How Tailoring Led to Variation in Care Issues, Dosage, and Outcomes: Part 1: Secondary Analysis of the PREP Trial for Frail Older Adults and Family Caregivers
Abstract
In family caregiving interventions for adults with health problems, tailoring has become the norm. Studies that evaluate tailored interventions, however, have rarely included intentional variation in dosage or explored the dosage-outcome association. In this Part 1 secondary analysis, we examine dosage and outcomes in intervention families (N = 116) who participated in the Oregon Health & Science University/Kaiser Permanente Northwest Region Family Care Study. The Family Care Study was a randomized controlled trial to evaluate the preparedness, skill, enrichment, and predictability (PREP) intervention with caregiving families of frail older adults referred for skilled home health. Tailoring of PREP began with assessment by the PREP nurse. Families then identified and selected care-related issues to work on with their PREP nurse; family needs and preferences guided the number and timing of nurse visits and calls. Families selected a median of 3 (range = 0 to 10) care-related issues in five categories: direct care (chosen by 57% of families), transitions (40%), caregiver strain and health (40%), arranging care (33%), and enrichment (22%). The number of issues strongly predicted number of PREP nurse visits and calls, whereas nurse visits in turn predicted caregivers' reports of improved family care and usefulness of home health assistance, highlighting the importance of visits for achieving outcomes. [Research in Gerontological Nursing, 16(2), 57–70.]
Introduction
In the late 1970s, researchers began to evaluate caregiving interventions to help families caring for adults with such health conditions as dementia and cancer. These interventions were mostly standardized programs delivered to caregivers in a group or individual format (Knight et al., 1993; Sörensen et al., 2002). Beginning in the 1990s, researchers started examining tailored interventions for family caregivers (Mohide et al., 1990), sometimes calling the practice “person-centered” or “individualized.” Tailoring has now become the norm, as tailored interventions show stronger effect sizes compared with a one-size-fits-all approach (Cheng et al., 2020).
Beck et al. (2010, p. 104) defined tailored interventions as “those designed to address the individual characteristics of persons within a sample, such as personality factors, goals, needs, preferences, and resources.” Caregiving interventions have been tailored to particular cultural groups, types and stages of disease, family preferences, and unmet needs (National Academies of Sciences, Engineering, and Medicine, 2016). Typically, the tailoring process begins with an assessment of specific caregiving needs or areas of risk that would benefit from intervention (Czaja et al., 2009).
Although tailoring can include variations in dosage, most tailored caregiving interventions aim for a specific dosage with respect to the number of sessions, visits, calls, and intervention duration. For example, the Tailored Activity Program (TAP) for dementia caregivers involved “up to 8, 1 to 1½ hour sessions over three months” (Gitlin et al., 2021, p. 3) with a minimal treatment threshold of more than four sessions. Examples of typical dosages have been summarized in meta-analyses of randomized controlled trials (RCTs) of caregiving interventions. For example, Cheng et al. (2020) reported that the average dosage across 131 dementia caregiving interventions was 12.2 sessions (SD = 11.7) over 4.1 months (SD = 3.6). In their meta-analysis of 29 cancer caregiving interventions, Northouse et al. (2010) described the average dosage as 6.7 contacts (range = 2 to 16) over 11.5 weeks (range = 1.2 to 56).
Evidence from meta-analyses about the dosage-outcome association is mixed. Northouse et al. (2010) determined that studies with more sessions reported better coping outcomes but worse caregiver burden and depression, whereas Cheng et al. (2020) noted that number of sessions did not moderate intervention effects (e.g., anxiety, subjective well-being).
Only a few caregiving researchers have examined the dosage-outcome relationship. For example, Teri et al. (2005) found that number of sessions attended was correlated with better outcomes. Luchsinger et al. (2018) showed that differences in caregiver contact with social workers did not influence intervention effects on outcomes.
As RCTs became the preferred design to evaluate caregiving interventions, researchers emphasized treatment implementation (Burgio et al., 2001) or treatment fidelity (Bellg et al., 2004). Researchers tried to ensure that all participants in the same experimental condition received the same intervention dosage—variation in dosage was not seen as desirable. By contrast, psychotherapy research since the mid-1980s has given considerable attention to the dosage-outcome relationship, including how more complex patients may require a larger number of therapy sessions to achieve a desirable outcome (de Beurs et al., 2020).
In their comprehensive review of dementia caregiving interventions, Gitlin and Hodgson (2015) pinpointed five key features of effective interventions: (a) involving caregivers in the intervention process instead of using a prescriptive approach, (b) tailoring the intervention to caregiver-identified needs, (c) addressing multiple needs, (d) providing longer-duration interventions, and (e) adjusting intervention dosage based on the caregiver's need profile. Data from studies of interventions characterized by these features would provide an opportunity to take a closer look at dosage.
The PREP Intervention
PREP's goals are to improve preparedness, skill, enrichment, and predictability in family care (Archbold et al., 1995). A model of in-home visits and telephone care delivered by nurses and other health providers, PREP is intended to help families manage complex care needs of frail older adults. PREP incorporates the approaches Gitlin and Hodgson (2015) highlighted:
1. | Caregivers and care recipients, when possible, are actively involved in the PREP process. |
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2. | PREP is tailored to family-identified issues using family-selected strategies. |
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3. | PREP addresses multiple issues. |
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4. | PREP provides continuous support over time. |
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5. | Families receive varying numbers of contacts depending on their needs and preferences. |
The effects of the PREP intervention were evaluated in the Oregon Health & Science University/Kaiser Permanente Northwest Region Family Care Study, a RCT conducted from 1999 to 2005 with caregiving families of older adults referred for skilled home health. In the Family Care Study, caregiving families worked together with their PREP nurse to choose family care issues to work on. The family and nurse decided on visit frequency and timing of contacts depending on the care recipient's needs, family care issues selected, and family preferences. Because the numbers of visits and calls had no predetermined limit within the year-long intervention, study data allow an examination of variation in intervention dosage and the dosage-outcome relationship.
Purpose
Using data from the Family Care Study, we conducted two secondary analyses to address important topics in caregiving intervention research that have received limited attention. Here in Part 1, we examine the nature of care issues and dosage and the dosage-outcome relationship resulting from tailored interventions that allow family choice in issues and contacts. In Part 2, we examine the moderating influences of concurrent services, with its added dosage, on intervention outcomes (Stewart et al., 2023).
In what follows, we describe how we tailored PREP and used data from 116 intervention families to answer four research questions:
1. | What kinds of family-identified care issues did families select to work on? |
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2. | What were typical levels of and variability in care issues and PREP dosage (i.e., visits and telephone calls)? |
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3. | Did the number of issues predict numbers of PREP visits, PREP calls, and skilled home health visits received? |
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4. | Did numbers of visits and calls predict two outcomes: caregivers' evaluation of improvement in their family care and usefulness from working with home health providers? |
Parent Study
In the Family Care Study, 234 care recipient–caregiver dyads were randomly assigned to either PREP (n = 116) or standard home health (SHH) (n = 118), the usual skilled home health services covered by Medicare. Before recruitment began, procedures for protecting human subjects in the study, titled “PREP: Family-Based Care for Frail Older Persons” (Study ID: NW-01PArch-01; Review ID: CR00004366), were approved by the Institutional Review Board. Care recipients and caregivers who agreed to participate gave informed written consent. When a care recipient was not competent to consent, either the caregiver or care recipient's power of attorney signed a proxy consent.
PREP was delivered within a home health department at a not-for-profit managed care organization (MCO) located in a large U.S. city. Care recipients included MCO members who were aged ≥65 years, referred for skilled home health, and receiving assistance with at least one activity of daily living (ADL) or two instrumental activities of daily living (IADLs) from a family member or friend.
Self-report family care and health outcomes were collected at 1 week (baseline) and 5, 10, 15, and 20 months after randomization. Health care utilization variables, measured for 12 months prior to randomization and 24 months after, were retrieved from the MCO's automated clinical information systems.
Main results from the parent study were that: (a) PREP caregivers reported greater improvements than SHH caregivers on the Home Care Effectiveness Scale, and (b) a smaller percentage of PREP care recipients than SHH care recipients were hospitalized or had emergency department (ED) visits by 6 months (Archbold et al., 2005; O'Keeffe-Rosetti et al., 2005). Reductions in hospitalizations and ED visits were not sustained over Months 7 to 24. Details regarding methods and results of the parent study are included in Part 2 (Stewart et al., 2023).
Method for the Secondary Analysis
Sample
The sample for this Part 1 secondary analysis included 116 care recipient–caregiver dyads randomized to the PREP intervention condition. PREP was delivered to these dyads and evaluation of intervention effects was based on data from randomized dyads. Because other relatives and friends were involved in PREP if desired by the dyad, we use both terms—dyad and family—as appropriate for the context.
Documents Used to Describe the PREP Tailoring Process
For purposes of intervention replication, we refer to three supplemental documents (all available in the online version of this article) to describe tailoring of the PREP intervention. Supplement A (The PREP Intervention) describes history, conceptual model, training, delivery tools, a PREP nurse's view of delivery, and comparison of PREP with other caregiving interventions. Supplement B (PREP Team Training and Operations Manual) was used in the 1-month, full-time training course and contains 18 sections, each focused on a topic important for PREP delivery. Supplement C (Appendices for the PREP Manual) contains 39 appendices: eight lecture outlines, five measures that PREP nurses used to assess families, 14 documents and three tables used to deliver PREP, and nine example documents based on families that participated in the Family Care Study.
Tailoring the PREP Intervention
In the decade before developing PREP, we conducted qualitative and quantitative studies to understand the experiences of frail older adults who received care in the home as well as their family caregivers, with the intention of finding ways that nurses could help families (Archbold et al., 1982; Stewart et al., 1993). Drawing on these studies, family role theory, and symbolic interactionism (Burr et al., 1979), we developed a conceptual model in which family care is co-created as the care recipient and caregiver interact with each other and with other family members, friends, and health systems (Supplement A).
The rationale underlying PREP originated in part from longitudinal findings that lower levels of caregiver preparedness, mutuality, rewards, and predictability were associated with higher levels of caregiver role strain and depression (Archbold et al., 1990; Archbold & Stewart, 2005). We hypothesized that strengthening family care—by helping families improve their preparedness and skill for giving care, enrich caregiving processes, and increase predictability in family care, especially when it is unstable—would decrease caregiver role strain and depression and improve the health of care recipients and caregivers alike.
PREP interventionists were guided by five key principles: (a) maintaining a family focus, (b) assessing family care, (c) blending family (local) and nursing (cosmopolitan) knowledge (Harvath et al., 1994), (d) using multiple strategies tailored to the family, and (e) detecting problematic transitions. The PREP team of four nurses, three aides, and an administrative assistant followed the Steps-of-PREP Checklist as a guide in delivering PREP (Supplement C, Appendices 5A–5B). Table A (available in the online version of this article) presents a brief Steps-of-PREP Checklist that outlines the intervention's four components:
1. | Working together on family care issues in the home. |
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2. | Working together on family care issues via telephone. |
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3. | Keep-in-touch (KIT). |
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4. | Completion. |
Step | Responsible Person | Action | Tools and Documentation |
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PREP Component 1: Working together on family care issues in the home | |||
1 | PREP nurse |
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2 | PREP nurse |
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3 | Study research assistant Study project director |
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4 | PREP nurse |
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5 | PREP nurse and family |
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6 | PREP nurse, PREP team, and family |
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7 | Family |
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8 | PREP nurse and family |
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9 | Family |
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10 | PREP nurse and family |
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11 | PREP nurse |
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7-11 | PREP nurse and family |
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12 | PREP nurse and family |
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PREP Component 2: Working together on family care issues via telephone | |||
(PREP Component 2 takes place concurrently with PREP Component 1) | |||
13 | PREP nurse |
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14 | Family |
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PREP Component 3: Keep-In-Touch (KIT) | |||
15 | PREP nurse |
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16 | Family |
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PREP Component 4: Completion | |||
17 | PREP nurse |
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18 | PREP nurse |
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At the first visit, nurses used the PREP brochure to introduce PREP goals. Families were given a Family Health Diary and instructions for using the PREP Advice Line (PAL) (Supplement C, Appendices 18A–18C).
Assessment was the cornerstone of tailoring (Steps 3 to 5). The PREP nurse systematically assessed the family's caregiving situation to help them identify issues to work on (Supplement C, Appendices 8A–8D, 9A–9G, 10A–10C).
After a family chose an issue to work on, the nurse conducted an in-depth assessment and collaborated with the family to generate potential strategies to manage the issue (Steps 6 to 11). The family decided which strategies to try and evaluated how they worked (Supplement C, Appendices 10D, 11A–11D).
Telephone contact was the delivery method in Steps 13 to 16. PREP nurses made check-in-monitoring (CIM) calls to families, families contacted PREP nurses on the PREP PAL, and nurses made KIT calls once issues were resolved (Supplement C, Appendices 12A–12C, 13A).
At the close of PREP (Steps 17 and 18), nurses made a last visit and gave families a completion letter summarizing the family's accomplishments as well as what the nurse learned from the family (Supplement C, Appendix 13B).
Secondary Data Analyzed
Family Care Issues. Text data and quantitative data were analyzed. For each care issue a family identified and chose to work on, PREP nurses recorded a brief text description, typically 10 to 20 words, in the PREP e-chart, a web-based e-chart in which each screen supported the sequential steps of PREP and prompted interventionists to record PREP dosage. We analyzed text data and number of issues.
Dosage: Visits and Calls. PREP dosage included intervention-related visits and phone calls that occurred during the 12-month intervention period. Skilled home health dosage included the total number of skilled home health visits (e.g., nursing, physical therapy) that occurred during the 12 months after randomization.
PREP nurses and aides recorded PREP dosage in the PREP e-chart. PREP nurses and PREP aides provided skilled nursing and skilled aide care to PREP care recipients and recorded these skilled visits in the separate MCO home health e-chart. Non-nurse home health providers (e.g., physical therapists) recorded their skilled visits to PREP care recipients only in the MCO home health e-chart.
We analyzed (a) three visit variables (PREP nurse visits, PREP aide visits, and skilled home health visits); (b) three PREP telephone call variables (CIM calls, PAL calls, and KIT calls); and (c) two total variables (total PREP contacts and total PREP + skilled home health contacts).
Outcome Measures
We used the 44-item Home Care Effectiveness Scale (HCES) to measure two outcomes: improved family care and usefulness of home health assistance. The HCES was developed during the PREP pilot study to measure the concept effects of home health on family care, defined as the “caregiver's view of the extent to which working with home health care providers helped improve their overall caregiving situation” (Archbold et al., 1995). Caregivers completed the HCES at 5, 10, 15, and 20 months after randomization. The HCES was included in the self-report Family Care Inventory (FCI) questionnaire that was mailed to caregivers and then collected by research assistants during an in-home interview (see Supplement D [available in the online version of this article] for a copy of the HCES).
Improved Family Care. For HCES Items 1 to 43, caregivers used a response format of 0 (not at all) to 4 (a great deal) to rate the extent to which working with their “nurse, or other home health provider” helped them, for example, “work out a system to make your family care go more smoothly.” We computed an improved family care score at each wave by averaging item responses for caregivers answering at least 50% of the 43 items. Score range was 0 to 4. Cronbach's alpha was 0.99 in the pilot and parent study. An effect size of 1.00 in the pilot study supported validity for detecting intervention effects. We calculated an overall score by averaging the improved family care scores across the four waves.
Usefulness of Home Health Assistance. We measured the caregiver's perception of “usefulness of assistance from their nurse or other home health providers” by HCES Item 44, a single-item rating from 0 (not at all useful) to 10 (extremely useful). We averaged the usefulness ratings across the four waves.
Content Analysis
To describe the nature of family care issues, two authors (P.G.A., B.J.S.) used directed content analysis to code family-identified care issues (Hsieh & Shannon, 2005). They began with five preliminary categories of issues found in pilot work and expanded and refined these preliminary categories to accommodate the increased variety of issues in the RCT.
Statistical Analysis
Descriptive statistics, including mean, standard deviation, median, and interquartile range (IQR; 25th to 75th percentile), were used to describe typical levels and variability of issues, visits, calls, and outcomes. Pearson correlations and simple linear regression were used to determine whether number of issues predicted visits and calls. Hierarchical multiple regression, with stepwise entry beginning at Step 2, was used to determine whether numbers of visits and calls predicted improved family care and usefulness outcomes.
Skewness. Because the distributions of visits and calls were positively skewed, they were Winsorized at the 95th percentile to reduce the influence of outliers in correlation and regression analyses. Scores exceeding the 95th percentile were recoded to the score value at the 95th percentile. As recommended (Leys et al., 2019), analyses using Winsorized and full-range variables are reported for comparison purposes. Spearman rank-order correlations (rs) were examined to confirm accuracy of parametric findings.
Covariates and Rationale. We computed primary regression models without covariates. We also computed exploratory models to evaluate whether covariates that were potential predictors of visits, calls, or outcomes altered primary regression results. Covariates included nine prior-year and baseline characteristics (Table 1) and duration of the PREP intervention (12, 9, or 6 months). The planned duration of PREP was 12 months, but as more families joined the RCT, heavier caseloads made it difficult for nurses to deliver PREP thoroughly. Investigators reduced caseload by slowing recruitment, but they also needed to decrease intervention duration for the final 36% of the sample to stay within funding resources. Of the 116 PREP dyads, PREP duration was 12, 9, or 6 months for 74, 23, and 19 dyads, respectively. The 12-month PREP families (a) worked on more issues than 9-month or 6-month families (mean = 3.6 vs. 2.2 and 2.0, respectively; p < 0.03); and (b) received more PREP nurse visits than 6-month families (mean = 6.8 vs. 4.5, respectively; p = 0.06).
Characteristic | n (%) | |
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Care Recipient | Caregiver | |
Sexa | ||
Female | 73 (62.9) | 84 (72.4) |
Marital status | ||
Married | 64 (55.2) | 86 (74.1) |
Ethnicity/race | ||
White | 103 (88.8) | 105 (90.5) |
Black | 6 (5.2) | 6 (5.2) |
American Indian | 4 (3.4) | 2 (1.7) |
Asian | 3 (2.6) | 3 (2.6) |
Educationa | ||
Partial high school or below | 27 (23.3) | 15 (12.9) |
High school graduate | 42 (36.2) | 29 (25) |
Partial college training | 23 (19.8) | 41 (35.3) |
Completed college | 10 (8.6) | 20 (17.2) |
Graduate/professional training | 13 (11.2) | 11 (9.5) |
Missing (don't know) | 1 (0.9) | |
General health | ||
Excellent | 10 (8.6) | |
Very good | 41 (35.3) | |
Good | 45 (38.8) | |
Fair | 15 (12.9) | |
Poor | 5 (4.3) | |
Relationship to care recipienta | ||
Wife | 36 (31) | |
Daughter | 31 (26.7) | |
Other relative or friend | 26 (22.4) | |
Husband | 23 (19.8) | |
Before randomization (prior year) | ||
Hospitalizationsa ≥1 | 66 (56.9) | |
ED visitsa ≥1 | 80 (69) | |
Skilled home health visitsa ≥1 | 30 (25.9) | |
Home health referralsb | ||
Physical therapy | 89 (76.7) | |
Skilled nursing | 23 (19.8) | |
Occupational therapy | 14 (12.1) | |
Otherc | 14 (12.1) | |
Caregiver lives with care recipient | 100 (86.2) | |
Employed for pay | 34 (29.3) | |
CES-D score ≥16 | 43 (37.1) | |
BOMC score >9 | 17 (14.7) | |
Age (years) | 79.9 (7.5) (65 to 102) | 63.9 (16.1) (19 to 92) |
ADL limitationsa | 2.8 (2.1) (0 to 6) | |
IADL limitations | 6.4 (2.2) (0 to 9) | |
MMSEa,b | 21.4 (8.5) (0 to 30) | |
Years of caregiving | 4.3 (6.2) (0.1 to 40) | |
Hours giving care in past 1 week (median [IQR]) | 42 (21 to 105) | |
CES-D scorea | 13.2 (10) (0 to 42) | |
BOMC score | 4 (3.7) (0 to 19) |
Results
Sample Characteristics
As shown in Table 1, care recipients ranged in age from 65 to 102 years (mean age = 80 years). Most care recipients were frail, averaging 2.8 ADL limitations. In the year before randomization, 69% had experienced one or more ED visits, 57% had been hospitalized, and 26% received home health services. Caregivers ranged in age from 19 to 92 years (mean age = 64 years). One half were spouses of the care recipient.
Family-Identified Care Issues: Typical Levels and Variability
Of the 116 PREP families, 98 (84%) chose at least one issue to work on with their PREP nurse (18 chose one issue, 35 chose two to three issues, and 45 chose four to 10 issues; median = 3, IQR = 1 to 5; see Supplement E [available in the online version of this article] for frequency distribution). Of the 18 PREP families who decided they had no issues to work on, 12 advanced to KIT. In their ratings of these 12 “zero-issue” families receiving KIT, PREP nurses wrote such comments as: “Very capable and organized caregiver” and “They voiced liking the fact that we were there if needed.”
We began the directed content analysis by coding the 352 family-identified issues into the five categories found in pilot work: unpreparedness, low enrichment, unpredictability, caregiver health problems, and caregiver strain (Miller, 1993). Results from the content analysis are shown in Table 2 and include the five revised categories and 21 subcategories of issues. Key revisions in the five categories included (a) re-framing category labels positively in terms of PREP goals to increase preparedness, skill, enrichment, and predictability; (b) separating “increase preparedness and skill for family care” into the two categories of providing direct care and arranging care; (c) emphasizing transitions in the “increase predictability” category; and (d) combining caregiver strain and health (see Supplement C, Appendix 10C, for examples.)
Categories (A–E) and Subcategories (A1–E3) of Family Care Issues | No. of Families (%) | No. of Issues (%) |
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A. Goal: Increase preparedness and skill in providing direct care | 66 (56.9) | 131 (37.2) |
A1: Managing symptoms | 36 (31) | 50 (14.2) |
A2: Keeping the care recipient safe | 20 (17.2) | 24 (6.8) |
A3: Doing personal care activities | 14 (12.1) | 14 (4) |
A4: Managing medications | 10 (8.6) | 11 (3.1) |
A5: Managing dementia-related symptoms | 9 (7.8) | 9 (2.6) |
A6: Fostering the care recipient's independence | 8 (6.9) | 11 (3.1) |
A7: Helping with instrumental activities of daily living | 8 (6.9) | 9 (2.6) |
A8. Improving caregiver, care recipient, and family communication | 3 (2.6) | 3 (0.9) |
B. Goal: Increase preparedness and skill in arranging care | 38 (32.8) | 60 (17) |
B1: Arranging in-home help | 21 (18.1) | 30 (8.5) |
B2: Working with health providers and care systems | 17 (14.7) | 23 (6.5) |
B3: Learning about and obtaining assistive devices | 6 (5.2) | 7 (2) |
C. Goal: Increase enrichment | 26 (22.4) | 26 (7.4) |
C1. Increasing pleasurable activities for the care recipient | 13 (11.2) | 13 (3.7) |
C2. Increasing shared pleasurable activities for the dyad | 7 (6) | 7 (2) |
C3. Increasing pleasurable activities for the caregiver | 6 (5.2) | 6 (1.7) |
D. Goal: Increase predictability in transitions | 47 (40.5) | 67 (19) |
D1: Monitoring and managing changing symptoms | 23 (19.8) | 25 (7.1) |
D2: Planning for and managing transitions | 22 (19) | 28 (8) |
D3: Planning transitions related to the care recipient's end of life | 12 (10.3) | 12 (3.4) |
D4: Managing unpredictability because of other family members | 2 (1.7) | 2 (0.6) |
E. Goal: Reduce caregiver strain and support caregiver health by increasing preparedness, skill, enrichment, and predictability | 46 (39.7) | 68 (19.3) |
E1: Reducing caregiver strain | 30 (25.9) | 32 (9.1) |
E2: Monitoring and managing caregiver illnesses and symptoms | 24 (20.7) | 29 (8.2) |
E3: Supporting caregivers after the care recipient's death | 6 (5.2) | 7 (2) |
PREP Visits and Calls and Skilled Care Visits: Typical Levels and Variability
As shown in Table 3, PREP families received between one and 101 total PREP-focused contacts (median = 16.5 contacts). PREP families received a median of six PREP nurse visits. Approximately one half of families received an intervention-focused visit from a PREP aide. PREP telephone call dosage shows that 95% received CIM calls, 65% made PAL calls, and 44% received KIT calls. PREP care recipients received between one and 118 skilled home health visits (median = 4 visits).
Issues, Visits, Calls, and Outcomes | Descriptive Statistics | ||||||||||
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Mean (SD) | Median (IQR) | Wins Range | Full Range | % ≥1 | |||||||
1. Family care issues | 3.0 (2.4) | 3.0 (1 to 5) | — | 0 to 10 | 84.5 | ||||||
2. PREP nurse visits | 6.0 (3.4) | 6.0 (4 to 8) | 0 to 13 | 0 to 24 | 98.3 | ||||||
3. PREP aide visits | 7.3 (12.9) | 0.0 (0 to 8) | 0 to 45 | 0 to 67 | 48.3 | ||||||
4. CIM calls (PREP nurse to family) | 5.8 (4.5) | 4.5 (2 to 9) | 0 to 16 | 0 to 24 | 94.8 | ||||||
5. PAL calls (family to PREP nurse) | 2.2 (2.8) | 1.0 (0 to 3) | 0 to 10 | 0 to 14 | 64.7 | ||||||
6. KIT calls (PREP nurse to family) | 1.2 (1.9) | 0.0 (0 to 1) | 0 to 6 | 0 to 9 | 44 | ||||||
7. Total PREP contacts (PREP visits, calls) | 22.3 (15.6) | 16.5 (11 to 31) | 1 to 57 | 1 to 101 | 100 | ||||||
8. Skilled home health visits | 8.2 (8.9) | 4.5 (2 to 11) | 1 to 34 | 1 to 118 | 100 | ||||||
9. Total PREP + home health contacts | 22.0 (19.4) | 14 (8 to 32) | 1 to 66 | 1 to 137 | 100 | ||||||
10. Improved family care (n= 104) | 2.1 (0.9) | 2.2 (1.4 to 2.9) | — | 0 to 4 | — | ||||||
11. Usefulness of home health assistance (n= 103) | 6.9 (2.4) | 7.3 (5.5 to 8.7) | — | 0 to 10 | — | ||||||
Correlations | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | |
1. Family care issues | — | ||||||||||
2. PREP nurse visits | 0.70 | — | |||||||||
3. PREP aide visits | 0.32 | 0.46 | — | ||||||||
4. CIM calls | 0.31 | 0.25 | 0.23 | — | |||||||
5. PAL calls | 0.54 | 0.37 | 0.22 | 0.48 | — | ||||||
6. KIT calls | −0.17 | −0.22 | −0.27 | −0.36 | −0.18 | — | |||||
7. Total PREP contacts | 0.56 | 0.66 | 0.85 | 0.54 | 0.55 | −0.26 | — | ||||
8. Skilled home health visits | 0.09 | 0.14 | 0.24 | 0.05 | 0.08 | 0.00 | 0.31 | — | |||
9. Total PREP + home health contacts | 0.38 | 0.54 | 0.83 | 0.25 | 0.29 | −0.22 | 0.82 | 0.67 | — | ||
10. Improved family care (n= 104) | 0.20 | 0.26 | 0.19 | 0.17 | 0.03 | −0.21 | 0.24 | 0.11 | 0.19 | — | |
11. Usefulness of home health assistance (n= 103) | 0.31 | 0.41 | 0.24 | 0.22 | 0.22 | −0.27 | 0.35 | 0.05 | 0.24 | 0.78 | — |
Issues as Predictors of Visits and Calls
Families who chose more issues to work on received more PREP nurse visits, PREP aide visits, and CIM calls and made more PAL calls to the nurse (r = 0.31 to 0.70, p < 0.001) but received fewer KIT calls (r = −0.17, p = 0.07) (Table 3). Number of issues was not related to number of skilled home health visits (r = 0.09, p = 0.18). To depict how number of issues translated into PREP visits, PREP calls, and total PREP contacts, we computed simple linear regression models using Winsorized visits and calls (Table 4).
X = No. of Issues | Simple Linear Regression: Family Care Issues as a Predictor of Visits and Calls | ||||
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Y = No. of Visits, Calls, and Totals | Intercept [95% CI] | B [95% CI] | β | R2 | p |
Issues → PREP nurse visits | 3.0 [2.3, 3.8] | 1.0 [0.8, 1.2] | 0.70 | 0.49 | <0.001 |
Issues → PREP aide visits | 2.1 [−1.6, 5.8] | 1.7 [0.8, 2.7] | 0.32 | 0.10 | <0.001 |
Issues → CIM calls | 4.0 [2.8, 5.3] | 0.6 [0.3, 0.9] | 0.31 | 0.10 | <0.001 |
Issues → PAL calls | 0.3 [−0.4, 1.0] | 0.6 [0.5, 0.8] | 0.54 | 0.30 | <0.001 |
Issues → KIT calls | 1.6 [1.0, 2.1] | −0.1 [−0.3, 0.0] | −0.17 | 0.03 | 0.068 |
Issues → Total PREP contacts | 11.1 [7.2, 15.0] | 3.7 [2.7, 4.7] | 0.56 | 0.32 | <0.001 |
Issues → Skilled home health visits | 7.2 [4.6. 9.9] | 0.3 [−0.4, 1.0] | 0.09 | 0.01 | 0.353 |
Issues → Total PREP + home health contacts | 18.7 [12.8, 24.6] | 4.3 [2.7, 5.8] | 0.46 | 0.21 | <0.001 |
X = No. of Visits and Calls | Hierarchical Multiple Regression: Visits and Calls as Predictors of Outcomes | ||||
Y = Outcomesa | Intercept [95% CI] | B [95% CI] | β | R2Δ | p |
Dosage → Improved family care | |||||
Step 1b: PREP nurse visits | 1.61 [1.23, 2.00] | 0.08 [0.02, 0.13] | 0.26 | 0.07 | 0.007 |
Dosage → Usefulness of home health assistance | |||||
Step 1c: PREP nurse visits | 5.01 [4.07, 5.94] | 0.30 [0.17, 0.43] | 0.41 | 0.17 | <0.001 |
Visits and Calls as Predictors of Outcomes
As shown in Table 3, families receiving more PREP nurse visits reported higher levels of improved family care and usefulness of home health assistance. KIT calls were negatively correlated with improved family care and usefulness outcomes. PREP aide visits, CIM calls, and PAL calls exhibited small positive correlations with usefulness but were not correlated with improved family care.
For an overall picture of how PREP and skilled home health dosage predicted the improved family care and usefulness outcomes, we conducted two hierarchical multiple regression analyses (Table 4). At Step 1, we entered PREP nurse visits. (We did not enter number of issues because of its 0.70 correlation with PREP nurse visits.) At Step 2, we used stepwise entry for PREP aide visits; CIM, PAL, and KIT calls; and skilled home health visits to determine if any of these variables explained additional significant variance in outcomes. PREP nurse visits predicted the outcome of improved family care (β = 0.26, p = 0.007) and usefulness of home health assistance (β = 0.41, p < 0.001), but no additional variance was explained by other PREP or skilled home health contacts.
Exploratory Analyses to Confirm Key Results
Supplements F and G show that results from full-range variables closely match the results from Winsorized variables in Tables 3 and 4. Further, regression results in Supplement G (available in the online version of this article) show that outliers were largely eliminated by using Winsorized variables. Of the 116 dyads, 14 were outliers when predicting dosage from issues (Supplement G).
Supplement H (available in the online version of this article) contains results from exploratory regression analyses, in which covariates were entered stepwise following the primary predictors. Although some covariates predicted higher dosage, initial and final beta weights for the primary predictor of number of issues were essentially unchanged.
Discussion
Four key takeaways emerged from the tailored PREP intervention and our secondary analysis of resulting issues, dosage, and outcomes. First, content analysis of family-identified care issues highlighted the broad range of concerns in caring for frail older adults that would benefit from intervention in home health care. Second, amidst the large variability in issues and dosage, the typical number of issues and contacts was not all that different from caregiving interventions where dosage is prescribed. Third, knowing the number of issues that families selected to work on allowed good estimates of visits and calls that would be needed. Fourth, more PREP nurse intervention visits were associated with better outcomes.
Family-Identified Care Issues Selected to Work On
The wide range of issues that families selected following a comprehensive assessment underscores the complexities of caregiving situations for frail older adults receiving skilled home health care. Given the opportunity to select issues, families often chose issues unrelated to the reason for home health referral. Yet, some subcategories occurred commonly. For example, at least 15% of families selected issues in each of the following subcategories: managing symptoms, keeping the care recipient safe, arranging in-home help, monitoring and managing changing symptoms, planning for and managing transitions, reducing caregiver strain, and monitoring and managing caregiver illnesses and symptoms. These findings closely match the picture of family care issues presented by Chase et al. (2019) in their content analysis of caregiver management of physical functioning needs following transition from acute care to skilled home health.
Content analysis of issues brought to the fore the concerns of caregiving families that warrant more attention from health systems. In their review of cancer caregiving interventions, Given and Given (2016, p. 109) concluded that few interventions help caregivers “acquire skills to perform care tasks, find access to resources, or manage their own health status.” These three areas of need are parallel to issues of increasing preparedness and skill in direct care (Table 2, Category A) and arranged care (Category B) and monitoring and managing caregiver illnesses and symptoms (Subcategory E2) identified by 57%, 33%, and 21% of PREP families, respectively.
In their meta-analysis of dementia caregiving interventions, Cheng et al. (2020) reported that only 12 of 131 RCTs measured positive aspects of caregiving, highlighting the early innovation of PREP's emphasis on enrichment. Unfortunately, only 22% of PREP families selected enrichment as an issue to work on, signaling a need to strengthen PREP's approaches to enrichment.
The nature of issues in the PREP intervention varied widely mainly because the intervention did not target specific family care issues but allowed families to choose them without restrictions. Most caregiving interventions have focused on care for people with dementia (Gitlin & Schulz, 2012) or specific health conditions (Burgio et al., 2016), with interventions aimed at issues relevant to the particular condition. Variability in the sample—for example, one half of PREP care recipients had normal cognitive functioning—likely explains variability in issues selected. It must be emphasized, however, that to generate potential strategies to address issues, PREP nurses relied heavily on evidence-based findings from targeted caregiving interventions and nursing interventions for common health problems in frail older adults.
Typical Levels of and Variability in Care Issues and PREP Dosage
The median of three issues selected by PREP families is comparable to the number of issues commonly addressed in caregiving interventions. For example, it matches the “maximum of 3 jointly negotiated problems” targeted in the REACH intervention for dementia caregivers (Belle et al., 2006, p. 731) and the “three specific activities of interest” that were prescribed in the TAP intervention (Gitlin et al., 2021, p. 5). Likewise, the typical numbers of PREP contacts were comparable to the average numbers of contacts described in meta-analyses of interventions with prescribed dosage (Cheng et al., 2020; Northouse et al., 2010).
The range of zero to 10 issues selected by PREP families, however, is considerably wider than the range of issues addressed in most caregiving interventions, just as the variability in numbers of PREP visits and calls was substantially greater than variability of contacts in most caregiving interventions. The main explanation for variation in PREP issues and dosage lies with PREP's tailored approach, which offers flexibility and family choice in issues and matching contacts to needs and preferences. Further, PREP's 6- to 12-month duration was longer than the average 3- to 4-month duration of typical caregiving interventions, allowing for detection of new issues and increased variability in PREP dosage. Most importantly, the variability in PREP dosage made possible our examination of the associations among issues, visits, calls, and outcomes.
The fact that 39% of PREP families worked on four to 10 issues illustrates the extensive difficulties some families face in caregiving as well as their engagement with PREP to address these challenges. For those families that did not identify any issue to work on, PREP provided an opportunity to develop a working relationship with the PREP nurse and periodic contact via PAL or KIT calls, so that when issues did arise, families were prepared with a system of collaboration to manage their situations.
Frequency distributions for issues and dosage were positively skewed, as typically occurs for measures of utilization. The median and IQR values provide good dosage estimates for the middle half of families, but an intervention team knows to expect that a small percentage of families may need a relatively large number of contacts to address their family care issues.
The Issues–Dosage Relationship
A notable finding was how strongly number of issues predicted numbers of PREP visits and calls, with the strongest association between issues and PREP nurse visits. Simple regression findings in Table 4 illustrate how numbers of PREP visits and calls could be estimated based on the number of issues families selected to work on. Specifically, families that selected zero issues were predicted to use the intercept values of 3.0 PREP nurse visits, 2.1 PREP aide visits, 4.0 CIM calls, 0.3 PAL calls, and 1.6 KIT calls for a total of 11 contacts with a PREP nurse or aide, which is the intercept for total PREP contacts. With each additional issue that a family worked on with their PREP nurse, the family was predicted to use an additional 1.0 PREP nurse visits, 1.7 PREP aide visits, 0.6 CIM calls, and 0.6 PAL calls, but 0.1 fewer KIT calls for a total of 3.8 contacts, which approximately matches the unstandardized B weight of 3.7 for total PREP contacts. Such estimates will be useful in future research with respect to staffing, costs, and sustainability of interventions.
As shown in Supplement H, the seven covariates that explained higher dosage included care recipient characteristics of ADL limitations, cognitive impairment, prior-year home health use, and prior-year hospitalization; caregiver characteristics of depression and low education; and duration of PREP (12, 9, or 6 months). These characteristics may signal families that would benefit from prolonged access to services.
The Dosage–Outcome Relationship
Our findings about the dosage-outcome relationship support the importance of contacts for intervention effectiveness, with beta weights of 0.26 and 0.41 for PREP nurse visits as a predictor of improved family care and usefulness of home health assistance. The number of PREP nurse visits can be viewed as representing the intensity of engagement of families in the PREP process, which included assessment to identify issues, family–nurse collaboration to generate strategies, and follow-up contact to monitor transitions. Although the intervention components of PREP aide visits, CIM calls, and PAL calls were modestly correlated with the usefulness outcome, PREP nurse visits and intervention activities during PREP nurse visits were key mechanisms for achieving outcomes of improved family care and usefulness of home health assistance. The negative correlations between KIT calls and other PREP contacts and outcomes were likely because families who received KIT calls selected fewer issues than families who did not advance to KIT (mean [SD] = 2.3 [2.3] vs. 3.6 [2.3], d = −0.56, p = 0.003).
Teaching families takes time and repetition. One or two visits may be insufficient. Families differ in their ability and experience, and caregivers vary in their physical health and cognitive functioning. But as situations change, even skillful caregivers may need input on new care issues, underscoring the benefits of an established relationship with a PREP nurse.
Methodological Strengths and Limitations
In addition to strengths and limitations of findings about intervention dosage and outcomes as described above, there were strengths and limitations in our secondary analysis. Advantages of this secondary analysis included a larger sample size and longer duration in the parent study than in most caregiving interventions. The availability of text and quantitative data provided a complex picture of family-identified care issues. A particular advantage was the availability of quantitative dosage from the MCO e-chart and PREP e-chart. Most caregiving interventions rely on caregiver self-report of dosage, which tends to underestimate actual use (Callahan et al., 2015). Although we had collected dosage on PREP telephone contacts—CIM, PAL, and KIT—a limitation was lack of telephone call data from skilled home health providers to PREP families.
Although PREP had a planned 12-month duration for the Family Care Study, we viewed the 12-month endpoint as artificial. We considered PREP an approach that should be ongoing to manage new family care issues that changed or arose over time. A study design change that complicated interpretation of secondary analysis results was the reduction of PREP duration from 12 months to 9 or 6 months for the final 36% of the sample, with 12-month families identifying more issues and receiving more PREP contacts than shorter-duration families. Although the 12-, 9-, and 6-month durations were not randomly assigned, preventing inferences about causation, the association of longer intervention duration with more issues identified may reflect the benefits of longer duration.
A main limitation of analyzing data collected in 2000 through 2004 is whether our conclusions would be relevant today. Pragmatic trials, which have recently been used to test caregiving interventions (Gitlin et al., 2019), share two key features with PREP—tailoring and implementation in real-world clinical settings. Although researchers continue to call for examining the dosage-outcome relationship, few reports on caregiving interventions contain such findings. Our results offer insights into intervention dosage and its relationship to outcomes.
Conclusion
Tailoring interventions to the needs of families is generally considered a desirable feature of caregiving interventions (Bakas et al., 2014). Our results support this perspective. Nonetheless, variation in dosage creates challenges for interpreting effectiveness and should be accounted for in the analysis of intervention outcomes. As reported in Part 2 (Stewart et al., 2023), PREP's effects compared to SHH remained strong after controlling for dosage. Future research needs to identify characteristics of those families for whom more visits would lead to better outcomes.
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Supplemental Material
archbold_part1-supplementf.pdf (74 KB)
archbold_part1-supplementc.pdf (19 MB)
archbold_part1-supplementa.pdf (320 KB)
archbold_part1-supplementh.pdf (81 KB)
archbold_part1-acknowledgments.pdf (91 KB)
archbold_part1-supplementb.pdf (210 KB)
archbold_part1-supplementg.pdf (116 KB)
archbold_part1-supplementd.pdf (193 KB)
archbold_part1-supplemente.pdf (29 KB)