Chronic DiseaseNCT01606930
A Pilot Study to Improve Patient-Doctor Communication
A study testing Patient Primer Tool in people with Chronic Disease and Hypertension, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Disease, Hypertension, Hyperlipidemia
- What is being tested?
- Patient Primer Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Military health care beneficiaries presenting for chronic medical care with their primary care clinician
- Over the age of 18
- At least 2 and no more than 10 visits with their primary care provider in the previous year
- Receiving pharmacological treatment for hypertension
- At least 2 of the following common chronic illnesses: hyperlipidemia, chronic obstructive pulmonary disease, asthma, congestive heart failure, chronic pain, ischemic heart disease, osteoarthritis, depression, back pain, chronic headaches, or diabetes
Who cannot join
- Over the age of 80
- Incapable of completing the questionnaires, either due to cognitive impairment or lack of English-literacy
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Medical Military Center (WRNMMC)
Bethesda, Maryland, 20889
About this study
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:
- Test the feasibility of a simple patient-centered intervention.
- Test the correlation between patient readiness to actively engage in conversation (assessed using a pre-visit patient survey) and actual patient behaviors in the encounter.
- Develop a coding tool that will quantify patient activation in clinical encounters.
- Test whether activating patients who are more involved and revealing in the patient-clinician dyad will improve patient and clinician outcomes.
Read the detailed description
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.
- Conditions
- Chronic Disease, Hypertension, Hyperlipidemia, Diabetes Mellitus, Osteoarthritis, COPD
- Being tested
- Patient Primer Tool
- Keywords
- Patient Satisfaction, Patient Doctor Communication, Shared Decision Making, Patient Activation
- Medical subject headings
- Chronic Disease, Hypertension, Hyperlipidemias, Diabetes Mellitus, Osteoarthritis, Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Primer ToolBehavioural
Also called Patient Activation Tool
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient Primer Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of shared medical decision-making
Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).
Measured: Baseline
Adherence to anti-hypertensive drug treatment at baseline
This outcome will be assessed using pill counts by the pharmacists.
Measured: Baseline
Adherence to anti-hypertensive drug treatment at one month
This outcome will be assessed using pill counts by the pharmacists.
Measured: One month
Adherence to anti-hypertensive drug treatment at three months
This outcome will be assessed using pill counts by the pharmacists.
Measured: Three months
Secondary outcomes (8)
Patient satisfaction
Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool
Measured: Baseline
Clinician rating of patient as "difficult"
Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).
Measured: Baseline
Patient Trust in their physician at baseline
Validated Trust in Physician (11-item) Instrument
Measured: Baseline
Patient Trust in their physician at one month
Validated Trust in Physician (11-item) Instrument
Measured: one month
Patient Trust in their physician at three months
Validated Trust in Physician (11-item) Instrument
Measured: 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.
Measured: 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.
Measured: 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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Milwaukee
- Responsible party
- Principal investigator, Patrick G. O'Malley, MD, MPH, Walter Reed National Military Medical Center
- Investigators
- Patrick O'Malley, MD, MPH, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606930
- Sponsor's protocol ID
- A-14352.4
- Status last verified
- May 2012
- First submitted
- 18 Apr 2012
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Improve Patient-Doctor Communication
- ClinicalTrials.gov ID
- NCT01606930
- Acronym / sponsor ID
- A-14352.4
- Conditions
- Chronic Disease, Hypertension, Hyperlipidemia, Diabetes Mellitus, Osteoarthritis, COPD
- Keywords
- Patient Satisfaction, Patient Doctor Communication, Shared Decision Making, Patient Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- University of Wisconsin, Milwaukee
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Test the feasibility of a simple patient-centered intervention.
- Test the correlation between patient readiness to actively engage in conversation (assessed using a pre-visit patient survey) and actual patient behaviors in the encounter.
- Develop a coding tool that will quantify patient activation in clinical encounters.
- Test whether activating patients who are more involved and revealing in the patient-clinician dyad will improve patient and clinician outcomes.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Group will see their physician without receiving the "activation" instrument. |
| "Activated" Group | Active comparator | Behavioral: Patient Primer ToolGroup will be given an "activation" instrument to complete before their appointment and instructed to refer to and use the instrument during their clinical encounter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Military health care beneficiaries presenting for chronic medical care with their primary care clinician
- Over the age of 18
- At least 2 and no more than 10 visits with their primary care provider in the previous year
- Receiving pharmacological treatment for hypertension
- At least 2 of the following common chronic illnesses: hyperlipidemia, chronic obstructive pulmonary disease, asthma, congestive heart failure, chronic pain, ischemic heart disease, osteoarthritis, depression, back pain, chronic headaches, or diabetes
Key exclusion criteria (2 listed)
- Over the age of 80
- Incapable of completing the questionnaires, either due to cognitive impairment or lack of English-literacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Primer ToolAlso: Patient Activation ToolThe 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. | Behavioural | "Activated" Group |
Primary outcome
Degree of shared medical decision-making
Time frame: Baseline
Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).
Adherence to anti-hypertensive drug treatment at baseline
Time frame: Baseline
This outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at one month
Time frame: One month
This outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at three months
Time frame: Three months
This outcome will be assessed using pill counts by the pharmacists.
8 secondary outcomes
Patient satisfaction
Time frame: Baseline
Clinician rating of patient as "difficult"
Time frame: Baseline
Patient Trust in their physician at baseline
Time frame: Baseline
Patient Trust in their physician at one month
Time frame: one month
Patient Trust in their physician at three months
Time frame: Three months
Systolic and Diastolic Blood Pressure at baseline
Time frame: Baseline
Systolic and Diastolic Blood Pressure at one month
Time frame: One month
Systolic and Diastolic Blood Pressure at three months
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick O'Malley, MD, MPH principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Primer Tool in people with Chronic Disease and Hypertension, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of shared medical decision-making (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.