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| Name | Class |
|---|---|
| Foundation for Informed Medical Decision Making | OTHER |
| University of Massachusetts, Boston | OTHER |
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The purpose of this study is to compare condition oriented whole person Health Coaching along with the provision of decision aids to decision aids without condition oriented Health Coaching to neither condition oriented health coaching nor decision aids on medical cost, preference sensitive surgeries and measures of subject knowledge, decision process and decision quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid with Health Coaching | Experimental |
| |
| Decision Aid only | Experimental |
| |
| No condition specific support | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provision of condition specific shared decision making (SDM) aids only | Behavioral | Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Medical Costs Per Member Per Month | total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy. | 6 months |
| Total Medical Costs That Can be Impacted Per Member Per Month | total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy. Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Targeted Conditions Surgeries | rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery | 6 months |
| Concordance | Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Veroff, MPP | Health Dialog Services Corporation | Principal Investigator |
| Patricia M Gallagher, PHD | University of Massachusetts, Boston | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Dialog | Boston | Massachusetts | 02109 | United States |
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75,795 health plan members recruited via Interactive Voice Response Telephone Call Survey to screen for study eligibility. 30,556 persons completed the screen. 9,925 were study eligible (1. Reported pain in knee, hip, or back; 2. Considering treatment; 3. Had not already had surgery for pain; 4. Not on a 'Do Not Call' list).
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Aid With Health Coaching | Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach. |
| FG001 | Decision Aid Only | Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you). |
| FG002 | No Condition Specific Support | Study participants do not receive outreach on knee, hip or herniated disc condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Aid With Health Coaching | Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach. |
| BG001 | Decision Aid Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Medical Costs Per Member Per Month | total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy. | Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Instituted >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study. | Posted | Mean | 95% Confidence Interval | Total dollars / member months | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Aid With Health Coaching | Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David R Veroff, MPP, SVP Analytic Development | Health Dialog | 617-406-5219 | dveroff@healthdialog.com |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C066906 | SDM |
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| Telephonic outreach and support by Health Coach | Behavioral | Subjects are direct dial attempted by Health Coaches up to three attempts. If contacted, Health Coaches tailor support around health matters of importance to the subjects and to help individuals become active participants in their treatment plans, and make more informed decisions in consort with their health care providers. The number of total contacts is determined by mutual agreement between the subject and the Health Coach. Health Coaches may provide additional educational materials and resources. |
|
| 6 months |
| Quality of Decision Making Process | Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions. | 6 months |
| Knowledge | Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items. | 12 weeks |
| Decision Conflict | Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options. | 12 weeks |
| Decision Satisfaction | Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again. | 6 months |
Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you). |
| BG002 | No Condition Specific Support | Study participants do not receive outreach on knee, hip or herniated disc condition. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Decision Aid Only | Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you). |
| OG002 | No Condition Specific Support | Study participants do not receive outreach on knee, hip or herniated disc condition. |
|
|
|
| Secondary | Rate of Targeted Conditions Surgeries | rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery | Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study. | Posted | Number | percentage of participants | 6 months |
|
|
|
|
| Secondary | Concordance | Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function | Not Posted | 6 months |
| Secondary | Quality of Decision Making Process | Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions. | Not Posted | 6 months |
| Secondary | Knowledge | Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items. | Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score. | Posted | Mean | 95% Confidence Interval | number of correct answers | 12 weeks |
|
|
|
|
| Secondary | Decision Conflict | Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options. | Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | Decision Satisfaction | Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again. | Not Posted | 6 months |
| Primary | Total Medical Costs That Can be Impacted Per Member Per Month | total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy. Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded | Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study. | Posted | Mean | 95% Confidence Interval | Total dollars / member months | 6 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Decision Aid Only | Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you). | 0 | 0 | 0 | 0 |
| EG002 | No Condition Specific Support | Study participants do not receive outreach on knee, hip or herniated disc condition. | 0 | 0 | 0 | 0 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Mean Difference (Net) |
| 0.15982 |
| 2-Sided |
| 95 |
| -0.06477 |
| 0.38441 |
| No |
| Superiority or Other |
| 0.6956 |
| Mean Difference (Net) |
| -0.0183548 |
| Standard Error of the Mean |
| 0.04690321 |
| 2-Sided |
| 95 |
| -0.1102961 |
| 0.07358642 |
| No |
| Superiority or Other |