61.3% |  0.005 |
| Smoker |        19.8% |       12.0% |  0.17 |
| CVD Score* mean(SD) |       1.08 (1.50) 
( 1 point each for MI,  |     0.84 (1.45)
Revasc, TIA,CVA, CHF |  0.17
  |

## Baseline Characteristics

| Type of Health Ins. | Control Group | Interv. Group | p for       Diff |
| --- | --- | --- | --- |
| Private |       70.3% |       52.5% |  |
| CMS |       27.5% |       37.6% | 0.03 |
| Other Ins. |         zero |         2.0% |  |
| Uninsured |         2.2% |         7.9% |  |

## “How important is it to you that this person

- “**How** **important** is it to you that this person
- support and help you...?

**p = .35**

## “How helpful or bothersome is this person in your efforts to keep appointments, take your medication, stay on your diet, and exercise?”

- “H**ow helpful or bothersome **is this person in your efforts to keep appointments, take your medication, stay on your diet, and exercise?”

**p = .58**

## Nested Chart Review Study

## Chart review:  were study participants different from all eligibles in clinics?

| Value | DM
n = 2074 | 2) DM+HBP
  n = 1370 | 3) IN STUDY 
    n = 199 | p for diff    3 vs 1 | p for diff    3 vs 2 |
| --- | --- | --- | --- | --- | --- |
| Age | 60     (SD 13)  | 61         (SD 13)  | 62         (SD 11) | <0.001 | 0.44 |
| SBP | 134    (SD 16) | 142       (SD 13) | 142       (SD 12)  | <0.001 | 0.42 |
| DBP | 78     (SD 10)  | 80         (SD  9) | 80         (SD 9) | <0.001 | 0.97 |
| LDL | 106 | 107 | 108 | 0.25 | 0.65 |

## Chart review:  were study participants different from all eligibles in clinics?

| Value | DM
n = 2074 | 2) DM+HBP
    n = 1370 | 3) INSTUDY 
 n = 199 | p for diff     3 vs 1 | p for diff    3 vs 2 |
| --- | --- | --- | --- | --- | --- |
| FBG     mg/dl | 166  (SD 64) | 168       (SD 66) | 161        (SD 62) | 0.80 | 0.24 |
| RanBG   mg/dl | 182    (SD 76) | 182       (SD 74) | 179       (SD 70) | 0.55 | 0.60 |
| HbA1C   % | 7.8    (SD 1.8) | 7.8
(SD 1.8) | 7.6       
(SD 1.5) | 0.73 | 0.72 |

## DM Patient Characteristics2074 Charts at 18 KAN Practices

| Value | Absolute Level | %  at Goal |
| --- | --- | --- |
| SBP |    134 mmHg
      (SD 16) | 44% < 130 mmHg |
| LDL |    106 mmHg
      (SD  35 ) | 51%  < 100 mg/dl |
| HbA1C |       7.8%
     (SD 1.8) |  39%  <  7.0 |

## 	Measure		   Method

**Blood pressure**
**LDL and HbA1C**
**Health-Related Quality of Life**

**Standardized paired readings readings at each visit done by BP-certified clinic staff**
**Phlebotomy at clinic site at prescribed visits.  Paired LDL levels**
**SF-36 HRQL Survey at visits **

## Measure		   Method

**Healthcare Satisfaction**
**     **
**Health Attitudes and beliefs:**
***Do they improve, and do they lead to better  outcomes?***

**Telephone interview: **
**AHRQ Consumer Assessment of Health Plans Patient Satisfaction Survey**
**Perceived Health Competence Scale survey at study visits**

## Measure		   Method

**Medication adherence     **
**Quality and degree of SP involvement **

**Medication adherence questionnaire**
**Social support for intervention survey**