DYNAMIC Study: (Diabetes Nurse Case Management And Motivational Interviewing for Change)
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Cholesterol, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2019 |
| Start Date: | August 10, 2006 |
| End Date: | July 27, 2011 |
Impact of Nurse Case Management on Diabetes Co-morbidities
Although strong clinical evidence exists that patients with diabetes should achieve certain
clinical goals (i.e. HbA1C, BP, LDL, etc.), to reduce morbidity and mortality national
surveys indicate that only a minority of people with diabetes achieves these goals.
Hypothesis: combination of nurse case management and enhanced behavior change counseling will
improve outcomes for glycemic control, blood pressure and cholesterol in high risk patients
with Type 2 diabetes when compared to usual care over a 3 year period.
Study design- The study will be a three year randomized control trial that will select
patients that have either A1C >8.5, LDL >130, or BP >140/90. Nurse case managers, trained in
clinical guidelines and brief behavior change counseling techniques (motivational
interviewing), will aim to foster patient adherence in the experimental group patients. Nurse
case managers will use standing orders to set an implementation of clinical guidelines (for
diabetes, hypertension, hyperlipidemia and depression) with individual follow up.
A total of 820 patients between the all 9 (6 Hershey Medical Center and 3 Reading Hospital
affiliated clinics) will be sought. One third of the study patients will be recruited from
the underserved Hispanic population in the Reading area. Patients will be randomized by
physician i.e. one physician will be randomly assigned to have all their patients co-managed
by a nurse case manager; the other will have usual care without any contact with nurse case
manager.
Nurses will be trained and then initiate a small pilot study in July thru August. Full
recruitment and initiation of study will begin in September 2006.
Clinic Activities - Each nurse will be responsible for 3 clinics. Nurses will work under the
supervision of the primary care physicians. A set of clinical guidelines will be developed
with physician input that will serve as the over-riding framework for the nurses.
Outcomes - Over a three-year period the investigators will evaluate clinical response
(improvements in A1C, BP, LDL, and depression when present) as well as a series of other
measures that will be obtained by surveys (patient satisfaction, quality of life,
self-management behaviors). Provider satisfaction will be measured using a standardized tool.
Finally, cost effectiveness of the intervention and evaluation of the potential barriers to
implementation will be studied.
clinical goals (i.e. HbA1C, BP, LDL, etc.), to reduce morbidity and mortality national
surveys indicate that only a minority of people with diabetes achieves these goals.
Hypothesis: combination of nurse case management and enhanced behavior change counseling will
improve outcomes for glycemic control, blood pressure and cholesterol in high risk patients
with Type 2 diabetes when compared to usual care over a 3 year period.
Study design- The study will be a three year randomized control trial that will select
patients that have either A1C >8.5, LDL >130, or BP >140/90. Nurse case managers, trained in
clinical guidelines and brief behavior change counseling techniques (motivational
interviewing), will aim to foster patient adherence in the experimental group patients. Nurse
case managers will use standing orders to set an implementation of clinical guidelines (for
diabetes, hypertension, hyperlipidemia and depression) with individual follow up.
A total of 820 patients between the all 9 (6 Hershey Medical Center and 3 Reading Hospital
affiliated clinics) will be sought. One third of the study patients will be recruited from
the underserved Hispanic population in the Reading area. Patients will be randomized by
physician i.e. one physician will be randomly assigned to have all their patients co-managed
by a nurse case manager; the other will have usual care without any contact with nurse case
manager.
Nurses will be trained and then initiate a small pilot study in July thru August. Full
recruitment and initiation of study will begin in September 2006.
Clinic Activities - Each nurse will be responsible for 3 clinics. Nurses will work under the
supervision of the primary care physicians. A set of clinical guidelines will be developed
with physician input that will serve as the over-riding framework for the nurses.
Outcomes - Over a three-year period the investigators will evaluate clinical response
(improvements in A1C, BP, LDL, and depression when present) as well as a series of other
measures that will be obtained by surveys (patient satisfaction, quality of life,
self-management behaviors). Provider satisfaction will be measured using a standardized tool.
Finally, cost effectiveness of the intervention and evaluation of the potential barriers to
implementation will be studied.
1. Rationale: Diabetes mellitus is a prevalent disease and results in high health care
expenditures, the majority of which are due to preventable complications of diabetes.
Current evidence indicates that care of patients with diabetes mellitus falls short of
the standards set by the American Diabetes Association and a large proportion of these
patients do not achieve their treatment goals. Multiple ways to deliver care to patients
with diabetes have been studies. The investigators propose a 3 year
randomized-controlled study to assess impact of the combination of nurse case management
(NCM) combined with enhanced behavior change counseling on glycemic control and
co-morbidity outcomes in high-risk patients with Type 2 diabetes when compared to usual
care
2. Key Objectives:
Specific Aim 1. Determine the efficacy of an enhanced nurse case management (NCM)
intervention to promote patient adherence leading to positive clinical outcomes (HbA1C,
LDL, blood pressure, and process measures) in high-risk patients in primary care over a
period of three years. High-risk patients with Type 2 diabetes will be recruited from 9
primary care clinics and randomized to NCM intervention vs. usual care. A major focus of
this proposal is to test the efficacy of NCM in a minority population with high risk of
poor outcomes (approximately 38 % of the study population will be Hispanic). The
investigators anticipate a significant increase in percentage of patients reaching the
goals for HbA1C (< 7.0%), BP (<130/80), LDL (<100 mg/dl) in patients in the NCM group
compared to the control group of usual care. The investigators also hypothesize that
there will be significant improvement in process measures (% patients having a yearly
dilated eye exam, foot exam, urinary screen for microalbuminuria, aspirin use, lipid
evaluation) and depression scores in patients in the NCM group compared to the control
group of usual care.
Specific Aim 2. Quantify the impact of enhanced nurse case management on health-related
quality of life, patient satisfaction, self-management behaviors, and provider
satisfaction. A unique feature of our study is to address the impact of our intervention
on these critical outcomes, which have not been addressed in the existing NCM
literature. The investigators anticipate improved adherence, lower levels of diabetes
specific emotional distress, higher levels of diabetes specific quality of life,
increased patient satisfaction with treatment, and improved provider satisfaction in the
NCM group compared to the usual care group. The following surveys will be completed and
analysed:the PAID survey looking at Emotional distress associated with diabetes, the
ADDQOL (Diabetes specific quality of life) survey, the DTSQ (Patient satisfaction)
survey and the SDSCA (Diabetes self care activities) survey.
Specific Aim 3. Evaluate the cost-effectiveness of an enriched NCM intervention. The
investigators expect that the NCM intervention will be effective in improving clinical
outcomes for patients with type 2 diabetes; however, there may still be barriers to more
widespread adoption unless the benefits of investing in or reimbursing for NCM can be
justified by the costs. Toward that end, the investigators will evaluate the
cost-effectiveness of the intervention from the perspective of the provider, payor, and
society. These cost-effectiveness ratios will help decision makers generate informed
decisions about appropriate and cost-effective treatment for high-risk patients with
type 2 diabetes.
3. Study Population: Patients with Type 2 diabetes, older than 18 years of age, will be
identified based on billing data (two visits with ICD-9 code of 250.xx in the preceding
year) and subsequent chart review from nine Hershey Medical Center (HMC) primary care
clinics and three Reading Hospital-affiliated primary care sites.
4. Major Inclusion Criteria: Inclusion criteria: Type 2 diabetes, age >18 who are at high
risk based on any one of the following criteria: HbA1C >8.5, LDL >130, or BP >140/90.
5. Allocation to Groups: a stratified group randomization scheme whereby all patients being
seen by the same doctor will be randomized to the same treatment group. The
randomization will also be stratified by clinic site and size of doctor's practice. One
group will be seen by nurse care managers, the other will continue with standard care.
6. Summary of Procedures: An initial pilot study will be performed with 60 patients from
HMC and Reading Hospital clinics, for 2 months. This will consist of nurse case
management intervention and feedback from the subjects to improve the study design.
Subjects will be seen at 2, 4, 6 and 8 weeks. This study will end with focus groups of
subjects to give their input as to what they did or did not like about the study, and
how it might be improved. Pilot participants will have the option to enroll into the
main study. No studies will be ordered for research purposes. Pregnancy screening will
occur by verbally asking the subjects whether they believe they could be pregnant, since
risk is very minimal.
The main study will enroll 820 subjects at clinics from the Hershey Medical Center and
Reading Hospital, with 2/3 of the subjects being enrolled at HMC, and 1/3 from the
underserved Hispanic population. The study intervention will continue for 3 years.
Patients will be enrolled into the nurse case management group or the control group
dependent upon where they see their physician - randomization will occur in blocks based
on clinics and physicians, not randomly per patient.
In the main study, the intervention group patients will have an initial appointment with
a nurse case manager (RN) (50 min) to review medical history, medications and control of
diabetes and co-morbidities. A plan with patient specific treatment goals will be set up
at this appointment. The patients will have follow up appointment set up for 2,4, and 6
weeks to review their progress, obtain standard diabetes laboratories and make necessary
medication adjustments. The patients then will be seen by a nurse case manager on
average once every 2-3 months, and a minimum of every 6 months, depending on their
diabetes control. They will also continue to see their PCP (as scheduled per their PCP,
normally once every 3-4 months). The control group patients will continue to follow with
their PCP as scheduled, there will be no change from their usual care. The patients in
both groups will be asked to complete 4 questionnaires (5 if they are depressed)
assessing their emotional stress with diabetes, quality of life and treatment
satisfaction at baseline and yearly for the study duration (3 years). Subjects will be
randomly audio taped to ensure nurse case managers are following recommended guidelines
of the research.
Study outcomes such as HbA1c, lipids, blood pressure will be evaluated at baseline and
then yearly in all patients. No laboratories will be done specifically for research
purposes. The data will be extracted from the Penn State Diabetes Center Registry and
charts (if required).
For cost analysis, the investigators will be tracking outpatient and inpatient costs at
the Hershey Medical Center and the Reading hospitals. In addition, the investigators
will be tracking hospitalization costs outside of the hospitals by obtaining records
from an existing registry managed by the State of Pennsylvania (the Pennsylvania Health
Cost Containment Council), identified by social security numbers. This information along
with all other information in the study will be safeguarded with strict confidentiality.
7. Major Risks & Discomforts: 1. Loss of confidentiality. 2. increased risk of low blood
sugars with improved glycemic control, therefore the patients will be asked to test
glucose on a regular basis - 2 -5 times daily, depending on their diabetes regimen. They
will have a 24-hour contact phone number, specific to their primary care clinic, to call
if problems arise.
8. Confidentiality: All research records, including those of subjects from Reading clinics,
will be coded and kept at HMC. All consent forms will be forwarded to HMC. Records,
audio tapes and the code key will be kept in the Endocrinology office in a locked file
accessible only by the investigators.
9. Study Site Location(s): University Physician Health Groups (UPHG) is made up of 10
practice sites. For the purpose of this project 6 of the 10 HMC practice sites will
participate and 3 of the Reading Hospital-affiliated ambulatory sites. All 3 sites are
owned by The Reading Hospital and Medical Center, a non-profit hospital and health care
organization.
expenditures, the majority of which are due to preventable complications of diabetes.
Current evidence indicates that care of patients with diabetes mellitus falls short of
the standards set by the American Diabetes Association and a large proportion of these
patients do not achieve their treatment goals. Multiple ways to deliver care to patients
with diabetes have been studies. The investigators propose a 3 year
randomized-controlled study to assess impact of the combination of nurse case management
(NCM) combined with enhanced behavior change counseling on glycemic control and
co-morbidity outcomes in high-risk patients with Type 2 diabetes when compared to usual
care
2. Key Objectives:
Specific Aim 1. Determine the efficacy of an enhanced nurse case management (NCM)
intervention to promote patient adherence leading to positive clinical outcomes (HbA1C,
LDL, blood pressure, and process measures) in high-risk patients in primary care over a
period of three years. High-risk patients with Type 2 diabetes will be recruited from 9
primary care clinics and randomized to NCM intervention vs. usual care. A major focus of
this proposal is to test the efficacy of NCM in a minority population with high risk of
poor outcomes (approximately 38 % of the study population will be Hispanic). The
investigators anticipate a significant increase in percentage of patients reaching the
goals for HbA1C (< 7.0%), BP (<130/80), LDL (<100 mg/dl) in patients in the NCM group
compared to the control group of usual care. The investigators also hypothesize that
there will be significant improvement in process measures (% patients having a yearly
dilated eye exam, foot exam, urinary screen for microalbuminuria, aspirin use, lipid
evaluation) and depression scores in patients in the NCM group compared to the control
group of usual care.
Specific Aim 2. Quantify the impact of enhanced nurse case management on health-related
quality of life, patient satisfaction, self-management behaviors, and provider
satisfaction. A unique feature of our study is to address the impact of our intervention
on these critical outcomes, which have not been addressed in the existing NCM
literature. The investigators anticipate improved adherence, lower levels of diabetes
specific emotional distress, higher levels of diabetes specific quality of life,
increased patient satisfaction with treatment, and improved provider satisfaction in the
NCM group compared to the usual care group. The following surveys will be completed and
analysed:the PAID survey looking at Emotional distress associated with diabetes, the
ADDQOL (Diabetes specific quality of life) survey, the DTSQ (Patient satisfaction)
survey and the SDSCA (Diabetes self care activities) survey.
Specific Aim 3. Evaluate the cost-effectiveness of an enriched NCM intervention. The
investigators expect that the NCM intervention will be effective in improving clinical
outcomes for patients with type 2 diabetes; however, there may still be barriers to more
widespread adoption unless the benefits of investing in or reimbursing for NCM can be
justified by the costs. Toward that end, the investigators will evaluate the
cost-effectiveness of the intervention from the perspective of the provider, payor, and
society. These cost-effectiveness ratios will help decision makers generate informed
decisions about appropriate and cost-effective treatment for high-risk patients with
type 2 diabetes.
3. Study Population: Patients with Type 2 diabetes, older than 18 years of age, will be
identified based on billing data (two visits with ICD-9 code of 250.xx in the preceding
year) and subsequent chart review from nine Hershey Medical Center (HMC) primary care
clinics and three Reading Hospital-affiliated primary care sites.
4. Major Inclusion Criteria: Inclusion criteria: Type 2 diabetes, age >18 who are at high
risk based on any one of the following criteria: HbA1C >8.5, LDL >130, or BP >140/90.
5. Allocation to Groups: a stratified group randomization scheme whereby all patients being
seen by the same doctor will be randomized to the same treatment group. The
randomization will also be stratified by clinic site and size of doctor's practice. One
group will be seen by nurse care managers, the other will continue with standard care.
6. Summary of Procedures: An initial pilot study will be performed with 60 patients from
HMC and Reading Hospital clinics, for 2 months. This will consist of nurse case
management intervention and feedback from the subjects to improve the study design.
Subjects will be seen at 2, 4, 6 and 8 weeks. This study will end with focus groups of
subjects to give their input as to what they did or did not like about the study, and
how it might be improved. Pilot participants will have the option to enroll into the
main study. No studies will be ordered for research purposes. Pregnancy screening will
occur by verbally asking the subjects whether they believe they could be pregnant, since
risk is very minimal.
The main study will enroll 820 subjects at clinics from the Hershey Medical Center and
Reading Hospital, with 2/3 of the subjects being enrolled at HMC, and 1/3 from the
underserved Hispanic population. The study intervention will continue for 3 years.
Patients will be enrolled into the nurse case management group or the control group
dependent upon where they see their physician - randomization will occur in blocks based
on clinics and physicians, not randomly per patient.
In the main study, the intervention group patients will have an initial appointment with
a nurse case manager (RN) (50 min) to review medical history, medications and control of
diabetes and co-morbidities. A plan with patient specific treatment goals will be set up
at this appointment. The patients will have follow up appointment set up for 2,4, and 6
weeks to review their progress, obtain standard diabetes laboratories and make necessary
medication adjustments. The patients then will be seen by a nurse case manager on
average once every 2-3 months, and a minimum of every 6 months, depending on their
diabetes control. They will also continue to see their PCP (as scheduled per their PCP,
normally once every 3-4 months). The control group patients will continue to follow with
their PCP as scheduled, there will be no change from their usual care. The patients in
both groups will be asked to complete 4 questionnaires (5 if they are depressed)
assessing their emotional stress with diabetes, quality of life and treatment
satisfaction at baseline and yearly for the study duration (3 years). Subjects will be
randomly audio taped to ensure nurse case managers are following recommended guidelines
of the research.
Study outcomes such as HbA1c, lipids, blood pressure will be evaluated at baseline and
then yearly in all patients. No laboratories will be done specifically for research
purposes. The data will be extracted from the Penn State Diabetes Center Registry and
charts (if required).
For cost analysis, the investigators will be tracking outpatient and inpatient costs at
the Hershey Medical Center and the Reading hospitals. In addition, the investigators
will be tracking hospitalization costs outside of the hospitals by obtaining records
from an existing registry managed by the State of Pennsylvania (the Pennsylvania Health
Cost Containment Council), identified by social security numbers. This information along
with all other information in the study will be safeguarded with strict confidentiality.
7. Major Risks & Discomforts: 1. Loss of confidentiality. 2. increased risk of low blood
sugars with improved glycemic control, therefore the patients will be asked to test
glucose on a regular basis - 2 -5 times daily, depending on their diabetes regimen. They
will have a 24-hour contact phone number, specific to their primary care clinic, to call
if problems arise.
8. Confidentiality: All research records, including those of subjects from Reading clinics,
will be coded and kept at HMC. All consent forms will be forwarded to HMC. Records,
audio tapes and the code key will be kept in the Endocrinology office in a locked file
accessible only by the investigators.
9. Study Site Location(s): University Physician Health Groups (UPHG) is made up of 10
practice sites. For the purpose of this project 6 of the 10 HMC practice sites will
participate and 3 of the Reading Hospital-affiliated ambulatory sites. All 3 sites are
owned by The Reading Hospital and Medical Center, a non-profit hospital and health care
organization.
Inclusion Criteria:
- Type 2 diabetes
- age > 18 years old who are at high risk based on any one of the following criteria:
- HbA1C > 8.5
- LDL > 130
- BP > 140/90 within the last 6 months
Exclusion Criteria:
- patients who are pregnant upon entry in the study (however if a patient becomes
pregnant in the course of the study, she can continue with the study)
- unable to communicate in either English or Spanish
- in nursing homes (and therefore unable to attend outpatient visits)
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