Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Wisconsin, Milwaukee | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this controlled pilot study is to determine whether an intervention aimed at patients will improve partnering, shared decision-making and open communication. Results from this pilot study will inform how to best proceed with a larger multi-centered randomized controlled trial.
The specific hypothesis for this pilot study is to:
Chronic illness requires a greater participation by the patient in the management of their own disease process. Patients now increasingly find themselves dealing with multiple illnesses over the span of their lifetime.
Patient-provider communication is key to optimal patient outcomes. Numerous studies have shown adverse effects of poor communication on a number of outcomes, including patient and provider satisfaction as well as medical compliance and health related outcomes.
An important next step in this field is to study whether it is possible to improve chronic illness care in real world settings by improving the quality of patient-provider interaction through feasible interventions focused on efficient, motivational, and empathic communication, targeted at both patients and providers.
There is little information on the best patterns of communication in dealing with patients with multiple comorbidities. The investigators believe that an optimal healing relationship between these patients and their healthcare providers includes shared decision-making, partnering between patients and clinicians to foster health and healthy behaviors in an environment of trust, and effective open communication.
An important outcome for this pilot study is feasibility. The investigators intend to conduct a follow-up multi-centered trial; planning and budgeting for such a trial will require information gleaned from this study. What is the rate of accrual and how many patients can realistically be enrolled and followed within the current study personnel. What outcomes are sensitive to change and how much change can the investigators expect to see? Will this intervention effect change in patient behavior? This study will give us insight to allow us to build a right-sized project.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | No Intervention | Group will see their physician without receiving the "activation" instrument. | |
| "Activated" Group | Active Comparator | Group will be given an "activation" instrument to complete before their appointment and instructed to refer to and use the instrument during their clinical encounter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Primer Tool | Behavioral | The instrument is completed before the scheduled appointment and is designed to prompt patients to reflect on their specific goals for the medical encounter, prioritize those goals, and to "Prime" them to engage in a discussion centered on their concerns and expectations. In addition, participants will be encouraged to bring this form into their physician visit and use it to engage their clinician in a discussion about their health needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of shared medical decision-making | Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS). | Baseline |
| Adherence to anti-hypertensive drug treatment at baseline | This outcome will be assessed using pill counts by the pharmacists. | Baseline |
| Adherence to anti-hypertensive drug treatment at one month | This outcome will be assessed using pill counts by the pharmacists. | One month |
| Adherence to anti-hypertensive drug treatment at three months | This outcome will be assessed using pill counts by the pharmacists. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool | Baseline |
| Clinician rating of patient as "difficult" | Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick O'Malley, MD, MPH | Walter Reed National Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Medical Military Center (WRNMMC) | Bethesda | Maryland | 20889 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 12, 2014 | |
| Reset | Jul 17, 2014 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 12, 2014 | Jul 17, 2014 |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| D010003 | Osteoarthritis |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002318 | Cardiovascular Diseases |
| D017060 | Patient Satisfaction |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Baseline |
| Patient Trust in their physician at baseline | Validated Trust in Physician (11-item) Instrument | Baseline |
| Patient Trust in their physician at one month | Validated Trust in Physician (11-item) Instrument | one month |
| Patient Trust in their physician at three months | Validated Trust in Physician (11-item) Instrument | Three months |
| Systolic and Diastolic Blood Pressure at baseline | Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated. | Baseline |
| Systolic and Diastolic Blood Pressure at one month | Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated. | One month |
| Systolic and Diastolic Blood Pressure at three months | Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated. | three months |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |